A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom.

Trial Profile

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom.

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2016

At a glance

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

    • 21 Mar 2011 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 11 Aug 2010 Status changed from completed to recruiting, according to UKCRN record.
    • 26 Mar 2010 Follow-on study identified and integrated (NCT01095471).
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