Clinical Trial: Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase IIIb, Open, Randomised, Multicentre, Primary Study in Healthy Children, to Establish the Non-inferiority of GlaxoSmithKline (GSK) Biologicals' MeMuRu-OKA Vaccine (Administered at 9 and 15 Mont
Brief Summary: The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: Seroconversion rates for measles, mumps, rubella and varicella [ Time Frame: Approximately 42 to 56 days after the second vaccine dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Seroconversion rates for measles, mumps and rubella [ Time Frame: Approximately 42 to 56 days after the first vaccine dose ]
- Measles, mumps, rubella and varicella antibody titres [ Time Frame: 42 to 56 days after the first and second dose. ]
- Occurrence of solicited local symptoms [ Time Frame: Within 4 days (Day 0 - 3) after vaccination ]
- Occurrence of solicited general symptoms [ Time Frame: Within 43 days (Day 0 - 42) after vaccination ]
- Occurrence of unsolicited signs and symptoms [ Time Frame: Within 43 days (Day 0 - 42) after vaccination ]
- Occurrence of serious adverse events [ Time Frame: From Day 0 up to 42 to 56 days after the second dose ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: August 20, 2009
Date Started: November 2009
Date Completion:
Last Updated: September 9, 2016
Last Verified: September 2016
