An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine

Sinovac

Status and phase: Invitation-only; Phase 4

Conditions: Varicella

Treatments: Biological: Live Attenuated Varicella Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06484686

PRO-VZV-4005

Details and patient eligibility

About

This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose.

Full description

A total of 792 subjects aged 2 to 6 years including in per-protocol set (PPS) of immunogenicity assessment from previous phase Ⅲ clinical trial were enrolled. About 3.0ml of venous blood was collected at 6 and 10 years after booster immunization for antibody detection.

Enrollment: 414 estimated patients

Sex: All

Ages: 8 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects in PPS of previous phase Ⅲ clinical trial of varicella vaccine;
• The subjects and/or guardian can understand and voluntarily sign the informed consent form;
• Proven legal identity.

Exclusion criteria

• Beyond the blood collection window period;
• History of varicella or shingles;
• History of varicella vaccination since phase Ⅲ clinical trial;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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414 participants in 1 patient group

Experimental Group

Experimental group

Description:

Subjects will be collected venous blood at 6 and 10 years after booster immunization.

Treatment:

Biological: Live Attenuated Varicella Vaccine