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GSK malaria vaccine 257049 Vaccine · 2 trials · 1 indication
The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (\>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | EXPERIMENTAL | - |
| GSK257049 Group | EXPERIMENTAL | Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60. |
| Rabipur Group | ACTIVE_COMPARATOR | Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60. |
| Name | Type | Description |
|---|---|---|
| GSK Malaria vaccine 257049 | BIOLOGICAL | Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A). |
| GSK malaria vaccine 257049 Vaccine | BIOLOGICAL | 3 dose intramuscular injection |
| Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine | BIOLOGICAL | 3 dose intramuscular injection |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 18 and 45 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Free of obvious hea...
| 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 malaria vaccine 257049 Vaccine is an investigational vaccine being studied for the prevention of malaria caused by Plasmodium falciparum infection. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
GSK malaria vaccine 257049 Vaccine is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK.
GSK malaria vaccine 257049 Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval for use in the general population.
GSK malaria vaccine 257049 Vaccine has been studied in two completed Phase 2 trials. NCT00380393 evaluated efficacy in 894 children aged 5 months and older in Kenya and Tanzania, and NCT00443131 characterized immune responses in 36 healthy adults in Belgium.
GSK malaria vaccine 257049 Vaccine is classified as a monoclonal antibody modality, though it is being developed as a vaccine to prevent malaria. It is administered to healthy volunteers in clinical trials to assess its safety and immune response.