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A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule

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Trial Profile

A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs Hib-meningococcal vaccine groups C and Y conjugate (Primary) ; DTaP-hepatitis B-poliovirus vaccine; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Hib-meningococcal vaccine group C conjugate; Meningococcal vaccine group C conjugate
  • Indications Haemophilus infections; Meningococcal meningitis
  • Focus Pharmacodynamics
  • Sponsors GlaxoSmithKline

Most Recent Events

  • 23 Dec 2014 New trial record

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