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 being developed for the prevention of Neisseria meningitidis infections, a bacterial cause of meningitis and septicemia. It is intended for use in healthy infants during primary series immunization, with a booster vaccination, and is administered concomitantly with a meningococcal serogroup C conjugate vaccine.
Sanofi (ticker: SNY) is developing the hexavalent vaccine. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in infants.
The hexavalent vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
The hexavalent vaccine has been studied in a Phase 3 trial with NCT number NCT01839175. This completed trial enrolled 350 healthy infants in Finland to evaluate concomitant administration with a meningococcal serogroup C conjugate vaccine during primary series immunization followed by a booster.
No, the hexavalent vaccine is classified as a monoclonal antibody modality in the development pipeline, but it is a vaccine designed to elicit an immune response against Neisseria meningitidis. It is not a therapeutic monoclonal antibody.
The Phase 3 trial for the hexavalent vaccine was a randomized, active-controlled study. It was not double-blind and enrolled 350 healthy infants aged 46 days and older in Finland. The trial has been completed.