Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
Condition: Measles; Mumps; Rubella; Measles-Mumps-Rubella Vaccine
MeSH terms: Measles; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate end of shelf-life potency in terms of the
      immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck
      & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
    

Detailed description: 
      This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center,
      multi-country study with four parallel groups. This study will evaluate the immunogenicity
      and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR
      vaccine, throughout this document) in contrast to the US standard of care comparator vaccine
      (M-M-R II, Merck and Co., Inc., referred to as Com_MMR throughout this document) in children
      during their second year of life. The first dose of this two-dose study is designed to
      establish the end of shelf-life potency of Inv_MMR vaccine. The Inv_MMR vaccine will be given
      as one of two lots; one of a minimum potency, designated Inv_MMR_Min; and the other at a
      mid-range or medium potency designated Inv_MMR_Med to two groups. The second dose for both of
      these Inv_MMR groups will have a potency within the release range of the marketed vaccine.
      The Com_MMR vaccine will consist of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be
      analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered
      with Varivax, Havrix and (in the US sub-cohort only) Prevnar 13 which are routinely
      administered to children of this age in the US.
    

Intervention name(s): Priorix; M-M-R II; Varivax; Havrix; Prevnar 13
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Subjects receive one dose of either minimum (Inv_MMR_Min) or medium (Inv_MMR_Med) potency lot at Day 0 and a dose of separate potency lot (Inv_MMR_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.; Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.; Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.; Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.; US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.
Other intervention name(s): GSK Biologicals' live attenuated measles; mumps; rubella vaccine; Merck & Co.; Inc.'s measles; mumps; rubella virus vaccine; live; Merck & Co.; Inc.'s varicella virus vaccine; live; GSK Biologicals' hepatitis A vaccine; inactivated; Pfizer Inc.'s pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Measles, mumps and rubella diseases; Immunogenicity