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Immunogenicity of an Inactivated COVID-19 Vaccine

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Inactivated COVID-19 Vaccine

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

3 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Rushan City Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental Group of children aged 3-5 years old

Experimental Group of children aged 6-11 years old

Arm Description

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

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

Outcomes

Primary Outcome Measures

Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2

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

Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05198336

First Posted

January 19, 2022

Last Updated

September 21, 2023

Sponsor

Sinovac Research and Development Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05198336

Brief Title

Immunogenicity of an Inactivated COVID-19 Vaccine

Official Title

Immunogenicity of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Population Aged 3-11 Years

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

January 8, 2022 (Actual)

Primary Completion Date

January 24, 2022 (Actual)

Study Completion Date

December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinovac Research and Development Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

395 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group of children aged 3-5 years old

Arm Type

Experimental

Arm Description

Arm Title

Experimental Group of children aged 6-11 years old

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Inactivated COVID-19 Vaccine

Other Intervention Name(s)

CoronaVac

Intervention Description

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Primary Outcome Measure Information:

Title

Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2

Description

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

Time Frame

Day 28(+14 days) after the second dose of vaccine

Title

Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2

Description

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

Time Frame

Day 28(+14 days) after the second dose of vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qing Xu

Organizational Affiliation

Shandong Provincial Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rushan City Center for Disease Control and Prevention

City

Weihai

State/Province

Shandong

ZIP/Postal Code

250014

Country

China

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity of an Inactivated COVID-19 Vaccine

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