Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DTPw-HBV/Hib-MenAC conjugate vaccine · 6 trials · 9 indications
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DTPw-HBV/Hib Kft vaccine GSK323527A | BIOLOGICAL | Intramuscular injection, 1 dose |
| Tritanrix™-HepB/Hiberix™ | BIOLOGICAL | Intramuscular injection, 1 dose |
| DTPw-HBV/Hib-MenAC conjugate vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose pr...
DTPw-HBV/Hib-MenAC conjugate vaccine is an investigational combination vaccine developed by GSK plc for protection against diphtheria, tetanus, whole cell pertussis, hepatitis B, Haemophilus influenzae type b, and meningococcal serogroups A and C disease. It is designed to combine multiple routine infant immunizations into a single product.
It is being developed to prevent diphtheria, tetanus, whole cell pertussis, hepatitis B, Haemophilus influenzae type b, and meningococcal A and C disease, primarily in infants. The clinical program has studied primary vaccination in infants as young as 4 days and booster vaccination in children from 10 months of age.
The vaccine is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK Biologicals is the sponsor of the clinical trials evaluating the vaccine, including studies conducted in Argentina, Nicaragua, the Philippines, Thailand, and South Africa.
DTPw-HBV/Hib-MenAC conjugate vaccine is in Phase 3 development. It is an investigational vaccine and has not been approved by the FDA. Two Phase 3 trials and one Phase 2 trial have been completed, and no trials are currently active.
Completed trials include NCT00317161, a Phase 3 immunogenicity and safety study in 1,000 infants in Thailand, and NCT00317122, a Phase 3 comparison against Tritanrix-HepB/Hiberix in 192 infants in South Africa. NCT00332566, a Phase 3 booster study, and NCT00317174, a Phase 2 antibody persistence study, are also completed.