Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hexavalent vaccine · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | - |
| Group 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Hexavalent vaccine | BIOLOGICAL | 0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster) |
| NeisVac-C | BIOLOGICAL | 0.5 mL intramuscular injection at 2 and 4 months of age |
| Prevenar 13 | BIOLOGICAL | 0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster) |
| RotaTeq | BIOLOGICAL | 2 mL oral administration at 2, 3 and 4 months |
| Nimenrix | BIOLOGICAL | 0.5 mL intramuscular injection at 12 months |
| M-M-RVAXPRO | BIOLOGICAL | 0.5 mL intramuscular or subcutaneous injection at 13 months of age |
Inclusion Criteria: * Healthy infant 46 to 74 days of age (both inclusive) * Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg * Subject's parent(s) or legal representative able to comply with the study procedures Exclusion Criteria: * Participation in another clinical ...
The hexavalent vaccine is an investigational vaccine developed by Sanofi for the prevention of Neisseria meningitidis infection. It is designed to protect against multiple pathogens in a single formulation. It is being studied in healthy infants as part of routine immunization schedules, including concomitant administration with other vaccines.
The hexavalent vaccine is intended for active immunization against Neisseria meningitidis, the bacterium that causes meningococcal disease. It is being evaluated in healthy infants during primary series immunization and booster vaccination. The goal is to prevent bacterial infections and related virus diseases in this population.
The hexavalent vaccine is being developed by Sanofi, a global pharmaceutical company. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY. The company is responsible for the clinical development program, including the Phase 3 trial conducted in Finland.
The hexavalent vaccine is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 trial has been completed, and no active trials are currently listed for this vaccine candidate.
The hexavalent vaccine has been studied in one completed Phase 3 clinical trial, NCT01839175. This trial enrolled 350 healthy infants in Finland, aged 46 days and older, and evaluated concomitant administration with a meningococcal serogroup C conjugate vaccine during primary series immunization followed by booster vaccination. The trial was randomized and active-controlled.