A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants.
Phase of Trial: Phase III
Latest Information Update: 12 Apr 2016
At a glance
- Drugs Meningococcal vaccine group B OMV Novartis (Primary) ; Hib-DTaP-hepatitis B-poliovirus vaccine; Meningococcal vaccine group C conjugate; Pneumococcal 7-valent CRM197 vaccine conjugate
- Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal group B infections; Pertussis; Poliomyelitis; Tetanus
- Focus Adverse reactions; Pharmacodynamics; Registrational
- Sponsors Novartis Vaccines
- 12 Apr 2016 Results (pooled analysis of this and other three studies) assessing whether pooled-sera hSBA titres predict individual seroprotection published in the Vaccine.
- 19 Jan 2013 Results for the immunogencity and safety substudies in the primary phase and for the booster study published in the Lancet.
- 01 Mar 2012 Actual patient number is 3600 as reported by EudraCT (Extension trial: EudraCT2008-006301-17).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History