Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DTaP-IPV/PRP~T combined vaccine & Recombinant hep B vaccine · 2 trials · 6 indications
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).
Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.
Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.
| Arm | Type | Description |
|---|---|---|
| Group A (SP0204) | EXPERIMENTAL | Participants will receive DTaP-IPV/Hib vaccine administered subcutaneously |
| Group B (control) | ACTIVE_COMPARATOR | Participants will be given a co-administration of DTaP-IPV vaccine and Hib vaccine subcutaneously |
| Group C | EXPERIMENTAL | Participants will receive DTaP-IPV/Hib vaccine administered intramuscularly |
| DTacP IPV HepB PRP-T Combined Vaccine Group | EXPERIMENTAL | Participant will receive a booster dose of PENTAXIM™ having received DTacP-IPV-HepB-PRP-T (primary series) in Study A3L02. |
| PENTAXIM™ and ENGERIX B® Vaccine Group | ACTIVE_COMPARATOR | Participant will receive a booster dose of PENTAXIM™ having received ENGERIX B® and PEDIATRICO in Study A3L02 (Primary series) |
| Name | Type | Description |
|---|---|---|
| DTaP-IPV/Hib Combined vaccine | BIOLOGICAL | 0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart |
| DTaP-IPV vaccine and Hib vaccine | BIOLOGICAL | 0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart |
| DTaP-IPV//PRP~T combined vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2 months for Group C) on the day of inclusion * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with all trial pr...
It is a combination vaccine approach that combines DTaP-IPV/PRP~T with a recombinant hepatitis B vaccine. The DTaP-IPV/PRP~T component is a combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b (Hib) disease. The recombinant hepatitis B vaccine adds protection against hepatitis B.
It is used for immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b (Hib) disease, together with hepatitis B. Clinical studies have evaluated it in infants for primary and booster vaccination, including in Japan and Argentina, covering conditions such as tetanus, diphtheria, pertussis, poliomyelitis, bacterial meningitis, and hepatitis B.
Sanofi (ticker SNY) is the developer of the DTaP-IPV/PRP~T combined vaccine and recombinant hepatitis B vaccine. The company is listed as the sponsor of the clinical trials evaluating this combination vaccine in infants.
The DTaP-IPV/PRP~T combined vaccine and recombinant hepatitis B vaccine is in Phase 3 development. It is an investigational combination vaccine and is not described as approved. The Phase 3 trials evaluating it have been completed.
Two completed Phase 3 trials are registered: NCT02274285, which studied DTaP-IPV/Hib vaccine primary and booster vaccinations versus co-administration of DTaP-IPV and Hib vaccine in Japanese infants, and NCT00303316, an immunogenicity study of antibody persistence and booster effect in healthy Argentinean infants.