Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Trial Profile

Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2016

At a glance

  • Drugs Hib-meningococcal vaccine groups C and Y conjugate (Primary) ; DTaP-hepatitis B-poliovirus vaccine; Hib vaccine conjugate; Measles mumps and rubella virus vaccine; Pneumococcal 7-valent CRM197 vaccine conjugate; Varicella zoster virus vaccine live
  • Indications Chickenpox; Diphtheria; Haemophilus infections; Hepatitis B; Measles; Meningococcal group C infections; Meningococcal group Y infections; Meningococcal infections; Mumps; Pertussis; Pneumococcal infections; Poliomyelitis; Rubella; Tetanus
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 11 Jun 2010 GlaxoSmithKline has received a complete response letter from the US FDA for the Biologics License application for the candidate meningococcal and Hib combination vaccine, MenBibrix, according to a company media release.
    • 31 Oct 2009 Results have been reported at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA).
    • 08 May 2008 Status changed from in progress to completed.
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