A phase III randomized, single-blind, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals' 10-valent pneumococcal conjugate vaccine with Pediacel™ versus co-administration with Infanrix hexa™, when administered to infants as a three-dose primary vaccination course during the first six months of life and as a booster dose at 11-13 months of age.

Trial Profile

A phase III randomized, single-blind, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals' 10-valent pneumococcal conjugate vaccine with Pediacel™ versus co-administration with Infanrix hexa™, when administered to infants as a three-dose primary vaccination course during the first six months of life and as a booster dose at 11-13 months of age.

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Sep 2017

At a glance

  • Drugs Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa) (Primary) ; Pneumococcal 10-valent vaccine conjugate (Primary) ; Hib-DTaP-poliovirus vaccine; Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Otitis media; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 28 Oct 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 17 Dec 2010 Planned End Date changed from 1 Nov 2010 to 1 Dec 2010 as reported by ClinicalTrials.gov.
    • 13 Jan 2010 Planned end date changed from 1 May 2010 to 1 Nov 2010 as reported by ClinicalTrials.gov.
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