Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Act-HIB™
DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age. |
| Study Group 2 | EXPERIMENTAL | Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age. |
| Study Group 3 | ACTIVE_COMPARATOR | Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age. |
| Name | Type | Description |
|---|---|---|
| DTaP//PRP-T Combined Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (each vaccine) |
Inclusion Criteria : * Aged 2 months on the day of inclusion * Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or legal representative * Participant and parent/legal representative able to attend all scheduled visits and to compl...
It is a combined pediatric vaccine developed by Sanofi that pairs DTaP, which protects against diphtheria, tetanus, and pertussis, with a PRP-tetanus conjugate component for Haemophilus influenzae type B. It is designed to deliver several infant immunizations in a single product.
It is used to protect healthy infants against diphtheria, tetanus, pertussis, and Haemophilus influenzae type B. The Phase 3 study enrolled infants from 60 days of age. Diphtheria is the lead indication, with the trial conditions also listing tetanus, pertussis, and Haemophilus influenzae type B.
Sanofi develops the DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The Phase 3 study was run in China and compared the combined vaccine against local DTaP and Act-HIB monovalent vaccine.
It is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study, ACTACEL versus local DTaP and Act-HIB monovalent vaccine, enrolled 1,056 healthy infants in China.
The vaccine has been studied in one completed Phase 3 trial, NCT01062477, titled A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants. It was randomized, active controlled, enrolled 1,056 infants from 60 days of age, and ran in China.
ACTACEL is the name used for this DTaP and PRP-T combined vaccine in its Phase 3 study, NCT01062477. The trial compared ACTACEL against local DTaP and Act-HIB monovalent vaccine in healthy infants in China.