A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Phase of Trial: Phase II
Latest Information Update: 26 Jul 2016
At a glance
- Drugs Meningococcal vaccine group B OMV Novartis (Primary)
- Indications Meningococcal group B infections
- 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.
- 13 Oct 2012 New source identified and integrated (second extension study: EudraCT2011-004931-30).
- 28 Apr 2012 Planned patient number of extension trial (EudraCT2009-011676-30) changed from 1587 to 1900.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History