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A Phase 3, Randomized, Active-Controlled, Double-Blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-Valent Pneumococcal Conjugate Vaccine Compared to a 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany

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Trial Profile

A Phase 3, Randomized, Active-Controlled, Double-Blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-Valent Pneumococcal Conjugate Vaccine Compared to a 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2012

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At a glance

  • Drugs Pneumococcal 13-valent CRM197 vaccine conjugate (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Otitis media; Pertussis; Pneumococcal infections; Pneumonia; Poliomyelitis; Tetanus
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Most Recent Events

    • 22 Jun 2011 Results published in Vaccine.
    • 29 Oct 2009 Results were presented at IDSA 2009.
    • 27 Oct 2008 Study results have been reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA).
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