Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hib-MenAC mixed with Tritanrix-HepB · 1 trial · 5 indications
| Name | Type | Description |
|---|---|---|
| Hib-MenAC mixed with Tritanrix™-HepB | BIOLOGICAL | - |
Inclusion criteria: * healthy male or female, between, and including, 56 and 83 days of age. * Born after a gestation period between 36 and 42 weeks * Birth dose of hepatitis B vaccine within the first 72 hours of life Exclusion criteria: * planned administration/administration of a vaccine not f...
Hib-MenAC mixed with Tritanrix-HepB is a combination vaccine candidate developed by GSK plc. It pairs Hib-MenAC with the Tritanrix-HepB vaccine, which targets diphtheria, tetanus, whole cell pertussis, hepatitis B, and Haemophilus influenzae type b. The combination is being studied for use in infants, with tetanus listed among its target indications.
GSK plc, which trades under the ticker GSK, is the developer of Hib-MenAC mixed with Tritanrix-HepB. The company also markets the Tritanrix-HepB and Hiberix vaccine components referenced in the clinical program for this combination candidate.
Hib-MenAC mixed with Tritanrix-HepB is in Phase 3 development. One Phase 3 trial has been completed, and no trials for this combination are currently active. The candidate remains investigational and is not approved for commercial use.
The Phase 3 trial NCT00197275 evaluated lot-to-lot consistency of Tritanrix-HepB/Hib-MenAC and its non-inferiority versus Tritanrix-HepB/Hiberix in infants. The study enrolled 800 participants in Thailand, included healthy volunteers aged 56 days and older, and has been completed.
The completed Phase 3 trial for Hib-MenAC mixed with Tritanrix-HepB listed tetanus, hepatitis B, Haemophilus influenzae type b, whole cell pertussis, and diphtheria among the conditions studied. The trial enrolled 800 infants in Thailand and used a randomized design without a control group.