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

D'Alessandro 1995.

Methods Randomized controlled trial
Generation of allocation sequence: method not reported
Allocation concealment: not reported
Blinding: double blind
Inclusion of all randomized participants: 630/669 (94.2%) infants received all 3 doses, but because of coding errors, only 547 were included in the analysis; 532/630 (84.4%) children were re‐enrolled in the second year
Length of follow up: 3.5 months after third dose (until end of malaria transmission season) in first year; 18 weeks of active follow up in second year
Participants 669 infants
Inclusion criteria: aged 6 to 11 months
Exclusion criteria: weight for age 60% or less; chronic disease (eg heart disease or sickle cell anaemia)
Interventions 1. 3 doses of SPf66 (1 mg per dose) given subcutaneously at weeks 0, 4, and 26
 2. Imovax polio given on same schedule
Fansidar given 1 to 2 weeks before the first and third doses
Outcomes 1. Incidence of clinical malaria (case definition: axillary temperature > 37.5 ºC plus Plasmodium falciparum parasitaemia ≥ 6000/µL)
 2. Total number of episodes of clinical malaria
 3. Adverse events
Notes Location: 210 villages in Upper River Division, The Gambia, an area of seasonal malaria with moderate transmission
Date: 1993 to 1995
Method of surveillance: active follow up by twice weekly visits from field workers; passive follow up by records from 6 health centers in area