A Phase 3, Randomized, Double-Blind Trial to Evaluate Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered With Trivalent Inactivated Influenza Vaccine in Adults 65 Years of Age or Older, Naive to 23-Valent Pneumococcal Polysaccharide Vaccine.

Trial Profile

A Phase 3, Randomized, Double-Blind Trial to Evaluate Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered With Trivalent Inactivated Influenza Vaccine in Adults 65 Years of Age or Older, Naive to 23-Valent Pneumococcal Polysaccharide Vaccine.

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jun 2013

At a glance

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

    • 16 Feb 2012 Actual patient number changed from 1160 to 1185 as reported by ClinicalTrials.gov.
    • 24 May 2011 Results published in the Vaccine.
    • 24 May 2011 Primary endpoint 'Immunological-response' has been met.
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