Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FMP1/AS02A Malaria vaccine · 1 trial · 1 indication
Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period
Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)
Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine
| Arm | Type | Description |
|---|---|---|
| FMP1/AS02A Malaria vaccine 10ug | EXPERIMENTAL | Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57 |
| FMP1/AS02A Malaria vaccine 25 ug | EXPERIMENTAL | Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70 |
| FMP1/AS02A Malaria vaccine 50 ug | EXPERIMENTAL | Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84 |
| Imovax Rabies Vaccine | ACTIVE_COMPARATOR | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days |
| Name | Type | Description |
|---|---|---|
| FMP1/AS02A Malaria vaccine | BIOLOGICAL | Subjects vaccinated with FMP1/AS02 vaccine |
| Imovax Rabies vaccine | BIOLOGICAL | Subjects vaccinated on corresponding FMP1/AS02A vaccination days |
Inclusion Criteria: * A healthy male or female child, 12 to 47 months of age at the time of screening. * Written informed consent obtained from at least one parent before study start. * Available to participate for the duration of the study (12 months). Exclusion Criteria: * Acute disease at the ...
FMP1/AS02 is an investigational vaccine candidate being studied for the prevention of malaria, specifically Plasmodium falciparum malaria. It is a monoclonal antibody modality developed by GSK plc. The vaccine is intended for use in healthy adults and children in malaria-endemic regions, as evaluated in clinical trials in Mali, Kenya, and the United States.
FMP1/AS02 targets the merozoite surface protein-1 (MSP-1) of the Plasmodium falciparum parasite, as indicated by its name Falciparum Merozoite Protein-1. This protein is expressed on the surface of merozoites, the invasive form of the malaria parasite, and is a key target for vaccine development aimed at inducing protective immune responses.
FMP1/AS02 is developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The vaccine candidate is being investigated for the prevention of malaria, with clinical trials conducted in collaboration with research institutions in Mali, Kenya, and the United States.
FMP1/AS02 is in Phase 1 clinical development. All three clinical trials associated with this vaccine candidate have been completed, with a total enrollment of 135 participants. The trials were randomized, double-blind, and placebo-controlled, evaluating safety and preliminary efficacy in healthy adults and children.
FMP1/AS02 has been evaluated in three completed Phase 1 clinical trials: NCT00308061 in healthy adults in Mali, NCT00317473 in young children in Kenya, and NCT01556945 in healthy adults in the United States. These trials assessed safety and preliminary efficacy of the vaccine candidate against malaria.
Yes, FMP1/AS02 is also known as FMP1/AS02A, as indicated by the clinical trial title 'Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali'. The vaccine candidate is being developed by GSK plc for the prevention of Plasmodium falciparum malaria.