A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age

Trial Profile

A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age

Completed
Phase of Trial: Phase III

Latest Information Update: 19 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; Mumps; Pertussis; Pneumococcal infections; Poliomyelitis; Rubella; Tetanus
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 03 Aug 2012 Official Title amended as reported by ClinicalTrials.gov.
    • 03 Aug 2012 Actual end date changed from 1 Feb 2008 to 1 Aug 2008 as reported by ClinicalTrials.gov.
    • 01 Jun 2011 Primary endpoint 'Immunological-response-rate' has been met.
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