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DTaP-IPV-Hep B-PRP~T combined vaccine · 1 trial · 6 indications
Anti-Diphtheria antibodies will be measured by a toxin neutralization test
Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Participants will receive 3 injections of the study vaccine (DTaP-IPV-Hep B-PRP\~T combined vaccine) at 2, 4, and 6 months of age |
| Group B | ACTIVE_COMPARATOR | Participants will receive 2 injections of monovalent Hep B vaccine (Euvax B®) at age 1 and 6 months and 3 injections of DTaP IPV//PRP\~T vaccine (Pentaxim™) at age 2, 4, and 6 months |
| Name | Type | Description |
|---|---|---|
| DTaP-IPV-Hep B-PRP~T combined vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP-IPV//PRP~T and Hepatitis B vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 30 to 40 days on the day of the first study visit * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative * Participant and parent/legally ...
DTaP-IPV-Hep B-PRP~T combined vaccine is an investigational combination vaccine being developed for the prevention of diphtheria, tetanus, pertussis, Haemophilus influenzae type b infection, poliomyelitis, and hepatitis B. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
DTaP-IPV-Hep B-PRP~T combined vaccine is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The vaccine is currently in Phase 3 clinical trials and remains investigational.
DTaP-IPV-Hep B-PRP~T combined vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed, and the vaccine is not currently in active clinical trials.
DTaP-IPV-Hep B-PRP~T combined vaccine has one completed Phase 3 clinical trial, registered as NCT02094833. This trial enrolled 310 participants in South Korea and compared the vaccine against a combination of DTaP-IPV//PRP~T vaccine plus hepatitis B vaccine in infants who were already primed for hepatitis B.
DTaP-IPV-Hep B-PRP~T combined vaccine is not the same as DTaP-IPV//PRP~T combined vaccine. The former includes a hepatitis B component, while the latter does not. In clinical trial NCT02094833, the two vaccines were compared directly, with the hepatitis B vaccine given separately in the comparator arm.