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 vaccine being developed for the prevention of Plasmodium falciparum malaria. It is currently in Phase 1 clinical development and has been studied in a pediatric population in Mali. The vaccine is designed to elicit an immune response against the malaria parasite.
FMP2.1/AS02A is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in children living in malaria-endemic regions.
FMP2.1/AS02A is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the vaccine is not currently in active clinical trials.
FMP2.1/AS02A has been studied in one completed Phase 1 clinical trial, identified as NCT00358332, titled 'Phase I Pediatric FMP2.1/AS02A Trial in Mali.' The trial enrolled 100 participants, including children as young as 1 year old, and was conducted in Mali.
FMP2.1/AS02A is a vaccine that contains the FMP2.1 antigen, a recombinant protein based on the apical membrane antigen 1 (AMA1) of Plasmodium falciparum, combined with the AS02A adjuvant system. It is designed to stimulate the immune system to produce antibodies against the malaria parasite.