Acosta 1999.
| Methods | Randomized controlled trial Generation of allocation sequence: vials were assigned letters A to F, three letters designating vaccine and three placebo; random sequence was generated and children got vaccinated from the next available lettered vial Allocation concealment: coded vials, with doses drawn up independent of administrators Blinding: double blind Inclusion of all randomized participants: 1096/1207 (90.8%) received all 3 doses Length of follow up: up to 2 years after third dose |
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| Participants | 1207 infants Inclusion criteria: age 1 month Exclusion criteria: requiring admission to hospital at time of first dose; twins (to avoid misidentification) |
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| Interventions | 1. 3 doses of SPf66 0.5 mg adsorbed onto 0.312 g alum in 0.125 mL; dosing planned to coincide with Expanded Programme on Immunization (EPI) vaccinations 2. Alum alone | |
| Outcomes | 1. Incidence of first or only episode of clinical malaria after 3 doses (case definition: axillary temperature ≥ 37.5 ºC together with slide positive (any density) for Plasmodium falciparum) 2. Adverse events | |
| Notes | Location: Ifakara, Kilombero district, southern Tanzania Date: 1997 to 1998 Method of surveillance: active follow up by cross‐sectional surveys at 8, 10, and 24 months of age; passive follow up from local clinic records |
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