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

2016-11-17 11:38:21 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Varicella

Intervention

Investigational live attenuated varicella vaccine, control live attenuated varicella vaccine, diluent of lyophilized vaccine

Location

Xiangcheng County Center for Disease Control and Prevention
Xuchang
Henan
China
461700

Status

Active, not recruiting

Source

Sinovac (Dalian) Vaccine Technology Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-17T11:38:21-0500

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