Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DTPw-HBV/Hib · 1 trial · 1 indication
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
| Arm | Type | Description |
|---|---|---|
| 10Pn_4d Group | EXPERIMENTAL | Subjects received 10Pn-PD-DIT, in its investigational 4-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2). |
| 10Pn Group | ACTIVE_COMPARATOR | Subjects received 10Pn-PD-DIT, in its licensed 1-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2). |
| Name | Type | Description |
|---|---|---|
| Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation) | BIOLOGICAL | 4 doses by intramuscular injection in the right left anterolateral thigh |
| Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation) | BIOLOGICAL | 4 doses by intramuscular injection in the right anterolateral thigh |
| DTPw-HBV/Hib | BIOLOGICAL | 3 doses by intramuscular injection in the left anterolateral thigh |
Inclusion Criteria: * Subjects for whom, in the opinion of the investigator, the parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol (e.g., return for vaccination and follow-up visits). * A male or female between, and including 6-10 we...
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.