NCT02965404

A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children

A Blind, Randomized and Controlled Clinical Trial to Evaluate the Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
• Sex: All
• Age: 1 Year – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.

Detailed description

This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group, positive control group, or negative control group in the ratio 1:1:1.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Investigational live attenuated varicella vaccine	The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
BIOLOGICAL	control live attenuated varicella vaccine	The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
BIOLOGICAL	diluent of lyophilized vaccine	The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-05-01
• Completion: 2016-08-01
• First posted: 2016-11-16
• Last updated: 2017-10-26

Locations

1 site across 1 country: China