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OpenTrials
Completed

NCT Number: NCT05198336

Immunogenicity of an Inactivated COVID-19 Vaccine

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.

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Key information

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rushan City Center for Disease Control and Prevention

Weihai, Shandong, 250014, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inactivated Covid-19 vaccine

Biological

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

Other names: CoronaVac

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sinovac Research and Development Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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