Urdaneta 1998.
Methods | Randomized controlled trial Generation of allocation sequence: numbers 1 to 800 randomly assigned; even numbers got one intervention, odd got the other Allocation concealment: not used Blinding: double blind Inclusion of all randomized participants: 572/800 (71.5%) participants received all 3 doses Length of follow up: 18 months after third dose |
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Participants | 800 persons Inclusion criteria: age 7 to 60 years; resident in study area Exclusion criteria: acute or severe diseases; history of allergies; pregnancy |
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Interventions | 1. 3 doses of SPf66 (0.5 mL) on days 0, 30, and 180 2. Tetanus toxoid for the first dose and aluminium hydroxide for the second and third doses | |
Outcomes | 1. Incidence of first, second, and all Plasmodium falciparum and Plasmodium vivax cases, total and by person‐weeks at risk (case definition: positive slide in a participant previously free of parasitaemia for at least 30 days) 2. Death 3. Parasite density per cubic mm 4. Spleen size | |
Notes | Location: rural settlements in Costa Marques, State of Rondonia, Brazil (incidence of malaria 500 per 1000 persons per year) Date: 1991 to 1993 Method of surveillance: blood slide on days 0, 30, 45, 90, 180, 195, 240, 300, 360, 450, 540, 630, and 720; passive surveillance records from four diagnostic and treatment stations |