Sempertegui 1994.
| Methods | Randomized controlled trial Generation of allocation sequence: method not reported; randomization within 5 age‐groups Allocation concealment: coded vials; codes kept by Ethical Committee (Ministry of Health) until end of study Blinding: double blind Inclusion of all randomized participants: 462/537 (86.0%) received all 3 doses Length of follow up: 1 year after third dose |
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| Participants | 537 persons Inclusion criteria: age > 1 year; resident in study area Exclusion criteria: pregnancy; history of allergy; acute infection; renal, cardiovascular or endocrine chronic disease |
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| Interventions | 1. 3 doses of SPf66 adsorbed onto aluminium hydroxide (2 mg in 0.5 mL for persons ≥ 5 years; 1 mg in 0.25 mL for children < 5 years) on days 0, 30, and 180 2. Tetanus toxoid adsorbed onto aluminium hydroxide for dose 1; aluminium hydroxide alone for doses 2 and 3 | |
| Outcomes | 1. Number of malaria cases (case definition: malaria parasites in a thick blood slide, with or without clinical symptoms) 2. Prevalence of anti‐SPf66 antibody titre | |
| Notes | Location: La T, Ecuador, an area 'highly endemic' for malaria Date: 1991 to 1992 Method of surveillance: bi‐monthly cross‐sectional surveys |
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