<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/NCT04456595</url>
  </required_header>
  <id_info>
    <org_study_id>COV-02-IB</org_study_id>
    <nct_id>NCT04456595</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals</brief_title>
  <acronym>PROFISCOV</acronym>
  <official_title>Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate Efficacy and Safety in Healthcare Professionals of the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Butantan Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sinovac Life Sciences Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Butantan Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19&#xD;
      (inactivated) vaccine manufactured by Sinovac in health care professionals&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19&#xD;
      (inactivated) vaccine manufactured by Sinovac in health care professionals.&#xD;
&#xD;
      The study will be double-blind placebo-controlled trial with participants randomly allocated&#xD;
      1:1 to placebo and vaccine arms.&#xD;
&#xD;
      The immunization schedule is two doses intramuscular injections (deltoid) with a 14-days&#xD;
      interval.&#xD;
&#xD;
      For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2&#xD;
      infections, after the second week post-immunization schedule.&#xD;
&#xD;
      For safety and immunogenicity, participants are categorized in two age groups, Adults (18-59&#xD;
      years) and Elderly (60 years and above). Safety database aims to detect adverse reactions&#xD;
      with frequency of 1:1000 or higher in adults and 1:500 in elderly.&#xD;
&#xD;
      All participants will be followed up to 12 months. Interim preliminary efficacy analysis can&#xD;
      be triggered by reaching the target number of 61 cases. Primary efficacy analysis requires&#xD;
      151 cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Actual">December 17, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</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>Incidence of COVID-19 cases after two-doses immunization schedule</measure>
    <time_frame>Two weeks after second dose up to one year after first dose</time_frame>
    <description>Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of adverse events up to seven days after immunization</measure>
    <time_frame>Seven days after each immunization</time_frame>
    <description>Frequency of adverse reaction in the seven days following each immunization per age group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of COVID-19 cases after two-doses immunization schedule according to previous exposure</measure>
    <time_frame>Two weeks after first dose up to one year after first dose</time_frame>
    <description>Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine according to previous exposure to SARS-CoV-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of COVID-19 cases after 14-days of first immunization</measure>
    <time_frame>Two weeks after last dose uup to one year after first dose</time_frame>
    <description>Number of virologically-confirmed symptomatic COVID-19 two weeks after first dose of vaccine, regardless the vaccination schedule was completed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined incidence of SARS-CoV-2 infection</measure>
    <time_frame>Two weeks after second dose up to one year after first dose</time_frame>
    <description>Number of virologically-confirmed and or serologically-confirmed SARS-CoV-2 infections two weeks after first dose of vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of severe COVID-19 cases after two-doses immunization schedule</measure>
    <time_frame>Two weeks after second dose up to one year after first dose</time_frame>
    <description>Number of virologically-confirmed severe COVID-19 two weeks after second dose of vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse events up to 28 days after immunization</measure>
    <time_frame>28 days after each immunization</time_frame>
    <description>Frequency of adverse reaction in the 28 days following each immunization per age group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of severe COVID-19 cases</measure>
    <time_frame>From first vaccination up to one year after first dose</time_frame>
    <description>Frequency of virologically-confirmed severe COVID-19 cases after receiving, at least, one dose of the vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse events of special interest after immunization</measure>
    <time_frame>From first vaccination up to one year after first dose</time_frame>
    <description>Frequency of adverse events of special interest after receiving, at least, one dose of the vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate</measure>
    <time_frame>Two weeks after each vaccination</time_frame>
    <description>Number of seroconversion responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cell-mediated immune profile</measure>
    <time_frame>Two and four weeks afer each vaccination</time_frame>
    <description>Number of cell-mediated immune response against SARS-CoV-2 in the week two and four after the second vaccination per age group in a subset of participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seropositivity rate</measure>
    <time_frame>Two weeks after second vaccination</time_frame>
    <description>Number of seropositive responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12688</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Adult - Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aging 18-59 years receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly - Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aging 60 years or above receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult - Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants aging 18-59 years receiving two doses with 14-days interval of placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly - Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants aging 60 years or above receiving two doses with 14-days interval of placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adsorbed COVID-19 (inactivated) Vaccine</intervention_name>
    <description>Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac</description>
    <arm_group_label>Adult - Vaccine</arm_group_label>
    <arm_group_label>Elderly - Vaccine</arm_group_label>
    <other_name>CoronaVac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac</description>
    <arm_group_label>Adult - Placebo</arm_group_label>
    <arm_group_label>Elderly - Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults 18 years of age or older;&#xD;
&#xD;
          2. Healthcare professionals who work in direct contact care of people with possible or&#xD;
             confirmed COVID-19 cases;&#xD;
&#xD;
          3. Agree with periodic contacts by phone or electronic means, and home visits;&#xD;
&#xD;
          4. Show voluntary intention to participate in the study, documented by the informed&#xD;
             consent form signed by participant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent&#xD;
             to engage in sexual relations with reproductive intent without use of birth control&#xD;
             methods in the three months following vaccination;&#xD;
&#xD;
          2. Evidence of uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease,&#xD;
             according to anamnesis or physical examination. Significant changes in treatment or&#xD;
             hospitalizations due to worsening of the condition in the last three months are&#xD;
             indicators of uncontrolled disease;&#xD;
&#xD;
          3. Diseases with impaired immune system including: neoplasms (except basal cell&#xD;
             carcinoma), congenital or acquired immunodeficiencies and autoimmune diseases not&#xD;
             controlled according to anamnesis or physical examination. Significant changes in&#xD;
             treatment or hospitalizations due to worsening of the condition in the last three&#xD;
             months are indicators of uncontrolled disease;&#xD;
&#xD;
          4. Behavioral, cognitive or psychiatric disease that, in the opinion of the principal&#xD;
             investigator or his or her representative physician, affects the participant's ability&#xD;
             to understand and cooperate with all study protocol requirements;&#xD;
&#xD;
          5. Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has&#xD;
             caused medical, professional or family problems, indicated by clinical history;&#xD;
&#xD;
          6. History of severe allergic reactions or anaphylaxis to the study vaccine or to&#xD;
             components thereof;&#xD;
&#xD;
          7. History of asplenia;&#xD;
&#xD;
          8. Participation in another clinical trial with an investigational product in the six&#xD;
             months prior to enrollment in the study or planned participation in another clinical&#xD;
             trial within the two years following enrollment;&#xD;
&#xD;
          9. Previous participation in a study to evaluate a COVID-19 vaccine or prior exposure to&#xD;
             a COVID-19 vaccine;&#xD;
&#xD;
         10. Use of immunosuppressant therapy regimens within the six months prior to enrollment in&#xD;
             the study for planned use within the two years following enrollment. Immunosuppressant&#xD;
             therapy regimens include: antineoplastic chemotherapy, radiation therapy and&#xD;
             immunosuppressants to induce transplant tolerance, among others.&#xD;
&#xD;
         11. Use of immunosuppressive doses of corticosteroids within the three months prior to the&#xD;
             enrollment in the study and planned use of immunosuppressive doses of corticoids&#xD;
             within the three months following enrollment in the study. Immunosuppressive doses of&#xD;
             corticosteroids will be considered the equivalent prednisone 20 mg/day for adults, for&#xD;
             longer than one week. Continued use of topical or nasal corticosteroids is not&#xD;
             considered an immunosuppressant;&#xD;
&#xD;
         12. Received blood products (transfusions or immunoglobulins) within the three months&#xD;
             prior to enrollment in the study, or planned administration of blood products or&#xD;
             immunoglobulins within the two years following enrollment in the study;&#xD;
&#xD;
         13. Suspected or confirmed fever within the 72 hours prior to vaccination or axillary&#xD;
             temperature greater than 37.8 °C* on the day of vaccination (enrollment may be&#xD;
             postponed until participant has gone 72 hours without fever);&#xD;
&#xD;
         14. Possible or confirmed case of COVID-19 on the day of vaccination (vaccination can be&#xD;
             postponed until the participant completes 72 hours without symptoms or the diagnosis&#xD;
             is ruled out);&#xD;
&#xD;
         15. Received live attenuated virus vaccine or inactivated vaccine within the 28 days or 14&#xD;
             days, respectively, prior to enrollment in the study, or immunization planned within&#xD;
             the 28 days after enrollment in the study;&#xD;
&#xD;
         16. History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet&#xD;
             disorder), or prior history of significant bleeding or bruising following IM&#xD;
             injections or venipuncture&#xD;
&#xD;
         17. Any other condition that, in the opinion of the principal investigator or his/her&#xD;
             representative physician, could put the safety/rights of potential participants at&#xD;
             risk or prevent them from complying with this protocol.&#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>Ricardo Palacios, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Butantan Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade de Brasília</name>
      <address>
        <city>Brasilia</city>
        <state>DF</state>
        <zip>71691-082</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de Minas Gerais</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30750-140</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário Júlio Müller</name>
      <address>
        <city>Cuiabá</city>
        <state>Mount</state>
        <zip>78048-902</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário Maria Aparecida Pedrossian</name>
      <address>
        <city>Campo Grande</city>
        <state>MS</state>
        <zip>79080-190</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da Universidade Federal do Paraná</name>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <zip>80060-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Escola da Universidade Federal de Pelotas</name>
      <address>
        <city>Pelotas</city>
        <state>RS</state>
        <zip>96020-360</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Lucas da Pontificia Universidade Catolica do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90619-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Amor - Fundação Pio XII</name>
      <address>
        <city>Barretos</city>
        <state>SP</state>
        <zip>14780-070</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da UNICAMP</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13083-888</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>SP</state>
        <zip>14015-069</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Infectologia Emílio Ribas</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01246-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Pesquisas Clínicas do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403 000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Israelita de Ensino e Pesquisa Albert Einstein</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05652-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Municipal de São Caetano do Sul</name>
      <address>
        <city>São Caetano do Sul</city>
        <state>SP</state>
        <zip>09521-160</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculdade de Medicina de São José do Rio Preto - FAMERP</name>
      <address>
        <city>São José Do Rio Preto</city>
        <state>São Paulo</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Infectologia Evandro Chagas - Fiocruz</name>
      <address>
        <city>Rio De Janeiro</city>
        <zip>21710-232</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Palacios R, Patino EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 15;21(1):853. doi: 10.1186/s13063-020-04775-4.</citation>
    <PMID>33059771</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04456595
org study id: COV-02-IB
nct id: NCT04456595
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19
      (inactivated) vaccine manufactured by Sinovac in health care professionals
This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19
      (inactivated) vaccine manufactured by Sinovac in health care professionals.

      The study will be double-blind placebo-controlled trial with participants randomly allocated
      1:1 to placebo and vaccine arms.

      The immunization schedule is two doses intramuscular injections (deltoid) with a 14-days
      interval.

      For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2
      infections, after the second week post-immunization schedule.

      For safety and immunogenicity, participants are categorized in two age groups, Adults (18-59
      years) and Elderly (60 years and above). Safety database aims to detect adverse reactions
      with frequency of 1:1000 or higher in adults and 1:500 in elderly.

      All participants will be followed up to 12 months. Interim preliminary efficacy analysis can
      be triggered by reaching the target number of 61 cases. Primary efficacy analysis requires
      151 cases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of COVID-19 cases after two-doses immunization schedule
time frame: Two weeks after second dose up to one year after first dose
description: Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine
measure: Frequency of adverse events up to seven days after immunization
time frame: Seven days after each immunization
description: Frequency of adverse reaction in the seven days following each immunization per age group
measure: Incidence of COVID-19 cases after two-doses immunization schedule according to previous exposure
time frame: Two weeks after first dose up to one year after first dose
description: Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine according to previous exposure to SARS-CoV-2
measure: Incidence of COVID-19 cases after 14-days of first immunization
time frame: Two weeks after last dose uup to one year after first dose
description: Number of virologically-confirmed symptomatic COVID-19 two weeks after first dose of vaccine, regardless the vaccination schedule was completed
measure: Combined incidence of SARS-CoV-2 infection
time frame: Two weeks after second dose up to one year after first dose
description: Number of virologically-confirmed and or serologically-confirmed SARS-CoV-2 infections two weeks after first dose of vaccine
measure: Incidence of severe COVID-19 cases after two-doses immunization schedule
time frame: Two weeks after second dose up to one year after first dose
description: Number of virologically-confirmed severe COVID-19 two weeks after second dose of vaccine
measure: Frequency of adverse events up to 28 days after immunization
time frame: 28 days after each immunization
description: Frequency of adverse reaction in the 28 days following each immunization per age group
measure: Frequency of severe COVID-19 cases
time frame: From first vaccination up to one year after first dose
description: Frequency of virologically-confirmed severe COVID-19 cases after receiving, at least, one dose of the vaccine
measure: Frequency of adverse events of special interest after immunization
time frame: From first vaccination up to one year after first dose
description: Frequency of adverse events of special interest after receiving, at least, one dose of the vaccine
measure: Seroconversion rate
time frame: Two weeks after each vaccination
description: Number of seroconversion responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants
measure: Cell-mediated immune profile
time frame: Two and four weeks afer each vaccination
description: Number of cell-mediated immune response against SARS-CoV-2 in the week two and four after the second vaccination per age group in a subset of participants
measure: Seropositivity rate
time frame: Two weeks after second vaccination
description: Number of seropositive responses to SARS-CoV-2 in the second week after each vaccination per age group in a subset of participants
arm group label: Adult - Vaccine
arm group type: Experimental
description: Participants aging 18-59 years receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
arm group label: Elderly - Vaccine
arm group type: Experimental
description: Participants aging 60 years or above receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine
arm group label: Adult - Placebo
arm group type: Placebo Comparator
description: Participants aging 18-59 years receiving two doses with 14-days interval of placebo
arm group label: Elderly - Placebo
arm group type: Placebo Comparator
description: Participants aging 60 years or above receiving two doses with 14-days interval of placebo
intervention type: Biological
intervention name: Adsorbed COVID-19 (inactivated) Vaccine
description: Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
arm group label: Adult - Vaccine
arm group label: Elderly - Vaccine
other name: CoronaVac
intervention type: Biological
intervention name: Placebo
description: Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
arm group label: Adult - Placebo
arm group label: Elderly - Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ricardo Palacios, MD, PhD
role: Study Director
affiliation: Butantan Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
citation: Palacios R, Patino EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 15;21(1):853. doi: 10.1186/s13063-020-04775-4.
PMID: 33059771
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided