Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Candidate Plasmodium falciparum malaria vaccine · 1 trial · 2 indications
Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The 95% confidence intervals were calculated using the Analysis of Variance (ANOVA) model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.
Concentrations were expressed as GMCs with the following unit of measure: EU/mL. The 95% confidence intervals were calculated using the ANOVA model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group. The analysis was re-evaluated and performed on the Per-Protocol set for immunogenicity defined at study end.
| Arm | Type | Description |
|---|---|---|
| Coad group | EXPERIMENTAL | Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age). |
| RTS,S group | EXPERIMENTAL | Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age). |
| Control group | EXPERIMENTAL | Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age). |
| Name | Type | Description |
|---|---|---|
| Vitamin A | DIETARY_SUPPLEMENT | Oral administration of Vitamin A (1 dose) |
| Candidate Plasmodium falciparum malaria vaccine | BIOLOGICAL | Intramuscular administration of SB257049 vaccine (4 doses) |
| MR-Vac | BIOLOGICAL | Subcutaneous injection of a combined measles and rubella vaccine (1 dose) |
| Stamaril | BIOLOGICAL | Intramuscular injection of a yellow fever (YF) vaccine (1 dose) |
Inclusion Criteria: * Subjects' parent(s)/Legally Acceptable Representative(s) (LAR\[s\]) who, in the opinion of the investigator, could and complied with the requirements of the protocol. * A male or female 6 months of age (from the day the child becomes 6 months of age until the day before the ch...
| 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 |
It is an investigational vaccine developed by GSK plc (ticker GSK) for the prevention of malaria caused by the Plasmodium falciparum parasite. It is a vaccine modality in the infectious disease therapeutic area and has been studied in a Phase 3 clinical trial. It is not described as approved.
It is being developed for malaria, specifically disease associated with the Plasmodium falciparum parasite. The clinical program studied immunization of infants in a malaria-endemic setting, with the vaccine given alongside measles, rubella and yellow fever vaccines followed by a booster dose of the malaria vaccine.
GSK plc, which trades under the ticker GSK, is the developer of this candidate Plasmodium falciparum malaria vaccine. The company sponsored the Phase 3 immunogenicity and safety study of the vaccine conducted in Ghana.
The candidate Plasmodium falciparum malaria vaccine has been evaluated in a Phase 3 clinical trial. That Phase 3 study is listed as completed, and no active trials are recorded for this candidate. It is an investigational vaccine and is not described as FDA approved.
The candidate Plasmodium falciparum malaria vaccine was studied in trial NCT02699099, a Phase 3 immunogenicity and safety study that has completed. It enrolled 699 participants aged 6 months and older in Ghana and used a controlled, randomized design without double blinding.
Trial NCT02699099 of the GSK candidate Plasmodium falciparum malaria vaccine enrolled 699 participants. The study was randomized and controlled, was not double blinded, and enrolled healthy volunteers starting at 6 months of age in Ghana. It has completed.