Clinical Trial: Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin

Brief Summary: The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.

Detailed Summary:

Observational Objectives:

To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.


Sponsor: Beijing Center for Disease Control and Prevention

Current Primary Outcome: To evaluate the immunogenicity of evaluated vaccine [ Time Frame: 8 months ]

The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.


Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the safety of live attenuated varicella vaccine [ Time Frame: 4 months ]

The incidence of adverse events was analyzed statistically.


Original Secondary Outcome: Same as current

Information By: Beijing Center for Disease Control and Prevention

Dates:
Date Received: September 9, 2012
Date Started: January 2011
Date Completion:
Last Updated: September 9, 2012
Last Verified: September 2012