Immunogenicity and safety study in preterm and full-term infants of GSK Biologicals' Hib-menC vaccine, Menitorix co-administered with Infanrix Penta and Prevenar at 2, 4, 6 months and as a booster with Infanrix IPV and Prevenar at 16-18 months.

Trial Profile

Immunogenicity and safety study in preterm and full-term infants of GSK Biologicals' Hib-menC vaccine, Menitorix co-administered with Infanrix Penta and Prevenar at 2, 4, 6 months and as a booster with Infanrix IPV and Prevenar at 16-18 months.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2016

At a glance

  • Drugs Hib-meningococcal vaccine group C conjugate (Primary) ; DTaP poliovirus vaccine; DTaP-hepatitis B-poliovirus vaccine; Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal infections; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics; Pharmacokinetics; Registrational
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 19 Feb 2010 Actual end date (1 Nov 2009) added as reported by ClinicalTrials.gv record.
    • 19 Feb 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 27 Jan 2010 Planned number of patients changed from 300 to 313 as reported by ClinicalTrials.gov.
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