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Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC | BIOLOGICAL | 0.5 mL, 4 doses, IM |
Inclusion Criteria: * Infants aged 42 to 89 days inclusive on the day of inclusion. * Born at full term of pregnancy (\>37 weeks). * Informed consent form signed by the parent(s) or legally authorized representative. * Able to attend all scheduled visits and to comply with the study procedures. * P...
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC is an investigational pediatric combination vaccine developed by Sanofi. It is designed to protect against diphtheria, pertussis, polio, hepatitis B, and tetanus in a single regimen. The vaccine combines diphtheria and tetanus toxoids, acellular pertussis components, inactivated poliovirus, and a hepatitis B component.
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC is being studied for active immunization against diphtheria, pertussis, polio, hepatitis B, and tetanus in infants and young children. The Phase 2 trial enrolled healthy pediatric participants starting at 42 days of age. It is an investigational combination vaccine and has not been approved for use.
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating this pediatric combination vaccine candidate.
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC is in Phase 2 clinical development. It is an investigational vaccine and is not FDA approved. The Phase 2 study has been completed, and no active trials of this candidate are currently listed.
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC was evaluated in one completed Phase 2 trial, NCT00362427, titled Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar. The trial enrolled 460 healthy participants in Canada, was randomized and active controlled, and included infants from 42 days of age.