Clinical Trial: Safety of a Second Dose of Biken's Varicella Vaccine

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

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

Brief Summary:

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.

Detailed Summary:
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: To provide information concerning the safety after administration of Varicella vaccine [ Time Frame: one month after vaccination ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: January 27, 2009
Date Started: January 2009
Date Completion:
Last Updated: June 6, 2013
Last Verified: June 2013