xml: <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/NCT05972993</url>
    </required_header>
    <id_info>
      <org_study_id>219112</org_study_id>
      <nct_id>NCT05972993</nct_id>
    </id_info>
    <brief_title>A Safety and Immune Response Study to Evaluate Varying Doses of an mRNA Vaccine Against Coronavirus Disease 2019 (COVID-19) in Healthy Adults</brief_title>
    <official_title>Exploratory, First Time in Human (FTIH), Observer-blind, Randomized, Controlled Study to Evaluate Safety, Reactogenicity and Immunogenicity of Various Doses of GlaxoSmithKline Biologicals SA's (GSK) Investigational Omicron Variant S Glycoprotein (mRNA-CR-04) Vaccine When Administered Intramuscularly in Healthy Adults 18 to 49 Years of Age</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GlaxoSmithKline</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GlaxoSmithKline</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the safety, reactogenicity and immune responses of&#xD;
        the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA-CR-04 vaccine construct&#xD;
        when administered in healthy adults previously vaccinated with SARS-CoV-2 mRNA vaccines.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There will be dose-escalation with sentinel dosing strategy implemented in each of 3 dosing&#xD;
        levels (Group 1; 2; 3). At start, enrolment in Group 1 and 2 will occur simultaneously with&#xD;
        the enrolment of 1st participant in Group 1. Each group will consist of 8 sentinel&#xD;
        participants, with 6 receiving the mRNA-CR-04 vaccine and 2 receiving a placebo. The safety&#xD;
        data from the sentinel participants in both groups, up to Day 8 post-vaccination, will be&#xD;
        reviewed by the Internal Safety Review Committee (iSRC). If no safety signal is observed,&#xD;
        vaccination of the non-sentinel participants in that group will continue. If there are no&#xD;
        safety signals observed from the sentinel participants in Group 1 and Group 2, the enrollment&#xD;
        and vaccination of the sentinel participants in Group 3 will begin.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 29, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>Dose escalation with sentinel dosing</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <masking_description>Data will be collected in an observer-blind manner.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with solicited administration site events</measure>
      <time_frame>During the 7 days follow-up period after study intervention administration on day 1</time_frame>
      <description>The solicited administration site events are pain, redness, swelling and Lymphadenopathy (axillary swelling/ tenderness ipsilateral to the site of injection).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with solicited systemic events</measure>
      <time_frame>During the 7 days follow-up period after study intervention on day 1</time_frame>
      <description>The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), chills, abdominal pain, vomiting and diarrhoea.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants reporting Unsolicited Adverse Events (AEs)</measure>
      <time_frame>During the 30-day follow-up period after study intervention administration on day 1</time_frame>
      <description>An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with any clinically significant hematological and biochemical laboratory abnormalities</measure>
      <time_frame>During the 15-day follow-up period after study intervention administration on day 1</time_frame>
      <description>Clinically significant hematological and biochemical abnormal laboratory findings as judged by the investigator.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants reporting medically attended adverse events (MAAEs)</measure>
      <time_frame>Up to Day 31</time_frame>
      <description>A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with serious adverse events (SAEs)</measure>
      <time_frame>Up to Day 31</time_frame>
      <description>An SAE is defined as any untoward medical occurrence that results 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 in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with adverse events of special interest (AESIs)</measure>
      <time_frame>Up to Day 31</time_frame>
      <description>AESIs include potential immune-mediated diseases (pIMDs) which are autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology, myocarditis, and pericarditis, virologically confirmed COVID-19 cases, anaphylaxis, or severe hypersensitivity within 24 hours after study vaccination.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants reporting MAAEs</measure>
      <time_frame>Up to Month 12</time_frame>
      <description>A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with SAEs</measure>
      <time_frame>Up to Month 12</time_frame>
      <description>An SAE is defined as any untoward medical occurrence that results 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 in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with AESIs</measure>
      <time_frame>Up to Month 12</time_frame>
      <description>AESIs include potential immune-mediated diseases (pIMDs) which are autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology, myocarditis, and pericarditis, virologically confirmed COVID-19 cases, anaphylaxis, or severe hypersensitivity within 24 hours after study vaccination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric mean titers (GMTs) of neutralizing antibody (Ab) against pseudovirus bearing S protein from vaccine encoded SARS-CoV-2 and Wild Type (WT) strains</measure>
      <time_frame>At Days 1, 15, and 31, Months 6 and 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric mean ratio (GMR) of neutralizing antibody (Ab) against pseudovirus bearing S protein from vaccine encoded SARS-CoV-2 and Wild Type (WT) strains</measure>
      <time_frame>At Days 1, 15, and 31, Months 6 and 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vaccine response rate (VRR) based on neutralizing titers against vaccine encoded SARS-CoV-2 and WT strains</measure>
      <time_frame>At Days 1, 15, and 31, Months 6 and 12</time_frame>
      <description>VRR is expressed as the percentage of participants with a vaccine response, defined as at least a 4-fold greater antibody titer as compared to the antibody titer at Day 1.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Group 1: mRNA CR-04 10 µg +Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>mRNA 10 micrograms (µg) or placebo administered on day 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: mRNA CR-04 30 µg +Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>mRNA 30µg or placebo administered on day 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3: mRNA CR-04 100 µg +Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>mRNA 100µg or placebo administered on day 1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-CR-04 vaccine 10μg</intervention_name>
      <description>mRNA CR-04 vaccine, 10 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.</description>
      <arm_group_label>Group 1: mRNA CR-04 10 µg +Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-CR-04 vaccine 30μg</intervention_name>
      <description>mRNA CR-04 vaccine, 30 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.</description>
      <arm_group_label>Group 2: mRNA CR-04 30 µg +Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-CR-04 vaccine 100μg</intervention_name>
      <description>mRNA CR-04 vaccine, 100 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.</description>
      <arm_group_label>Group 3: mRNA CR-04 100 µg +Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.</description>
      <arm_group_label>Group 1: mRNA CR-04 10 µg +Placebo</arm_group_label>
      <arm_group_label>Group 2: mRNA CR-04 30 µg +Placebo</arm_group_label>
      <arm_group_label>Group 3: mRNA CR-04 100 µg +Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written or witnessed informed consent obtained from the participant prior to&#xD;
               performance of any study-specific procedure.&#xD;
  &#xD;
            2. Participants, who in the opinion of the investigator, can and will comply with the&#xD;
               requirements of the protocol (e.g., completion of the eDiary and study procedures).&#xD;
  &#xD;
            3. Has received 2 doses of primary series and booster dose(s) of an authorized or&#xD;
               licensed mRNA COVID-19 vaccine (only Moderna or Pfizer vaccines) with the last dose&#xD;
               administered between 6 and 18 months prior to screening and has provided documentation&#xD;
               of receiving the vaccination series (e.g., vaccination card).&#xD;
  &#xD;
            4. Negative for SARS-CoV-2 infection by RT-PCR test at screening within 7 days prior to&#xD;
               study vaccination.&#xD;
  &#xD;
            5. Is a male or nonpregnant female of 18 to 49 years, inclusive, at screening.&#xD;
  &#xD;
            6. If the participant is a woman of childbearing potential (WOCBP), the participant&#xD;
               agrees to practice true abstinence or use at least 1 highly effective form of&#xD;
               contraception for at least 30 days prior to study vaccination up to 1 month after&#xD;
               study vaccination.&#xD;
  &#xD;
            7. Agrees to refrain from blood or plasma donation from screening and up to 6 months&#xD;
               after vaccination.&#xD;
  &#xD;
            8. Is healthy or medically stable as determined by investigator judgment based on medical&#xD;
               history, clinical laboratory tests, vital sign measurements, and physical examination&#xD;
               findings.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Has a new onset, clinically significant, abnormal biochemistry or hematology finding&#xD;
               [defined as greater than or equal to (&gt;=) Grade 1] at screening (participants with&#xD;
               Grade 1 laboratory abnormalities that have been stable for at least 6 months before&#xD;
               enrollment may be included in the study).&#xD;
  &#xD;
            2. Has any medical disease or condition that, in the opinion of the investigator,&#xD;
               precludes study participation. This includes any acute, subacute, intermittent, or&#xD;
               chronic medical disease or condition that would place the participant at an&#xD;
               unacceptable risk of injury, render the participant unable to meet the requirements of&#xD;
               the protocol, or may interfere with the evaluation of responses or the participant's&#xD;
               successful completion of the trial.&#xD;
  &#xD;
            3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
               medical history and physical examination (no laboratory testing required).&#xD;
  &#xD;
            4. History of myocarditis, pericarditis, second- and third-degree heart block or&#xD;
               idiopathic cardiomyopathy, or presence of any medical condition that increases risk of&#xD;
               myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial&#xD;
               fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis eosinophilic&#xD;
               granulomatosis with polyangiitis, persistent myocardial viral infection (e.g., due to&#xD;
               enterovirus or adenovirus).&#xD;
  &#xD;
            5. Has an acute febrile illness with a temperature &gt;=38.0 degree Celsius (°C) or &gt;=100.4&#xD;
               degree Fahrenheit (°F) observed by the participant or at the study site within 72&#xD;
               hours prior to study vaccination. Participants with suspected COVID-19 symptoms should&#xD;
               be excluded and referred for medical care.&#xD;
  &#xD;
            6. Has a history of hypersensitivity or severe allergic reaction, including anaphylaxis,&#xD;
               generalized urticaria, angioedema, and other significant reactions to any previous&#xD;
               vaccine, or any component of the study vaccine.&#xD;
  &#xD;
            7. Has a body mass index greater than (&gt;) 40 Kilograms meter per square (kg/m^2).&#xD;
  &#xD;
            8. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection&#xD;
               within 14 days before study vaccination.&#xD;
  &#xD;
            9. Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before&#xD;
               the date of screening visit.&#xD;
  &#xD;
           10. Has any self-reported or medically documented clinically significant medical or&#xD;
               psychiatric condition. Significant medical conditions include, but are not limited to,&#xD;
               the following:&#xD;
  &#xD;
                 1. Moderate or severe respiratory disease (e.g., chronic obstructive pulmonary&#xD;
                    disease, asthma).&#xD;
  &#xD;
                 2. Uncontrolled hypertension, defined as an average systolic blood pressure &gt;= 140&#xD;
                    millimeters of mercury (mmHg) or an average diastolic blood pressure &gt;= 90 mmHg,&#xD;
                    based on an average of up to 3 blood pressure measurements.&#xD;
  &#xD;
                 3. Clinically significant cardiovascular disease (e.g., congestive heart failure,&#xD;
                    cardiomyopathy, ischemic heart disease).&#xD;
  &#xD;
                 4. Neurological or neurodevelopmental conditions (e.g., Down syndrome, dementia,&#xD;
                    chronic migraine not controlled by medication, epilepsy, stroke or seizures in&#xD;
                    the last 3 years, encephalopathy, focal neurologic deficits, Guillain- Barré&#xD;
                    syndrome, encephalomyelitis, or transverse myelitis).&#xD;
  &#xD;
                 5. Ongoing malignancy or recent diagnosis of malignancy in the last 5 years&#xD;
                    (excluding basal cell and squamous cell carcinoma of the skin).&#xD;
  &#xD;
                 6. Tuberculosis or non-tuberculosis mycobacterial infection.&#xD;
  &#xD;
                 7. Autoimmune disease, including hypothyroidism without a defined nonautoimmune&#xD;
                    cause.&#xD;
  &#xD;
                 8. Immunodeficiency of any cause, including from solid organ transplant, blood, or&#xD;
                    bone marrow transplant, or use of other immune-weakening medicine.&#xD;
  &#xD;
                 9. Type 1 or 2 diabetes mellitus regardless of disease control.&#xD;
  &#xD;
           11. Has any of the following self-reported or medically documented risk factors for severe&#xD;
               COVID-19:&#xD;
  &#xD;
                 1. Chronic kidney disease&#xD;
  &#xD;
                 2. Cerebrovascular disease&#xD;
  &#xD;
                 3. Cystic fibrosis&#xD;
  &#xD;
                 4. Chronic liver disease&#xD;
  &#xD;
                 5. Pulmonary fibrosis&#xD;
  &#xD;
           12. Has participated or plans to participate in another investigational study involving&#xD;
               any investigational drug or device within 60 days or 5 half-lives, whichever is&#xD;
               longer, before study vaccination and throughout the study.&#xD;
  &#xD;
           13. Has received a licensed or authorized non-mRNA COVID-19 vaccine (primary series or&#xD;
               booster dose).&#xD;
  &#xD;
           14. Has received or plans to receive any licensed vaccine within 4 weeks before or after&#xD;
               study vaccination. Inactivated vaccines for influenza are permitted during the study&#xD;
               if they are administered at least 14 days before or after study vaccination.&#xD;
  &#xD;
           15. Is planning to receive an authorized or licensed COVID-19 booster vaccination for the&#xD;
               duration of the study (for participants who are not covered by local recommendations&#xD;
               to receive booster per current standard of care) OR is planning to receive an&#xD;
               authorized or licensed COVID-19 booster vaccination on or before Day 31 of the study&#xD;
               (for participants covered by local recommendations to receive booster).&#xD;
  &#xD;
           16. Has received or plans to receive immunoglobulins or any blood or blood products within&#xD;
               90 days before study vaccination and throughout the study.&#xD;
  &#xD;
           17. Reports chronic use (more than 14 continuous days) of any medication that may be&#xD;
               associated with changes in immune function including, but not limited to, systemic&#xD;
               corticosteroids exceeding 20 mg/day of prednisone equivalent, allergy injections,&#xD;
               immunoglobulins, interferons, immunomodulators, cytotoxic drugs, or other similar or&#xD;
               toxic drugs within 6 months of study vaccination. Note: The use of low-dose topical,&#xD;
               ophthalmic, inhaled, intra-articular and intranasal steroid preparations is permitted.&#xD;
  &#xD;
           18. Pregnant or lactating female.&#xD;
  &#xD;
           19. Female participant planning to become pregnant or planning to discontinue&#xD;
               contraceptive precautions within 1 month following study vaccination.&#xD;
  &#xD;
           20. Participant is an employee or family member of the investigator or study site&#xD;
               personnel.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>49 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>EU GSK Clinical Trials Call Center</last_name>
      <phone>+44 (0) 20 89904466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92108</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Patrick R Yassini</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Melbourne</city>
          <state>Florida</state>
          <zip>32934</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Murray A. Kimmel</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Peoria</city>
          <state>Illinois</state>
          <zip>61614</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Daniel H Brune</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78705</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Laurence Chu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COVID-19</keyword>
    <keyword>SARS-CoV-2</keyword>
    <keyword>Master Protocol</keyword>
    <keyword>Omicron</keyword>
    <keyword>mRNA</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.</ipd_time_frame>
      <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972993
  org study id: 219112
  nct id: NCT05972993
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this study is to evaluate the safety, reactogenicity and immune responses of
        the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA-CR-04 vaccine construct
        when administered in healthy adults previously vaccinated with SARS-CoV-2 mRNA vaccines.
  There will be dose-escalation with sentinel dosing strategy implemented in each of 3 dosing
        levels (Group 1; 2; 3). At start, enrolment in Group 1 and 2 will occur simultaneously with
        the enrolment of 1st participant in Group 1. Each group will consist of 8 sentinel
        participants, with 6 receiving the mRNA-CR-04 vaccine and 2 receiving a placebo. The safety
        data from the sentinel participants in both groups, up to Day 8 post-vaccination, will be
        reviewed by the Internal Safety Review Committee (iSRC). If no safety signal is observed,
        vaccination of the non-sentinel participants in that group will continue. If there are no
        safety signals observed from the sentinel participants in Group 1 and Group 2, the enrollment
        and vaccination of the sentinel participants in Group 3 will begin.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: Dose escalation with sentinel dosing
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: Data will be collected in an observer-blind manner.
  measure: Number of participants with solicited administration site events
  time frame: During the 7 days follow-up period after study intervention administration on day 1
  description: The solicited administration site events are pain, redness, swelling and Lymphadenopathy (axillary swelling/ tenderness ipsilateral to the site of injection).
  measure: Number of participants with solicited systemic events
  time frame: During the 7 days follow-up period after study intervention on day 1
  description: The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), chills, abdominal pain, vomiting and diarrhoea.
  measure: Number of participants reporting Unsolicited Adverse Events (AEs)
  time frame: During the 30-day follow-up period after study intervention administration on day 1
  description: An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs.
  measure: Number of participants with any clinically significant hematological and biochemical laboratory abnormalities
  time frame: During the 15-day follow-up period after study intervention administration on day 1
  description: Clinically significant hematological and biochemical abnormal laboratory findings as judged by the investigator.
  measure: Number of participants reporting medically attended adverse events (MAAEs)
  time frame: Up to Day 31
  description: A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
  measure: Number of participants with serious adverse events (SAEs)
  time frame: Up to Day 31
  description: An SAE is defined as any untoward medical occurrence that results 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 in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator.
  measure: Number of participants with adverse events of special interest (AESIs)
  time frame: Up to Day 31
  description: AESIs include potential immune-mediated diseases (pIMDs) which are autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology, myocarditis, and pericarditis, virologically confirmed COVID-19 cases, anaphylaxis, or severe hypersensitivity within 24 hours after study vaccination.
  measure: Number of participants reporting MAAEs
  time frame: Up to Month 12
  description: A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
  measure: Number of participants with SAEs
  time frame: Up to Month 12
  description: An SAE is defined as any untoward medical occurrence that results 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 in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator.
  measure: Number of participants with AESIs
  time frame: Up to Month 12
  description: AESIs include potential immune-mediated diseases (pIMDs) which are autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology, myocarditis, and pericarditis, virologically confirmed COVID-19 cases, anaphylaxis, or severe hypersensitivity within 24 hours after study vaccination.
  measure: Geometric mean titers (GMTs) of neutralizing antibody (Ab) against pseudovirus bearing S protein from vaccine encoded SARS-CoV-2 and Wild Type (WT) strains
  time frame: At Days 1, 15, and 31, Months 6 and 12
  measure: Geometric mean ratio (GMR) of neutralizing antibody (Ab) against pseudovirus bearing S protein from vaccine encoded SARS-CoV-2 and Wild Type (WT) strains
  time frame: At Days 1, 15, and 31, Months 6 and 12
  measure: Vaccine response rate (VRR) based on neutralizing titers against vaccine encoded SARS-CoV-2 and WT strains
  time frame: At Days 1, 15, and 31, Months 6 and 12
  description: VRR is expressed as the percentage of participants with a vaccine response, defined as at least a 4-fold greater antibody titer as compared to the antibody titer at Day 1.
  arm group label: Group 1: mRNA CR-04 10 µg +Placebo
  arm group type: Experimental
  description: mRNA 10 micrograms (µg) or placebo administered on day 1.
  arm group label: Group 2: mRNA CR-04 30 µg +Placebo
  arm group type: Experimental
  description: mRNA 30µg or placebo administered on day 1.
  arm group label: Group 3: mRNA CR-04 100 µg +Placebo
  arm group type: Experimental
  description: mRNA 100µg or placebo administered on day 1.
  intervention type: Biological
  intervention name: mRNA-CR-04 vaccine 10μg
  description: mRNA CR-04 vaccine, 10 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.
  arm group label: Group 1: mRNA CR-04 10 µg +Placebo
  intervention type: Biological
  intervention name: mRNA-CR-04 vaccine 30μg
  description: mRNA CR-04 vaccine, 30 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.
  arm group label: Group 2: mRNA CR-04 30 µg +Placebo
  intervention type: Biological
  intervention name: mRNA-CR-04 vaccine 100μg
  description: mRNA CR-04 vaccine, 100 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.
  arm group label: Group 3: mRNA CR-04 100 µg +Placebo
  intervention type: Drug
  intervention name: Placebo
  description: Placebo is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.
  arm group label: Group 1: mRNA CR-04 10 µg +Placebo
  arm group label: Group 2: mRNA CR-04 30 µg +Placebo
  arm group label: Group 3: mRNA CR-04 100 µg +Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 49 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: US GSK Clinical Trials Call Center
  phone: 877-379-3718
  email: GSKClinicalSupportHD@gsk.com
  last name: EU GSK Clinical Trials Call Center
  phone: +44 (0) 20 89904466
  email: GSKClinicalSupportHD@gsk.com
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Vaccines
  sharing ipd: Yes
  ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
  ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.