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Also known as DTaP-IPV-Hep B-PRP~T combined vaccine, DTaP-IPV-Hep B-PRP~T vaccine, Prevenar™
DTaP-IPV-Hep B-PRP~T combined vaccine+ Pneumococcal polysaccharide · 2 trials · 7 indications
Anti-Diphtheria antibodies will be measured by a toxin neutralization test
Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers
Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations \< LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but \< 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30. Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Participants will receive 3 injections of the study vaccine (DTaP-IPV-Hep B-PRP\~T combined vaccine) at 2, 4, and 6 months of age |
| Group B | ACTIVE_COMPARATOR | Participants will receive 2 injections of monovalent Hep B vaccine (Euvax B®) at age 1 and 6 months and 3 injections of DTaP IPV//PRP\~T vaccine (Pentaxim™) at age 2, 4, and 6 months |
| Study Group 1 | EXPERIMENTAL | Participants previously primed with DTaP-IPV-Hep B-PRP\~T, will receive one dose of DTaP-IPV-Hep B-PRP\~T vaccine + one dose of Prevenar™ |
| Study Group 2 | ACTIVE_COMPARATOR | Participants previously primed with DTaP-IPV-Hep B-PRP\~T, will receive one dose of Infanrix hexa™ vaccine + one dose of Prevenar™ |
| Study Group 3 | EXPERIMENTAL | Participants previously primed with Infanrix hexa™ will receive one dose of DTaP-IPV-Hep B-PRP\~T + one dose of Prevenar™. |
| Name | Type | Description |
|---|---|---|
| DTaP-IPV-Hep B-PRP~T combined vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP-IPV//PRP~T and Hepatitis B vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide | BIOLOGICAL | 0.5 mL, Intramuscular each into the right and left deltoid muscle |
| DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide | BIOLOGICAL | 0.5 mL, Intramuscular each into the right and left deltoid muscle |
| DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine | BIOLOGICAL | 0.5 mL (each), Intramuscular each into the right and left deltoid muscle |
Inclusion Criteria: * Aged 30 to 40 days on the day of the first study visit * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative * Participant and parent/legally ...
It is an investigational combination vaccine developed by Sanofi (ticker SNY) that combines DTaP-IPV-Hep B-PRP~T with pneumococcal polysaccharide. It is designed to protect against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, and pneumococcal disease in a single regimen.
It is being developed for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b infection, and pneumococcal disease. The Phase 3 program evaluated it in healthy infants, including hepatitis B primed infants and as a booster in children from 12 months of age.
Sanofi, which trades under the ticker SNY, is the developer of the DTaP-IPV-Hep B-PRP~T combined vaccine plus pneumococcal polysaccharide. The company sponsored both Phase 3 trials of the combination.
The DTaP-IPV-Hep B-PRP~T combined vaccine plus pneumococcal polysaccharide is in Phase 3 development. Two Phase 3 trials have been completed, with no active trials currently listed. It is an investigational product and has not been approved by the FDA.
Two completed Phase 3 trials have evaluated the combination. NCT02094833 compared the combined vaccine with DTaP-IPV//PRP~T plus hepatitis B vaccine in hepatitis B primed infants in South Korea. NCT01444781 studied the booster effect of the combined vaccine or Infanrix Hexa and Prevenar in healthy infants in Colombia and Costa Rica.
The full name includes the addition of pneumococcal polysaccharide, while the shorter name DTaP-IPV-Hep B-PRP~T combined vaccine refers to the same development program. Both names are used interchangeably for the Sanofi combination vaccine candidate.