Gosling 2009 TZA.

Study characteristics
Methods	Trial design: RCT Trial dates: December 2004 to May 2008 Length of follow‐up: 24 months of age
Participants	Number of participants: 2419 infants Inclusion criteria: all infants aged 8 to 16 weeks who attended clinics for WHO’s Extended Program on Immunization (EPI) at the ten study health facilities (five in each site) for DPT2 and polio vaccination were eligible for inclusion. Exclusion criteria: infants who had any of the following conditions: history of allergy to study drugs; history of convulsions; clinical features of severe malnutrition or chronic illness, including infants with signs of HIV/AIDS; plans to leave the study area before 12 months of age; weight less than 4.5 kg at enrolment; and no witnessed, written consent from the caretaker.
Interventions	Interventions: IPTi with one of the following. SP: 250 mg sulfadoxine plus 12.5 mg pyrimethamine (Fansidar, F Hoffmann‐La Roche, Basel, Switzerland) Chlorproguanil‐dapsone: 15 mg chlorproguanil plus 18.75 mg dapsone (Lapdap, GlaxoSmithKline, London, UK) for 3 days Mefloquine: 125 mg mefloquine (Lariam, F Hoff mann‐La Roche, Basel, Switzerland) given with DPT and Polio 2 immunization at about 2 months of age; DPT and polio 3 at 3 months of age; and measles vaccines at 9 months of age The 1st and 2nd doses of IPTi were either: SP: 250 mg sulfadoxine plus 12.5 mg pyrimethamine CD: 15 mg chlorproguanil plus 18.75 mg dapsone for 3 days MQ: 125 mg mefloquine The 3rd dose of IPTi at 9 months of age were either: SP: 500 mg sulfadoxine plus 25 mg pyrimethamine CD: 22.5 mg chlorproguanil plus 28.125 mg dapsone for 3 days MQ: 250 mg mefloquine Placebo: identical placebos given at the same time points with iPTi All treatments at the health facility were observed and administered with routine immunizations. Field workers visited participants on days 2 and 3 to ensure doses were taken.
Outcomes	Outcomes included in review Clinical malaria All‐cause mortality Hospital admissions Anaemia Adverse events Outcomes not included in the review: none
Notes	Location: Korogwe and Same Districts, Tanzania Malaria transmission: moderate transmission site (Korogwe District, Tanga region) and a neighbouring low‐transmission site (Same District, Kilimanjaro region). High SP resistance reported. EIR in neighbouring district (Muheza) was 148 infective bites per year (2000). Funding: IPTi Consortium and Gates Malaria Partnership (both supported by Bill & Melinda Gates Foundation) Additional notes: enrolment was prematurely suspended in the low‐transmission site after interim analysis (low malaria incidence resulting in lower power) thus only data from moderate‐transmission site is reported. Witnessed bed net coverage: 87% at enrolment Reported insecticide‐treated net (ITN) coverage: 53% at enrolment
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The trial used computer‐generated numbers for sequence generation
Allocation concealment (selection bias)	Low risk	The trial administered drugs to participants in a secluded cubicle
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Both research team and child were masked to treatment allocation."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Both research team and child were masked to treatment allocation."
Incomplete outcome data (attrition bias) All outcomes	High risk	Percentage loss 15.3% (per protocol)
Selective reporting (reporting bias)	Low risk	The trial authors reported relevant outcomes
Other bias	Low risk	The trial appears to be free of other sources of bias