A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS.

Trial Profile

A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS.

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2017

At a glance

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

    • 08 Oct 2017 Results of immune response associated with sequential administration PCV13 followed by PPSV23 presented at the IDWeek 2017
    • 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
    • 04 Mar 2014 Results published in the Vaccine.
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