Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FMP2.1/AS02A · 1 trial · 1 indication
The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.
The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.
Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.
The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.
| Arm | Type | Description |
|---|---|---|
| Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine. | EXPERIMENTAL | 20 children will be randomized to receive either the 10 mcg dose of FMP2.1/AS02A (n=15) or rabies vaccine (n=5) on study days 0, 30 +/- 7, and 60 +/- 7. |
| Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine. | EXPERIMENTAL | 40 children will be randomized to receive either the 25 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7. |
| Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine. | EXPERIMENTAL | 40 children will be randomized to receive either the 50 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7. |
| Name | Type | Description |
|---|---|---|
| FMP2.1/AS02A | BIOLOGICAL | FMP2.1 will be reconstituted in AS02A adjuvant. Dosages: 10, 25, or 50 mcg of FMP2.1 or 0.1, 0.25 or 0.5 mL of FMP2.1/AS02A administered by intramuscular injection. |
| Rabies vaccine (RabAvert) | BIOLOGICAL | RabAvert, white, freeze-dried vaccine for reconstitution with diluent. Dosage: 1.0 mL of rabies vaccine. |
Inclusion Criteria: * Age 1-6 years inclusive at the time of screening. * Residing in Bandiagara town. * Appear to be in generally good health based on clinical and laboratory investigation. * Separate written informed consent obtained from the parent/guardian before screening and study start, resp...
FMP2.1/AS02A is an investigational monoclonal antibody vaccine candidate developed by GSK plc for prevention of Plasmodium falciparum malaria. It combines the FMP2.1 antigen with the AS02A adjuvant system. It has been studied in a Phase 1 pediatric trial conducted in Mali and is not an approved product.
FMP2.1/AS02A is being developed for the prevention of Plasmodium falciparum malaria, the most severe form of malaria. The clinical program has focused on pediatric use in malaria-endemic regions, with the completed Phase 1 trial enrolling children in Mali. It remains an investigational candidate rather than an approved therapy.
FMP2.1/AS02A is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this malaria vaccine candidate. The candidate pairs a GSK antigen component with the company's AS02A adjuvant system.
FMP2.1/AS02A is in Phase 1 development. Its single recorded trial, NCT00358332, is a completed Phase 1 pediatric study. No active trials are currently listed for this candidate, and it has not been approved by the FDA. It remains an investigational product in clinical development.
FMP2.1/AS02A has been evaluated in one clinical trial, NCT00358332, titled Phase I Pediatric FMP2.1/AS02A Trial in Mali. That trial was a completed Phase 1 study with 100 enrolled participants, randomized, double-blind, and controlled, conducted in Mali in healthy volunteers aged one year and older.
No. FMP2.1/AS02A is not FDA approved. It is an investigational monoclonal antibody vaccine candidate that has completed a Phase 1 pediatric trial in Mali. Development remains at the early clinical stage, and no regulatory approval has been granted for this product.