Alonso 1994.

Methods	Randomized controlled trial Generation of allocation sequence: method not reported Allocation concealment: code held by monitors Blinding: double blind Inclusion of all randomized participants 586/631 (92.9%) received all 3 doses Length of follow up: 12 months after third dose
Participants	586 children Inclusion criteria: age 1 to 5 years; resident in study area Exclusion criteria: history of allergies leading to medical consultation or treatment; acute conditions warranting hospital admission; chronic conditions; packed cell volume < 25%
Interventions	1. 3 doses of SPf66, 2 mg per dose to > 5 year olds, 1 mg to under 5 year olds, at weeks 0, 4, and 25 2. Tetanus toxoid plus aluminium hydroxide on same schedule Blood stage parasitaemia cleared with Fansidar (25 mg sulfadoxine/0.75 mg pyrimethamine per kg body weight) before each vaccination
Outcomes	1. Incidence of first clinical malaria episode after (a) at least 2 doses, (b) 3 doses of vaccine (case definition: axillary temperature ≥ 37.5 ºC together with Plasmodium falciparum density > 20,000/µL) 2. Total number of clinical malaria episodes (by active or passive case detection) after (a) at least 2 doses (b) 3 doses of vaccine 3. Prevalence of P. falciparum parasitaemia 4. Incidence of P. falciparum parasitaemia 5. Density of P. falciparum parasitaemia 6. Hospitalization 7. Hospitalization with a diagnosis of malaria 8. Death 9. Death from malaria 10. Packed cell volume 11. Geometric mean anti‐SPf66 and anti‐P. falciparum antibody titre 12. Chloroquine in urine 13. Adverse events
Notes	Location: Idete, Southern Tanzania, an area of intense perennial transmission Date: 1993 to 1994 Method of surveillance: active follow up by weekly home visits by field assistants for a pre‐selected (randomized) subgroup; passive follow up from records of Idete dispensary