Clinical Trial: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

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

Official Title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)

Brief Summary: The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

Detailed Summary:

The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine (Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.

The Inv_MMR vaccine will be administered as a second dose to children who already received a first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.


Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given with VV and DTaP-IPV vaccines in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ]
  • Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given without VV and DTaP-IPV in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunogenicity with respect to VV in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ]
  • Immunogenicity with respect to the components of DTaP- IPV vaccine in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ]
  • Occurrence of solicited local symptoms [ Time Frame: Days 0-3 ]
  • Occurrence of solicited general symptoms [ Time Frame: Days 0-42 ]
  • Occurrence of Adverse events of specific interest [ Time Frame: From Day 0 through the end of study (Day 180) ]
  • Occurrence of Unsolicited adverse events [ Time Frame: From Day 0 to Day 42 ]
  • Occurrence of serious adverse events [ Time Frame: From Day 0 through end of study (Day 180) ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: June 14, 2012
Date Started: June 2012
Date Completion:
Last Updated: October 3, 2016
Last Verified: October 2016