Immunogenicity of an Inactivated COVID-19 Vaccine

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Inactivated COVID-19 Vaccine

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 Type: Interventional
• Enrollment (Actual): 395
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Weihai, Shandong, China, 250014
      • Rushan City Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sinovac Research and Development Co., Ltd.
• Investigators: Principal Investigator: Qing Xu, Shandong Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2022
• Primary Completion (Actual): January 24, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRO-nCOV-MA4007-SD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No