A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months.

Trial Profile

A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2017

At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; MMR-varicella zoster virus vaccine; Pneumococcal 13-valent CRM197 vaccine conjugate; Rotavirus W179-9 vaccine
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Measles; Mumps; Pertussis; Pneumococcal infections; Poliomyelitis; Rotavirus infections; Rubella; Tetanus; Varicella zoster virus infections
  • Focus Pharmacodynamics; Therapeutic Use
  • Sponsors sanofi pasteur MSD
  • Most Recent Events

    • 11 Nov 2016 Primary endpoint has been met. (Compare the immunogenicity elicited by DTaP5-HB-IPV-Hib to that of Control when given at 2, 3, 4, and 12 months)
    • 11 Nov 2016 Primary endpoint has been met. (Evaluate the immunogenicity of DTaP5-HB-IPV-Hib when given at 2, 3, 4, and 12 months)
    • 11 Nov 2016 Results published in the Pediatric Infectious Disease Journal
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