NCT05669625

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Live Attenuated Varicella Vaccine in Healthy People

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,440 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 1 Year – 59 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.

Detailed description

This trial is aim to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children aged 1-12 years old. This study will be conducted in two stage. the stage 1 adopts an open design, and 20 subjects aged 18\~59 and 13\~17 years old (18\~59 years old→ 13\~17 years old, sequentially enrolled) are enrolled, and 1 dose of the trial vaccine is administered to explore safety. The stage 2 adopts a randomized, blinded, placebo-controlled design, 12400 healthy participants aged 1-12 years old will be randomly assigned into experimental group or control group with the ratio 1:1.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Investigational live attenuated varicella vaccine	0.5 ml/vial
BIOLOGICAL	Placebo of live attenuated varicella vaccine	0.5 ml/vial

Timeline

• Start date: 2022-12-26
• Primary completion: 2024-04-14
• Completion: 2026-09-14
• First posted: 2023-01-03
• Last updated: 2023-06-18

Locations

13 sites across 1 country: China