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
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
- 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