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Also known as DTaP-IPV and ActHIB®, DTaP-IPV and ActHIB
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...
DTaP IPV/Hib vaccine is a combination vaccine used to protect against tetanus, diphtheria, pertussis, poliomyelitis, and Haemophilus influenzae type b infections. It is also being studied for use in dengue and dengue hemorrhagic fever prevention. The vaccine is in Phase 3 clinical development.
Sanofi (ticker: SNY) is developing DTaP IPV/Hib vaccine. The vaccine is currently in Phase 3 clinical trials for infectious disease indications including tetanus, diphtheria, and dengue.
DTaP IPV/Hib vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. All three completed trials were Phase 3 studies.
DTaP IPV/Hib vaccine has completed three Phase 3 trials: NCT00303316, a booster study in Argentinean infants; NCT01411241, a booster study with dengue vaccine in Mexican toddlers; and NCT02274285, a primary and booster study in Japanese infants. All trials are completed.
Yes, DTaP IPV/Hib vaccine is also known as PENTAXIM. Clinical trials NCT00303316 and NCT01411241 specifically study PENTAXIM, while NCT02274285 studies the DTaP-IPV/Hib vaccine formulation.