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

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
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
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