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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...
Meningococcal B vaccine is an investigational vaccine being developed for the prevention of meningococcal meningitis and meningococcal infections. It is intended for use in infants, with clinical studies evaluating its safety and immunogenicity in this population.
Meningococcal B vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.
Meningococcal B vaccine is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
Meningococcal B vaccine has been studied in a completed Phase 2 trial with the identifier NCT00937521. This trial evaluated safety and immunogenicity in a dose-ranging and formulation-finding study in 2-month-old infants, enrolling 1,507 participants across Argentina, Chile, Czechia, Hungary, and Italy.
Meningococcal B vaccine is commonly referred to as MenB vaccine. The clinical trial NCT00937521 describes it as a Meningococcal B (MenB) vaccine, confirming that these names refer to the same investigational product.