Leach 1995.

Methods	Randomized controlled trial Generation of allocation sequence: method not reported Allocation concealment: not specified Blinding: double blind Inclusion of all randomized participants: 147/150 (98%) received all 3 doses; 127 children (84.7%) were located and followed in the second year Length of follow up: 9 months in first year, then 18 weeks in the second year
Participants	150 infants Inclusion criteria: age 6 to 11 months Exclusion criteria: none stated
Interventions	1. 3 doses of SPf66 on days 0, 30, and 180 in 4 groups: 1 mg Colombian vaccine (25 participants); 0.5 mg Colombian vaccine (25 participants); 1 mg American vaccine (25 participants); 0.5 mg American vaccine (25 participants) 2. Inactivated polio vaccine (50 participants)
Outcomes	1. Incidence of first episode of malaria, after 2 and 3 doses of vaccine (case definition: fever of ≥ 37.5 ºC and Plasmodium falciparum parasitaemia of ≥ 6000/µL) 2. Total number of episodes of malaria 3. Death 4. Severe anaemia 5. Cerebral malaria 6. Admission to hospital with malaria 7. Antibodies to SPf66 by ELISA 8. Adverse events
Notes	Location: villages near Basse, The Gambia Date: 1993 to 1995 Method of surveillance: active by home visits every 2 weeks during rainy season; passive by attendance at clinic Adverse effects assessed on days 1, 2, and 6