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. 2006 Apr 19;2006(2):CD005966. doi: 10.1002/14651858.CD005966

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
Participants 800 persons
Inclusion criteria: age 7 to 60 years; resident in study area
Exclusion criteria: acute or severe diseases; history of allergies; pregnancy
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