Immunogenicity of an Inactivated COVID-19 Vaccine

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05198336
• Other study ID #: PRO-nCOV-MA4007-SD
• Status: Completed
• Phase: Phase 4
• Start date: January 8, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2022
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: December 30, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
China	Rushan City Center for Disease Control and Prevention	Weihai	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Research and Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 28(+14 days) after the second dose of vaccine
Primary	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	Day 28(+14 days) after the second dose of vaccine