A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India.

Trial Profile

A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Pneumococcal 13-valent CRM197 vaccine conjugate (Primary) ; Hib-DTP-hepatitis B vaccine; Pneumococcal 7-valent CRM197 vaccine conjugate; Poliovirus vaccine live oral
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Most Recent Events

    • 23 Feb 2010 Actual end date changed from Dec 2009 to Feb 2010 as reported by ClinicalTrials.gov.
    • 09 Feb 2010 Actual patient number (708) added as reported by ClinicalTrials.gov.
    • 09 Feb 2010 Actual end date (Dec 2009) added as reported by ClinicalTrials.gov.
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