Clinical Trial: Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age

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

Official Title: Safety and Immunogenicity Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine

Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix®), comparing it to Merck's MMR vaccine (M-M-R®II), which is approved for use in the US in healthy children 12 to 15 months of age.

Detailed Summary:

This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV_MMR vaccine) at a potency that will be used to define maximum release limits for the Inv_MMR in comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as Com_MMR vaccine). In order to obtain more representative data on the comparator vaccine, the Com_MMR used in this study will consist of two lots designated Com_MMR_L1 and Com_MMR_L2. Throughout the study Com_MMR_L1 and Com_MMR_L2 will be analyzed as pooled lots. This study is intended to support licensure of GSK's MMR vaccine in the US.

All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to participants enrolled in selected non-US countries if local health departments do not routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and varicella vaccine is not part of the study procedures.


Sponsor: GlaxoSmithKline

Current Primary Outcome: Assessment of fever after MMR vaccination [ Time Frame: From Day 5 through Day 12 after vaccination ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of immunogenicity of the MMR vaccines in terms of seroresponse [ Time Frame: At Day 42 after vaccination ]
  • Evaluation of immunogenicity of the MMR vaccines in terms of antibody concentration [ Time Frame: At Day 42 after vaccination ]
  • Occurrence of solicited local symptoms [ Time Frame: From Day 0 to Day 3 after vaccination ]
  • Occurrence of solicited general symptoms [ Time Frame: From Day 0 to Day 14 after vaccination ]
  • Occurrence of solicited general symptoms [ Time Frame: From Day 0 to Day 42 after vaccination ]
  • Occurrence of unsolicited adverse events (AEs) [ Time Frame: From Day 0 to Day 42 after vaccination ]
  • Occurrence of AEs of specific interest [ Time Frame: From Day 0 through study end (Day 180) ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From Day 0 through study end (Day 180) ]
  • Occurrence of any measles-like illness [ Time Frame: From Day 5 through Day 12 after vaccination ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: July 3, 2014
Date Started: August 2014
Date Completion:
Last Updated: September 22, 2016
Last Verified: May 2016