Trial Profile
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
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 03 Aug 2021
Price :
$35
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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.