Figure 1

Table A

Table B

Table C

Trial profile

Table A Characteristics of infants enrolled in the trial

Characteristics	Placebo (n=1243)	SP (n=1242)
No (%) male	608 (49)	654 (53)
No (%) rural	1034 (83)	1045 (84)
No (%) bed net use�	152/921 (17)	177/924 (19)
Mean (SD) age (months):	�	�
At enrolment	8.7 (2.7)	8.6 (2.9)
At IPTi dose 1	13.2 (3.3)	12.9 (3.2)
At IPTi dose 2	17.9 (4.0)	17.6 (3.9)
At IPTi dose 3	41.3 (3.4)	41.2 (3.2)
At IPTi dose 4	54.8 (3.9)	54.8 (3.9)
Mean (SD) packed cell volume at IPTi dose 1	0.33 (0.04)	0.33 (0.04)
Mean (SD) weight (kg) at IPTi dose 1	5.6 (0.9)	5.6 (0.9)
Mean (SD) height (cm) at IPTi dose 1	58.6 (2.9)	58.5 (2.9)

IPTi=intermittent preventive treatment for malaria in infants; SP= sulfadoxine-pyrimethamine.

�Data on net use missing for 322 infants in placebo group and 318 in SP group.

�

Table B Effect on mean packed cell volume (PCV) and prevalence of parasitaemia determined by active surveillance

Approximate age at survey (months)	Mean (SD) % PCV			�	Parasitaemia (%)
Approximate age at survey (months)	Placebo	SP	P value	�	Placebo	SP	P value
3	32.7 (4.0)	32.9 (4.1)	0.110	�	10.1	10.2	0.947
9	31.3 (4.3)	31.6 (4.0)	0.101	�	24.5	20.6	0.033
12	31.1 (4.3)	31.5 (4.4)	0.014	�	26.5	20.6	0.001
18	31.4 (4.2)	31.0 (4.2)	0.058	�	31.5	25.7	0.004

SP=sulfadoxine-pyrimethamine.

�

Table C Adverse events and serious adverse events after IPTi administration

Outcomes	Placebo			�	SP			Odds ratio (95% CI)
Outcomes	Events	PYAR	Rate/1000	�	Events	PYAR	Rate/1000	Odds ratio (95% CI)
Outpatient attendance
1 month after dose 1	300	88.4	3394.3	�	246	90.2	2728.7	0.80 (0.68 to 0.96)
1 month after dose 2	313	91.8	3410.3	�	309	92.1	3355.9	0.98 (0.83 to 1.15)
1 month after dose 3	323	82.8	3902.3	�	234	85.2	2745.7	0.71 (0.59 to 0.84)
1 month after dose 4	262	85.3	3073.1	�	225	86.7	2595.0	0.85 (0.71 to 1.01)
All cause hospital admissions
1 month after dose 1	21	88.4	237.6	�	14	90.2	155.3	0.65 (0.31 to 1.35)
1 month after dose 2	22	91.8	239.7	�	21	92.1	228.1	0.95 (0.50 to 1.80)
1 month after dose 3	35	82.8	422.9	�	15	85.2	176.0	0.42 (0.21 to 0.79)
1 month after dose 4	37	85.3	434.0	�	13	86.7	150.0	0.35 (0.17 to 0.67)