Clinical Trial: Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biolog
Brief Summary: Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
- Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: GlaxoSmithKline
Dates:
Date Received: December 1, 2006
Date Started: July 2004
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016
