Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REPEVAX · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| REPEVAX | EXPERIMENTAL | - |
| Monovalent tetanus vaccine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| REPEVAX | BIOLOGICAL | 1 dose of 0.5 mL at Day 0 |
| Monovalent Tetanus vaccine | BIOLOGICAL | 1 dose of 0.5 mL at Day 0 |
Inclusion Criteria: * Healthy adults aged ≥18 years * Last booster with a T-containing vaccine received 5 to 10 years prior to the administration of the study vaccine (documented by written evidence) * Subject with vaccination history of a primary immunisation with a tetanus, diphtheria and poliomy...
REPEVAX is an investigational vaccine candidate developed by Sanofi. It is being studied as a combined Tdap-IPV vaccine, meaning it combines tetanus, diphtheria, pertussis, and inactivated poliovirus components. It has been evaluated in healthy adult volunteers rather than in a specific disease population.
REPEVAX is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the vaccine candidate.
REPEVAX is in Phase 3 clinical development. It is investigational and has not been established as an approved product based on the available development information. The Phase 3 trial evaluating it has been completed.
REPEVAX has been studied in one Phase 3 trial, NCT00928785, titled Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults. The trial enrolled 52 participants, was randomized and active-controlled, and was conducted in France and Germany. It is now completed.
The completed Phase 3 trial of REPEVAX, NCT00928785, enrolled healthy adult volunteers aged 18 years and older, with no restriction by sex. Participants were randomized to receive either the Tdap-IPV combined vaccine or a tetanus monovalent vaccine as the active control.