Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tritanrix- HepB · 2 trials · 1 indication
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
Antibody cut-offs were higher than or equal to (≥) 1:128
| Arm | Type | Description |
|---|---|---|
| AC primed Group | EXPERIMENTAL | - |
| AC unprimed Group | ACTIVE_COMPARATOR | - |
| TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP | EXPERIMENTAL | Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP | ACTIVE_COMPARATOR | Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| Name | Type | Description |
|---|---|---|
| Tritanrix™- HepB | BIOLOGICAL | One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months |
| Hiberix™ | BIOLOGICAL | One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months |
| Mencevax™ ACW | BIOLOGICAL | One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months |
| Mencevax™ ACWY | BIOLOGICAL | One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 15 and 18 months of age at the time of vaccination. * Written informed consent obtained from the parent or ...
Tritanrix-HepB is a vaccine used for protection against diphtheria, whole cell pertussis, hepatitis B, and related infections, including meningococcal disease. It is being developed by GSK plc for use in infants and young children as part of a vaccination schedule.
Tritanrix-HepB is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is currently in Phase 3 clinical development.
Tritanrix-HepB is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. All completed trials are Phase 3 studies.
Tritanrix-HepB has completed four Phase 3 trials: NCT00136604, NCT00169442, NCT00291343, and NCT00317109. These studies evaluated immune response, safety, and booster doses in infants and toddlers across Thailand, the Philippines, and South Africa.
Tritanrix-HepB is also known as DTPw-HBV/Hib in clinical trial records. The trials reference this combination vaccine, which includes whole cell pertussis, diphtheria, tetanus, hepatitis B, and Haemophilus influenzae type b components.