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Also known as GSK Malaria vaccine 257049, RTS
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 | 4 | PHASE3 | Tafenoquine, GSK3772701, Mosquirix, GSK4425689A |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
GSK malaria vaccine 257049 Vaccine is an investigational vaccine developed by GSK plc for the prevention of malaria. It is a Phase 2 candidate studied in healthy volunteers and children. The vaccine has been evaluated in two completed clinical trials, including one in Kenya and Tanzania.
GSK malaria vaccine 257049 Vaccine is being developed for the prevention of malaria, an infectious disease caused by Plasmodium parasites. Clinical studies have focused on malaria due to P. falciparum infection. It is not yet approved and remains an investigational product.
GSK malaria vaccine 257049 Vaccine is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this vaccine candidate for malaria prevention.
GSK malaria vaccine 257049 Vaccine is in Phase 2 clinical development. Both of its completed trials were Phase 2 studies. It is an investigational vaccine and has not been approved by the FDA or any regulatory authority.
GSK malaria vaccine 257049 Vaccine has been studied in two completed Phase 2 trials: NCT00443131, which characterized immune responses in 36 healthy volunteers in Belgium, and NCT00380393, which evaluated efficacy against P. falciparum malaria in 894 children in Kenya and Tanzania. Both trials are completed.
Yes, GSK malaria vaccine 257049 Vaccine is also known as GSK Malaria vaccine 257049. These names refer to the same investigational vaccine candidate developed by GSK plc for malaria prevention.