TABLE 5 Summary of Outcomes of the Six IPTi-SP Trials Through 12 Months of Age

 

Episodes of Clinical Malaria

Risk of Anemiab

Episodes of Hospitalization

 

Any Parasites

Local Specific Density Cut-offa

High Density Cut-off

with Malaria Parasites

All Cause

Study

% PE

95% CI

% PE

 

95% CI

% PE

 

95% CI

% PE

95% CI

% PE

95% CI

% PE

95% CI

Ifakara

59

(41, 71)

61

 

(43, 74)

56

 

(26, 75)

50

(8, 72)

58

(29, 76)

29

(7, 46)

Navrongo

29

(17, 40)

32

 

(16, 44)

34

 

(15, 48)

10

(−15, 30)

50

(23, 68)

18

(0, 32)

Manhiça

20

(2, 35)

31

 

(14, 45)

28

 

(8, 44)

10

(−19, 32)

22

(−16, 48)

25

(7, 39)

Kumasi

21

(9, 31)

23

 

(9, 34)

18

 

(−15, 42)

10

(−9, 27)

−7

(−103, 44)

18

(−22, 45)

Lambaréné

22

(−25, 52)

29

 

(−16, 56)

26

 

(−49, 64)

26

(0, 45)

NA

NA

−36

(−142, 24)

Tamale

33

(21, 44)

28

 

(6, 45)

30

 

(−15, 57)

15

(−1, 29)

44

(−80, 83)

50

(18, 69)

Combinedc

30

(20, 39)

 

NA

 

 

NA

 

15

(6, 23)

38

(13, 55)

23

(10, 34)

Ranged

(26, 33)

 

 

NA

 

 

NA

 

(14, 17)

 

(31, 44)

 

(20, 24)

 

NOTES: NA = not provided; PE = protective efficacy. Incidence of episodes (malaria and hospitalizations) analyzed “with a negative binomial regression to account for potential clustering within individuals. Robust standard errors were used to account for intra-cluster correlation at the community level for the Navrongo trial.” Clinical malaria: history of fever with any P. falciparum parasitemia. Risk of anemia (at least one episode) was analyzed using a Poisson regression model with a log-link and a robust error variance. To assess the sensitivity of the results to any single study, the SWG analyzed each outcome omitting one trial at a time. Estimates rounded to the nearest whole percentage.

aLocally cut-offs:>500μ/l for Ifakara, Manhiça, and Kumasi; >600μ/l for Lambaréné; >5000μ/l for Tamale; >8000μ/l for Navrongo.

bAnemia: PCV<25% for Ifakara, Manhiça, and Kumasi; Hb<8g/dl for Kumasi, Lambaréné, and Tamale.

cCombined estimates are basedon random-effects meta-analyses.

dRange: lowest and highest estimated protective efficacy for the sensitivity analyses.

SOURCE: Compiled from data in the Report of the Statistical Working Group (IPTi Consortium, 2007b).



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