NCT03555071

A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine

A Double-blind, Randomized, Bridging Clinical Trial to Evaluate the Consistency, Immunogenicity and Safety of Live Attenuated Varicella Vaccines for Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,197 (actual)
• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children.

Detailed description

The study is a single-center, double-blind, randomized, bridging clinical trial. The purpose of this study is to evaluate the consistency between each two lots of live attenuated varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated varicella vaccines manufactured at commercialized scale compared to trial-scale, and to evaluate the safety of live attenuated varicella vaccines. 1197 healthy Chinese children aged 1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. Children in the first three groups were administered with one dose of live attenuated varicella vaccines manufactured at commercialized scale, and children in the last group were administered with one dose of live attenuated varicella vaccines manufactured at trial-scale .

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Vaccine manufactured at commercialized scale	Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0
BIOLOGICAL	Vaccine manufactured at trial-scale	Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0

Timeline

• Start date: 2014-04-07
• Primary completion: 2017-05-20
• Completion: 2017-09-14
• First posted: 2018-06-13
• Last updated: 2018-06-13