Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Meningococcal B vaccine · 1 trial · 2 indications
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever \>=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | Vaccine candidate formulation I |
| 2 | OTHER | Vaccine candidate formulation II |
| 3 | OTHER | Vaccine candidate formulation III |
| 4 | OTHER | Vaccine candidate formulation IV |
| 5 | OTHER | Vaccine candidate formulation V |
| 6 | OTHER | Vaccine candidate formulation VI |
| 7 | OTHER | Control |
| 8 | OTHER | Vaccine candidate formulation I with antipyretic |
| Name | Type | Description |
|---|---|---|
| Meningococcal B vaccine | BIOLOGICAL | Vaccine candidate formulation I |
| Control | BIOLOGICAL | Control |
| Meningococcal B vaccine with antipyretic | BIOLOGICAL | Vaccine candidate formulation I with antipyretic |
Inclusion Criteria: * Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg * Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol re...
The Meningococcal B vaccine is an investigational vaccine developed by Novartis AG for the prevention of meningococcal meningitis and meningococcal infections caused by serogroup B bacteria. It is designed to stimulate immune protection in young infants, with clinical testing focused on dosing and formulation in two-month-old babies.
The Meningococcal B vaccine is being studied to prevent meningococcal meningitis and other meningococcal infections. The completed Phase 2 trial evaluated safety and immune response in healthy two-month-old infants across Argentina, Chile, Czechia, Hungary, and Italy, targeting protection at the earliest possible age.
Novartis AG, which trades under the ticker NVS, is the developer of the Meningococcal B vaccine. The company sponsored the clinical program evaluating this vaccine candidate in infants for the prevention of meningococcal meningitis and related meningococcal infections.
The Meningococcal B vaccine is in Phase 2 development. Its single recorded trial, NCT00937521, is a completed Phase 2 study, and no trials are currently listed as active. The vaccine remains investigational and is not described as approved.
The Meningococcal B vaccine has been studied in one clinical trial, NCT00937521, titled Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants. This completed Phase 2 trial enrolled 1,507 healthy infants, was randomized and controlled, and took place in Argentina, Chile, Czechia, Hungary, and Italy.