Reason for request
-
Clinical Benefit
Substantial |
Substantial in subjects aged 12 months and older, and only in those populations recommended by the Haut Conseil de santé publique ( HCSP, or the French High Council for Public Health), i.e., people with risk factors for invasive meningococcal infections and people visiting an endemic area. |
Clinical Added Value
major |
In light of the available information and given the lack of alternative treatments with a Marketing Authorisation for serogroups A, W135 and Y in the 12-to-23-month age range, the Committee considers that NIMENRIX offers a substantial improvement in actual benefit (IAB I) in the prevention of invasive meningococcal infection caused by serogroups A, W135 and Y in children 12 to 23 months of age in the populations recommended by the HCSP. |
no clinical added value |
NIMENRIX does not offer an improvement in actual benefit (non-existent IAB) in the prevention of invasive meningococcal infection caused by serogroups A, C, W135 and Y in children aged 2 years and older, adolescents and adults. |