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Also known as DTaP-HB-PRP~T vaccine
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...
The DTaP-HB-PRP~T vaccine plus OPV is a combination immunization approach that pairs a multi-component vaccine with oral polio vaccine. The DTaP-HB-PRP~T component is designed to protect against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b, while OPV provides protection against poliovirus.
It is used for immunization against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and polio. The DTaP-HB-PRP~T vaccine is given alongside oral polio vaccine to provide combined protection in a single vaccination schedule, targeting these infectious diseases in infants and young children.
Sanofi develops the DTaP-HB-PRP~T vaccine plus OPV. Sanofi trades under the ticker SNY. The company conducted the clinical development program for this combination vaccine approach, including Phase 3 studies evaluating the DTaP-HB-PRP~T vaccine given with oral polio vaccine.
The DTaP-HB-PRP~T vaccine plus OPV has completed Phase 3 clinical development. Two Phase 3 trials have been completed, with no trials currently active. The program enrolled a total of 741 participants across both studies, which were randomized and actively controlled.
Two completed Phase 3 trials studied the DTaP-HB-PRP~T vaccine plus OPV. NCT00534833 evaluated antibody persistence and booster effect in 362 participants aged 15 months and older in the Philippines. NCT00343889 compared the combined vaccine to Tritanrix-HepB/Hib, both given with oral polio vaccine, in 379 participants from 42 days of age.
The DTaP-HB-PRP~T vaccine plus OPV refers to the same combination approach also written as DTaP-HB-PRP~T vaccine + OPV. The plus OPV notation indicates the DTaP-HB-PRP~T combined vaccine is administered concomitantly with oral polio vaccine, as studied in the Phase 3 trials.