Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 indicated for protection against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b infection. It is given to infants, with the studied population starting at 56 days of age. The vaccine combines multiple antigens in a single product to cover these five infectious diseases.
PENTAXIM is developed and manufactured by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor behind the clinical development program for this combined pediatric vaccine.
PENTAXIM is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently listed as active. The completed study enrolled 370 infants and was conducted in South Korea.
PENTAXIM has been evaluated in the Phase 3 trial NCT01214889, titled a study of PENTAXIM vaccine versus TETRAXIM vaccine given with ACTHIB vaccine in South Korean infants. The trial enrolled 370 healthy infants, was randomized and active controlled, and has completed.
PENTAXIM is a combined vaccine designed to induce immune protection against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b. It presents multiple antigens, including diphtheria and tetanus toxoids, acellular pertussis components, inactivated poliovirus, and the PRP polysaccharide conjugated to tetanus protein, to stimulate protective immunity in infants.