A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Compared to a 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) in Adults 60 to 64 Years Old Who Are Naive to 23vPS and the Safety, Tolerability, and Immunogenicity of 13vPnC in Adults 18 to 59 Years Old Who Are Naïve to 23vPS.

Trial Profile

A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Compared to a 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) in Adults 60 to 64 Years Old Who Are Naive to 23vPS and the Safety, Tolerability, and Immunogenicity of 13vPnC in Adults 18 to 59 Years Old Who Are Naïve to 23vPS.

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Apr 2017

At a glance

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

    • 25 Apr 2017 Results of pooled post-hoc analysis comparing population from two studies (6115A1-004 and 6115A1-3010) and a subset of immunogenicity from CAPiTA study presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases
    • 12 Jul 2016 According to a Pfizer media release, Prevnar 13 received US FDA approval for expanded age indication to include adults 18 through 49 years of age for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes based on results from this trial.
    • 08 Sep 2015 Results of safety and immunogenicity analysis(n=1285) were published in the Vaccine.
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