Study on Booster Immunization With Varicella Vaccine at Different Intervals

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

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.

Study Overview

• Status: Completed
• Conditions: Varicella Immunisation; VZV
• Intervention / Treatment: Biological: Varicella vaccine

• Study Type: Interventional
• Enrollment (Actual): 412
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Participants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination.	Biological: Varicella vaccine; lyophilized powder, subcutaneous injection
Experimental: Group B; Participants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination.	Biological: Varicella vaccine; lyophilized powder, subcutaneous injection
Experimental: Group C; Participants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination.	Biological: Varicella vaccine; lyophilized powder, subcutaneous injection
Experimental: Group D; Participants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination.	Biological: Varicella vaccine; lyophilized powder, subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean titer (GMT) of varicella-zoster virus (VZV) antibodies	GMT of VZV antibodies 30 days after booster dose immunization	30 days after booster dose immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate of varicella-zoster virus (VZV) antibodies	Seroconversion rate of VZV antibodies 30 days after booster dose immunization	30 days after booster dose immunization
Seropositive rate of varicella-zoster virus (VZV) antibodies	Seropositive rate of VZV antibodies 30 days after booster dose immunization	30 days after booster dose immunization
Geometric mean increase (GMI) of varicella-zoster virus (VZV) antibodies	GMI of VZV antibodies 30 days after booster dose immunization	30 days after booster dose immunization

Collaborators and Investigators

• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: May 20, 2025
• First Submitted That Met QC Criteria: May 20, 2025
• First Posted (Actual): May 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Zoster; Chickenpox
• Other Study ID Numbers: PRO-VAR-MA4004-JS-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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