Valero 1993.

Methods	Randomized controlled trial Generation of allocation sequence: method not reported Allocation concealment: coded vials at vaccination site: codes kept in Bogota until final analysis Blinding: double blind Inclusion of all randomized participants: it appears that 2496 were randomized prior to applying exclusion criteria; 2033 received first dose and 1548/2033 (76.1%) received all 3 doses Length of follow up: 1 year, starting 1 month after third dose
Participants	2496 persons Inclusion criteria: age > 1 year; resident in study area Exclusion criteria: pregnancy; history of allergy or other chronic disease (tuberculosis, asthma, rickets, marasmus)
Interventions	1. 3 doses of SPf66 on days 0, 30, and 180; 0.5 mL if > 5 years, 0.25 mL if 1 to 4 years (adsorbed onto aluminium hydroxide, 4 mg/mL) 2. Tetanus toxoid for first dose, saline in aluminium hydroxide for second and third doses
Outcomes	1. Number of episodes of Plasmodium falciparum malaria 2. Incidence of first episode of malaria by person weeks at risk, by age group and sex (case definition: axillary temperature ≥ 37.5 ºC, symptoms of malaria and positive blood slide) 3. Incidence of second episode of malaria by person weeks at risk, by age group and sex 4. Density of parasitaemia 5. Cases of Plasmodium vivax 6. Incidence by antibody titre group 7. Adverse events
Notes	Location: La Tola, Colombia, which has perennial transmission with fluctuating incidence (20 to 500/ cases per 1000 person per year) Date: 1990 to 1991 Method of surveillance: active follow up by monthly home visits; blood slides if fever or other symptoms present; passive from records of 4 village‐based malaria control posts and the health center