TABLE 2 Characteristics of the Six IPTi-SP Trials

Location, Country

Ifakara, Tanzania

Navrongo, Ghana

Manhiça, Mozambique

Kumasi, Ghana

Lambaréné, Gabon

Tamale, Ghana

Reference

Schellenberg et al.

Chandramohan et al.

Macete et al.

Kobbe et al.

Grobusch et al.

Mockenhaupt et al.

 

Lancet 2001, 2005

BMJ 2005

JID 2006

CID 2007

JID 2007

AAC 2007

Recruitment (years)

1999–2000

2000–2002

2002–2004

2003–2005

2004–2005

2003

Entire study period

8/1999–4/2001

9/2000–6/2004

9/2002–2/2004

1/2003–9/2005

12/2002–8/2006

3/2003–7/2005

EIR/year

29

418

38

400

50

Not available

Transmission

Perennial

Highly seasonal

Perennial with seasonal peaks

Perennial

Perennial with seasonal peaks

Perennial with seasonal peaks

Predicted annual incidence of clinical malaria in placebo group (all episodes)

0.43

1.0

0.55

1.29

0.22

0.88

In vivo SP treatment resistance by day 14%

31 (1999–2000)

22 (2004)

17 (2001)

NA

21 (2004)

14 (2002)

Use of bed nets (treated or untreated), % placebo/SP

67/68

17/19

0/0 (14/15)

20/20a (39/38)

5/5 (80/80)

<1%

Iron supplementation

Daily unsupervised from 2 to 6 mo of age (2mg/kg/day)

Twice weekly unsupervised for 1 mo after each IPTi dose, (2.5 ml, 15 mg elemental iron)

None

None

None

None

Ages at dosing (months)

2, 3, 9 (at time of DPT2, DPT3, & measles)

3, 4, 9, 12 (at time of DPT2, DPT3, measles + extra at 12 months)

3, 4, 9 (at time of DPT2, DPT3 & measles)

3, 9, 15 (at time of DPT3 & measles + extra at 15 months)

3, 9, 15 (at time of DPT3 & measles + extra at 15 months)

3, 9, 15 (at time of DPT3 & measles + extra at 15 months)

Method & duration of follow-up

PCD to age 24 mo (CSS at age 12 & 18 mo)

PCD to age 24 mo (CSS at age 2, 9, 12 & 18 mo)

PCD to age 24 mo (CSS at age 12 & 24 mo)

ACD monthly to age 21 mo & PCD

ACD monthly to age 30 mo & PCD

ACD every 3 mo to age 24 mo & PCD

No.of children enrolled, placebo/active

351/350 = 701

1,242/1,243 = 2,485

755/748 = 1,503

535/535 = 1,070

595/594 = 1,189

600/600 = 1,200

Follow-up

332/329 = 661 (94%) followed for 1year; 278/277 = 555 (79%) followed for 2 years

1103/1088=2191 (88%) followed for 2 years

687/688 = 1375 (91%) followed for 1 year

439/448 = 887 (83%) followed for 2 years

315/287 = 602 (51%) followed for 18 months

527/520 = 1047 (87%) followed for 24 months

Type of randomization

Individual

Cluster

Individual

Individual

Individual

Individual

EPI serology analysis

 

Measles and yellow fever

DTP, polio, hep B, and measles

 

 

 

Vitamin A supplementation

100,000 IU at time of measles vaccination

100,000 IU at 6 mo of age, then every 6 mo

100,000 IU starting at 6 mo of age, once every 6 mo up to 5 years of age

Every 6 mo, and for treatment of measles (6–11 mo = 100,000 IU; 12–59 mo = 200,000 IU)

None

None

NOTES: ACD = active case detection; CSS = Cross-sectional surveys; EIR = Entomological inoculation rate; mo = month; PCD = passive case detection; SAE = severe adverse event.

aEstimate.

SOURCE: Grobusch et al., 2007b; data on lines labeled “Entire study period” and percent follow-up from papers for the individual trials.



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