Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK 257049 · 1 trial · 1 indication
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
| Arm | Type | Description |
|---|---|---|
| GSK 257049 1 Group | EXPERIMENTAL | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| GSK 257049 2 Group | EXPERIMENTAL | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| Tritanrix™ HepB/Hiberix™ Group | ACTIVE_COMPARATOR | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| Name | Type | Description |
|---|---|---|
| GSK 257049 | BIOLOGICAL | GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine |
| Tritanrix™ HepB/Hib | BIOLOGICAL | GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™) |
| Rouvax™ | BIOLOGICAL | Aventis Pasteur's attenuated measles vaccine. |
| Stamaril™ | BIOLOGICAL | Aventis Pasteur's attenuated yellow fever vaccine. |
| Polio Sabin™ | BIOLOGICAL | GSK Biologicals' oral polio virus vaccine |
Inclusion Criteria: * A male or female infant between 6 and 10 weeks of age at the time of first vaccination. * Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witn...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
GSK 257049 is an investigational monoclonal antibody being developed for the prevention of malaria. It is currently in Phase 2 clinical development and is intended for use in infants as young as 6 weeks old, as part of an Expanded Programme on Immunization (EPI) regimen.
GSK 257049 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and immunogenicity of this malaria vaccine candidate.
GSK 257049 is currently in Phase 2 clinical development. It is an investigational product and has not yet been approved by regulatory authorities. One Phase 2 trial has been completed, involving 511 participants across multiple African countries.
GSK 257049 has been studied in one completed Phase 2 clinical trial, registered as NCT00436007. This trial assessed the safety and immunogenicity of the vaccine when incorporated into an EPI regimen, enrolling 511 healthy infants aged 6 weeks and older in Gabon, Ghana, and Tanzania.
GSK 257049 is a malaria vaccine candidate being developed by GSK plc. It is a monoclonal antibody designed to prevent malaria, and it is currently in Phase 2 clinical trials. It is not yet approved for public use and remains under investigation.