Immunogenicity of an Inactivated COVID-19 Vaccine

NCT05198336 | Completed Phase 4

• 1 other identifier: PRO-nCOV-MA4007-SD
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental Group of children aged 3-5 years old

EXPERIMENTAL

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

Experimental Group of children aged 6-11 years old

EXPERIMENTAL

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

Interventions

Inactivated COVID-19 Vaccine BIOLOGICAL

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

Also known as: CoronaVac

Experimental Group of children aged 3-5 years old; Experimental Group of children aged 6-11 years old

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac Research and Development Co., Ltd.: lead

Study Sites (1)

Rushan City Center for Disease Control and Prevention

Weihai, Shandong, 250014, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Qing Xu

  Shandong Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 20, 2022
• Study Start: January 8, 2022
• Primary Completion: January 24, 2022
• Study Completion: December 30, 2022
• Last Updated: September 25, 2023

Record last verified: 2022-01

Locations

CN (1)