Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00358332 | Phase I Pediatric FMP2.1/AS02A Trial in Mali | PHASE1 | COMPLETED | 100 | — | — | Nov 1, 2006 | Dec 1, 2007 | Oct 24, 2011 | 1 | Mali |
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...