A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants.

Trial Profile

A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants.

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jan 2014

At a glance

  • Drugs Meningococcal vaccine groups A C Y W-135 conjugate (Primary) ; DTaP vaccine; Hepatitis A vaccine; Hib vaccine; Measles mumps and rubella virus vaccine; Pneumococcal vaccine conjugate; Poliovirus vaccine inactivated; Varicella vaccines
  • Indications Meningococcal group A infections; Meningococcal group C infections; Meningococcal group W-135 infections; Meningococcal group Y infections; Meningococcal infections
  • Focus Adverse reactions; Registrational
  • Sponsors Novartis
  • Most Recent Events

    • 03 Jun 2011 Planned end date changed from 1 Mar 2011 to 1 Nov 2011 as reported by ClinicalTrials.gov.
    • 17 Aug 2010 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
    • 13 May 2009 Planned number of patients changed from 4300 to 7700 as reported by ClinicalTrials.gov.
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