A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China

Trial Profile

A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China

Completed
Phase of Trial: Phase III

Latest Information Update: 31 May 2016

At a glance

  • Drugs Pneumococcal 13-valent CRM197 vaccine conjugate (Primary) ; Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Pfizer
  • Most Recent Events

    • 31 May 2016 Primary endpoint (Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3) has been met according to the results published in the Pediatric Infectious Disease Journal.
    • 31 May 2016 Primary endpoint(Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2) has been met according to the results published in the Pediatric Infectious Disease Journal.
    • 31 May 2016 Primary endpoint (Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level 0.35 mcg/mL 1 Month After the Infant Series in Group 3) has been met according to the results published in the Pediatric Infectious Disease Journal.
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