NCT00969436

Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM

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 Months of Age) Versus Priorix™ (9 Months of Age) and Priorix™ Co-administered With Varilrix™ at 15 Months of Age (Comparator) and Also to Evaluate the Non-inferiority of Priorix™ (9 Months of Age) and MeMuRu-OKA Vaccine (15 Months of Age) Versus the Comparator, All Administered Subcutaneously as Two-dose Primary Vaccination Course

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 9 Months – 10 Months
• Healthy volunteers: Accepted

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.

Conditions

• Varicella
• Rubella
• Mumps
• Measles

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biological's investigational MMRV vaccine 208136	Subcutaneous injection
BIOLOGICAL	Priorix™	Subcutaneous injection
BIOLOGICAL	Varilrix™	Subcutaneous injection

Timeline

• Start date: 2009-11-09
• Primary completion: 2011-02-21
• Completion: 2011-02-21
• First posted: 2009-09-01
• Last updated: 2018-06-08
• Results posted: 2017-09-25

Locations

6 sites across 1 country: India