A phase II, double-blind, multicentre study to evaluate the safety and immunogenicity of a booster dose of new formulations of GlaxoSmithKline Biologicals' combined DTPa-HBV-IPV/Hib vaccine in healthy toddlers, previously primed with three doses of the same vaccine in study 113948 (DTPA-HBV-IPV-124 PRI)

Trial Profile

A phase II, double-blind, multicentre study to evaluate the safety and immunogenicity of a booster dose of new formulations of GlaxoSmithKline Biologicals' combined DTPa-HBV-IPV/Hib vaccine in healthy toddlers, previously primed with three doses of the same vaccine in study 113948 (DTPA-HBV-IPV-124 PRI)

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Sep 2014

At a glance

  • Drugs Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa) (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics
  • Acronyms DTPa-HBV-IPV-125 BST:124
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 08 May 2013 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health: NCT01453998).
    • 17 Feb 2013 Planned number of patients changed to 720.
    • 17 Feb 2013 New trial record
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