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 Brazil.

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 Brazil.

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Oct 2012

At a glance

  • Drugs Pneumococcal 13-valent CRM197 vaccine conjugate (Primary) ; Diphtheria tetanus and pertussis vaccine; Hepatitis B vaccine; Hib vaccine; Pneumococcal 7-valent CRM197 vaccine conjugate; Poliovirus vaccine live oral; Rotavirus vaccine
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Rotavirus infections; Tetanus
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 22 Oct 2012 Primary endpoint 'Immunological-response-rate' has been met.
    • 22 Oct 2012 Results published in Vaccine.
    • 09 Oct 2009 Actual number of patients (309) added as reported by ClinicalTrials.gov
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