<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/NCT04470609</url>
  </required_header>
  <id_info>
    <org_study_id>20200402</org_study_id>
    <nct_id>NCT04470609</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 in People Aged ⩾60 Years</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Phase Ib/IIb Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged ⩾60 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West China Second University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yunnan Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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 study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical&#xD;
      trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the&#xD;
      vaccine in healthy people aged ⩾60 Years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase Ib/IIb trial is designed to evaluate the safety and immunogenicity of different&#xD;
      doses of the Inactivated SARS-CoV-2 Vaccine based upon the randomized, double-blind and&#xD;
      placebo-controlled principle. A total of 471 subjects aged ⩾60 years will be enrolled in the&#xD;
      study, of which 96 and 375 will be enrolled for phase Ib and phase Ⅱb,respectively. The&#xD;
      enrolled subjects in phase Ib receive two doses of low-, medium-, or high-dose of&#xD;
      experimental vaccines or placebo at an interval of 28 days, while the enrolled subjects in&#xD;
      Phase Ⅱb receive two doses of medium, high-dose experimental vaccines or placebo at an&#xD;
      interval of 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Adverse reactions/events rate</measure>
    <time_frame>7 days after vaccination</time_frame>
    <description>Occurence of adverse reactions/events after vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse reactions/events rate</measure>
    <time_frame>28 days after vaccination</time_frame>
    <description>Occurence of adverse reactions/events after vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIb</measure>
    <time_frame>28 days after vaccination</time_frame>
    <description>Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIb</measure>
    <time_frame>28 days after vaccination</time_frame>
    <description>Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>12 months after the second vaccination</time_frame>
    <description>Occurence of Serious adverse events after vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ib</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ib</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase Ib</measure>
    <time_frame>7 and 28 days after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase Ib</measure>
    <time_frame>7 and 28 days after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase IIb</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase IIb</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Level of IgM antibodies against SARS-CoV-2 Phase Ib</measure>
    <time_frame>7 and 28 days after the second vaccination</time_frame>
    <description>Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase Ib</measure>
    <time_frame>3, 6, 9 and 12 months after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase Ib</measure>
    <time_frame>3, 6, 9 and 12 months after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28</description>
  </other_outcome>
  <other_outcome>
    <measure>Cellular immune responses Phase Ib</measure>
    <time_frame>7 and 28 days after the second vaccination</time_frame>
    <description>Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for Phase Ib with vaccination schedule of day 0, 28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of IgM antibodies against SARS-CoV-2 Phase IIb</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of anti-N protein antibodies Phase IIb</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Level of anti-N protein antibodies for Phase IIb with vaccination schedule of day 0, 28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase IIb</measure>
    <time_frame>6 and 12 months after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase IIb</measure>
    <time_frame>6 and 12 months after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28</description>
  </other_outcome>
  <other_outcome>
    <measure>Cellular immune responses Phase IIb</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for Phase IIb with vaccination schedule of day 0, 28</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">471</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Low dosage vaccine on a 0- and 28-day schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dosage vaccine on a 0- and 28-day schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dosage vaccine on a 0- and 28-day schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo on a 0- and 28-day schedule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two doses of placebo at the vaccination schedule of day 0, 28</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule</intervention_name>
    <description>Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28</description>
    <arm_group_label>Low dosage vaccine on a 0- and 28-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule</intervention_name>
    <description>Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28</description>
    <arm_group_label>Medium dosage vaccine on a 0- and 28-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule</intervention_name>
    <description>Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28</description>
    <arm_group_label>High dosage vaccine on a 0- and 28-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo on a 0- and 28-day schedule</intervention_name>
    <description>Two doses of placebo at the vaccination schedule of day 0,28</description>
    <arm_group_label>Placebo on a 0- and 28-day schedule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phase Ib:&#xD;
&#xD;
               1. Healthy people aged ⩾60 years (including boundary values), both men and women.&#xD;
&#xD;
               2. Proven legal identity.&#xD;
&#xD;
               3. Participants should understand the contents of the informed consent form, the&#xD;
                  vaccine in this trial, voluntarily sign the informed consent form, and be capable&#xD;
                  of using thermometers, scales, and filling in diary cards and contact cards as&#xD;
                  required.&#xD;
&#xD;
               4. Participants should be able to communicate well with investigators, understand&#xD;
                  and comply with the requirements of this trial.&#xD;
&#xD;
               5. Axillary temperature ≤37.0 ℃.&#xD;
&#xD;
          -  Phase IIb:&#xD;
&#xD;
               1. Healthy people aged ⩾60 years (including boundary values), both men and women.&#xD;
&#xD;
               2. Proven legal identity.&#xD;
&#xD;
               3. Participants should understand the contents of the informed consent form, the&#xD;
                  vaccine in this trial, voluntarily sign the informed consent form, and be capable&#xD;
                  of using thermometers, scales, and filling in diary cards and contact cards as&#xD;
                  required.&#xD;
&#xD;
               4. Participants should be able to communicate well with investigators, understand&#xD;
                  and comply with the requirements of this trial.&#xD;
&#xD;
               5. Axillary temperature ≤37.0 ℃.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Phase Ib:&#xD;
&#xD;
               1. Contraindications for vaccination.&#xD;
&#xD;
               2. History of allergy to vaccines or drugs.&#xD;
&#xD;
               3. Immunization with any vaccine within 1 month.&#xD;
&#xD;
               4. Diseases that cannot be controlled by drugs, such as hypertension, diabetes,&#xD;
                  asthma, etc.&#xD;
&#xD;
               5. Those who developed acute disease within 2 weeks, or had symptoms of fever or&#xD;
                  upper respiratory tract infection within 7 days.&#xD;
&#xD;
               6. Those who have a hereditary bleeding tendency or coagulation dysfunction, or a&#xD;
                  history of thrombosis or bleeding disorders.&#xD;
&#xD;
               7. Those who cannot tolerate venipuncture, or have a history of halo needles or halo&#xD;
                  blood.&#xD;
&#xD;
               8. For any reason, the spleen was removed partially or completely.&#xD;
&#xD;
               9. Those who have undergone surgery within 3 months before signing the informed&#xD;
                  consent, or those who plan to perform surgery during the trial or within 3 months&#xD;
                  after the end of the trial (including cosmetic surgery, dental and oral surgery).&#xD;
&#xD;
              10. Those who donated or lost blood (≥200 mL) in the past 3 months, who received&#xD;
                  blood transfusion or use of blood products, or who planned blood donation during&#xD;
                  the trial.&#xD;
&#xD;
              11. Receipt of other investigational or unregistered products (drugs, vaccines,&#xD;
                  biological product or devices) in the past 3 months, or plan to use other&#xD;
                  investigational or unregistered products during the study.&#xD;
&#xD;
              12. Receipt of immunosuppressive therapy within 6 months before signing the informed&#xD;
                  consent form, such as long-term systemic glucocorticoid therapy (with systemic&#xD;
                  glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone&#xD;
                  or similar drugs) ), but local administration (such as ointment, eye drops,&#xD;
                  inhalation, or nasal spray) is allowed. The local administration should not&#xD;
                  exceed the dosage recommended in the instructions or have any signs of systemic&#xD;
                  exposure.&#xD;
&#xD;
              13. Those who have took soft drugs (such as marijuana) within 3 months before signing&#xD;
                  the informed consent form or took hard drugs (such as: cocaine, phencyclidine,&#xD;
                  etc.) within 1 year before the trial.&#xD;
&#xD;
              14. Those who smoked more than 5 cigarettes per day within 3 months before signing&#xD;
                  the informed consent form.&#xD;
&#xD;
              15. The weekly drinking volume is greater than 14 units within 3 months before&#xD;
                  signing the informed consent form (1 unit alcohol approximately equal to 360 mL&#xD;
                  beer or 45 mL spirits with 40% alcohol content or 150 mL wine).&#xD;
&#xD;
              16. The comprehensive physical examination does not meet the health standards, mainly&#xD;
                  including: (1) Those with abnormal vital signs with clinical significance. (2)&#xD;
                  BMI&lt;18 kg/m^2 or&gt; 30 kg/m^2. (3) Abnormal laboratory examination with clinical&#xD;
                  significance. (4) Those who tested positive for human immunodeficiency virus&#xD;
                  (HIV) antibody, hepatitis B surface antigen, hepatitis B e antigen, hepatitis C&#xD;
                  virus antibody, or Treponema pallidum antibody (tp-trust).&#xD;
&#xD;
              17. Women who have a positive pregnancy test, or men who have a birth plan or plan to&#xD;
                  donate sperm from the screening to 12 months after the second vaccination.&#xD;
&#xD;
              18. Positive in drug abuse screening during the screening period (Morphine,&#xD;
                  Methamphetamine, Ketamine, MDMA and Tetrahydrocannabinolic acid).&#xD;
&#xD;
              19. Positive in alcohol breath test during the screening period.&#xD;
&#xD;
              20. Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM)&#xD;
                  screening.&#xD;
&#xD;
              21. History of severe acute respiratory syndrome (SARS) or Middle East respiratory&#xD;
                  syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63,&#xD;
                  HCoV-HKU1).&#xD;
&#xD;
              22. History of contact with confirmed or suspected cases infected with SARS-CoV-2&#xD;
                  within 1 month.&#xD;
&#xD;
              23. Any other situations judged by investigators as not suitable for participating in&#xD;
                  this study.&#xD;
&#xD;
          -  Phase IIb:&#xD;
&#xD;
               1. Contraindications for vaccination.&#xD;
&#xD;
               2. History of allergy to vaccines or drugs.&#xD;
&#xD;
               3. Immunization with any vaccine within 1 month.&#xD;
&#xD;
               4. Diseases that cannot be controlled by drugs, such as hypertension, diabetes,&#xD;
                  asthma, etc.&#xD;
&#xD;
               5. Those who developed acute disease within 2 weeks, or had symptoms of fever or&#xD;
                  upper respiratory tract infection within 7 days.&#xD;
&#xD;
               6. Those who have a hereditary bleeding tendency or coagulation dysfunction, or a&#xD;
                  history of thrombosis or bleeding disorders.&#xD;
&#xD;
               7. For any reason, the spleen was removed partially or completely.&#xD;
&#xD;
               8. Those who have undergone surgery within 3 months before signing the informed&#xD;
                  consent, or those who plan to perform surgery during the trial or within 3 months&#xD;
                  after the end of the trial (including cosmetic surgery, dental and oral surgery).&#xD;
&#xD;
               9. Those who donated or lost blood (≥200 mL) in the past 3 months, who received&#xD;
                  blood transfusion or use of blood products, or who planned blood donation during&#xD;
                  the trial.&#xD;
&#xD;
              10. Receipt of other investigational or unregistered products (drugs, vaccines,&#xD;
                  biological product or devices) in the past 3 months, or plan to use other&#xD;
                  investigational or unregistered products during the study.&#xD;
&#xD;
              11. Receipt of immunosuppressive therapy within 6 months before signing the informed&#xD;
                  consent form, such as long-term systemic glucocorticoid therapy (with systemic&#xD;
                  glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone&#xD;
                  or similar drugs) ), but local administration (such as ointment, eye drops,&#xD;
                  inhalation, or nasal spray) is allowed. The local administration should not&#xD;
                  exceed the dosage recommended in the instructions or have any signs of systemic&#xD;
                  exposure.&#xD;
&#xD;
              12. Women who have a positive pregnancy test, or men who have a birth plan or plan to&#xD;
                  donate sperm from the screening to 12 months after the second vaccination.&#xD;
&#xD;
              13. History of severe acute respiratory syndrome (SARS) or Middle East respiratory&#xD;
                  syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63,&#xD;
                  HCoV-HKU1).&#xD;
&#xD;
              14. History of contact with confirmed or suspected cases infected with SARS-CoV-2&#xD;
                  within 1 month.&#xD;
&#xD;
              15. The comprehensive physical examination does not meet the health standards, mainly&#xD;
                  including: (1) Those with abnormal vital signs (Pulse &lt;55 beats per minute or&gt;&#xD;
                  100 beats per minute at rest, Systolic blood pressure ≥140mmHg or Diastolic blood&#xD;
                  pressure ≥90mmHg, breathing&gt; 20 beats per minute or &lt;12 beats per minute). (2)&#xD;
                  Those who tested positive for human immunodeficiency virus (HIV) antibody,&#xD;
                  hepatitis B surface antigen, hepatitis B e antigen, hepatitis C virus antibody,&#xD;
                  or Treponema pallidum antibody (tp-trust).&#xD;
&#xD;
              16. Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM)&#xD;
                  screening.&#xD;
&#xD;
              17. Any other situations judged by investigators as not suitable for participating in&#xD;
                  this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qin Yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Second University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaoqiang Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yunnan Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West China Second University Hospital, Sichuan University / West China women's and children's Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Qihan Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT04470609
org study id: 20200402
nct id: NCT04470609
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical
      trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the
      vaccine in healthy people aged ⩾60 Years.
This phase Ib/IIb trial is designed to evaluate the safety and immunogenicity of different
      doses of the Inactivated SARS-CoV-2 Vaccine based upon the randomized, double-blind and
      placebo-controlled principle. A total of 471 subjects aged ⩾60 years will be enrolled in the
      study, of which 96 and 375 will be enrolled for phase Ib and phase Ⅱb,respectively. The
      enrolled subjects in phase Ib receive two doses of low-, medium-, or high-dose of
      experimental vaccines or placebo at an interval of 28 days, while the enrolled subjects in
      Phase Ⅱb receive two doses of medium, high-dose experimental vaccines or placebo at an
      interval of 28 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse reactions/events rate
time frame: 7 days after vaccination
description: Occurence of adverse reactions/events after vaccination
measure: Adverse reactions/events rate
time frame: 28 days after vaccination
description: Occurence of adverse reactions/events after vaccination
measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIb
time frame: 28 days after vaccination
description: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28
measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIb
time frame: 28 days after vaccination
description: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
measure: Serious adverse events
time frame: 12 months after the second vaccination
description: Occurence of Serious adverse events after vaccination
measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ib
time frame: 28 days after the second vaccination
description: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28
measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ib
time frame: 28 days after the second vaccination
description: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ib
time frame: 7 and 28 days after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28
measure: Level of IgG antibodies against SARS-CoV-2 Phase Ib
time frame: 7 and 28 days after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIb
time frame: 28 days after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28
measure: Level of IgG antibodies against SARS-CoV-2 Phase IIb
time frame: 28 days after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
measure: Level of IgM antibodies against SARS-CoV-2 Phase Ib
time frame: 7 and 28 days after the second vaccination
description: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ib
time frame: 3, 6, 9 and 12 months after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28
measure: Level of IgG antibodies against SARS-CoV-2 Phase Ib
time frame: 3, 6, 9 and 12 months after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
measure: Cellular immune responses Phase Ib
time frame: 7 and 28 days after the second vaccination
description: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for Phase Ib with vaccination schedule of day 0, 28
measure: Level of IgM antibodies against SARS-CoV-2 Phase IIb
time frame: 28 days after the second vaccination
description: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
measure: Level of anti-N protein antibodies Phase IIb
time frame: 28 days after the second vaccination
description: Level of anti-N protein antibodies for Phase IIb with vaccination schedule of day 0, 28
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIb
time frame: 6 and 12 months after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28
measure: Level of IgG antibodies against SARS-CoV-2 Phase IIb
time frame: 6 and 12 months after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
measure: Cellular immune responses Phase IIb
time frame: 28 days after the second vaccination
description: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for Phase IIb with vaccination schedule of day 0, 28
arm group label: Low dosage vaccine on a 0- and 28-day schedule
arm group type: Experimental
description: Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
arm group label: Medium dosage vaccine on a 0- and 28-day schedule
arm group type: Experimental
description: Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
arm group label: High dosage vaccine on a 0- and 28-day schedule
arm group type: Experimental
description: Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
arm group label: Placebo on a 0- and 28-day schedule
arm group type: Placebo Comparator
description: Two doses of placebo at the vaccination schedule of day 0, 28
intervention type: Biological
intervention name: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
description: Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
arm group label: Low dosage vaccine on a 0- and 28-day schedule
intervention type: Biological
intervention name: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
description: Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
arm group label: Medium dosage vaccine on a 0- and 28-day schedule
intervention type: Biological
intervention name: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
description: Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
arm group label: High dosage vaccine on a 0- and 28-day schedule
intervention type: Biological
intervention name: Placebo on a 0- and 28-day schedule
description: Two doses of placebo at the vaccination schedule of day 0,28
arm group label: Placebo on a 0- and 28-day schedule
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Qin Yu
role: Principal Investigator
affiliation: West China Second University Hospital
last name: Xiaoqiang Liu
role: Principal Investigator
affiliation: Yunnan Center for Disease Control and Prevention
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Qihan Li
investigator title: Professor
mesh term: COVID-19
mesh term: Vaccines