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DTaP-HB-PRP~T vaccine+ OPV · 2 trials · 6 indications
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization 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 at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.
Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination
Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | DTaP-Hep B-PRP-T + OPV vaccine group |
| Group 2 | ACTIVE_COMPARATOR | Tritanrix-HepB/Hib™ + OPV vaccine group |
| Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine | EXPERIMENTAL | Participants received 3 doses of the DTaP-Hep B-PRP\~T concomitantly with Oral Polio Vaccine (OPV), 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 Tritanrix-Hep B/Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age. |
| Name | Type | Description |
|---|---|---|
| DTaP-HB-PRP~T vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tritanrix-HepB/Hib™ | BIOLOGICAL | 0.5 mL, Intramuscular |
| Oral Polio Vaccine | BIOLOGICAL | 0.5 mL, Oral |
| DTaP-HB-PRP~T vaccine + OPV | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tritanrix-HepB/Hib™ + OPV vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive) * Participated in the AL203 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 * I...
DTaP-HB-PRP~T vaccine+ OPV is a combination vaccine being studied for use in preventing diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus infections, including Haemophilus influenzae type b. It is given concomitantly with oral polio vaccine. The vaccine is currently in Phase 3 clinical development.
DTaP-HB-PRP~T vaccine+ OPV is being developed by Sanofi, a global biopharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY on the stock exchange.
DTaP-HB-PRP~T vaccine+ OPV is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total of 741 participants enrolled.
DTaP-HB-PRP~T vaccine+ OPV has been studied in two completed Phase 3 trials. NCT00343889 compared the vaccine to Tritanrix-HepB/Hib, both given with oral polio vaccine, in 379 infants in the Philippines. NCT00534833 studied antibody persistence and booster effect in 362 toddlers aged 15 months and older.
DTaP-HB-PRP~T vaccine+ OPV is a combination vaccine designed to stimulate the immune system to produce antibodies against multiple diseases. It contains antigens for diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b, along with the oral polio vaccine, to provide broad protection.
DTaP-HB-PRP~T vaccine+ OPV is not the same as Tritanrix-HepB/Hib. In clinical trials, Tritanrix-HepB/Hib was used as an active comparator to evaluate the investigational vaccine's immunogenicity and safety. Both are combination vaccines, but they are distinct products.