A Phase 3b, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life.

Trial Profile

A Phase 3b, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life.

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2015

At a glance

  • Drugs Meningococcal vaccine groups A C Y W-135 conjugate; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Meningococcal group A infections; Meningococcal group C infections; Meningococcal group W-135 infections; Meningococcal group Y infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis Vaccines
  • Most Recent Events

    • 16 Oct 2015 Primary endpoint has been met. (Percentage of Subjects With hSBA 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.), as per an article published in the Pediatric Infectious Disease Journal
    • 16 Oct 2015 Primary endpoint has been met. (Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.), as per an article published in the Pediatric Infectious Disease Journal
    • 16 Oct 2015 Results published in the Pediatric Infectious Disease Journal
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