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 | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
The Candidate Plasmodium falciparum malaria vaccine is an investigational vaccine being studied for the prevention of malaria. It is designed to be given to infants at 6, 7.5 and 9 months of age, co-administered with measles, rubella and yellow fever vaccines, followed by a booster dose of the malaria vaccine.
The Candidate Plasmodium falciparum malaria vaccine is being developed by GSK plc, a biopharma company listed on the stock exchange under the ticker GSK. The company conducted a Phase 3 clinical trial of the vaccine in Ghana.
The Candidate Plasmodium falciparum malaria vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not been approved for use and is still being studied for safety and efficacy in clinical trials.
The Candidate Plasmodium falciparum malaria vaccine was studied in a Phase 3 clinical trial with the identifier NCT02699099. This completed trial enrolled 699 participants in Ghana and evaluated the vaccine's immunogenicity and safety when given at 6, 7.5 and 9 months of age alongside measles, rubella and yellow fever vaccines, followed by a booster dose.
Yes, the Candidate Plasmodium falciparum malaria vaccine is classified as a monoclonal antibody modality. It is being developed as a vaccine against malaria, with a Phase 3 trial completed that involved 699 participants.