Safety of a Second Dose of Biken's Varicella Vaccine
The objective of the present study is to assess and document the safety of a second dose of Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having previously received a first dose of Varicella Biken vaccine.
All subjects will receive a second dose of Varicella vaccine (Varicella Biken) at 4 to 6 years of age.
The expected total duration of follow-up (first visit to last visit) for each subject will be one month.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Safety of a Second Dose of Biken's Varicella Vaccine Administered at 4 to 6 Years of Age in Healthy Children in Argentina|
- To provide information concerning the safety after administration of Varicella vaccine [ Time Frame: one month after vaccination ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Biological: Live Attenuated Varicella Virus Vaccine
0.5 mL, Subcutaneous
Other Name: Varicela Biken
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830648
|Buenos Aires, Argentina, C1406DGI|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|