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PENTAXIM: DTacP IPV/PRP~T combined vaccine · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| Study Group A | EXPERIMENTAL | Participants will receive a single dose of DTacP-IPV//PRP T combined vaccine (PENTAXIM™) at age 2, 4 and 6 months. |
| Study Group B | ACTIVE_COMPARATOR | Participants will receive a dose of DTacP IPV combined vaccine (TETRAXIM™) and PRP-T vaccine (ActHIB™) at 2, 4, and 6 months of age. |
| Name | Type | Description |
|---|---|---|
| PENTAXIM™: DTacP IPV//PRP~T combined vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
| TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine | BIOLOGICAL | 0.5 mL of each vaccine; intramuscular |
Inclusion Criteria: * Aged 2 months (56 to 70 days) inclusive on the day of inclusion * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with...
PENTAXIM is a combined vaccine used for immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type B. It is being studied in infants as young as 56 days old. The vaccine is currently in Phase 3 clinical development and is not yet approved.
PENTAXIM is developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in pediatric populations.
PENTAXIM is in Phase 3 clinical development. One Phase 3 trial has been completed, involving 370 participants in South Korea. The vaccine remains investigational and has not received regulatory approval.
PENTAXIM has one completed Phase 3 trial registered as NCT01214889. This study compared PENTAXIM to TETRAXIM given with ACTHIB in South Korean infants. The trial enrolled 370 healthy infants and was active-controlled, though not double-blinded.
PENTAXIM and TETRAXIM are different vaccines. In clinical trials, PENTAXIM was compared against TETRAXIM given with ACTHIB. Both are combination vaccines developed by Sanofi, but they have distinct formulations and are not the same product.