Bojang 2005b.

Methods	Randomized controlled trial Generation of allocation sequence: random selection from list of eligible participants sent to external statistician at GlaxoSmithKline Biologicals, in ratio 2 vaccine to 1 placebo per dose level Allocation concealment: masked identical syringes prepared by staff otherwise uninvolved in trial Blinding: investigators, participants, and evaluators blinded Inclusion of all randomized participants: 130/135 (96.3%) completed follow up Length of follow up: 30 days after last dose
Participants	Number: 135 children Inclusion criteria: age 1 to 5 years; no clinically significant chronic or acute disease (chronic hepatitis B carriers were not excluded) Exclusion criteria: known allergy to any vaccine; severe malnutrition (weight for height < 3 Z scores); haematocrit < 30%
Interventions	1. RTS,S/AS02A vaccine: 10 µg in 0.1 mL adjuvant; 3 doses at 0, 1, and 3 month intervals 2. RTS,S/AS02A vaccine: 25 µg in 0.25 mL adjuvant; 3 doses at 0, 1, and 3 month intervals 3. RTS,S/AS02A vaccine: 50 µg in 0.5 mL adjuvant; 3 doses at 0, 1, and 3 month intervals 4. Rabies human diploid cell vaccine (Merieux HDCV): single‐dose vial with diluent; 3 doses at 0, 1, and 3 month intervals plus dose 4 given after trial completion; (vaccine groups were also offered 3 doses of rabies vaccine after trial completion) Increasing doses of vaccine were given in a dose‐escalating fashion, ie dose groups were staggered at 10 day intervals
Outcomes	1. Injection site pain 2. Swelling > 20 mm 3. Fever 4. Drowsiness 5. Loss of appetite 6. Irritability/fussiness 7. Haemoglobin, haematocrit, white blood cell count, and platelets on days 14, 60, and 104 8. Creatinine and alanine aminotransferase (ALT) on days 14, 60, and 104 9. Antibody to circumsporozoite protein repeat epitopes 10. Circulating hepatitis B surface antigen (HBsAG) antigen 11. Anti‐HbSAg antibodies
Notes	Location: village of Dampha Kunda, near Basse, Upper River Division, The Gambia; highly seasonal malaria with peak in October to November Method of surveillance: home visits daily for 3 days or until symptoms resolved; case reporting on standardized forms by study nurse in village or at clinic in Basse This trial reported in same publication as Bojang 2005b