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DTaP-HB-PRP~T combined vaccine · 2 trials · 5 indications
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.
Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | DTaP-Hep B-PRP-T + OPV vaccine group |
| Group 2 | EXPERIMENTAL | Tritanrix-HepB/Hib™ + OPV vaccine group |
| Group 1: DTaP-Hep B-PRP-T + OPV vaccine | EXPERIMENTAL | Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age. |
| Group 2: Tritanrix-HepB/Hib™ + OPV vaccine | ACTIVE_COMPARATOR | Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age. |
| Name | Type | Description |
|---|---|---|
| DTaP-HB PRP~T Combined Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (IM) |
| DTaP-HB-PRP~T vaccine | BIOLOGICAL | 0.5 mL, IM |
| Oral Polio Vaccine | BIOLOGICAL | Oral co-administered with study vaccine. |
| DTaP-HB-PRP~T combined vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tritanrix-HepB/Hib™ vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Oral poliomyelitis vaccine (OPV) | BIOLOGICAL | Oral co-administered with study vaccine. |
Inclusion Criteria: * Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive) * Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, an...
DTaP-HB-PRP~T combined vaccine is used for the prevention of diphtheria, tetanus, pertussis, hepatitis B, and influenza in infants. It is a combination vaccine being developed by Sanofi to provide protection against multiple infectious diseases in a single shot.
DTaP-HB-PRP~T combined vaccine targets the bacterial and viral pathogens that cause diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b. It combines antigens from these organisms to stimulate an immune response against each disease.
Sanofi (ticker: SNY) is developing DTaP-HB-PRP~T combined vaccine. The company is conducting Phase 3 clinical trials to evaluate the vaccine's safety and immunogenicity in healthy infants.
DTaP-HB-PRP~T combined vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total of 3,976 participants enrolled.
DTaP-HB-PRP~T combined vaccine has completed two Phase 3 trials: NCT00348881, which compared it with Tritanrix HepB/Hib and OPV in 2,133 healthy infants in the Philippines, and NCT00514709, which studied antibody persistence and booster effects in 1,843 Filipino infants aged 12 months and older.
No, DTaP-HB-PRP~T combined vaccine is not the same as Tritanrix HepB/Hib. In clinical trial NCT00348881, the DTaP-HB-PRP~T vaccine was compared against Tritanrix HepB/Hib, which was used as an active control. They are distinct vaccine formulations.