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, 4, and 11 to 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, 4, and 11 to 12 months

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jul 2017

At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate; RIX 4414
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Rotavirus infections; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors sanofi pasteur MSD
  • Most Recent Events

    • 07 Jun 2016 Primary endpoint for the non-inferiority hypothesis (Vaccine-induced antibody responses against antigens that are contained in both PR5I and the control vaccine after the Toddler dose (~12 months)) has been met according to the results published in the Vaccine.
    • 07 Jun 2016 Primary endpoint for the acceptability hypothesis (Vaccine-induced antibody responses to all antigens contained in PR5I following the Toddler dose (~12 months)) has been met according to the results published in the Vaccine.
    • 07 Jun 2016 Results published in the Vaccine
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top