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 a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain [Estudio fase 3, randomizado, controlado, doble ciego para evaluar la seguridad, tolerabilidad e inmunogenicidad de la Vacuna Neumocócica Conjugada 13-valente en niños sanos administrada con la vacuna Meningocóccica C conjugada a toxoide tetánico y otras vacunas de rutina del calendario vacunal en España]

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 a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain [Estudio fase 3, randomizado, controlado, doble ciego para evaluar la seguridad, tolerabilidad e inmunogenicidad de la Vacuna Neumocócica Conjugada 13-valente en niños sanos administrada con la vacuna Meningocóccica C conjugada a toxoide tetánico y otras vacunas de rutina del calendario vacunal en España]

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2013

At a glance

  • Drugs Pneumococcal 13-valent CRM197 vaccine conjugate (Primary) ; Hib-DTaP-hepatitis B-poliovirus vaccine; Hib-DTaP-poliovirus vaccine; Meningococcal vaccine group C conjugate; Pneumococcal 7-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal group C infections; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors Wyeth
  • Most Recent Events

    • 01 Feb 2012 Primary endpoint 'Immunological-response' has been met.
    • 16 Jun 2009 Actual end date (Mar 2009) added as reported by ClinicalTrials.gov.
    • 16 Jun 2009 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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