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Also known as DTaP-IPV-Hep B-PRP-T Vaccine, DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
DTaP-IPV-Hep B-PRP~T+ Pneumococcal polysaccharide vaccine · 3 trials · 8 indications
Anti-D concentrations, ≥0.01 IU/mL, ≥0.1 IU/mL and ≥1.0 IU/mL: Anti-T antibody concentrations ≥0.01 IU/mL, ≥0.1 IU/mL and ≥ 1.0 IU/mL; Anti-Hep B antibody concentrations ≥10 mIU/mL and ≥100 mIU/mL; Anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL; Anti-pertussis toxin antibody and anti-filamentous haemagglutinin (FHA) antibody concentrations Lower Limit of Quantitation (LLOQ), ≥2x LLOQ and ≥4x LLOQ and Anti-poliovirus 1, 2, and 3 antibody titers ≥8 (1/dil)
Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.
Antibody persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants who received 3 doses of DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study. |
| Study Group 2 | EXPERIMENTAL | Participants who received 3 doses of DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of Infanrix hexa vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study. |
| Study Group 3 | ACTIVE_COMPARATOR | Participants who received 3 doses of Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of DTaP-IPV-Hep B-PRP\~T vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study. |
| Group 1: DTaP-IPV-Hep B-PRP-T (Lot A) | EXPERIMENTAL | - |
| Group 2: DTaP-IPV-Hep B-PRP-T (Lot B) | EXPERIMENTAL | - |
| Group 3: DTaP-IPV-Hep B-PRP-T (Lot C) | EXPERIMENTAL | - |
| Group 4: Active Control | ACTIVE_COMPARATOR | - |
| DTaP-IPV-Hep B-PRP~T Batch 1 | EXPERIMENTAL | Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study. |
| DTaP-IPV-Hep B-PRP~T Batch 2 | EXPERIMENTAL | Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study. |
| DTaP-IPV-Hep B-PRP~T Batch 3 | EXPERIMENTAL | Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study. |
| Infanrix Hexa™ | ACTIVE_COMPARATOR | Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), (Infanrix Hexa™) plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 (NCT00404651) and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study. |
| Name | Type | Description |
|---|---|---|
| DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine | BIOLOGICAL | DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study |
| DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine | BIOLOGICAL | DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age) and a booster dose of Infanrix hexa vaccine with Prevnar at 12 to 24 months of age in a previous study. |
| Infanrix hexa + Prevenar + Rotarix vaccine | BIOLOGICAL | Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster dose of DTaP-IPV-Hep B-PRP\~T vaccine concomitantly with Prevenar vaccine concomitantly with Prevenar at 12 to 24 months of age in a previous study. |
| DTaP-IPV-Hep B-PRP-T Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP-Hep B-IPV vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP-IPV-Hep B-PRP~T vaccine (Batch 1) | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP-IPV-Hep B-PRP~T vaccine (Batch 2) | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP-IPV-Hep B-PRP~T vaccine (Batch 3) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Infanrix Hexa™ | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness/es if required by local regulations) * Subject and parent...
It is a combination vaccine candidate developed by Sanofi that combines diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, Haemophilus influenzae type b, and pneumococcal polysaccharide components in a single regimen. It is being studied in healthy infants and children for protection against these infectious diseases.
Sanofi develops this combination vaccine candidate. Sanofi trades on the New York Stock Exchange under the ticker SNY. The vaccine combines Sanofi's DTaP-IPV-Hep B-PRP~T backbone with pneumococcal polysaccharide coverage, and it has been studied alongside other pediatric vaccines in Sanofi's portfolio.
It is in Phase 3 clinical development. Three Phase 3 trials have been completed, with no active trials currently listed. The completed studies enrolled a total of 2,814 participants and were randomized, double-blind, and active-controlled, evaluating the vaccine in healthy infants and children.
Three completed Phase 3 trials have evaluated this vaccine: NCT01983540 studied antibody persistence at ages 3.5 and 4.5 years in 558 children in Colombia and Costa Rica; NCT01177722 studied the vaccine given with Prevenar and Rotarix in 1,375 healthy Latin American infants; and NCT00654901 studied it following a primary series in 881 children in Mexico.
It is being developed to protect against diphtheria, tetanus, whooping cough, hepatitis B, poliomyelitis, and Haemophilus influenzae type b infection, with added pneumococcal polysaccharide coverage. The completed Phase 3 trials enrolled healthy infants and children, including those receiving the vaccine alongside Prevenar and Rotarix.
Yes. DTaP-IPV-Hep B-PRP-T Vaccine is an alternative name for the same Sanofi combination vaccine candidate. Other recorded names include DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine and DTaP-IPV-Hep B-PRP~T + Prevenar + Rotarix vaccine, reflecting study protocols where it was co-administered with Prevenar and Rotarix.