A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13 and RotaTeq.

Trial Profile

A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13 and RotaTeq.

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jul 2017

At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; DTaP vaccine; Hepatitis B vaccine; Hib vaccine conjugate; Hib-DTaP-poliovirus vaccine; Pneumococcal 13-valent CRM197 vaccine conjugate; Rotavirus W179-9 vaccine
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Rotavirus infections; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 15 Mar 2016 Time frame of primary endpoints changed, according to ClinicalTrials.gov record.
    • 27 Jul 2015 Results published in the Pediatrics.
    • 12 Oct 2014 Results presented at the IDWeek 2014.
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