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Tritanrix-HepB · 2 trials · 5 indications
Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.
| Arm | Type | Description |
|---|---|---|
| Tritanrix™-HepB+Rotarix™ Group | EXPERIMENTAL | Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. |
| Tritanrix™-HepB+Placebo Group | EXPERIMENTAL | Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age. |
| Zilbrix™+Rotarix™ Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. |
| Zilbrix™+Placebo Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age. |
| Triple Antigen™+Engerix™-B Group | ACTIVE_COMPARATOR | Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively. |
| Hib-MenAC Lot 1 Group | EXPERIMENTAL | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh. |
| Hib-MenAC Lot 2 Group | EXPERIMENTAL | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh. |
| Hib-MenAC Lot 3 Group | EXPERIMENTAL | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh. |
| Hiberix Group | ACTIVE_COMPARATOR | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh. |
| Name | Type | Description |
|---|---|---|
| Tritanrix™-HepB | BIOLOGICAL | GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine. |
| Rotarix™ | BIOLOGICAL | GSK Biologicals' live attenuated human rotavirus vaccine |
| Zilbrix™ | BIOLOGICAL | GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine |
| Triple Antigen™ | BIOLOGICAL | Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine. |
| Engerix™-B | BIOLOGICAL | GSK Biologicals' hepatitis B vaccine |
| Placebo | DRUG | Placebo for the Rotarix™ vaccine |
| Tritanrix-HepB/Meningitec conjugate vaccine | BIOLOGICAL | The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection |
| Tritanrix/Hiberix vaccine | BIOLOGICAL | The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection. |
Inclusion criteria: * Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol. * Administration of one dose of hepatitis B vaccine at birth. * A male or female between, and including, 11 and 17 weeks of age at the time of the first...
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.