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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2012

At a glance

  • Drugs Hib-DTaP-poliovirus vaccine; Pneumococcal 13-valent CRM197 vaccine conjugate; Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Most Recent Events

    • 14 Aug 2012 Actual patient number changed from 600 to 613 as reported by ClinicalTrials.gov (Parent trial: NCT00366678).
    • 14 Aug 2012 Actual patient number changed from 600 to 613 as reported by ClinicalTrials.gov (Parent trial: NCT00366678).
    • 27 Apr 2012 Actual initiation adet changed from Apr 2010 to Feb 2010 as reported by European Clinical Trials Database (Extension trial: EudraCT2009-015321-37).
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