Appendix F
List of Tables, Figures, and Boxes

TABLES

Table 1

 

World Health Organization—Recommended EPI Schedule,

 

8

Table 2

 

Characteristics of the Six IPTi-SP Trials,

 

18

Table 3

 

Primary Outcome and Power of the Six IPTi-SP Trials,

 

21

Table 4

 

Summary of Outcomes of the Six IPTi-SP Studies and the Kisumu Trial During the First Year of Life,

 

22

Table 5

 

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

 

25

Table 6

 

Mortality in the First Year of Life for the Six IPTi-SP Trials,

 

26

Table 7

 

Effect of SP During Treatment Period, Rebound Period, and Time from Randomization to End of Follow-Up,

 

29

Table 8

 

Incidence of Malaria During Prophylactic Effect 1 (Period of 35 Days After Dose at 3 Months),

 

30

Table 9

 

Incidence of Malaria During Prophylactic Effect 2 (Period of 35 Days After Dose at 9 Months),

 

30

Table 10

 

Incidence of Malaria During the Inter-Dose 1 Period,

 

32

Table 11

 

Protective Efficacy (PE) and Reported 95% Confidence Intervals (CI) for Outcomes During the 5 Months After Last Dose of SP or Placebo,

 

35

Table 12

 

Incidence of Malaria from Randomization up to 5 Months After the Last Dose of SP,

 

36

Table 13

 

Risk of Anemia from Randomization Up to 5 Months After the Last Dose of SP,

 

36

Table 14

 

Incidence of Hospital Admission with Malaria Parasites from Randomization Up to 5 Months After the Last Dose of SP,

 

37

Table 15

 

Incidence of All-Cause Hospital Admissions from Randomization Up to 5 Months After the Last Dose of SP,

 

37

Table 16

 

Protective efficacy (PE) and Reported 95% Confidence Intervals (CI) for Outcomes During the 11 Months After Last Dose of SP or Placebo,

 

39

Table 17

 

Protective Efficacy (PE) and Reported 95% Confidence Intervals (CI) for Outcomes from Randomization Through 11 Months After Last Dose of SP or Placebo,

 

40

Table 18

 

Overall Pooled Estimates of Efficacy Against Clinical Malaria and Other Relevant Outcomes During Two Periods of Follow-Up,

 

43

Table 19

 

Safety Monitoring for IPTi Surveillance Methods of the Six IPTi-SP Studies and the Kisumu Trial,

 

48

FIGURES

Figure 1

 

Incidence of first clinical malaria episodes over the course of the malaria season among subjects who received curative sulfadoxine-pyrimethamine,

 

13

BOXES

Box 1

 

A Summary of the Methods Used in Each IPTi-SP Study to Detect Critical Outcomes Including Clinical Malaria and (Depending on the Specific Study) Anemia, Hospitalization of Patients with Malaria Parasites, and All Cause Hospitalizations,

 

15

Box 2

 

List of Committee Findings and Conclusions by Order of Appearance in the Letter Report,

 

59

Box 3

 

Committee Recommendations in Order of Significance,

 

63



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Appendix F List of Tables, Figures, and Boxes TABLES Table 1 World Health Organization—Recommended EPI Schedule, 8 Table 2 Characteristics of the Six IPTi-SP Trials, 18 Table 3 Primary Outcome and Power of the Six IPTi-SP Trials, 21 Table 4 Summary of Outcomes of the Six IPTi-SP Studies and the Kisumu Trial During the First Year of Life, 22 Table 5 Summary of Outcomes of the Six IPTi-SP Trials Through 12 Months of Age, 25 Table 6 Mortality in the First Year of Life for the Six IPTi-SP Trials, 26 Table 7 Effect of SP During Treatment Period, Rebound Period, and Time from Randomization to End of Follow-Up, 29 Table 8 Incidence of Malaria During Prophylactic Effect 1 (Period of 35 Days After Dose at 3 Months), 30 Table 9 Incidence of Malaria During Prophylactic Effect 2 (Period of 35 Days After Dose at 9 Months), 30 Table 10 Incidence of Malaria During the Inter-Dose 1 Period, 32 Table 11 Protective Efficacy (PE) and Reported 95% Confidence Intervals (CI) for Outcomes During the 5 Months After Last Dose of SP or Placebo, 35 Table 12 Incidence of Malaria from Randomization up to 5 Months After the Last Dose of SP, 36 Table 13 Risk of Anemia from Randomization Up to 5 Months After the Last Dose of SP, 36 Table 14 Incidence of Hospital Admission with Malaria Parasites from Randomization Up to 5 Months After the Last Dose of SP, 37 Table 15 Incidence of All-Cause Hospital Admissions from Randomization Up to 5 Months After the Last Dose of SP, 37 Table 16 Protective efficacy (PE) and Reported 95% Confidence Intervals (CI) for Outcomes During the 11 Months After Last Dose of SP or Placebo, 39 Table 17 Protective Efficacy (PE) and Reported 95% Confidence Intervals (CI) for Outcomes from Randomization Through 11 Months After Last Dose of SP or Placebo, 40 Table 18 Overall Pooled Estimates of Efficacy Against Clinical Malaria and Other Relevant Outcomes During Two Periods of Follow-Up, 43 Table 19 Safety Monitoring for IPTi Surveillance Methods of the Six IPTi-SP Studies and the Kisumu Trial, 48 FIGURES Figure 1 Incidence of first clinical malaria episodes over the course of the malaria season among subjects who received curative sulfadoxine-pyrimethamine, 13 BOXES Box 1 A Summary of the Methods Used in Each IPTi-SP Study to Detect Critical Outcomes Including Clinical Malaria and (Depending on the Specific Study) Anemia, Hospitalization of Patients with Malaria Parasites, and All Cause Hospitalizations, 15 Box 2 List of Committee Findings and Conclusions by Order of Appearance in the Letter Report, 59 Box 3 Committee Recommendations in Order of Significance, 63 80