Valero 1996.

Methods	Randomized controlled trial Generation of allocation sequence: "pseudorandom numbers generated in a program written in dBase III"; randomization within 5 age groups and by sex (10 strata) Allocation concealment: codes kept by clinical monitor in sealed envelopes until end of study Blinding: double blind Inclusion of all randomized participants: 1257/1825 (68.9%) participants received all 3 doses Length of follow up: 22 months after second dose
Participants	1825 persons Inclusion criteria: age 1 to 86 years; resident in study area Exclusion criteria: pregnancy; positive blood slide at time of vaccination; history of allergy; acute infection; renal, cardiovascular, or endocrinological chronic infection
Interventions	1. 3 doses of SPf66, adsorbed onto aluminium hydroxide (2 mg per dose, 1 mg for those < 5 years) given subcutaneously at days 0, 30, and 180 2. Tetanus toxoid at first dose, aluminium hydroxide at doses 2 and 3
Outcomes	1. First cases of Plasmodium falciparum and Plasmodium vivax (case definition: positive blood slide in persons free of parasitaemia for previous 30 days) 2. Subsequent cases of P. falciparum and P. vivax 3. Density of parasitaemia
Notes	Location: 14 villages along Rio Rosario, Colombia, an area endemic for malaria Date: 1992 to 1994