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A Phase I/II, 2-Stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants

Trial Profile

A Phase I/II, 2-Stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 17 Aug 2012

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At a glance

  • Drugs Pneumococcal 13-valent CRM197 vaccine conjugate (Primary) ; Aluminium phosphate; DTaP-hepatitis B-poliovirus vaccine; Hib vaccine conjugate; Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Wyeth
  • Most Recent Events

    • 01 May 2010 Results reported in Pediatrics.
    • 04 Dec 2007 Status changed from no longer recruiting to completed, according to clinicaltrials.gov record
    • 11 Dec 2006 Status change
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