NCT06484686

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

An Open-label Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 6 and 10 Years After Booster Dose Immunization with Live Attenuated Varicella Vaccine

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Live Attenuated Varicella Vaccine	lyophilized powder, subcutaneous injection

Timeline

• Start date: 2024-09-16
• Primary completion: 2028-12-01
• Completion: 2031-12-01
• First posted: 2024-07-03
• Last updated: 2025-01-27

Locations

1 site across 1 country: China