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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...
The DTaP-HB-PRP~T combined vaccine is a Sanofi-developed vaccine that combines protection against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b in a single formulation. It is designed to reduce the number of injections infants receive during routine immunization schedules.
The DTaP-HB-PRP~T combined vaccine is used for immunization against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b infections. Clinical trials have evaluated it in healthy infants, including as a booster and in comparison with other combination vaccine regimens.
Sanofi, which trades under the ticker SNY, develops the DTaP-HB-PRP~T combined vaccine. Sanofi is the sponsor of the clinical trials evaluating this vaccine candidate.
The DTaP-HB-PRP~T combined vaccine is in Phase 3 clinical development. Both of its recorded trials are Phase 3 studies, and both have been completed. It is an investigational vaccine candidate.
Two completed Phase 3 trials have evaluated the DTaP-HB-PRP~T combined vaccine. NCT00514709 studied antibody persistence and booster effect in Filipino infants, enrolling 1,843 participants. NCT00348881 compared the vaccine with Tritanrix HepB/Hib given alongside oral polio vaccine in healthy infants, enrolling 2,133 participants.
Yes, DTaP-HB PRP~T Combined Vaccine is an alternative name for the DTaP-HB-PRP~T combined vaccine. Both names refer to the same Sanofi vaccine candidate against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b.