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Immunogenicity of an Inactivated COVID-19 Vaccine

Sponsor
Sinovac Research and Development Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05198336
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
5.7
Anticipated Duration (Months)
70.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is an open phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity of the CoronaVac in healthy children aged 3-11 years old.

Condition or Disease Intervention/Treatment Phase
  • Biological: Inactivated COVID-19 Vaccine
 Phase 4

Detailed Description

This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy subjects who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the CoronaVac.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Immunogenicity of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Population Aged 3-11 Years
Actual Study Start Date :
Jan 8, 2022
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group of children aged 3-5 years old

200 subjects aged 3-5 years old who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose

Biological: Inactivated COVID-19 Vaccine
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
  • CoronaVac

    		•
    Experimental: Experimental Group of children aged 6-11 years old

    200 subjects aged 6-11 years old who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose

    Biological: Inactivated COVID-19 Vaccine
    600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
    Other Names:
  • CoronaVac

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2 [Day 28(+14 days) after the second dose of vaccine]

      Seropositivity rate of the neutralizing antibody day 28(+14 days) after the second dose of vaccine

    2. Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2 [Day 28(+14 days) after the second dose of vaccine]

      GMT of the neutralizing antibody to SARS-CoV-2 day 28(+14 days) after the second dose of vaccine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose;

    • The subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8 years, both subjects and guardians need to sign the informed consent form);

    • The subjects and their legal guardians voluntarily participate the study and comply with the study procedure to collect 3ml venous blood;

    • Proven legal identity.

    Exclusion Criteria:

    • Haven't received two doses of inactivated COVID-19 vaccine(CoronaVac);

    • Have received COVID-19 vaccines from other manufacturers;

    • The interval between blood collection and the second dose is less than 28 days or more than 42 days;

    • The subjets and their legal guardians can't cooperate to complete 3ml venous blood collection.

    • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rushan City Center for Disease Control and Prevention Weihai Shandong China 250014

    Sponsors and Collaborators

    • Sinovac Research and Development Co., Ltd.

    Investigators

    • Principal Investigator: Qing Xu, Shandong Provincial Center for Disease Control and Prevention

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sinovac Research and Development Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05198336
    Other Study ID Numbers:
    • PRO-nCOV-MA4007-SD
    First Posted:
    Jan 20, 2022
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jan 20, 2022