Novartis Phase III study shows meningococcal B vaccine candidate could be first to provide broad coverage against deadly disease, Novartis International AG
Release Date: 2010-09-12
New Phase III data presented by Novartis Vaccines indicate that the investigational Multicomponent Meningococcal Serogroup B Vaccine (4CMenB) has the potential to be the first broad-coverage vaccine against the dynamic and deadly meningococcal B (MenB) disease. The data were presented at the International Pathogenic Neisseria Conference (IPNC) in Banff, Canada.This trial involving more than 3,600 infants has met its primary end points. Results show that the large majority of those vaccinated with 4CMenB at the same time as other routine vaccines achieved a robust immune response against all vaccine MenB antigens. Additionally, results show that 4CMenB had an acceptable tolerability profile when co-administered with other routine infant vaccines, which supports potential use of the vaccine in the first year of life, when the medical need is greatest.
These new phase III data are part of a comprehensive clinical program led by Novartis to show that 4CMenB can be used across all age groups and can be either co-administered with other routine vaccines or as part of a flexible vaccination schedule. Additional Phase III trial results from ongoing studies are expected this autumn. The comprehensive data of more than 7,500 subjects is expected to be the basis for the planned filing in the EU by year end.
| Type: | NORMAL |
| Company: | Novartis International AG |
| Country: | Switzerland |