A phase III, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa (TM)) administered to Indian infants according to a 6-10-14 weeks and a 2-4-6 months schedule.

Trial Profile

A phase III, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa (TM)) administered to Indian infants according to a 6-10-14 weeks and a 2-4-6 months schedule.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa) (Primary)
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 05 Oct 2012 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
    • 25 May 2012 Actual initiation date (Apr 2012) added as reported by ClinicalTrials.gov.
    • 25 May 2012 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.
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