Study on Booster Immunization With Varicella Vaccine at Different Intervals

NCT ID: NCT06994052

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-21

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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VZV Varicella Immunisation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Varicella vaccine

Intervention Type BIOLOGICAL

lyophilized powder, subcutaneous injection

Group B

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

Group Type EXPERIMENTAL

Varicella vaccine

Intervention Type BIOLOGICAL

lyophilized powder, subcutaneous injection

Group C

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

Group Type EXPERIMENTAL

Varicella vaccine

Intervention Type BIOLOGICAL

lyophilized powder, subcutaneous injection

Group D

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

Group Type EXPERIMENTAL

Varicella vaccine

Intervention Type BIOLOGICAL

lyophilized powder, subcutaneous injection

Interventions

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Varicella vaccine

lyophilized powder, subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac (Dalian) Vaccine Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangsu Provincial Center for Disease control and Prevention

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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PRO-VAR-MA4004-JS-1

Identifier Type: -

Identifier Source: org_study_id

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