Study on Booster Immunization With Varicella Vaccine at Different Intervals

NCT06994052 | Completed Phase 4

• 1 other identifier: PRO-VAR-MA4004-JS-1
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

VZV; Varicella Immunisation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Seroconversion rate of varicella-zoster virus (VZV) antibodies

  30 days after booster dose immunization

• Seropositive rate of varicella-zoster virus (VZV) antibodies

  30 days after booster dose immunization

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

  30 days after booster dose immunization

Study Arms (4)

Group A

EXPERIMENTAL

Participants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination.

Biological: Varicella vaccine

Group B

EXPERIMENTAL

Participants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination.

Biological: Varicella vaccine

Group C

EXPERIMENTAL

Participants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination.

Biological: Varicella vaccine

Group D

EXPERIMENTAL

Participants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination.

Biological: Varicella vaccine

Interventions

Varicella vaccine BIOLOGICAL

lyophilized powder, subcutaneous injection

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Jiangsu Provincial Center for Disease control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Interventions

Chickenpox Vaccine

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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: May 20, 2025
• First Posted: May 29, 2025
• Study Start: September 21, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)