Skip to main content
OpenTrials
Completed

NCT Number: NCT06994052

Study on Booster Immunization With Varicella Vaccine at Different Intervals

The goal of this clinical trial is to evaluate the immunogenicity and safety of booster immunization of varicella live attenuated vaccine (varicella vaccine hereafter) at different intervals.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jiangsu Provincial Center for Disease control and Prevention

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy children aged 7-12 years;
  • Has previously received a single dose of varicella vaccine, with at least 3 months since the first dose;
  • The subject or legal guardian can understand and sign the informed consent form (double signature is required for those over 8 years old);
  • Participants and their legal guardians voluntarily participate in the study and are able to comply with all study procedures;
  • Provide legal identity proof;

Exclusion criteria

  • History of varicella;
  • History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioedema, dyspnea, etc.);
  • Suffering from acute disease, severe chronic disease, acute exacerbation of chronic disease;
  • With any confirmed or suspected immunodeficiency disease, immunocompromised or receiving immunosuppressive therapy (including systemic steroid therapy);
  • With a history of congenital immune diseases or close contact with family members with a history of congenital immune diseases;
  • With encephalopathy, uncontrolled epilepsy, other progressive neurological disorders, history of Guillain-Barre syndrome;
  • Body temperature >37℃ at the time of vaccination;
  • Receipt of blood products within 3 months before receiving investigational vaccine;
  • Receipt of another study drug within 30 days before receipt of the investigational vaccine;
  • Receipt of live attenuated vaccine within 28 days before receipt of investigational vaccine;
  • Receipt of subunit or inactivated vaccine within 7 days before receipt of investigational vaccine;
  • Participated in other clinical trials before enrollment and were enrolled in another clinical trial during the follow-up period or planned to participate in another clinical trial within 3 months;
  • The participant had any other factors that were ineligible for vaccination by in the investigator's judgment.

Treatment and study plan

Varicella vaccine

Biological

lyophilized powder, subcutaneous injection

Primary outcomes

  1. Geometric mean titer (GMT) of varicella-zoster virus (VZV) antibodies

    Time frame: 30 days after booster dose immunization

    GMT of VZV antibodies 30 days after booster dose immunization

Secondary outcomes

  1. Seroconversion rate of varicella-zoster virus (VZV) antibodies

    Time frame: 30 days after booster dose immunization

    Seroconversion rate of VZV antibodies 30 days after booster dose immunization

  2. Seropositive rate of varicella-zoster virus (VZV) antibodies

    Time frame: 30 days after booster dose immunization

    Seropositive rate of VZV antibodies 30 days after booster dose immunization

  3. Geometric mean increase (GMI) of varicella-zoster virus (VZV) antibodies

    Time frame: 30 days after booster dose immunization

    GMI of VZV antibodies 30 days after booster dose immunization

Sponsors and collaborators

Lead sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd.

Industry

Registry information

Official study title

A Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Immunization With Varicella Vaccine at Different Intervals Among Children Aged 7-12 Years

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 29, 2025
Registry last updated
May 29, 2025

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.

Published trials that share one or more normalized conditions with this study.