<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04505722</url>
  </required_header>
  <id_info>
    <org_study_id>CR108876</org_study_id>
    <secondary_id>VAC31518COV3001</secondary_id>
    <nct_id>NCT04505722</nct_id>
  </id_info>
  <brief_title>A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants</brief_title>
  <acronym>ENSEMBLE</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Vaccines &amp; Prevention B.V.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Vaccines &amp; Prevention B.V.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly&#xD;
      confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2020</start_date>
  <completion_date type="Actual">March 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 31, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study)</measure>
    <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
    <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription-polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute, oxygen saturation (SpO2) &lt;= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study)</measure>
    <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
    <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats/minute and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute, SpO2 less than or equal to (&lt;=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)</measure>
    <time_frame>Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])</time_frame>
    <description>Participants who receive the booster dose was asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)</measure>
    <time_frame>Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])</time_frame>
    <description>Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature &gt;= 38.0 degree Celsius or &gt;=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)</measure>
    <time_frame>Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])</time_frame>
    <description>Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)</measure>
    <time_frame>From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)</time_frame>
    <description>SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events of Special Interest (AESI) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)</measure>
    <time_frame>From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)</time_frame>
    <description>Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)</measure>
    <time_frame>14 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 546)</time_frame>
    <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)</measure>
    <time_frame>28 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 560)</time_frame>
    <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)</measure>
    <time_frame>14 days after booster vaccination (Day 379) to end of study (up to 2 years and 3 month)</time_frame>
    <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)</measure>
    <time_frame>28 days after booster vaccination (Day 393) to end of study (up to 2 years and 3 month)</time_frame>
    <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)</measure>
    <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
    <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)</measure>
    <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
    <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)</measure>
    <time_frame>1 Day after double-blind vaccination (Day 2)</time_frame>
    <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)</measure>
    <time_frame>14 days after double-blind vaccination (Day 15)</time_frame>
    <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)</measure>
    <time_frame>28 days after double-blind vaccination (Day 29)</time_frame>
    <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)</measure>
    <time_frame>14 days after double-blind vaccination (Day 15)</time_frame>
    <description>Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO], linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)</measure>
    <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
    <description>Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants With Molecularly Confirmed, Moderate to Severe/Critical COVID-19 (Main Study)</measure>
    <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
    <description>The viral load of SARS-CoV-2 was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)</measure>
    <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
    <description>Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (&gt;=38°C or &gt;=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)</measure>
    <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
    <description>Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (&gt;=38°C or &gt;=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)</measure>
    <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
    <description>Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)</measure>
    <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
    <description>Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)</measure>
    <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
    <description>BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)</measure>
    <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
    <description>BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Main Study)</measure>
    <time_frame>From Day 29 until end of double-blind phase (up to 284 days after first vaccination)</time_frame>
    <description>Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Main Study)</measure>
    <time_frame>Month 6</time_frame>
    <description>Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Main Study)</measure>
    <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
    <description>Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs) (Main Study)</measure>
    <time_frame>Up to 35 weeks</time_frame>
    <description>SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events of Special Interest (AESI) (Main Study)</measure>
    <time_frame>Up to 35 weeks</time_frame>
    <description>Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Medically-Attended Adverse Events (MAAEs) (Main Study)</measure>
    <time_frame>Up to 6 months after double-blind vaccination on Day 1</time_frame>
    <description>MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With MAAEs Leading to Study Discontinuation (Main Study)</measure>
    <time_frame>Up to 35 weeks</time_frame>
    <description>MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Main Study)</measure>
    <time_frame>Up to Day 8 (7 Days after double-blind vaccination on Day 1)</time_frame>
    <description>Participants who were enrolled in safety subset were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Main Study)</measure>
    <time_frame>Up to Day 8 (7 Days after double-blind vaccination on Day 1)</time_frame>
    <description>Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature &gt;= 38.0 degree Celsius or &gt;=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Main Study)</measure>
    <time_frame>Up to Day 29 (28 Days after double-blind vaccination on Day 1)</time_frame>
    <description>Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study)</measure>
    <time_frame>Baseline (Day 1), Day 29, and Day 71</time_frame>
    <description>Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (&gt;LLOQ).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44325</enrollment>
  <condition>Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol</condition>
  <arm_group>
    <arm_group_label>Ad26.COV2.S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ad26.COV2.S</intervention_name>
    <description>Ad26.COV2.S will be administered at a single dose of 5*10^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.</description>
    <arm_group_label>Ad26.COV2.S</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>JNJ-78436735</other_name>
    <other_name>Ad26COVS1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive Placebo.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Contraceptive (birth control) use should be consistent with local regulations&#xD;
             regarding the acceptable methods of contraception for those participating in clinical&#xD;
             studies&#xD;
&#xD;
          -  All participants of childbearing potential must: have a negative highly sensitive&#xD;
             urine pregnancy test at screening; and have a negative highly sensitive urine&#xD;
             pregnancy test immediately prior to each study vaccine administration&#xD;
&#xD;
          -  Participant agrees to not donate bone marrow, blood, and blood products from the first&#xD;
             study vaccine administration until 3 months after receiving the last dose of study&#xD;
             vaccine&#xD;
&#xD;
          -  Must be willing to provide verifiable identification, has means to be contacted and to&#xD;
             contact the investigator during the study&#xD;
&#xD;
          -  Must be able to read, understand, and complete questionnaires in the electronic&#xD;
             clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19]&#xD;
             signs and symptoms surveillance question, the e-Diary, and the electronic&#xD;
             patient-reported outcomes (ePROs). Note: Participants with visual impairment are&#xD;
             eligible for study participation and may have caregiver assistance in completing the&#xD;
             electronic clinical outcome assessment (eCOA) questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a clinically significant acute illness (this does not include minor&#xD;
             illnesses such as diarrhea or mild upper respiratory tract infection) or temperature&#xD;
             greater than or equal to (&gt;=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24&#xD;
             hours prior to the planned first dose of study vaccine; randomization at a later date&#xD;
             is permitted at the discretion of the investigator and after consultation with the&#xD;
             sponsor&#xD;
&#xD;
          -  Participant received or plans to receive: (a) licensed live attenuated vaccines -&#xD;
             within 28 days before or after planned administration of study vaccine ; and (b) other&#xD;
             licensed (not live) vaccines - within 14 days before or after planned administration&#xD;
             of study vaccine&#xD;
&#xD;
          -  Participant previously received a coronavirus vaccine&#xD;
&#xD;
          -  Participant received an investigational drug (including investigational drugs for&#xD;
             prophylaxis of COVID-19) within 30 days or used an invasive investigational medical&#xD;
             device within 30 days or received investigational immunoglobulin (Ig) or monoclonal&#xD;
             antibodies within 3 months, or received convalescent serum for COVID-19 treatment&#xD;
             within 4 months or received an investigational vaccine (including investigational&#xD;
             Adenoviral-vectored vaccines) within 6 months before the planned administration of the&#xD;
             first dose of study vaccine or is currently enrolled or plans to participate in&#xD;
             another investigational study during the course of this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Vaccines &amp; Prevention B.V. Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Vaccines &amp; Prevention B.V.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alabama Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alabama Vaccine Research Clinic at UAB</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Research</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Phoenix Medical Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality of Life Medical &amp; Research Center, LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Arkansas Veterans Healthcare System</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials, LLC</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ark Clinical Research</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anthony Mills Medical, Inc</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD Antiviral Research Center AVRC</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wr-McCr, Llc</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121-1545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Regional VA Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research, LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Florida South Georgia Veteran Health System</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research, Hallandale Beach</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centers of America, LLC</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Research Group</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami - Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Immunology Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advent Health Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James A Haley VA Hospital GNS</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>The Villages</city>
        <state>Florida</state>
        <zip>32162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hope Clinic at Emory University</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030-1705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Medical Center</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jesse Brown VAMC Department of Surgery</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of IL Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University Of Chicago Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Research</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buynak Clinical Research</name>
      <address>
        <city>Valparaiso</city>
        <state>Indiana</state>
        <zip>46383</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johnson County Clin-Trials</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Kentucky Research Associates, Inc.</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Management, LLC</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Adolescent Trials Unit CRS</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Louisiana Veterans Health Care Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baltimore VA Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Research</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Brigham and Women's Hospital, Inc.</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cherry Street Services, Inc.</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital Clinic</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSync Clinical Research</name>
      <address>
        <city>Petal</city>
        <state>Mississippi</state>
        <zip>39465</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center For Pharmaceutical Research</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-1035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consortium, an AMR company</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Sierra Nevada Health Care System</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Robert Wood Johnson Medical School</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Michaels Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raymond G. Murphy VA Medical Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronx Veterans Affairs Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10468</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Endwell</city>
        <state>New York</state>
        <zip>13760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harlem Hospital Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Blood Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Clinical Research, Inc</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Tryon Medical Group</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Institute for Clinical Research</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28304</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Durham VAMC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTI Clinical Trial and Consulting Services</name>
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        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Velocity Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Rapid Medical Research</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corvallis Clinic PC</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97330</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Clinical Research Institute of Southern Oregon, P.C.</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621-2062</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>VA Medical Center</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>PMG Research of Charleston, LLC</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Spartanburg Medical Research</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>St Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimal Research, LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIDS Arms Incorporated Trinity Health and Wellness Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Baylor Scott &amp; White Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>North Texas Infectious Diseases Consultants</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Texas Center for Drug Development, Inc</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77081</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Gordon Crofoot, MD</name>
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        <city>Houston</city>
        <state>Texas</state>
        <zip>77098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Advanced Clinical Research</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Kaiser Permanente Washington Health Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>CIPREC</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1119ACN</zip>
        <country>Argentina</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Helios Salud Sa</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1141ACG</zip>
        <country>Argentina</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>CEMEDIC</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1440CFD</zip>
        <country>Argentina</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Centro Medico Viamonte SRL</name>
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        <city>Ciudad Autonoma Buenos Aires</city>
        <zip>C1120AAC</zip>
        <country>Argentina</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Clinical Trials Division-Stamboulian Servicios de Salud</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <zip>C1425AWK</zip>
        <country>Argentina</country>
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  <location>
    <facility>
      <name>Clínica y Maternidad Suizo Argentina</name>
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        <city>Ciudad Autonoma de Buenos Aires</city>
        <zip>1118</zip>
        <country>Argentina</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Fundacion Huesped</name>
      <address>
        <city>Ciudad Autonoma De Buenos Aire</city>
        <zip>C1202ABB</zip>
        <country>Argentina</country>
      </address>
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  <location>
    <facility>
      <name>CEMIC Saavedra</name>
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        <city>Ciudad de Buenos Aires</city>
        <zip>1431</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital J. M. Ramos Mejía</name>
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        <city>Ciudad de Buenos Aires</city>
        <zip>C1221Adc</zip>
        <country>Argentina</country>
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  <location>
    <facility>
      <name>Instituto Medico Platense</name>
      <address>
        <city>La Plata</city>
        <zip>B1900AVG</zip>
        <country>Argentina</country>
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  <location>
    <facility>
      <name>Hospital Italiano de La Plata</name>
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        <city>La Plata</city>
        <zip>B1900AXI</zip>
        <country>Argentina</country>
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  <location>
    <facility>
      <name>DIM Clinica Privada</name>
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        <city>Ramos Mejia</city>
        <zip>B1704ETD</zip>
        <country>Argentina</country>
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  <location>
    <facility>
      <name>Faculdade de Medicina Barretos FACISB</name>
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        <city>Barretos</city>
        <zip>14785-002</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Universidade Federal De Minas Gerais - Hospital das Clínicas</name>
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        <city>Belo Horizonte</city>
        <zip>30130-100</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Santa Casa de Misericordia de Belo Horizonte</name>
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        <city>Belo Horizonte</city>
        <zip>30150-221</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>L2IP - Instituto de Pesquisas Clínicas</name>
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        <city>Brasília</city>
        <zip>70200-730</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro</name>
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        <city>Campinas</city>
        <zip>13060-904</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Fundação Universidade Federal de Mato Grosso do Sul</name>
      <address>
        <city>Campo Grande</city>
        <zip>778606-715</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Sociedade Literaria e Caritativa Santo Agostinho - Hospital Sao Jose</name>
      <address>
        <city>Criciúma</city>
        <zip>88811-508</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Oncovida - Centro de Onco-Hematologia de Mato Grosso</name>
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        <city>Cuiabá</city>
        <zip>78043-142</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Hospital Nossa Senhora Das Gracas</name>
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        <city>Curitiba</city>
        <zip>80810-040</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Centro de Estudos e Pesquisas em Moléstias Infecciosas</name>
      <address>
        <city>Natal</city>
        <zip>59025-050</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Hospital das Clinicas de Porto Alegre</name>
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        <city>Porto Alegre</city>
        <zip>90035-903</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Hospital Nossa Senhora da Conceicao S.A</name>
      <address>
        <city>Porto Alegre</city>
        <zip>91350-200</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP</name>
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        <city>Ribeirao Preto</city>
        <zip>14040-900</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Ministerio da Saude - Hospital dos Servidores do Estado - RJ</name>
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        <city>Rio de Janeiro</city>
        <zip>20221-160</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Instituto Brasil de Pesquisa Clinica</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20241-180</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Fundacao Oswaldo Cruz</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21040-900</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu</name>
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        <city>Rio de Janeiro</city>
        <zip>26030-380</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Fundação Bahiana De Infectologia</name>
      <address>
        <city>Salvador</city>
        <zip>40110-060</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Universidade Municipal de Sao Caetano do Sul</name>
      <address>
        <city>Sao Caetano do Sul</city>
        <zip>09521-160</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base</name>
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        <city>Sao Jose do Rio Preto</city>
        <zip>15090-000</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Instituto de infectologia Emilio Ribas</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246-900</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Centro de Referencia E Treinamento Dst/Aids</name>
      <address>
        <city>Sao Paulo</city>
        <zip>02141-000</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>Hospital Das Clinicas Da Faculdade De Medicina Da USP</name>
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        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
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  <location>
    <facility>
      <name>CPQuali Pesquisa Clinica LTDA ME</name>
      <address>
        <city>São Paulo</city>
        <zip>01228-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sociedade Beneficente de Senhoras - Hospital Sírio Libanês</name>
      <address>
        <city>São Paulo</city>
        <zip>01308-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Real e Benemérita Associação Portuguesa de Beneficência</name>
      <address>
        <city>São Paulo</city>
        <zip>01323-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos</name>
      <address>
        <city>São Paulo</city>
        <zip>04266-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios Clínicos e Investigación Médica (CeCim)</name>
      <address>
        <city>Santiago</city>
        <zip>8331143</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facultad de Medicina Universidad de Chile</name>
      <address>
        <city>Santiago</city>
        <zip>8380453</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Padre Hurtado</name>
      <address>
        <city>Santiago</city>
        <zip>8880465</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion del Maule</name>
      <address>
        <city>Talca</city>
        <zip>3465586</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dr Hernan Henriquez Aravena</name>
      <address>
        <city>Temuco</city>
        <zip>47811-51</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios Clínicos V Región Ltda</name>
      <address>
        <city>Viña del Mar</city>
        <zip>2520997</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de la Costa</name>
      <address>
        <city>Barranquilla</city>
        <zip>080001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Reumatologia y Ortopedia</name>
      <address>
        <city>Barranquilla</city>
        <zip>080020</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universidad del Norte</name>
      <address>
        <city>Barranquilla</city>
        <zip>80020</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Atencion e Investigacion Medica S.A. - CAIMED</name>
      <address>
        <city>Bogota</city>
        <zip>00000</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medplus Medicina Prepagada S.A.</name>
      <address>
        <city>Bogota</city>
        <zip>110111</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solano y Terront Servicios Médicos Ltda.</name>
      <address>
        <city>Bogota</city>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Clinicas S.A.S.</name>
      <address>
        <city>Cali</city>
        <zip>760001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Valle del Lili</name>
      <address>
        <city>Cali</city>
        <zip>760032</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca</name>
      <address>
        <city>Floridablanca</city>
        <zip>6810002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Oftalmologica de Santander - FOSCAL</name>
      <address>
        <city>Floridablanca</city>
        <zip>681002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Programa de Estudio y Control de Enfermedades Tropicales</name>
      <address>
        <city>Medellin</city>
        <zip>00000</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Centro de Investigacion Clinica CIC</name>
      <address>
        <city>Medellin</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobon Uribe</name>
      <address>
        <city>Medellín</city>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán</name>
      <address>
        <city>Ciudad de Mexico</city>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Salud Publica</name>
      <address>
        <city>Cuernavaca</city>
        <zip>62100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Civil Fray Antonio Alcalde</name>
      <address>
        <city>Guadalajara</city>
        <zip>44280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Atención Medica e Investigacion en Salud (UNAMIS)</name>
      <address>
        <city>Merida</city>
        <zip>97000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Nacional Siglo XXI IMSS</name>
      <address>
        <city>Mexico</city>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAIMED Investigacion en salud S.A de C.V.</name>
      <address>
        <city>Mexico</city>
        <zip>06750</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Enfermedades Respiratorias</name>
      <address>
        <city>Mexico</city>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectolab</name>
      <address>
        <city>Tijuana</city>
        <zip>CP 22010</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Invetigaciones Medicas</name>
      <address>
        <city>Callao</city>
        <zip>0000</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Daniel Alcides Carrion</name>
      <address>
        <city>Callao</city>
        <zip>02</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)</name>
      <address>
        <city>Callao</city>
        <zip>07066</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asociacion Civil Selva Amazonica (ACSA)</name>
      <address>
        <city>Iquitos</city>
        <zip>16001</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asociacion Civil Impacta Salud y Educacion - Barranco</name>
      <address>
        <city>Lima - Barranco</city>
        <zip>Barranco 15063</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Edgardo Rebagliati Martins</name>
      <address>
        <city>Lima</city>
        <zip>11</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Arzobispo Loayza</name>
      <address>
        <city>Lima</city>
        <zip>15082</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asociacion Civil Via Libre</name>
      <address>
        <city>Lima</city>
        <zip>LIMA 01</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigacion Nutricional</name>
      <address>
        <city>Lima</city>
        <zip>LIMA12</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asociacion Civil Impacta Salud y Educacion- San Miguel CRS</name>
      <address>
        <city>Lima</city>
        <zip>LIMA32</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Josha Research</name>
      <address>
        <city>Bloemfontein</city>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Helderberg Clinical Research Centre</name>
      <address>
        <city>Cape Town</city>
        <zip>7130</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Clinical Research Unit FAM-CRU</name>
      <address>
        <city>Cape Town</city>
        <zip>7505</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TASK Central</name>
      <address>
        <city>Cape Town</city>
        <zip>7530</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desmond Tutu HIV Foundation</name>
      <address>
        <city>Cape Town</city>
        <zip>7750</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cape Town IDM/CIDRI Research Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7784</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desmond Tutu Hiv Foundation - University Of Cape Town</name>
      <address>
        <city>Cape Town</city>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Masiphumelele Research Centre</name>
      <address>
        <city>Cape Town</city>
        <zip>7975</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ndlovu Elandsdoorn Site</name>
      <address>
        <city>Dennilton</city>
        <zip>0485</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SA Medical Research Council</name>
      <address>
        <city>Durban</city>
        <zip>3660</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SA Medical Research Council</name>
      <address>
        <city>Durban</city>
        <zip>4400</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRISMO Bertha Gxowa Research Centre</name>
      <address>
        <city>Johannesburg</city>
        <zip>1401</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandukani Research Centre</name>
      <address>
        <city>Johannesburg</city>
        <zip>2001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Aurum Institute Klerksdorp Clinical Research Centre</name>
      <address>
        <city>Klerksdorp</city>
        <zip>2571</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qhakaza Mbokodo Research Centre</name>
      <address>
        <city>KwaZulu-Natal</city>
        <zip>4030</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South African Medical Research Council Chatsworth Clinical Research Site</name>
      <address>
        <city>KwaZulu-Natal</city>
        <zip>4030</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for the AIDS Programme of Research in South Africa</name>
      <address>
        <city>KwaZulu-Natal</city>
        <zip>4110</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanza Clinical Research Centre : Mamelodi</name>
      <address>
        <city>Mamelodi East</city>
        <zip>0122</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mzansi Ethical Research Centre</name>
      <address>
        <city>Middelburg</city>
        <zip>1055</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nelson Mandela Academic Clinical Research Unit 'NeMACRU'</name>
      <address>
        <city>Mthatha</city>
        <zip>5099</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PHOENIX PHARMA (Pty) Ltd</name>
      <address>
        <city>Port Elizabeth</city>
        <zip>6001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MeCRU Clinical Research Unit</name>
      <address>
        <city>Pretoria</city>
        <zip>0204</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Watermeyer</name>
      <address>
        <city>Pretoria</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Aurum Institute Rustenburg Clinical Research Site</name>
      <address>
        <city>Rustenburg</city>
        <zip>300</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Setshaba Research Centre</name>
      <address>
        <city>Soshanguve</city>
        <zip>152</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perinatal HIV Research Unit (PHRU), Kliptown</name>
      <address>
        <city>Soweto</city>
        <zip>1809</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital</name>
      <address>
        <city>Soweto</city>
        <zip>2013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Aurum Institute: Tembisa - Clinic 4</name>
      <address>
        <city>Tembisa</city>
        <zip>1632</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAPRISA Vulindlela Clinic</name>
      <address>
        <city>Vulindlela</city>
        <zip>4013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre</name>
      <address>
        <city>Westdene Johannesburg Gauteng</city>
        <zip>2092</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SATVI, Brewelskloof Hospital</name>
      <address>
        <city>Worcester</city>
        <zip>6850</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>South Africa</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Philippines</country>
    <country>Ukraine</country>
  </removed_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <results_first_submitted>January 25, 2022</results_first_submitted>
  <results_first_submitted_qc>April 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 15, 2022</results_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prevention</keyword>
  <keyword>Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 4, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04505722/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04505722/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 44325 participants were randomized, of which 1 participant was randomized in error due to lack of a signed informed consent form. This participant has not been included in the analysis.</recruitment_details>
      <pre_assignment_details>Per protocol amendment 6 (04-Sep-2021), booster vaccination was offered at Year 1 to all ongoing participants; data is still under evaluation, so primary outcome measure results of booster phase will be reported in Mar-2024. Participant flow (PF) information below included data from study start date (07-Sep-2020) to data cutoff date (09-Jul-2021), hence 3 deaths reported in AE section but not included in PF as onset date of fatal AEs was before 9jul2021, however participants died after 9jul2021.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ad26.COV2.S</title>
          <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22174"/>
                <participants group_id="P2" count="22150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccinated</title>
              <participants_list>
                <participants group_id="P1" count="21898"/>
                <participants group_id="P2" count="21890"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants in Entire Double Blind Phase</title>
              <participants_list>
                <participants group_id="P1" count="21894"/>
                <participants group_id="P2" count="21882"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22174"/>
                <participants group_id="P2" count="22150"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="271"/>
                <participants group_id="P2" count="333"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="376"/>
                <participants group_id="P2" count="714"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Still ongoing</title>
              <participants_list>
                <participants group_id="P1" count="21138"/>
                <participants group_id="P2" count="20662"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized not vaccinated</title>
              <participants_list>
                <participants group_id="P1" count="276"/>
                <participants group_id="P2" count="260"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS) included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment.</population>
      <group_list>
        <group group_id="B1">
          <title>Ad26.COV2.S</title>
          <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21898"/>
            <count group_id="B2" value="21890"/>
            <count group_id="B3" value="43788"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.7" spread="15.08"/>
                    <measurement group_id="B2" value="50.7" spread="15.04"/>
                    <measurement group_id="B3" value="50.7" spread="15.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9828"/>
                    <measurement group_id="B2" value="9907"/>
                    <measurement group_id="B3" value="19735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12067"/>
                    <measurement group_id="B2" value="11979"/>
                    <measurement group_id="B3" value="24046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Undifferentiated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2083"/>
                    <measurement group_id="B2" value="2060"/>
                    <measurement group_id="B3" value="4143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="743"/>
                    <measurement group_id="B2" value="686"/>
                    <measurement group_id="B3" value="1429"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4253"/>
                    <measurement group_id="B2" value="4262"/>
                    <measurement group_id="B3" value="8515"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12858"/>
                    <measurement group_id="B2" value="12843"/>
                    <measurement group_id="B3" value="25701"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1207"/>
                    <measurement group_id="B2" value="1248"/>
                    <measurement group_id="B3" value="2455"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="698"/>
                    <measurement group_id="B2" value="744"/>
                    <measurement group_id="B3" value="1442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>ARGENTINA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1498"/>
                    <measurement group_id="B2" value="1498"/>
                    <measurement group_id="B3" value="2996"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BRAZIL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3644"/>
                    <measurement group_id="B2" value="3635"/>
                    <measurement group_id="B3" value="7279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHILE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="563"/>
                    <measurement group_id="B2" value="570"/>
                    <measurement group_id="B3" value="1133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COLOMBIA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2125"/>
                    <measurement group_id="B2" value="2123"/>
                    <measurement group_id="B3" value="4248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MEXICO</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="241"/>
                    <measurement group_id="B3" value="479"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PERU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="886"/>
                    <measurement group_id="B2" value="885"/>
                    <measurement group_id="B3" value="1771"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SOUTH AFRICA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3287"/>
                    <measurement group_id="B2" value="3289"/>
                    <measurement group_id="B3" value="6576"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED STATES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9657"/>
                    <measurement group_id="B2" value="9649"/>
                    <measurement group_id="B3" value="19306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study)</title>
        <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription-polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute, oxygen saturation (SpO2) &lt;= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
        <population>Per-protocol Efficacy (PP) set: participants of the FAS (all randomized participants with double-blind study vaccine administration, regardless of protocol deviations and serostatus at enrollment) who received double-blind study vaccine and who were seronegative at the time of vaccination and who had no other major protocol deviations to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study)</title>
          <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription-polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute, oxygen saturation (SpO2) &lt;= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
          <population>Per-protocol Efficacy (PP) set: participants of the FAS (all randomized participants with double-blind study vaccine administration, regardless of protocol deviations and serostatus at enrollment) who received double-blind study vaccine and who were seronegative at the time of vaccination and who had no other major protocol deviations to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19400"/>
                <count group_id="O2" value="19398"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Age: 18-59 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="381"/>
                    <measurement group_id="O2" value="847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age: Greater than or equal to (&gt;=) 60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study)</title>
        <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats/minute and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute, SpO2 less than or equal to (&lt;=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.</description>
        <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
        <population>PP set included participants of the Full Analysis Set (FAS) who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study)</title>
          <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats/minute and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute, SpO2 less than or equal to (&lt;=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.</description>
          <population>PP set included participants of the Full Analysis Set (FAS) who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19113"/>
                <count group_id="O2" value="18924"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Age: 18-59 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="340"/>
                    <measurement group_id="O2" value="716"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age: &gt;=60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)</title>
        <description>Participants who receive the booster dose was asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).</description>
        <time_frame>Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])</time_frame>
        <posting_date>03/2024</posting_date>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)</title>
        <description>Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature &gt;= 38.0 degree Celsius or &gt;=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.</description>
        <time_frame>Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])</time_frame>
        <posting_date>03/2024</posting_date>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)</title>
        <description>Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.</description>
        <time_frame>Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])</time_frame>
        <posting_date>03/2024</posting_date>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)</title>
        <description>SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.</description>
        <time_frame>From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)</time_frame>
        <posting_date>03/2024</posting_date>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events of Special Interest (AESI) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)</title>
        <description>Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.</description>
        <time_frame>From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)</time_frame>
        <posting_date>03/2024</posting_date>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)</title>
        <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>14 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 546)</time_frame>
        <posting_date>03/2024</posting_date>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)</title>
        <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>28 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 560)</time_frame>
        <posting_date>03/2024</posting_date>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)</title>
        <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>14 days after booster vaccination (Day 379) to end of study (up to 2 years and 3 month)</time_frame>
        <posting_date>03/2024</posting_date>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)</title>
        <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>28 days after booster vaccination (Day 393) to end of study (up to 2 years and 3 month)</time_frame>
        <posting_date>03/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)</title>
        <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)</title>
          <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19400"/>
                <count group_id="O2" value="19398"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)</title>
        <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)</title>
          <description>Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19113"/>
                <count group_id="O2" value="18924"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)</title>
        <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>1 Day after double-blind vaccination (Day 2)</time_frame>
        <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)</title>
          <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
          <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21898"/>
                <count group_id="O2" value="21890"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="575"/>
                    <measurement group_id="O2" value="1189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)</title>
        <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>14 days after double-blind vaccination (Day 15)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine, regardless of their Serostatus at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. This excludes participants who had a COVID-19 case with an onset before day 15.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)</title>
          <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine, regardless of their Serostatus at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. This excludes participants who had a COVID-19 case with an onset before day 15.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21537"/>
                <count group_id="O2" value="21467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="487"/>
                    <measurement group_id="O2" value="1079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)</title>
        <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
        <time_frame>28 days after double-blind vaccination (Day 29)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine, regardless of their Serostatus at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. This excludes participants who had a COVID-19 case with an onset before day 29.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)</title>
          <description>Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate &gt;= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate &gt;= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate &gt;=30 breaths/minute, heart rate &gt;=125 beats/minute,SpO2 &lt;=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine, regardless of their Serostatus at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. This excludes participants who had a COVID-19 case with an onset before day 29.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21244"/>
                <count group_id="O2" value="20978"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="436"/>
                    <measurement group_id="O2" value="895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)</title>
        <description>Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO], linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination were reported.</description>
        <time_frame>14 days after double-blind vaccination (Day 15)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)</title>
          <description>Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO], linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination were reported.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19400"/>
                <count group_id="O2" value="19398"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)</title>
        <description>Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.</description>
        <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)</title>
          <description>Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19113"/>
                <count group_id="O2" value="18924"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants With Molecularly Confirmed, Moderate to Severe/Critical COVID-19 (Main Study)</title>
        <description>The viral load of SARS-CoV-2 was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.</description>
        <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded. Here Number of participants analyzed signifies participants evaluable for this OM.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants With Molecularly Confirmed, Moderate to Severe/Critical COVID-19 (Main Study)</title>
          <description>The viral load of SARS-CoV-2 was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded. Here Number of participants analyzed signifies participants evaluable for this OM.</population>
          <units>Log10 copies*day per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="1041"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="823.7" spread="33.668"/>
                    <measurement group_id="O2" value="921.47" spread="25.706"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)</title>
        <description>Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (&gt;=38°C or &gt;=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.</description>
        <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)</title>
          <description>Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (&gt;=38°C or &gt;=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19400"/>
                <count group_id="O2" value="19398"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)</title>
        <description>Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (&gt;=38°C or &gt;=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.</description>
        <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)</title>
          <description>Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (&gt;=38°C or &gt;=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19113"/>
                <count group_id="O2" value="18924"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)</title>
        <description>Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.</description>
        <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)</title>
          <description>Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19400"/>
                <count group_id="O2" value="19398"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="492"/>
                    <measurement group_id="O2" value="1067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)</title>
        <description>Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.</description>
        <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)</title>
          <description>Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19113"/>
                <count group_id="O2" value="18924"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="441"/>
                    <measurement group_id="O2" value="884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)</title>
        <description>BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.</description>
        <time_frame>14 Days after double-blind vaccination (Day 15)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)</title>
          <description>BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19400"/>
                <count group_id="O2" value="19398"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="495"/>
                    <measurement group_id="O2" value="1082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)</title>
        <description>BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.</description>
        <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)</title>
          <description>BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19113"/>
                <count group_id="O2" value="18924"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="443"/>
                    <measurement group_id="O2" value="895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Main Study)</title>
        <description>Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.</description>
        <time_frame>From Day 29 until end of double-blind phase (up to 284 days after first vaccination)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a COVID-19 case with an onset or discontinued before day 29 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Main Study)</title>
          <description>Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a COVID-19 case with an onset or discontinued before day 29 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19113"/>
                <count group_id="O2" value="18924"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="550"/>
                    <measurement group_id="O2" value="724"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Main Study)</title>
        <description>Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.</description>
        <time_frame>Month 6</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a COVID-19 case with an onset or discontinued before day 29 in PP set were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Main Study)</title>
          <description>Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a COVID-19 case with an onset or discontinued before day 29 in PP set were excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19113"/>
                <count group_id="O2" value="18924"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Main Study)</title>
        <description>Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.</description>
        <time_frame>28 Days after double-blind vaccination (Day 29)</time_frame>
        <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Here &quot;N&quot; signifies the excluded participants who had a COVID-19 case with an onset or discontinued before Day 29.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Main Study)</title>
          <description>Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.</description>
          <population>PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Here &quot;N&quot; signifies the excluded participants who had a COVID-19 case with an onset or discontinued before Day 29.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19113"/>
                <count group_id="O2" value="18924"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1038"/>
                    <measurement group_id="O2" value="1699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs) (Main Study)</title>
        <description>SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.</description>
        <time_frame>Up to 35 weeks</time_frame>
        <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs) (Main Study)</title>
          <description>SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.</description>
          <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21894"/>
                <count group_id="O2" value="21882"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="235"/>
                    <measurement group_id="O2" value="358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events of Special Interest (AESI) (Main Study)</title>
        <description>Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.</description>
        <time_frame>Up to 35 weeks</time_frame>
        <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events of Special Interest (AESI) (Main Study)</title>
          <description>Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.</description>
          <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21894"/>
                <count group_id="O2" value="21882"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Medically-Attended Adverse Events (MAAEs) (Main Study)</title>
        <description>MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.</description>
        <time_frame>Up to 6 months after double-blind vaccination on Day 1</time_frame>
        <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Medically-Attended Adverse Events (MAAEs) (Main Study)</title>
          <description>MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.</description>
          <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21894"/>
                <count group_id="O2" value="21882"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1672"/>
                    <measurement group_id="O2" value="1885"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With MAAEs Leading to Study Discontinuation (Main Study)</title>
        <description>MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.</description>
        <time_frame>Up to 35 weeks</time_frame>
        <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With MAAEs Leading to Study Discontinuation (Main Study)</title>
          <description>MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.</description>
          <population>FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21894"/>
                <count group_id="O2" value="21882"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Main Study)</title>
        <description>Participants who were enrolled in safety subset were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).</description>
        <time_frame>Up to Day 8 (7 Days after double-blind vaccination on Day 1)</time_frame>
        <population>Safety population is a subset of FAS for the analysis of solicited local adverse event. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Main Study)</title>
          <description>Participants who were enrolled in safety subset were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).</description>
          <population>Safety population is a subset of FAS for the analysis of solicited local adverse event. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3356"/>
                <count group_id="O2" value="3379"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1839"/>
                    <measurement group_id="O2" value="684"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Main Study)</title>
        <description>Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature &gt;= 38.0 degree Celsius or &gt;=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.</description>
        <time_frame>Up to Day 8 (7 Days after double-blind vaccination on Day 1)</time_frame>
        <population>Safety population is a subset of FAS for the analysis of solicited systemic adverse event. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Main Study)</title>
          <description>Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature &gt;= 38.0 degree Celsius or &gt;=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.</description>
          <population>Safety population is a subset of FAS for the analysis of solicited systemic adverse event. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3356"/>
                <count group_id="O2" value="3379"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2021"/>
                    <measurement group_id="O2" value="1307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Main Study)</title>
        <description>Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.</description>
        <time_frame>Up to Day 29 (28 Days after double-blind vaccination on Day 1)</time_frame>
        <population>Safety population is a subset of FAS for the analysis of unsolicited adverse event. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Main Study)</title>
          <description>Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.</description>
          <population>Safety population is a subset of FAS for the analysis of unsolicited adverse event. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3356"/>
                <count group_id="O2" value="3379"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="456"/>
                    <measurement group_id="O2" value="422"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study)</title>
        <description>Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (&gt;LLOQ).</description>
        <time_frame>Baseline (Day 1), Day 29, and Day 71</time_frame>
        <population>PPI set included all randomized and vaccinated participants, including those who were part of the immunogenicity subset and for whom immunogenicity data were available, excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Ad26.COV2.S</title>
            <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
          </group>
        </group_list>
        <measure>
          <title>Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study)</title>
          <description>Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (&gt;LLOQ).</description>
          <population>PPI set included all randomized and vaccinated participants, including those who were part of the immunogenicity subset and for whom immunogenicity data were available, excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at specified time points.</population>
          <units>ELISA units per milliliter (EU/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Here NA signifies that the sample was not positive as Geometric mean, and 95% confidence interval value were less than LLOQ i.e., 50.3 EU/mL.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Here NA signifies that the sample was not positive as Geometric mean, and 95% confidence interval value were less than LLOQ i.e., 50.3 EU/mL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="336" lower_limit="284" upper_limit="398"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Here NA signifies that the sample was not positive as Geometric mean, and 95% confidence interval value were less than LLOQ i.e., 50.3 EU/mL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="164"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="526" lower_limit="437" upper_limit="633"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Here NA signifies that the sample was not positive as Geometric mean, and 95% confidence interval value were less than LLOQ i.e., 50.3 EU/mL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 35 weeks for DB Phase (SAEs and Other AEs); Up to 41 weeks for open-label plus DB Phase (all-cause mortality)</time_frame>
      <desc>All-cause mortality and SAEs were monitored in FAS; other (not-including serious) adverse events were monitored in safety population (subset of FAS for solicited and unsolicited AEs analysis) as planned. 'Number of participants at risk' for SAEs are participants in entire double blind (DB) vaccination phase (who received outside vaccination before study start excluded from DB phase). All-cause mortality was reported for DB and open-label phase, while all other safety data reported for DB phase.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ad26.COV2.S</title>
          <description>Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 24.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="21898"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="21890"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="235" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="358" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Retinal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Gallstone ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Gastrointestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pancreatolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Accidental death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Drowning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Drug withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to chemicals</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Acute hepatitis B</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Campylobacter infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Complicated appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Epiglottitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Epstein-Barr virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Genital abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Medical device site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Meningitis cryptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Neurosyphilis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Peritoneal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Scrotal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Suspected COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Anastomotic complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Anastomotic ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Incarcerated incisional hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Multiple fractures</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Muscle rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Nasal injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pneumothorax traumatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Post vaccination syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Stab wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Urinary retention postoperative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>HIV test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pulse absent</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>SARS-CoV-2 test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Smear cervix abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Brain cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Breast neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Chronic myeloid leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ductal adenocarcinoma of pancreas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Endometrial adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Glioblastoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Intraosseous meningioma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Neoplasm of orbit</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Neuroendocrine tumour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Oesophageal carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pancreatic neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pituitary tumour benign</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Thymoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Uterine cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Bell's palsy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Brain stem stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Carotid artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cerebral venous sinus thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Complex regional pain syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Guillain-Barre syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hypertensive encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Intracranial aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Intracranial mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Optic neuritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Spinal cord haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Transient global amnesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Transverse sinus thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Uraemic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion incomplete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Foetal growth abnormality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Catatonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Substance dependence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Bladder trabeculation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Renal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Renal mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal uterine bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Heavy menstrual bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Ovarian hyperstimulation syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Testicular torsion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pleural mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Physical assault</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombophlebitis of the right upper limb cephalic vein</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Embolism venous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hypertensive urgency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21894"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21882"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA Version 24.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="151" subjects_at_risk="3356"/>
                <counts group_id="E2" subjects_affected="124" subjects_at_risk="3380"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="3356"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="3380"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="3356"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="3380"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="3356"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="3380"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>SENIOR ADVISOR CLINICAL DEVELOPMENT</name_or_title>
      <organization>Janssen R&amp;D US</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04505722
org study id: CR108876
secondary id: VAC31518COV3001
nct id: NCT04505722
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly
      confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult
      participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study)
time frame: 14 Days after double-blind vaccination (Day 15)
description: Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription-polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute, oxygen saturation (SpO2) <= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study)
time frame: 28 Days after double-blind vaccination (Day 29)
description: Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats/minute and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute, SpO2 less than or equal to (<=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.
measure: Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
time frame: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
description: Participants who receive the booster dose was asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).
measure: Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
time frame: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
description: Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.
measure: Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
time frame: Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])
description: Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
measure: Number of Participants With Serious Adverse Events (SAEs) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)
time frame: From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)
description: SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
measure: Number of Participants With Adverse Events of Special Interest (AESI) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)
time frame: From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)
description: Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
time frame: 14 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 546)
description: Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
time frame: 28 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 560)
description: Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
time frame: 14 days after booster vaccination (Day 379) to end of study (up to 2 years and 3 month)
description: Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
time frame: 28 days after booster vaccination (Day 393) to end of study (up to 2 years and 3 month)
description: Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)
time frame: 14 Days after double-blind vaccination (Day 15)
description: Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)
time frame: 28 Days after double-blind vaccination (Day 29)
description: Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
time frame: 1 Day after double-blind vaccination (Day 2)
description: Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
time frame: 14 days after double-blind vaccination (Day 15)
description: Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
time frame: 28 days after double-blind vaccination (Day 29)
description: Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
measure: Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)
time frame: 14 days after double-blind vaccination (Day 15)
description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO], linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination were reported.
measure: Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)
time frame: 28 Days after double-blind vaccination (Day 29)
description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.
measure: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants With Molecularly Confirmed, Moderate to Severe/Critical COVID-19 (Main Study)
time frame: 14 Days after double-blind vaccination (Day 15)
description: The viral load of SARS-CoV-2 was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)
time frame: 14 Days after double-blind vaccination (Day 15)
description: Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
measure: Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)
time frame: 28 Days after double-blind vaccination (Day 29)
description: Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
measure: Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)
time frame: 14 Days after double-blind vaccination (Day 15)
description: Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
measure: Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)
time frame: 28 Days after double-blind vaccination (Day 29)
description: Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
measure: Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)
time frame: 14 Days after double-blind vaccination (Day 15)
description: BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
measure: Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)
time frame: 28 Days after double-blind vaccination (Day 29)
description: BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
measure: Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Main Study)
time frame: From Day 29 until end of double-blind phase (up to 284 days after first vaccination)
description: Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.
measure: Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Main Study)
time frame: Month 6
description: Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.
measure: Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Main Study)
time frame: 28 Days after double-blind vaccination (Day 29)
description: Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.
measure: Number of Participants With Serious Adverse Events (SAEs) (Main Study)
time frame: Up to 35 weeks
description: SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
measure: Number of Participants With Adverse Events of Special Interest (AESI) (Main Study)
time frame: Up to 35 weeks
description: Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
measure: Number of Participants With Medically-Attended Adverse Events (MAAEs) (Main Study)
time frame: Up to 6 months after double-blind vaccination on Day 1
description: MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
measure: Number of Participants With MAAEs Leading to Study Discontinuation (Main Study)
time frame: Up to 35 weeks
description: MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.
measure: Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Main Study)
time frame: Up to Day 8 (7 Days after double-blind vaccination on Day 1)
description: Participants who were enrolled in safety subset were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
measure: Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Main Study)
time frame: Up to Day 8 (7 Days after double-blind vaccination on Day 1)
description: Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
measure: Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Main Study)
time frame: Up to Day 29 (28 Days after double-blind vaccination on Day 1)
description: Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
measure: Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study)
time frame: Baseline (Day 1), Day 29, and Day 71
description: Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (>LLOQ).
arm group label: Ad26.COV2.S
arm group type: Experimental
description: Participants will receive intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
arm group label: Placebo
arm group type: Experimental
description: Participants will receive IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
intervention type: Biological
intervention name: Ad26.COV2.S
description: Ad26.COV2.S will be administered at a single dose of 5*10^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.
arm group label: Ad26.COV2.S
arm group label: Placebo
other name: JNJ-78436735
other name: Ad26COVS1
intervention type: Other
intervention name: Placebo
description: Participants will receive Placebo.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: Study Director
affiliation: Janssen Vaccines & Prevention B.V.
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country: Argentina
country: Brazil
country: Chile
country: Colombia
country: Mexico
country: Peru
country: South Africa
country: United States
country: Philippines
country: Ukraine
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 