Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DTaP-IPV-Hep B-PRP-T 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...
DTaP-IPV-Hep B-PRP-T Vaccine is a combination vaccine used for immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b infection. It is being developed by Sanofi for use in infants and young children, with clinical trials conducted in healthy volunteers.
DTaP-IPV-Hep B-PRP-T Vaccine is a combination vaccine that targets multiple pathogens: diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and Haemophilus influenzae type b. It works by stimulating the immune system to produce antibodies against these six diseases, providing protection through vaccination.
DTaP-IPV-Hep B-PRP-T Vaccine is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting Phase 3 clinical trials for this combination vaccine, which is designed to protect against multiple infectious diseases in pediatric populations.
DTaP-IPV-Hep B-PRP-T Vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. Three Phase 3 trials have been completed, with a total enrollment of 2,814 participants, all of which were randomized, double-blind, and active-controlled studies.
DTaP-IPV-Hep B-PRP-T Vaccine has completed three Phase 3 clinical trials: NCT00654901 (881 participants in Mexico), NCT01177722 (1,375 participants in Colombia and Costa Rica), and NCT01983540 (558 participants in Colombia and Costa Rica). All trials were completed and involved healthy infants and young children.
DTaP-IPV-Hep B-PRP-T Vaccine is not the same as Infanrix Hexa, but it has been studied in comparison to it. Clinical trials NCT00654901 and NCT01983540 evaluated DTaP-IPV-Hep B-PRP-T Vaccine against Infanrix Hexa as an active control, assessing antibody persistence and immune responses following primary and booster vaccination.