Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children.
This study has been completed.
Information provided by:
First received: July 3, 2007
Last updated: December 9, 2008
Last verified: December 2008
To observe the safety and tolerability of the administration of VARIVAX in varicella history negative Indian children 12 months to 12 years of age.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX (V210)in Healthy Indian Children|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination [ Time Frame: 6 weeks post-vaccination ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
Biological: Varicella Virus Vaccine Live (Oka-Merck)
VARIVAX(TM) (Refrigerated) [Varicella Virus Vaccine Live (Oka/Merck), Refrigerator-Stable Formulation.] Subjects enrolled in the study received one 0.5 mL subcutaneous dose of VARIVAX(TM). Frequency is single dose.
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