Immunogenicity of an Inactivated COVID-19 Vaccine

Phase 4

Completed

• Conditions: COVID-19
• Interventions: Biological: Inactivated COVID-19 Vaccine

• Registration Number: NCT05198336
• Lead Sponsor: Sinovac Research and Development Co., Ltd.

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.

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-08
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-20
• Primary Completion: 2022-01-24
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group of children aged 6-11 years old	Inactivated COVID-19 Vaccine	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
Experimental Group of children aged 3-5 years old	Inactivated COVID-19 Vaccine	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

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Rushan City Center for Disease Control and Prevention; 🇨🇳 Weihai, Shandong, China