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Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK 134612) When Co-administered With Routine Vaccines in Healthy Infants and Toddlers.

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Trial Profile

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK 134612) When Co-administered With Routine Vaccines in Healthy Infants and Toddlers.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2023

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At a glance

  • Drugs Meningococcal vaccine groups A C Y W-135 conjugate (Primary) ; Hib-DTP hepatitis B vaccine (Tritanrix-HepB/Hiberix); Pneumococcal 11-valent vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal infections; Pertussis; Pneumococcal infections; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline; GSK

Most Recent Events

  • 18 May 2018 Primary endpoint (Immunogenicity with respect to components of the investigational vaccine in terms of number of subjects with a titer equal to or above the cut-off value) has been met, according to results published in the Vaccine Journal.
  • 18 May 2018 Results published in the Vaccine Journal.
  • 24 Nov 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.

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