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DTPw-HBV/Hib Kft vaccine GSK323527A · 1 trial · 5 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 |
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 is an investigational combination vaccine studied for preventing diphtheria, tetanus, whole cell pertussis, hepatitis B, and Haemophilus influenzae type b disease in infants. It is being developed by GSK plc (GSK) and has completed Phase 3 clinical trials.
DTPw-HBV/Hib is developed by GSK plc, traded as GSK on the stock exchange. The vaccine is intended for pediatric immunization against multiple infectious diseases including diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b.
DTPw-HBV/Hib is in Phase 3 clinical development. It is investigational and not yet approved. Two Phase 3 trials have been completed, along with one Phase 2 trial, all with healthy infant participants.
DTPw-HBV/Hib has completed trials NCT00317122 and NCT00317161, both Phase 3 studies in infants. NCT00317122 enrolled 192 participants in South Africa, while NCT00317161 enrolled 1,000 participants in Thailand. A Phase 2 trial NCT00291967 enrolled 525 infants in the Philippines.
DTPw-HBV/Hib is being compared to Tritanrix-HepB/Hiberix in clinical trials. In NCT00317122, the immune response following primary vaccination with Tritanrix-HepB/Hib-MenAC was compared to Tritanrix-HepB/Hiberix in infants.
DTPw-HBV/Hib trials enrolled a total of 1,525 participants across two completed studies. The trials were randomized, double-blind, and actively controlled, involving healthy infants aged from 4 days to 56 days in countries including South Africa, Thailand, and the Philippines.