NCT05839301

A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age

A Single-center, Randomized, Double-blind Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the lot-to-lot consistency, immunogenicity, and safety of 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 lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy people 1 to 12 years of age.1200 healthy subjects aged 1-12 years were enrolled after their guardians passed the informed consent, inclusion and exclusion criteria screening in turn. Three batches were randomized in a 1:1: 1 ratio, with 400 subjects in each batch.All subjects received 1 dose of trial vaccine (Batch 1 or Batch 2 or Batch 3) and all were collected Blood samples were collected from subjects before vaccination, on Day 30 after vaccination for serum neutralizing antibody testing to evaluate immunogenicity, and Safety observations were performed until 6 months post-vaccination in all subjects.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Investigational live attenuated varicella vaccine (lot 1)	0.5ml/vial
BIOLOGICAL	Investigational live attenuated varicella vaccine (lot 2)	0.5ml/vial
BIOLOGICAL	Investigational live attenuated varicella vaccine (lot 3)	0.5ml/vial

Timeline

• Start date: 2023-04-27
• Primary completion: 2023-07-30
• Completion: 2024-04-30
• First posted: 2023-05-03
• Last updated: 2023-06-18

Locations

1 site across 1 country: China