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Also known as DTaP-IPV-Hep B-PRP~T combined vaccine
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 ...
DTaP-IPV-Hep B-PRP~T combined vaccine is an investigational combination vaccine being developed for the prevention of diphtheria, tetanus, pertussis, Haemophilus influenzae type b infection, poliomyelitis, and hepatitis B. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
DTaP-IPV-Hep B-PRP~T combined vaccine is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The vaccine is currently in Phase 3 clinical trials and remains investigational.
DTaP-IPV-Hep B-PRP~T combined vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed, and the vaccine is not currently in active clinical trials.
DTaP-IPV-Hep B-PRP~T combined vaccine has one completed Phase 3 clinical trial, registered as NCT02094833. This trial enrolled 310 participants in South Korea and compared the vaccine against a combination of DTaP-IPV//PRP~T vaccine plus hepatitis B vaccine in infants who were already primed for hepatitis B.
DTaP-IPV-Hep B-PRP~T combined vaccine is not the same as DTaP-IPV//PRP~T combined vaccine. The former includes a hepatitis B component, while the latter does not. In clinical trial NCT02094833, the two vaccines were compared directly, with the hepatitis B vaccine given separately in the comparator arm.