Epidemiology Study of Malaria Transmission Intensity in Africa

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01190202
Collaborator
The PATH Malaria Vaccine Initiative (MVI) (Other)
21,618
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2702.3
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Study Details

Study Description

Brief Summary

The aim of this epidemiology study is to characterize in a standardized way malaria transmission intensity at the clinical trial centers participating in study 110021 (NCT00866619).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood sampling
  • Procedure: Assessment of body temperature
N/A

Detailed Description

This study is a multicenter epidemiology study at centers that are participating in GSK's pivotal Phase III candidate malaria vaccine 110021 ( NCT00866619) trial and will involve 4 annual cross sectional surveys performed preferably at peak transmission.

There will be no study vaccine administered in this epidemiology study.

Study Design

Study Type:
Interventional
Actual Enrollment :
21618 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Primary Purpose:
Other
Official Title:
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Actual Study Start Date :
Mar 14, 2011
Actual Primary Completion Date :
Dec 20, 2013
Actual Study Completion Date :
Dec 20, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Overall Study Group (Survey 1)

Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.

Procedure: Blood sampling
Capillary blood samples collected by finger/heel prick

Procedure: Assessment of body temperature
Assessment of axial body temperature with a digital thermometer

Experimental: Overall Study Group (Survey 2)

Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.

Procedure: Blood sampling
Capillary blood samples collected by finger/heel prick

Procedure: Assessment of body temperature
Assessment of axial body temperature with a digital thermometer

Experimental: Overall Study Group (Survey 3)

Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.

Procedure: Blood sampling
Capillary blood samples collected by finger/heel prick

Procedure: Assessment of body temperature
Assessment of axial body temperature with a digital thermometer

Experimental: Overall Study Group (Survey 4)

Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.

Procedure: Blood sampling
Capillary blood samples collected by finger/heel prick

Procedure: Assessment of body temperature
Assessment of axial body temperature with a digital thermometer

Outcome Measures

Primary Outcome Measures

  1. Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey [At each Survey visit]

    The Overall parasite prevalence (PP) data were collected across centers from subjects aged between and including: 6 months to 4 Years (6M-4Y), 5 to 19 Years (5-19 Y) and 20 Years or older (20Y+), for each Survey. The number of subjects P. Falciparum parasitemia infected among the number of subjects with known result for P.falciparum parasitemia test was tabulated.

Secondary Outcome Measures

  1. Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey [At each Survey visit]

    The overall parasite prevalence (PP) data were collected across centers from subjects aged 4 years or less, for each Survey. The number of subjects P. Falciparum parasitemia infected among the number of subjects with known result for P.falciparum parasitemia test was tabulated.

  2. Number of Subjects With Anemia and Severe Anemia for Each Survey [During the survey period (approximatively 1 year)]

    The overall anemia and severe anemia data were collected across centers from subjects, aged between and including: 6M-4Y, 5-19 Y and 20Y+, for each survey. Hemoglobin (Hgb) cut-offs used to define anemia and severe anemia in people living at sea level are: Anemia: children 6M to 5Y, Hgb lower than (<) 11 gram per deciliter (g/dL); children 5-11Y, Hgb <11.5 g/dL; children 12-13Y, Hgb <12 g/dL; non-pregnant females, Hgb <12 g/dL; pregnant females, Hgb <11 g/dL; males, Hgb <13 g/dL. Severe anemia: any age or gender, Hgb <7 g/dL. Missing/ Not applicable (NA) = if age or pregnancy status was not available. Among each age category, results for both sub-categories "Yes" (subjects with anemia) and "Missing/NA" are presented below, results for the category "No" can be deduced from the number of participants analyzed in the corresponding age category, minus (number of "Yes" + number of "Missing/NA"). Similar presentation is followed for "severe anemia" results.

  3. Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density [During the survey period (approximatively 1 year)]

    The overall anti-malaria therapy data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg). Results include the following categories: Malaria treatment (MT) in past 14 days with sub-categories assessed: Yes, No; Exact days of malaria treatment (EDMT) with sub-categories assessed: Ongoing, 1-3 Days, ≥ 4 Days, Missing/NA; Other medication (OM) in past 14 days with sub-categories assessed: Yes, No; Days of other medication (DOM) with sub-categories assessed: Ongoing, 1-7 Days, ≥ 8 Days, Missing/NA; Malaria hospitalization (MH) in the last 3 months with sub-categories assessed: Yes, No. Missing/NA = Missing or Not Applicable.* In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.

  4. Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density [During the survey period (approximatively 1 year)]

    The overall anti-malaria therapy data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg). Results include the following categories: Malaria treatment (MT) in past 14 days with sub-categories assessed: Yes, No; Exact days of malaria treatment (EDMT) with sub-categories assessed: Ongoing, 1-3 Days, ≥ 4 Days, Missing/NA; Other medication (OM) in past 14 days with sub-categories assessed: Yes, No; Days of other medication (DOM) with sub-categories assessed: Ongoing, 1-7 Days, ≥ 8 Days, Missing/NA; Malaria hospitalization (MH) in the last 3 months with sub-categories assessed: Yes, No. Missing/NA = Missing or Not Applicable.* In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.

  5. Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density [During the survey period (approximatively 1 year)]

    The overall anti-malaria therapy data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg). Results include the following categories: Malaria treatment (MT) in past 14 days with sub-categories assessed: Yes, No; Exact days of malaria treatment (EDMT) with sub-categories assessed: Ongoing, 1-3 Days, ≥ 4 Days, Missing/NA; Other medication (OM) in past 14 days with sub-categories assessed: Yes, No; Days of other medication (DOM) with sub-categories assessed: Ongoing, 1-7 Days, ≥ 8 Days, Missing/NA; Malaria hospitalization (MH) in the last 3 months with sub-categories assessed: Yes, No. Missing/NA = Missing or Not Applicable.* In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.

  6. Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density [During the survey period (approximatively 1 year)]

    The overall anti-malaria therapy data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg). Results include the following categories: Malaria treatment (MT) in past 14 days with sub-categories assessed: Yes, No; Exact days of malaria treatment (EDMT) with sub-categories assessed: Ongoing, 1-3 Days, ≥ 4 Days, Missing/NA; Other medication (OM) in past 14 days with sub-categories assessed: Yes, No; Days of other medication (DOM) with sub-categories assessed: Ongoing, 1-7 Days, ≥ 8 Days, Missing/NA; Malaria hospitalization (MH) in the last 3 months with sub-categories assessed: Yes, No. Missing/NA = Missing or Not Applicable.* In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.

  7. Mean Number of Days With Malaria Treatment at Survey 1 [During the 14 day-period before the malaria treatment]

    The mean and standard deviation of the number of days of malaria treatment (DMT) were calculated for the past 14 days period of treatment. The malaria treatment data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  8. Mean Number of Days With Malaria Treatment at Survey 2 [During the 14 day-period before the malaria treatment]

    The mean and standard deviation of the number of days of malaria treatment (DMT) were calculated for the past 14 days period of treatment. The malaria treatment data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  9. Mean Number of Days With Malaria Treatment at Survey 3 [During the 14 day-period before the malaria treatment]

    The mean and standard deviation of the number of days of malaria treatment (DMT) were calculated for the past 14 days period of treatment. The malaria treatment data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  10. Mean Number of Days With Malaria Treatment at Survey 4 [During the 14 day-period before the malaria treatment]

    The mean and standard deviation of the number of days of malaria treatment (DMT) were calculated for the past 14 days period of treatment. The malaria treatment data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  11. Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 1 [In the last 24 hours or at the survey visit]

    Measured characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever at visit (F at V). Note: Fever set to "Yes" if temperature recorded after axillary conversion was ≥ 37.5 degrees Celsius (°C). Missing/NA = Missing or Not Applicable. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  12. Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 2 [In the last 24 hours or at the survey visit]

    Measured characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever at visit (F at V). Note: Fever set to "Yes" if temperature recorded after axillary conversion was ≥ 37.5 degrees Celsius (°C). Missing/NA = Missing or Not Applicable. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  13. Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 3 [In the last 24 hours or at the survey visit]

    Measured characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever at visit (F at V). Note: Fever set to "Yes" if temperature recorded after axillary conversion was ≥ 37.5 degrees Celsius (°C). Missing/NA = Missing or Not Applicable. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  14. Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 4 [In the last 24 hours or at the survey visit]

    Measured characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever at visit (F at V). Note: Fever set to "Yes" if temperature recorded after axillary conversion was ≥ 37.5 degrees Celsius (°C). Missing/NA = Missing or Not Applicable. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  15. Mean Number of Days With Fever at Survey 1 [During the survey period (approximatively 1 year)]

    The mean and standard deviation of the number of days ago with fever start (DaFs) were calculated for subjects having fever in the last 24 hours. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  16. Mean Number of Days With Fever at Survey 2 [During the survey period (approximatively 1 year)]

    The mean and standard deviation of the number of days ago with fever start (DaFs) were calculated for subjects having fever in the last 24 hours. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  17. Mean Number of Days With Fever at Survey 3 [During the survey period (approximatively 1 year)]

    The mean and standard deviation of the number of days ago with fever start (DaFs) were calculated for subjects having fever in the last 24 hours. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  18. Mean Number of Days With Fever at Survey 4 [During the survey period (approximatively 1 year)]

    The mean and standard deviation of the number of days ago with fever start (DaFs) were calculated for subjects having fever in the last 24 hours. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  19. Axillary Temperature at Visit in Survey 1 [At Survey visit]

    The mean and standard deviation of the axillary temperature at visit (A temp. at V) were calculated. Axillary temperature data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  20. Axillary Temperature at Visit in Survey 2 [At Survey visit]

    The mean and standard deviation of axillary temperature at visit (A temp. at V) were calculated. Axillary temperature data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  21. Axillary Temperature at Visit in Survey 3 [At Survey visit]

    The mean and standard deviation of axillary temperature at visit (A temp. at V) were calculated. Axillary temperature data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  22. Axillary Temperature at Visit in Survey 4 [At Survey visit]

    The mean and standard deviation of axillary temperature at visit (A temp. at V) were calculated. Axillary temperature data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  23. Number of Subjects Living in the Same House at Survey 1 [At Survey visit]

    The malaria prevention and risk factors characteristics were: Number of persons living in the same part of the house (PLSPH) among persons enrolled in the study (PES), in the following combinations: < y/x (less than [<] y PLSPH among x PES), y-z/x (y to z PLSPH among x PES), > z/x (more than [>] z PLSPH among x PES), y-z/> x (y to z PLSPH among more than [>] x PES), > z/> x (more than [>] z PLSPH among more than [>] x PES, or missing information). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  24. Number of Subjects Living in the Same House at Survey 2 [At Survey visit]

    The malaria prevention and risk factors characteristics were: Number of persons living in the same part of the house (PLSPH) among persons enrolled in the study (PES), in the following combinations: < y/x (less than [<] y PLSPH among x PES), y-z/x (y to z PLSPH among x PES), > z/x (more than [>] z PLSPH among x PES), y-z/> x (y to z PLSPH among more than [>] x PES), > z/> x (more than [>] z PLSPH among more than [>] x PES, or missing information). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  25. Number of Subjects Living in the Same House at Survey 3 [At Survey visit]

    The malaria prevention and risk factors characteristics were: Number of persons living in the same part of the house (PLSPH) among persons enrolled in the study (PES), in the following combinations: < y/x (less than [<] y PLSPH among x PES), y-z/x (y to z PLSPH among x PES), > z/x (more than [>] z PLSPH among x PES), y-z/> x (y to z PLSPH among more than [>] x PES), > z/> x (more than [>] z PLSPH among more than [>] x PES, or missing information). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  26. Number of Subjects Living in the Same House at Survey 4 [At Survey visit]

    The malaria prevention and risk factors characteristics were: Number of persons living in the same part of the house (PLSPH) among persons enrolled in the study (PES), in the following combinations: < y/x (less than [<] y PLSPH among x PES), y-z/x (y to z PLSPH among x PES), > z/x (more than [>] z PLSPH among x PES), y-z/> x (y to z PLSPH among more than [>] x PES), > z/> x (more than [>] z PLSPH among more than [>] x PES, or missing information). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  27. Mean Number of Subjects Living in the Same House at Survey 1 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: the mean and standard deviation of the number of persons living in the same part of the house (PLSPH). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  28. Mean Number of Subjects Living in the Same House at Survey 2 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: the mean and standard deviation of the number of persons living in the same part of the house (PLSPH). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  29. Mean Number of Subjects Living in the Same House at Survey 3 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: the mean and standard deviation of the number of persons living in the same part of the house (PLSPH). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  30. Mean Number of Subjects Living in the Same House at Survey 4 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: the mean and standard deviation of the number of persons living in the same part of the house (PLSPH). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  31. Number of Subjects by Localisation and Type of Location at Survey 1 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: localisation categories (i.e.: rural, urban, semi-rural or missing) and Type of Location (i.e.: Large city: >1 million habitants; Small city: >50000 & < 1 million habitants; Town: > 10000 and < 50000 habitants; Countryside: < 10000 habitants or missing type of location). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  32. Number of Subjects by Localisation and Type of Location at Survey 2 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: localisation categories (i.e.: rural, urban, semi-rural) and Type of Location (i.e.: Large city: >1 million habitants; Small city: >50000 & < 1 million habitants; Town: > 10000 and < 50000 habitants; Countryside: < 10000 habitants). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  33. Number of Subjects by Localisation and Type of Location at Survey 3 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: localisation categories (i.e.: rural, urban, semi-rural) and Type of Location (i.e.: Large city: >1 million habitants; Small city: >50000 & < 1 million habitants; Town: > 10000 and < 50000 habitants; Countryside: < 10000 habitants). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  34. Number of Subjects by Localisation and Type of Location at Survey 4 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: localisation categories (i.e.: rural, urban, semi-rural) and Type of Location (i.e.: Large city: >1 million habitants; Small city: >50000 & < 1 million habitants; Town: > 10000 and < 50000 habitants; Countryside: < 10000 habitants). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  35. Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: Main house construction material (MHCM) walls and MHCM floor. MHCM walls data were assessed for the following sub-categories: mud, brick, cement/plaster, cement/paint, other and missing. MHCM floor data were assessed for the following sub-categories: natural floor, rudimentary floor, parquet polished wood, vinyl or asphalt strips, ceramic tiles, cement, carpet, missing. Note: Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  36. Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: Main house construction material (MHCM) walls and MHCM floor. MHCM walls data were assessed for the following sub-categories: mud, brick, cement/plaster, cement/paint, other. MHCM floor data were assessed for the following sub-categories: natural floor, rudimentary floor, parquet polished wood, vinyl or asphalt strips, ceramic tiles, cement, carpet. Note: Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  37. Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: Main house construction material (MHCM) walls and MHCM floor. MHCM walls data were assessed for the following sub-categories: mud, brick, cement/plaster, cement/paint, other. MHCM floor data were assessed for the following sub-categories: natural floor, rudimentary floor, ceramic tiles, cement, carpet. Note: Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  38. Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: Main house construction material (MHCM) walls and MHCM floor. MHCM walls data were assessed for the following sub-categories: mud, brick, cement/plaster, cement/paint, other. MHCM floor data were assessed for the following sub-categories: natural floor, rudimentary floor, vinyl or asphalt strips, ceramic tiles, cement, carpet. Note: Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  39. Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 1 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: main house construction material (MHCM) roof, windows/eaves, nets. MHCM roof data were assessed for the following sub-categories: grass/palm, iron sheet, tiles, other, missing. MHCM windows/eaves data were assessed for the following sub-categories: closed, open, partially open, missing. MHCM nets data were assessed for the following sub-categories: nets not present, nets present on all windows, nets present on some windows, missing. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  40. Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: main house construction material (MHCM) roof, windows/eaves, nets. MHCM roof data were assessed for the following sub-categories: grass/palm, iron sheet, tiles, other. MHCM windows/eaves data were assessed for the following sub-categories: closed, open, partially open. MHCM nets data were assessed for the following sub-categories: nets not present, nets present on all windows, nets present on some windows. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  41. Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 3 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: main house construction material (MHCM) roof, windows/eaves, nets. MHCM roof data were assessed for the following sub-categories: grass/palm, iron sheet, tiles, other. MHCM windows/eaves data were assessed for the following sub-categories: closed, open, partially open. MHCM nets data were assessed for the following sub-categories: nets not present, nets present on all windows, nets present on some windows. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  42. Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 4 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: main house construction material (MHCM) roof, windows/eaves, nets. MHCM roof data were assessed for the following sub-categories: grass/palm, iron sheet, other. MHCM windows/eaves data were assessed for the following sub-categories: closed, open, partially open. MHCM nets data were assessed for the following sub-categories: nets not present, nets present on all windows, nets present on some windows. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  43. Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 1 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: Main source of drinking water (MSDW): bottled water, closed water source (piped water, tube well, dug well, protected well), open water source (unprotected well, spring water, rainwater, tanker truck, surface water), missing; and Presence of electricity (PE): Yes, No, missing. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  44. Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 2 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: Main source of drinking water (MSDW): bottled water, closed water source (piped water, tube well, dug well, protected well), open water source (unprotected well, spring water, rainwater, tanker truck, surface water); and Presence of electricity (PE): Yes, No. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  45. Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 3 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: Main source of drinking water (MSDW): bottled water, closed water source (piped water, tube well, dug well, protected well), open water source (unprotected well, spring water, rainwater, tanker truck, surface water); and Presence of electricity (PE): Yes, No. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  46. Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 4 [At Survey visit]

    The malaria prevention and risk factors characteristics were the following: Main source of drinking water (MSDW): bottled water, closed water source (piped water, tube well, dug well, protected well), open water source (unprotected well, spring water, rainwater, tanker truck, surface water); and Presence of electricity (PE): Yes, No. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).

  47. Number of Subjects With Malaria Prevention Measures (MPM) at Each Survey [At each Survey visit]

    The malaria prevention measures (MPM) data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for each Survey. The MPM results include the following categories: Use of Mosquito coils over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM) or Use of indoor residual spray- no spray (Uirs-no spray): the number of months ago for each Uirs-nM sub-categories is defined using the following [x Months]. Not all Uirs-nM sub-categories were analyzed in each survey.

  48. Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 1 [At Survey visit]

    Data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. The other Plasmodium species assessed were: P. Malaria, P. Vivax, P. Ovale. Infection were determined using a blood smear slide, and categorized according positive (Pos) and negative (Neg) results.

  49. Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 2 [At Survey visit]

    Data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. The other Plasmodium species assessed were: P. Malaria, P. Vivax, P. Ovale. Infection were determined using a blood smear slide, and categorized according positive (Pos) and negative (Neg) results.

  50. Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 3 [At Survey visit]

    Data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. The other Plasmodium species assessed were: P. Malaria, P. Vivax, P. Ovale. Infection were determined using a blood smear slide, and categorized according positive (Pos) and negative (Neg) results.

  51. Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 4 [At Survey visit]

    Data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. The other Plasmodium species assessed were: P. Malaria, P. Vivax, P. Ovale. Infection were determined using a blood smear slide, and categorized according positive (Pos) and negative (Neg) results.

  52. Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedure for Each Survey [At each Survey visit]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Capillary blood sampling was the only invasive procedure involved in this study. SAEs related to this procedure were recorded at the Survey visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Subjects who the investigator believes that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.

  • A male or female 6 months or older at the time of survey.

  • Written informed consent obtained from the subject/from the parent(s)/ Legally Acceptable Representative(s) of the subject.

Exclusion Criteria:
  • Child in care.

  • Previous or current participation in any malaria vaccine trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Ouagadougou 01 Burkina Faso
2 GSK Investigational Site Lambaréné Gabon
3 GSK Investigational Site Kintampo Ghana
4 GSK Investigational Site Kumasi Ghana
5 GSK Investigational Site Kisumu Kenya
6 GSK Investigational Site Lilongwe Malawi
7 GSK Investigational Site Dar-es-Salaam Tanzania
8 GSK Investigational Site Korogwe, Tanga Tanzania

Sponsors and Collaborators

  • GlaxoSmithKline
  • The PATH Malaria Vaccine Initiative (MVI)

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01190202
Other Study ID Numbers:
  • 114001
First Posted:
Aug 27, 2010
Last Update Posted:
Aug 18, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details For each year and each site, approximately 400 subjects at least 6 months and < 5 years old, approximately 200 subjects at least 5 years and < 20 years old and approximately 200 subjects at least 20 years old were to be enrolled. The study was conducted at 8 sites and 6 countries for the first 3 surveys and 3 sites from 3 countries for Survey 4.
Pre-assignment Detail
Arm/Group Title Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Arm/Group Description Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
Period Title: Overall Study
STARTED 6404 6414 6400 2400
COMPLETED 6404 6414 6400 2400
NOT COMPLETED 0 0 0 0

Baseline Characteristics

Arm/Group Title Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4) Total
Arm/Group Description Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Total of all reporting groups
Overall Participants 6404 6414 6400 2400 21618
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
12.6
(14.6)
12.1
(14.3)
12.1
(14.2)
12.4
(14.4)
12.28
(14.37)
Sex: Female, Male (Count of Participants)
Female
3670
57.3%
3791
59.1%
3752
58.6%
1420
59.2%
12633
58.4%
Male
2734
42.7%
2623
40.9%
2648
41.4%
980
40.8%
8985
41.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%

Outcome Measures

1. Primary Outcome
Title Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey
Description The Overall parasite prevalence (PP) data were collected across centers from subjects aged between and including: 6 months to 4 Years (6M-4Y), 5 to 19 Years (5-19 Y) and 20 Years or older (20Y+), for each Survey. The number of subjects P. Falciparum parasitemia infected among the number of subjects with known result for P.falciparum parasitemia test was tabulated.
Time Frame At each Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Arm/Group Description Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
Measure Participants 6401 6411 6400 2399
6M-4Y, Overall
720
11.2%
574
8.9%
605
9.5%
345
14.4%
5-19Y, Overall
446
7%
469
7.3%
483
7.5%
278
11.6%
20+Y, Overall
147
2.3%
146
2.3%
193
3%
92
3.8%
2. Secondary Outcome
Title Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey
Description The overall parasite prevalence (PP) data were collected across centers from subjects aged 4 years or less, for each Survey. The number of subjects P. Falciparum parasitemia infected among the number of subjects with known result for P.falciparum parasitemia test was tabulated.
Time Frame At each Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Arm/Group Description Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
Measure Participants 3200 3197 3193 1193
Children aged 0 year
21
0.3%
38
0.6%
41
0.6%
25
1%
Children aged 1 year
94
1.5%
75
1.2%
128
2%
62
2.6%
Children aged 2 years
139
2.2%
122
1.9%
125
2%
86
3.6%
Children aged 3 years
223
3.5%
174
2.7%
135
2.1%
86
3.6%
Children aged 4 years
243
3.8%
165
2.6%
176
2.8%
86
3.6%
3. Secondary Outcome
Title Number of Subjects With Anemia and Severe Anemia for Each Survey
Description The overall anemia and severe anemia data were collected across centers from subjects, aged between and including: 6M-4Y, 5-19 Y and 20Y+, for each survey. Hemoglobin (Hgb) cut-offs used to define anemia and severe anemia in people living at sea level are: Anemia: children 6M to 5Y, Hgb lower than (<) 11 gram per deciliter (g/dL); children 5-11Y, Hgb <11.5 g/dL; children 12-13Y, Hgb <12 g/dL; non-pregnant females, Hgb <12 g/dL; pregnant females, Hgb <11 g/dL; males, Hgb <13 g/dL. Severe anemia: any age or gender, Hgb <7 g/dL. Missing/ Not applicable (NA) = if age or pregnancy status was not available. Among each age category, results for both sub-categories "Yes" (subjects with anemia) and "Missing/NA" are presented below, results for the category "No" can be deduced from the number of participants analyzed in the corresponding age category, minus (number of "Yes" + number of "Missing/NA"). Similar presentation is followed for "severe anemia" results.
Time Frame During the survey period (approximatively 1 year)

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Arm/Group Description Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
Measure Participants 6401 6411 6400 2399
Overall Yes, Anaemia, 6M-4Y
1974
30.8%
2025
31.6%
1974
30.8%
871
36.3%
Missing/NA Anemia, 6M-4Y
4
0.1%
2
0%
Overall Yes, Anemia, 5-19Y
806
12.6%
794
12.4%
765
12%
371
15.5%
Missing/NA Anemia, 5-19Y
2
0%
2
0%
Overall Yes, Anemia, 20Y+
673
10.5%
631
9.8%
651
10.2%
313
13%
Missing/NA Anemia, 20Y+
1
0%
0
0%
Overall Yes, Severe anaemia, 6M-4Y
85
1.3%
70
1.1%
84
1.3%
34
1.4%
Missing/NA Severe anemia, 6M-4Y
1226
19.1%
1172
18.3%
1219
19%
322
13.4%
Overall Yes, Severe anaemia, 5-19Y
10
0.2%
12
0.2%
19
0.3%
5
0.2%
Missing/NA Severe anemia, 5-19Y
807
12.6%
833
13%
847
13.2%
235
9.8%
Overall Yes, Severe anaemia, 20Y+
17
0.3%
14
0.2%
9
0.1%
4
0.2%
Missing/NA Severe anemia, 20Y+
915
14.3%
956
14.9%
944
14.8%
287
12%
4. Secondary Outcome
Title Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density
Description The overall anti-malaria therapy data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg). Results include the following categories: Malaria treatment (MT) in past 14 days with sub-categories assessed: Yes, No; Exact days of malaria treatment (EDMT) with sub-categories assessed: Ongoing, 1-3 Days, ≥ 4 Days, Missing/NA; Other medication (OM) in past 14 days with sub-categories assessed: Yes, No; Days of other medication (DOM) with sub-categories assessed: Ongoing, 1-7 Days, ≥ 8 Days, Missing/NA; Malaria hospitalization (MH) in the last 3 months with sub-categories assessed: Yes, No. Missing/NA = Missing or Not Applicable.* In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.
Time Frame During the survey period (approximatively 1 year)

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 786 258 81 188 5088
6M-4Y, MT in past 14 days, Yes
22
0.3%
9
0.1%
2
0%
12
0.5%
262
1.2%
6M-4Y, MT in past 14 days, No
351
5.5%
161
2.5%
56
0.9%
107
4.5%
2218
10.3%
6M-4Y, EDMT *, Ongoing
3
0%
2
0%
0
0%
0
0%
28
0.1%
6M-4Y, EDMT *, 1-3 days
18
0.3%
5
0.1%
2
0%
9
0.4%
206
1%
6M-4Y, EDMT *, ≥ 4days
1
0%
2
0%
0
0%
3
0.1%
27
0.1%
6M-4Y, EDMT *, Missing/Not applicable
351
5.5%
161
2.5%
56
0.9%
107
4.5%
2219
10.3%
6M-4Y, OM in past 14 days, Yes
35
0.5%
33
0.5%
21
0.3%
33
1.4%
445
2.1%
6M-4Y, OM in past 14 days, No
338
5.3%
137
2.1%
37
0.6%
86
3.6%
2035
9.4%
6M-4Y, DOM *, Ongoing
8
0.1%
7
0.1%
2
0%
5
0.2%
79
0.4%
6M-4Y, DOM *, 1-7 days
25
0.4%
26
0.4%
19
0.3%
27
1.1%
365
1.7%
6M-4Y, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
0
0%
1
0%
6M-4Y, DOM *, Missing/Not applicable
340
5.3%
137
2.1%
37
0.6%
87
3.6%
2035
9.4%
6M-4Y, MH in the last 3 months, Yes
7
0.1%
4
0.1%
1
0%
7
0.3%
90
0.4%
6M-4Y, MH in the last 3 months, No
366
5.7%
166
2.6%
57
0.9%
112
4.7%
2390
11.1%
5-19Y, MT in past 14 days, Yes
5
0.1%
6
0.1%
4
0.1%
2
0.1%
85
0.4%
5-19Y, MT in past 14 days, No
289
4.5%
65
1%
19
0.3%
56
2.3%
1082
5%
5-19Y, EDMT *, Ongoing
1
0%
0
0%
0
0%
0
0%
5
0%
5-19Y, EDMT *, 1-3 days
4
0.1%
6
0.1%
4
0.1%
1
0%
75
0.3%
5-19Y, EDMT *, ≥ 4days
0
0%
0
0%
0
0%
1
0%
5
0%
5-19Y, EDMT *, Missing/Not applicable
289
4.5%
65
1%
19
0.3%
56
2.3%
1082
5%
5-19Y, OM in past 14 days, Yes
29
0.5%
12
0.2%
8
0.1%
7
0.3%
143
0.7%
5-19Y, OM in past 14 days, No
265
4.1%
59
0.9%
15
0.2%
51
2.1%
1024
4.7%
5-19Y, DOM *, Ongoing
4
0.1%
1
0%
1
0%
2
0.1%
17
0.1%
5-19Y, DOM *, 1-7 days
25
0.4%
11
0.2%
7
0.1%
5
0.2%
125
0.6%
5-19Y, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, DOM *, Missing/Not applicable
265
4.1%
59
0.9%
15
0.2%
51
2.1%
1025
4.7%
5-19Y, MH in the last 3 months, Yes
0
0%
3
0%
0
0%
1
0%
24
0.1%
5-19Y, MH in the last 3 months, No
294
4.6%
68
1.1%
23
0.4%
57
2.4%
1143
5.3%
20Y+, MT in past 14 days, Yes
1
0%
0
0%
0
0%
102
4.3%
20Y+, MT in past 14 days, No
118
1.8%
17
0.3%
11
0.2%
1339
55.8%
20Y+, EDMT *, Ongoing
0
0%
0
0%
0
0%
14
0.6%
20Y+, EDMT *, 1-3 days
1
0%
0
0%
0
0%
80
3.3%
20Y+, EDMT *, ≥ 4days
0
0%
0
0%
0
0%
8
0.3%
20Y+, EDMT *, Missing/Not applicable
118
1.8%
17
0.3%
11
0.2%
1339
55.8%
20Y+, OM in past 14 days, Yes
20
0.3%
6
0.1%
2
0%
203
8.5%
20Y+, OM in past 14 days, No
99
1.5%
11
0.2%
9
0.1%
1238
51.6%
20Y+, DOM *, Ongoing
5
0.1%
1
0%
1
0%
41
1.7%
20Y+, DOM *, 1-7 days
15
0.2%
5
0.1%
1
0%
158
6.6%
20Y+, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
2
0.1%
20Y+, DOM *, Missing/Not applicable
99
1.5%
11
0.2%
9
0.1%
1240
51.7%
20Y+, MH in the last 3 months, Yes
0
0%
2
0%
0
0%
18
0.8%
20Y+, MH in the last 3 months, No
119
1.9%
15
0.2%
11
0.2%
1423
59.3%
5. Secondary Outcome
Title Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density
Description The overall anti-malaria therapy data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg). Results include the following categories: Malaria treatment (MT) in past 14 days with sub-categories assessed: Yes, No; Exact days of malaria treatment (EDMT) with sub-categories assessed: Ongoing, 1-3 Days, ≥ 4 Days, Missing/NA; Other medication (OM) in past 14 days with sub-categories assessed: Yes, No; Days of other medication (DOM) with sub-categories assessed: Ongoing, 1-7 Days, ≥ 8 Days, Missing/NA; Malaria hospitalization (MH) in the last 3 months with sub-categories assessed: Yes, No. Missing/NA = Missing or Not Applicable.* In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.
Time Frame During the survey period (approximatively 1 year)

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 740 229 101 119 5222
6M-4Y, MT in past 14 days, Yes
14
0.2%
6
0.1%
2
0%
5
0.2%
257
1.2%
6M-4Y, MT in past 14 days, No
269
4.2%
142
2.2%
65
1%
71
3%
2366
10.9%
6M-4Y, EDMT *, Ongoing
1
0%
3
0%
0
0%
1
0%
25
0.1%
6M-4Y, EDMT *, 1-3 days
12
0.2%
1
0%
1
0%
4
0.2%
206
1%
6M-4Y, EDMT *, ≥ 4days
1
0%
2
0%
1
0%
0
0%
26
0.1%
6M-4Y, EDMT *, Missing/NA
269
4.2%
142
2.2%
65
1%
71
3%
2366
10.9%
6M-4Y, OM in past 14 days, Yes
42
0.7%
15
0.2%
9
0.1%
17
0.7%
535
2.5%
6M-4Y, OM in past 14 days, No
241
3.8%
133
2.1%
58
0.9%
59
2.5%
2088
9.7%
6M-4Y, DOM *, Ongoing
12
0.2%
6
0.1%
3
0%
2
0.1%
118
0.5%
6M-4Y, DOM *, 1-7 days
30
0.5%
9
0.1%
6
0.1%
15
0.6%
410
1.9%
6M-4Y, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
0
0%
7
0%
6M-4Y, DOM *, Missing/NA
241
3.8%
133
2.1%
58
0.9%
59
2.5%
2088
9.7%
6M-4Y, MH in the last 3 months, Yes
3
0%
3
0%
2
0%
3
0.1%
77
0.4%
6M-4Y, MH in the last 3 months, No
280
4.4%
145
2.3%
65
1%
73
3%
2546
11.8%
5-19Y, MT in past 14 days, Yes
11
0.2%
3
0%
2
0%
4
0.2%
77
0.4%
5-19Y, MT in past 14 days, No
322
5%
68
1.1%
27
0.4%
32
1.3%
1081
5%
5-19Y, EDMT *, Ongoing
1
0%
1
0%
0
0%
0
0%
11
0.1%
5-19Y, EDMT *, 1-3 days
8
0.1%
1
0%
2
0%
4
0.2%
66
0.3%
5-19Y, EDMT *, ≥ 4days
2
0%
1
0%
0
0%
0
0%
0
0%
5-19Y, EDMT *, Missing/NA
322
5%
68
1.1%
27
0.4%
32
1.3%
1081
5%
5-19Y, OM in past 14 days, Yes
33
0.5%
10
0.2%
8
0.1%
9
0.4%
134
0.6%
5-19Y, OM in past 14 days, No
300
4.7%
61
1%
21
0.3%
27
1.1%
1024
4.7%
5-19Y, DOM *, Ongoing
7
0.1%
1
0%
0
0%
1
0%
30
0.1%
5-19Y, DOM *, 1-7 days
26
0.4%
9
0.1%
8
0.1%
8
0.3%
102
0.5%
5-19Y, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
0
0%
2
0%
5-19Y, DOM *, Missing/NA
300
4.7%
61
1%
21
0.3%
27
1.1%
1024
4.7%
5-19Y, MH in the last 3 months, Yes
5
0.1%
1
0%
1
0%
1
0%
19
0.1%
5-19Y, MH in the last 3 months, No
328
5.1%
70
1.1%
28
0.4%
35
1.5%
1139
5.3%
20Y+, MT in past 14 days, Yes
2
0%
0
0%
0
0%
2
0.1%
84
0.4%
20Y+, MT in past 14 days, No
122
1.9%
10
0.2%
5
0.1%
5
0.2%
1357
6.3%
20Y+, EDMT *, Ongoing
0
0%
0
0%
0
0%
1
0%
5
0%
20Y+, EDMT *, 1-3 days
2
0%
0
0%
0
0%
1
0%
72
0.3%
20Y+, EDMT *, ≥ 4days
0
0%
0
0%
0
0%
0
0%
7
0%
20Y+, EDMT *, Missing/NA
122
1.9%
10
0.2%
5
0.1%
5
0.2%
1357
6.3%
20Y+, OM in past 14 days, Yes
10
0.2%
2
0%
2
0%
3
0.1%
214
1%
20Y+, OM in past 14 days, No
114
1.8%
8
0.1%
3
0%
4
0.2%
1227
5.7%
20Y+, DOM *, Ongoing
1
0%
0
0%
1
0%
2
0.1%
71
0.3%
20Y+, DOM *, 1-7 days
9
0.1%
2
0%
1
0%
1
0%
138
0.6%
20Y+, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
0
0%
5
0%
20Y+, DOM *, Missing/NA
114
1.8%
8
0.1%
3
0%
4
0.2%
1227
5.7%
20Y+, MH in the last 3 months, Yes
1
0%
1
0%
0
0%
0
0%
19
0.1%
20Y+, MH in the last 3 months, No
123
1.9%
9
0.1%
5
0.1%
7
0.3%
1422
6.6%
6. Secondary Outcome
Title Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density
Description The overall anti-malaria therapy data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg). Results include the following categories: Malaria treatment (MT) in past 14 days with sub-categories assessed: Yes, No; Exact days of malaria treatment (EDMT) with sub-categories assessed: Ongoing, 1-3 Days, ≥ 4 Days, Missing/NA; Other medication (OM) in past 14 days with sub-categories assessed: Yes, No; Days of other medication (DOM) with sub-categories assessed: Ongoing, 1-7 Days, ≥ 8 Days, Missing/NA; Malaria hospitalization (MH) in the last 3 months with sub-categories assessed: Yes, No. Missing/NA = Missing or Not Applicable.* In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.
Time Frame During the survey period (approximatively 1 year)

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 791 268 92 130 5119
6M-4Y, MT in past 14 days, Yes
17
0.3%
13
0.2%
3
0%
9
0.4%
267
1.2%
6M-4Y, MT in past 14 days, No
262
4.1%
148
2.3%
71
1.1%
82
3.4%
2321
10.7%
6M-4Y, EDMT *, Ongoing
4
0.1%
1
0%
0
0%
4
0.2%
33
0.2%
6M-4Y, EDMT *, 1-3 days
11
0.2%
10
0.2%
3
0%
5
0.2%
210
1%
6M-4Y, EDMT *, ≥ 4days
2
0%
2
0%
0
0%
0
0%
24
0.1%
6M-4Y, EDMT *, Missing/NA
262
4.1%
148
2.3%
71
1.1%
82
3.4%
2321
10.7%
6M-4Y, OM in past 14 days, Yes
65
1%
30
0.5%
18
0.3%
18
0.8%
547
2.5%
6M-4Y, OM in past 14 days, No
214
3.3%
131
2%
56
0.9%
73
3%
2041
9.4%
6M-4Y, DOM *, Ongoing
10
0.2%
8
0.1%
3
0%
6
0.3%
142
0.7%
6M-4Y, DOM *, 1-7 days
55
0.9%
22
0.3%
15
0.2%
12
0.5%
394
1.8%
6M-4Y, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
0
0%
11
0.1%
6M-4Y, DOM *, Missing/NA
214
3.3%
131
2%
56
0.9%
73
3%
2041
9.4%
6M-4Y, MH in the last 3 months, Yes
14
0.2%
4
0.1%
3
0%
0
0%
99
0.5%
6M-4Y, MH in the last 3 months, No
265
4.1%
157
2.4%
71
1.1%
91
3.8%
2489
11.5%
5-19Y, MT in past 14 days, Yes
14
0.2%
4
0.1%
1
0%
1
0%
58
0.3%
5-19Y, MT in past 14 days, No
327
5.1%
90
1.4%
12
0.2%
34
1.4%
1071
5%
5-19Y, EDMT *, Ongoing
4
0.1%
1
0%
0
0%
0
0%
4
0%
5-19Y, EDMT *, 1-3 days
8
0.1%
3
0%
1
0%
1
0%
50
0.2%
5-19Y, EDMT *, ≥ 4days
2
0%
0
0%
0
0%
0
0%
4
0%
5-19Y, EDMT *, Missing/NA
327
5.1%
90
1.4%
12
0.2%
34
1.4%
1071
5%
5-19Y, OM in past 14 days, Yes
44
0.7%
18
0.3%
3
0%
13
0.5%
128
0.6%
5-19Y, OM in past 14 days, No
297
4.6%
76
1.2%
10
0.2%
22
0.9%
1001
4.6%
5-19Y, DOM *, Ongoing
13
0.2%
1
0%
0
0%
2
0.1%
19
0.1%
5-19Y, DOM *, 1-7 days
31
0.5%
17
0.3%
3
0%
11
0.5%
109
0.5%
5-19Y, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, DOM *, Missing/NA
297
4.6%
76
1.2%
10
0.2%
22
0.9%
1001
4.6%
5-19Y, MH in the last 3 months, Yes
7
0.1%
0
0%
0
0%
1
0%
17
0.1%
5-19Y, MH in the last 3 months, No
334
5.2%
94
1.5%
13
0.2%
34
1.4%
1112
5.1%
20Y+, MT in past 14 days, Yes
5
0.1%
2
0%
0
0%
0
0%
70
0.3%
20Y+, MT in past 14 days, No
166
2.6%
11
0.2%
5
0.1%
4
0.2%
1332
6.2%
20Y+, EDMT *, Ongoing
0
0%
0
0%
0
0%
0
0%
6
0%
20Y+, EDMT *, 1-3 days
5
0.1%
1
0%
0
0%
0
0%
63
0.3%
20Y+, EDMT *, ≥ 4days
0
0%
1
0%
0
0%
0
0%
1
0%
20Y+, EDMT *, Missing/NA
166
2.6%
11
0.2%
5
0.1%
4
0.2%
1332
6.2%
20Y+, OM in past 14 days, Yes
25
0.4%
3
0%
3
0%
1
0%
227
1.1%
20Y+, OM in past 14 days, No
146
2.3%
10
0.2%
2
0%
3
0.1%
1175
5.4%
20Y+, DOM *, Ongoing
5
0.1%
3
0%
0
0%
1
0%
70
0.3%
20Y+, DOM *, 1-7 days
19
0.3%
0
0%
3
0%
0
0%
151
0.7%
20Y+, DOM *, ≥ 8 days
1
0%
0
0%
0
0%
0
0%
6
0%
20Y+, DOM *, Missing/NA
146
2.3%
10
0.2%
2
0%
3
0.1%
1175
5.4%
20Y+, MH in the last 3 months, Yes
0
0%
0
0%
0
0%
0
0%
12
0.1%
20Y+, MH in the last 3 months, No
171
2.7%
13
0.2%
5
0.1%
4
0.2%
1390
6.4%
7. Secondary Outcome
Title Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density
Description The overall anti-malaria therapy data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg). Results include the following categories: Malaria treatment (MT) in past 14 days with sub-categories assessed: Yes, No; Exact days of malaria treatment (EDMT) with sub-categories assessed: Ongoing, 1-3 Days, ≥ 4 Days, Missing/NA; Other medication (OM) in past 14 days with sub-categories assessed: Yes, No; Days of other medication (DOM) with sub-categories assessed: Ongoing, 1-7 Days, ≥ 8 Days, Missing/NA; Malaria hospitalization (MH) in the last 3 months with sub-categories assessed: Yes, No. Missing/NA = Missing or Not Applicable.* In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.
Time Frame During the survey period (approximatively 1 year)

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 453 158 36 68 1684
6M-4Y, MT in past 14 days, Yes
5
0.1%
2
0%
1
0%
5
0.2%
71
0.3%
6M-4Y, MT in past 14 days, No
163
2.5%
101
1.6%
19
0.3%
49
2%
777
3.6%
6M-4Y, EDMT *, Ongoing
2
0%
1
0%
0
0%
4
0.2%
21
0.1%
6M-4Y, EDMT *, 1-3 days
3
0%
1
0%
1
0%
1
0%
49
0.2%
6M-4Y, EDMT *, ≥ 4days
0
0%
0
0%
0
0%
0
0%
1
0%
6M-4Y, EDMT *, Missing/NA
163
2.5%
101
1.6%
19
0.3%
49
2%
777
3.6%
6M-4Y, OM in past 14 days, Yes
21
0.3%
11
0.2%
7
0.1%
12
0.5%
152
0.7%
6M-4Y, OM in past 14 days, No
147
2.3%
92
1.4%
13
0.2%
42
1.8%
696
3.2%
6M-4Y, DOM *, Ongoing
5
0.1%
2
0%
3
0%
5
0.2%
48
0.2%
6M-4Y, DOM *, 1-7 days
16
0.2%
8
0.1%
4
0.1%
7
0.3%
103
0.5%
6M-4Y, DOM *, ≥ 8 days
0
0%
1
0%
0
0%
0
0%
1
0%
6M-4Y, DOM *, Missing/NA
147
2.3%
92
1.4%
13
0.2%
42
1.8%
696
3.2%
6M-4Y, MH in the last 3 months, Yes
9
0.1%
1
0%
0
0%
2
0.1%
28
0.1%
6M-4Y, MH in the last 3 months, No
159
2.5%
102
1.6%
20
0.3%
52
2.2%
820
3.8%
5-19Y, MT in past 14 days, Yes
2
0%
0
0%
0
0%
0
0%
10
0%
5-19Y, MT in past 14 days, No
196
3.1%
51
0.8%
16
0.3%
13
0.5%
318
1.5%
5-19Y, EDMT *, Ongoing
0
0%
0
0%
0
0%
0
0%
3
0%
5-19Y, EDMT *, 1-3 days
2
0%
0
0%
0
0%
0
0%
7
0%
5-19Y, EDMT *, ≥ 4days
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, EDMT *, Missing/NA
196
3.1%
51
0.8%
16
0.3%
13
0.5%
318
1.5%
5-19Y, OM in past 14 days, Yes
13
0.2%
4
0.1%
0
0%
2
0.1%
28
0.1%
5-19Y, OM in past 14 days, No
185
2.9%
47
0.7%
16
0.3%
11
0.5%
300
1.4%
5-19Y, DOM *, Ongoing
1
0%
0
0%
0
0%
1
0%
6
0%
5-19Y, DOM *, 1-7 days
12
0.2%
4
0.1%
0
0%
1
0%
22
0.1%
5-19Y, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, DOM *, Missing/NA
185
2.9%
47
0.7%
16
0.3%
11
0.5%
300
1.4%
5-19Y, MH in the last 3 months, Yes
0
0%
0
0%
0
0%
0
0%
2
0%
5-19Y, MH in the last 3 months, No
198
3.1%
51
0.8%
16
0.3%
13
0.5%
326
1.5%
20Y+, MT in past 14 days, Yes
1
0%
0
0%
0
0%
8
0.3%
20Y+, MT in past 14 days, No
86
1.3%
4
0.1%
1
0%
500
20.8%
20Y+, EDMT *, Ongoing
0
0%
0
0%
0
0%
1
0%
20Y+, EDMT *, 1-3 days
1
0%
0
0%
0
0%
5
0.2%
20Y+, EDMT *, ≥ 4days
0
0%
0
0%
0
0%
2
0.1%
20Y+, EDMT *, Missing/NA
86
1.3%
4
0.1%
1
0%
500
20.8%
20Y+, OM in past 14 days, Yes
5
0.1%
0
0%
0
0%
57
2.4%
20Y+, OM in past 14 days, No
82
1.3%
4
0.1%
1
0%
451
18.8%
20Y+, DOM *, Ongoing
1
0%
0
0%
0
0%
18
0.8%
20Y+, DOM *, 1-7 days
4
0.1%
0
0%
0
0%
36
1.5%
20Y+, DOM *, ≥ 8 days
0
0%
0
0%
0
0%
3
0.1%
20Y+, DOM *, Missing/NA
82
1.3%
4
0.1%
1
0%
451
18.8%
20Y+, MH in the last 3 months, Yes
0
0%
0
0%
0
0%
5
0.2%
20Y+, MH in the last 3 months, No
87
1.4%
4
0.1%
1
0%
503
21%
8. Secondary Outcome
Title Mean Number of Days With Malaria Treatment at Survey 1
Description The mean and standard deviation of the number of days of malaria treatment (DMT) were calculated for the past 14 days period of treatment. The malaria treatment data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame During the 14 day-period before the malaria treatment

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit and who have data available during the past 14 days period of Malaria treatment.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 24 13 6 14 401
6M-4Y, DMT
2.6
(1.02)
3.7
(1.70)
2.5
(0.71)
3.1
(0.67)
3.1
(1.45)
5-19Y, DMT
2.0
(0.82)
2.2
(0.98)
2.8
(0.50)
3.5
(0.71)
2.5
(1.09)
20+Y, DMT
1.0
(0.00)
2.6
(1.37)
9. Secondary Outcome
Title Mean Number of Days With Malaria Treatment at Survey 2
Description The mean and standard deviation of the number of days of malaria treatment (DMT) were calculated for the past 14 days period of treatment. The malaria treatment data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame During the 14 day-period before the malaria treatment

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit and who have data available during the past 14 days period of Malaria treatment.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 25 5 4 9 377
6M-4Y, DMT
2.8
(1.48)
5.7
(2.31)
3.5
(0.71)
2.0
(1.15)
3.1
(1.16)
5-19Y, DMT
2.8
(1.81)
3.5
(2.12)
3.0
(0.00)
2.5
(1.00)
2.5
(0.81)
20+Y, DMT
3.0
(0.00)
1.0
(0.00)
2.5
(1.37)
10. Secondary Outcome
Title Mean Number of Days With Malaria Treatment at Survey 3
Description The mean and standard deviation of the number of days of malaria treatment (DMT) were calculated for the past 14 days period of treatment. The malaria treatment data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame During the 14 day-period before the malaria treatment

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit and who have data available during the past 14 days period of Malaria treatment.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 28 17 4 6 352
6M-4Y, DMT
3.0
(0.71)
3.3
(1.07)
2.3
(1.15)
2.2
(1.10)
3.1
(1.08)
5-19Y, DMT
3.9
(2.88)
1.7
(1.15)
3.0
(0.00)
1.0
(0.00)
2.9
(1.27)
20+Y, DMT
1.4
(0.89)
5.0
(2.83)
2.3
(1.12)
11. Secondary Outcome
Title Mean Number of Days With Malaria Treatment at Survey 4
Description The mean and standard deviation of the number of days of malaria treatment (DMT) were calculated for the past 14 days period of treatment. The malaria treatment data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame During the 14 day-period before the malaria treatment

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit and who have data available during the past 14 days period of Malaria treatment.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 6 1 1 1 64
6M-4Y, DMT
2.3
(1.15)
3.0
(0.00)
3.0
(0.00)
1.0
(0.00)
3.1
(0.59)
5-19Y, DMT
3.0
(0.00)
2.9
(0.38)
20+Y, DMT
1.0
(0.00)
3.3
(2.14)
12. Secondary Outcome
Title Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 1
Description Measured characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever at visit (F at V). Note: Fever set to "Yes" if temperature recorded after axillary conversion was ≥ 37.5 degrees Celsius (°C). Missing/NA = Missing or Not Applicable. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame In the last 24 hours or at the survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 786 258 81 188 5088
6M-4Y, F 24h - Yes
71
1.1%
53
0.8%
21
0.3%
60
2.5%
361
1.7%
6M-4Y, F 24h - No
302
4.7%
117
1.8%
37
0.6%
59
2.5%
2119
9.8%
6M-4Y, F at V - Yes
26
0.4%
13
0.2%
7
0.1%
22
0.9%
79
0.4%
6M-4Y, F at V - No
347
5.4%
157
2.4%
51
0.8%
97
4%
2400
11.1%
6M-4Y, F at V - Missing/NA
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, F 24h - Yes
37
0.6%
25
0.4%
10
0.2%
24
1%
124
0.6%
5-19Y, F 24h - No
257
4%
46
0.7%
13
0.2%
34
1.4%
1043
4.8%
5-19Y, F at V - Yes
6
0.1%
5
0.1%
5
0.1%
17
0.7%
29
0.1%
5-19Y, F at V - No
288
4.5%
66
1%
18
0.3%
41
1.7%
1138
5.3%
20+Y, F 24h - Yes
30
0.5%
9
0.1%
2
0%
181
7.5%
20+Y, F 24h - No
89
1.4%
8
0.1%
9
0.1%
1260
52.5%
20+Y, F at V - Yes
3
0%
0
0%
1
0%
23
1%
20+Y, F at V - No
115
1.8%
17
0.3%
10
0.2%
1418
59.1%
20+Y, F at V - Missing/NA
1
0%
0
0%
0
0%
0
0%
13. Secondary Outcome
Title Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 2
Description Measured characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever at visit (F at V). Note: Fever set to "Yes" if temperature recorded after axillary conversion was ≥ 37.5 degrees Celsius (°C). Missing/NA = Missing or Not Applicable. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame In the last 24 hours or at the survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 740 229 101 119 5222
6M-4Y, F 24h - Yes
41
0.6%
23
0.4%
15
0.2%
35
1.5%
357
1.7%
6M-4Y, F 24h - No
242
3.8%
125
1.9%
52
0.8%
41
1.7%
2266
10.5%
6M-4Y, F at V - Yes
26
0.4%
16
0.2%
15
0.2%
29
1.2%
98
0.5%
6M-4Y, F at V - No
257
4%
132
2.1%
52
0.8%
47
2%
2525
11.7%
5-19Y, F 24h - Yes
39
0.6%
11
0.2%
11
0.2%
13
0.5%
115
0.5%
5-19Y, F 24h - No
294
4.6%
60
0.9%
18
0.3%
23
1%
1043
4.8%
5-19Y, F at V - Yes
24
0.4%
4
0.1%
3
0%
8
0.3%
26
0.1%
5-19Y, F at V - No
309
4.8%
67
1%
26
0.4%
28
1.2%
1132
5.2%
20+Y, F 24h - Yes
14
0.2%
4
0.1%
3
0%
2
0.1%
169
0.8%
20+Y, F 24h - No
110
1.7%
6
0.1%
2
0%
5
0.2%
1272
5.9%
20+Y, F at V - Yes
10
0.2%
0
0%
0
0%
1
0%
36
0.2%
20+Y, F at V - No
114
1.8%
10
0.2%
5
0.1%
6
0.3%
1404
6.5%
20+Y, F at V - Missing/NA
0
0%
0
0%
0
0%
0
0%
1
0%
14. Secondary Outcome
Title Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 3
Description Measured characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever at visit (F at V). Note: Fever set to "Yes" if temperature recorded after axillary conversion was ≥ 37.5 degrees Celsius (°C). Missing/NA = Missing or Not Applicable. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame In the last 24 hours or at the survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 791 268 92 130 5119
6M-4Y, F 24h - Yes
60
0.9%
44
0.7%
28
0.4%
44
1.8%
360
1.7%
6M-4Y, F 24h - No
219
3.4%
117
1.8%
46
0.7%
47
2%
2228
10.3%
6M-4Y, F at V - Yes
8
0.1%
16
0.2%
9
0.1%
22
0.9%
56
0.3%
6M-4Y, F at V - No
271
4.2%
145
2.3%
65
1%
69
2.9%
2532
11.7%
5-19Y, F 24h - Yes
54
0.8%
25
0.4%
4
0.1%
17
0.7%
92
0.4%
5-19Y, F 24h - No
287
4.5%
69
1.1%
9
0.1%
18
0.8%
1037
4.8%
5-19Y, F at V - Yes
11
0.2%
6
0.1%
1
0%
14
0.6%
21
0.1%
5-19Y, F at V - No
330
5.2%
87
1.4%
12
0.2%
21
0.9%
1107
5.1%
5-19Y, F at V - Missing/NA
0
0%
1
0%
0
0%
0
0%
1
0%
20+Y, F 24h - Yes
20
0.3%
4
0.1%
4
0.1%
1
0%
167
0.8%
20+Y, F 24h - No
151
2.4%
9
0.1%
1
0%
3
0.1%
1235
5.7%
20+Y, F at V - Yes
5
0.1%
0
0%
3
0%
1
0%
23
0.1%
20+Y, F at V - No
166
2.6%
13
0.2%
2
0%
3
0.1%
1378
6.4%
20+Y, F at V - Missing/NA
0
0%
0
0%
0
0%
0
0%
1
0%
15. Secondary Outcome
Title Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 4
Description Measured characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever at visit (F at V). Note: Fever set to "Yes" if temperature recorded after axillary conversion was ≥ 37.5 degrees Celsius (°C). Missing/NA = Missing or Not Applicable. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame In the last 24 hours or at the survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 453 158 36 68 1684
6M-4Y, F 24h - Yes
39
0.6%
18
0.3%
5
0.1%
27
1.1%
115
0.5%
6M-4Y, F 24h - No
129
2%
85
1.3%
15
0.2%
27
1.1%
733
3.4%
6M-4Y, F at V - Yes
8
0.1%
8
0.1%
4
0.1%
18
0.8%
20
0.1%
6M-4Y, F at V - No
160
2.5%
95
1.5%
16
0.3%
36
1.5%
827
3.8%
6M-4Y, F at V - Missing/NA
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, F 24h - Yes
38
0.6%
8
0.1%
4
0.1%
4
0.2%
22
0.1%
5-19Y, F 24h - No
160
2.5%
43
0.7%
12
0.2%
9
0.4%
306
1.4%
5-19Y, F at V - Yes
5
0.1%
0
0%
2
0%
1
0%
4
0%
5-19Y, F at V - No
193
3%
51
0.8%
14
0.2%
12
0.5%
324
1.5%
20+Y, F 24h - Yes
11
0.2%
0
0%
0
0%
25
1%
20+Y, F 24h - No
76
1.2%
4
0.1%
1
0%
483
20.1%
20+Y, F at V - Yes
0
0%
0
0%
0
0%
3
0.1%
20+Y, F at V - No
87
1.4%
4
0.1%
1
0%
505
21%
16. Secondary Outcome
Title Mean Number of Days With Fever at Survey 1
Description The mean and standard deviation of the number of days ago with fever start (DaFs) were calculated for subjects having fever in the last 24 hours. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame During the survey period (approximatively 1 year)

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit and with fever reported in the last 24 hours.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 138 87 31 86 663
6M-4Y, DaFs
2.5
(2.18)
2.6
(2.23)
2.1
(1.42)
2.5
(4.13)
2.3
(1.77)
5-19Y, DaFs
2.2
(1.41)
2.2
(1.29)
2.7
(2.06)
1.7
(1.05)
2.3
(1.93)
20+Y, DaFs
2.3
(1.56)
2.3
(1.87)
2.5
(0.71)
2.9
(3.36)
17. Secondary Outcome
Title Mean Number of Days With Fever at Survey 2
Description The mean and standard deviation of the number of days ago with fever start (DaFs) were calculated for subjects having fever in the last 24 hours. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame During the survey period (approximatively 1 year)

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit and with fever reported in the last 24 hours.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 94 38 29 50 641
6M-4Y, DaFs
2.1
(1.35)
2.7
(1.99)
1.4
(0.51)
2.0
(1.46)
2.4
(1.76)
5-19Y, DaFs
2.5
(1.62)
2.6
(2.38)
2.5
(2.34)
2.1
(1.80)
2.1
(1.38)
20+Y, DaFs
4.0
(3.64)
2.0
(1.15)
2.0
(1.00)
4.0
(2.83)
3.2
(2.96)
18. Secondary Outcome
Title Mean Number of Days With Fever at Survey 3
Description The mean and standard deviation of the number of days ago with fever start (DaFs) were calculated for subjects having fever in the last 24 hours. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame During the survey period (approximatively 1 year)

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit and with fever reported in the last 24 hours.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 134 72 36 62 619
6M-4Y, DaFs
2.3
(1.90)
2.4
(1.95)
2.2
(1.33)
2.1
(1.37)
2.5
(1.80)
5-19Y, DaFs
2.3
(1.58)
2.8
(1.63)
2.5
(1.73)
1.8
(0.53)
2.7
(2.21)
20+Y, DaFs
3.0
(1.81)
2.8
(0.50)
3.8
(2.22)
3.0
(0.00)
3.3
(4.28)
19. Secondary Outcome
Title Mean Number of Days With Fever at Survey 4
Description The mean and standard deviation of the number of days ago with fever start (DaFs) were calculated for subjects having fever in the last 24 hours. Fever data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame During the survey period (approximatively 1 year)

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit and with fever reported in the last 24 hours.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 88 26 9 31 162
6M-4Y, DaFs
2.2
(1.05)
2.4
(2.43)
1.6
(0.89)
2.2
(1.64)
2.7
(1.88)
5-19Y, DaFs
2.0
(0.97)
3.8
(2.38)
1.5
(0.58)
2.0
(1.15)
2.1
(1.23)
20+Y, DaFs
2.5
(1.21)
3.2
(1.38)
20. Secondary Outcome
Title Axillary Temperature at Visit in Survey 1
Description The mean and standard deviation of the axillary temperature at visit (A temp. at V) were calculated. Axillary temperature data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 785 258 81 188 5087
6M-4Y, A temp. at V
36.65
(0.521)
36.64
(0.623)
36.72
(0.782)
37.04
(0.803)
36.55
(0.522)
5-19Y, A temp. at V
36.56
(0.469)
36.70
(0.597)
37.07
(0.853)
37.29
(0.928)
36.63
(0.496)
20+Y, A temp. at V
36.55
(0.459)
36.70
(0.387)
36.82
(0.462)
36.60
(0.478)
21. Secondary Outcome
Title Axillary Temperature at Visit in Survey 2
Description The mean and standard deviation of axillary temperature at visit (A temp. at V) were calculated. Axillary temperature data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 740 229 101 119 5221
6M-4Y, A temp. at V
36.69
(0.574)
36.75
(0.628)
36.86
(0.725)
37.41
(1.201)
36.60
(0.479)
5-19Y, A temp. at V
36.70
(0.522)
36.76
(0.507)
36.76
(0.773)
37.36
(0.949)
36.66
(0.447)
20+Y, A temp. at V
36.70
(0.478)
36.75
(0.375)
36.64
(0.559)
37.09
(0.713)
36.67
(0.430)
22. Secondary Outcome
Title Axillary Temperature at Visit in Survey 3
Description The mean and standard deviation of axillary temperature at visit (A temp. at V) were calculated. Axillary temperature data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 791 267 92 130 5117
6M-4Y, A temp. at V
36.47
(0.517)
36.66
(0.652)
36.68
(0.701)
36.97
(0.951)
36.54
(0.496)
5-19Y, A temp. at V
36.56
(0.551)
36.66
(0.571)
36.61
(0.475)
37.45
(1.117)
36.59
(0.462)
20+Y, A temp. at V
36.44
(0.515)
36.42
(0.409)
37.54
(1.135)
37.18
(0.727)
36.55
(0.493)
23. Secondary Outcome
Title Axillary Temperature at Visit in Survey 4
Description The mean and standard deviation of axillary temperature at visit (A temp. at V) were calculated. Axillary temperature data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 453 158 36 68 1683
6M-4Y, A temp. at V
36.51
(0.508)
36.51
(0.535)
36.95
(0.927)
37.16
(1.187)
36.40
(0.492)
5-19Y, A temp. at V
36.53
(0.510)
36.55
(0.379)
36.53
(0.570)
36.61
(0.431)
36.38
(0.430)
20+Y, A temp. at V
36.42
(0.444)
36.68
(0.206)
36.50
(0.000)
36.39
(0.457)
24. Secondary Outcome
Title Number of Subjects Living in the Same House at Survey 1
Description The malaria prevention and risk factors characteristics were: Number of persons living in the same part of the house (PLSPH) among persons enrolled in the study (PES), in the following combinations: < y/x (less than [<] y PLSPH among x PES), y-z/x (y to z PLSPH among x PES), > z/x (more than [>] z PLSPH among x PES), y-z/> x (y to z PLSPH among more than [>] x PES), > z/> x (more than [>] z PLSPH among more than [>] x PES, or missing information). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 786 258 81 188 5088
6M-4Y, PLSPH/PES, <3/1
34
0.5%
13
0.2%
3
0%
2
0.1%
78
0.4%
6M-4Y, PLSPH/PES, 4-5/1
32
0.5%
15
0.2%
1
0%
2
0.1%
146
0.7%
6M-4Y, PLSPH/PES, >5/1
20
0.3%
10
0.2%
0
0%
3
0.1%
123
0.6%
6M-4Y, PLSPH/PES, <3/2
46
0.7%
14
0.2%
6
0.1%
14
0.6%
280
1.3%
6M-4Y, PLSPH/PES, 4-5/2
106
1.7%
49
0.8%
13
0.2%
36
1.5%
737
3.4%
6M-4Y, PLSPH/PES, >5/2
119
1.9%
59
0.9%
28
0.4%
59
2.5%
1038
4.8%
6M-4Y, PLSPH/PES, <3/3
1
0%
0
0%
0
0%
0
0%
3
0%
6M-4Y, PLSPH/PES, 4-5/3
1
0%
1
0%
1
0%
1
0%
19
0.1%
6M-4Y, PLSPH/PES, >5/3
13
0.2%
7
0.1%
4
0.1%
1
0%
45
0.2%
6M-4Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
1
0%
0
0%
1
0%
6M-4Y, PLSPH/PES, >5/>3
1
0%
2
0%
1
0%
1
0%
9
0%
6M-4Y, Missing
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, PLSPH/PES, <3/1
20
0.3%
6
0.1%
0
0%
0
0%
28
0.1%
5-19Y, PLSPH/PES, 4-5/1
14
0.2%
2
0%
1
0%
1
0%
17
0.1%
5-19Y, PLSPH/PES, >5/1
8
0.1%
3
0%
1
0%
0
0%
37
0.2%
5-19Y, PLSPH/PES, <3/2
19
0.3%
4
0.1%
1
0%
5
0.2%
75
0.3%
5-19Y, PLSPH/PES, 4-5/2
76
1.2%
13
0.2%
9
0.1%
17
0.7%
357
1.7%
5-19Y, PLSPH/PES, >5/2
111
1.7%
38
0.6%
10
0.2%
34
1.4%
560
2.6%
5-19Y, PLSPH/PES, <3/3
0
0%
1
0%
0
0%
0
0%
2
0%
5-19Y, PLSPH/PES, 4-5/3
10
0.2%
1
0%
0
0%
0
0%
14
0.1%
5-19Y, PLSPH/PES, >5/3
25
0.4%
2
0%
1
0%
1
0%
59
0.3%
5-19Y, PLSPH/PES, 4-5/>3
1
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, PLSPH/PES, >5/>3
10
0.2%
1
0%
0
0%
0
0%
17
0.1%
5-19Y, Missing
0
0%
0
0%
0
0%
0
0%
1
0%
20+Y, PLSPH/PES, <3/1
3
0%
0
0%
0
0%
49
2%
20+Y, PLSPH/PES, 4-5/1
1
0%
0
0%
0
0%
16
0.7%
20+Y, PLSPH/PES, >5/1
6
0.1%
1
0%
0
0%
26
1.1%
20+Y, PLSPH/PES, <3/2
22
0.3%
2
0%
2
0%
234
9.8%
20+Y, PLSPH/PES, 4-5/2
40
0.6%
7
0.1%
3
0%
449
18.7%
20+Y, PLSPH/PES, >5/2
33
0.5%
7
0.1%
6
0.1%
575
24%
20+Y, PLSPH/PES, <3/3
0
0%
0
0%
0
0%
2
0.1%
20+Y, PLSPH/PES, 4-5/3
3
0%
0
0%
0
0%
18
0.8%
20+Y, PLSPH/PES, >5/3
10
0.2%
0
0%
0
0%
51
2.1%
20+Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
1
0%
20+Y, PLSPH/PES, >5/>3
1
0%
0
0%
0
0%
18
0.8%
20+Y, Missing
0
0%
0
0%
0
0%
2
0.1%
25. Secondary Outcome
Title Number of Subjects Living in the Same House at Survey 2
Description The malaria prevention and risk factors characteristics were: Number of persons living in the same part of the house (PLSPH) among persons enrolled in the study (PES), in the following combinations: < y/x (less than [<] y PLSPH among x PES), y-z/x (y to z PLSPH among x PES), > z/x (more than [>] z PLSPH among x PES), y-z/> x (y to z PLSPH among more than [>] x PES), > z/> x (more than [>] z PLSPH among more than [>] x PES, or missing information). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 740 229 101 119 5222
6M-4Y, PLSPH/PES, <3/1
27
0.4%
18
0.3%
8
0.1%
2
0.1%
59
0.3%
6M-4Y, PLSPH/PES, 4-5/1
33
0.5%
18
0.3%
8
0.1%
3
0.1%
112
0.5%
6M-4Y, PLSPH/PES, >5/1
13
0.2%
9
0.1%
3
0%
4
0.2%
84
0.4%
6M-4Y, PLSPH/PES, <3/2
37
0.6%
21
0.3%
8
0.1%
14
0.6%
306
1.4%
6M-4Y, PLSPH/PES, 4-5/2
93
1.5%
48
0.7%
17
0.3%
24
1%
964
4.5%
6M-4Y, PLSPH/PES, >5/2
76
1.2%
32
0.5%
19
0.3%
27
1.1%
1059
4.9%
6M-4Y, PLSPH/PES, <3/3
1
0%
0
0%
0
0%
0
0%
2
0%
6M-4Y, PLSPH/PES, 4-5/3
0
0%
0
0%
0
0%
0
0%
11
0.1%
6M-4Y, PLSPH/PES, >5/3
3
0%
1
0%
4
0.1%
2
0.1%
24
0.1%
6M-4Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
0
0%
2
0%
6M-4Y, PLSPH/PES, >5/>3
0
0%
1
0%
0
0%
0
0%
0
0%
5-19Y, PLSPH/PES, <3/1
34
0.5%
3
0%
1
0%
3
0.1%
23
0.1%
5-19Y, PLSPH/PES, 4-5/1
30
0.5%
13
0.2%
2
0%
0
0%
20
0.1%
5-19Y, PLSPH/PES, >5/1
16
0.2%
3
0%
0
0%
0
0%
38
0.2%
5-19Y, PLSPH/PES, <3/2
30
0.5%
3
0%
0
0%
2
0.1%
69
0.3%
5-19Y, PLSPH/PES, 4-5/2
98
1.5%
17
0.3%
10
0.2%
13
0.5%
426
2%
5-19Y, PLSPH/PES, >5/2
105
1.6%
28
0.4%
15
0.2%
17
0.7%
548
2.5%
5-19Y, PLSPH/PES, <3/3
2
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, PLSPH/PES, 4-5/3
4
0.1%
0
0%
0
0%
0
0%
9
0%
5-19Y, PLSPH/PES, >5/3
14
0.2%
4
0.1%
1
0%
1
0%
20
0.1%
5-19Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
0
0%
4
0%
5-19Y, PLSPH/PES, >5/>3
0
0%
0
0%
0
0%
0
0%
0
0%
20+Y, PLSPH-PES, <3/1
14
0.2%
0
0%
0
0%
0
0%
40
0.2%
20+Y, PLSPH/PES, 4-5/1
8
0.1%
0
0%
0
0%
0
0%
26
0.1%
20+Y, PLSPH/PES, >5/1
5
0.1%
0
0%
1
0%
0
0%
51
0.2%
20+Y, PLSPH/PES, <3/2
34
0.5%
2
0%
1
0%
2
0.1%
253
1.2%
20+Y, PLSPH/PES, 4-5/2
39
0.6%
3
0%
0
0%
2
0.1%
553
2.6%
20+Y, PLSPH/PES, >5/2
21
0.3%
5
0.1%
3
0%
3
0.1%
476
2.2%
20+Y, PLSPH/PES, <3/3
0
0%
0
0%
0
0%
0
0%
3
0%
20+Y, PLSPH/PES, 4-5/3
0
0%
0
0%
0
0%
0
0%
9
0%
20+Y, PLSPH/PES, >5/3
3
0%
0
0%
0
0%
0
0%
25
0.1%
20+Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
0
0%
2
0%
20+Y, PLSPH/PES, >5/>3
0
0%
0
0%
0
0%
0
0%
3
0%
26. Secondary Outcome
Title Number of Subjects Living in the Same House at Survey 3
Description The malaria prevention and risk factors characteristics were: Number of persons living in the same part of the house (PLSPH) among persons enrolled in the study (PES), in the following combinations: < y/x (less than [<] y PLSPH among x PES), y-z/x (y to z PLSPH among x PES), > z/x (more than [>] z PLSPH among x PES), y-z/> x (y to z PLSPH among more than [>] x PES), > z/> x (more than [>] z PLSPH among more than [>] x PES, or missing information). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 791 268 92 130 5119
6M-4Y, PLSPH/PES, <3/1
31
0.5%
16
0.2%
7
0.1%
11
0.5%
63
0.3%
6M-4Y, PLSPH/PES, 4-5/1
31
0.5%
26
0.4%
8
0.1%
11
0.5%
94
0.4%
6M-4Y, PLSPH/PES, >5/1
15
0.2%
10
0.2%
6
0.1%
2
0.1%
94
0.4%
6M-4Y, PLSPH/PES, <3/2
43
0.7%
24
0.4%
13
0.2%
17
0.7%
340
1.6%
6M-4Y, PLSPH/PES, 4-5/2
76
1.2%
30
0.5%
19
0.3%
22
0.9%
973
4.5%
6M-4Y, PLSPH/PES, >5/2
75
1.2%
44
0.7%
19
0.3%
26
1.1%
984
4.6%
6M-4Y, PLSPH/PES, <3/3
0
0%
0
0%
0
0%
0
0%
0
0%
6M-4Y, PLSPH/PES, 4-5/3
2
0%
0
0%
1
0%
0
0%
11
0.1%
6M-4Y, PLSPH/PES, >5/3
6
0.1%
11
0.2%
1
0%
2
0.1%
29
0.1%
6M-4Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
0
0%
0
0%
6M-4Y, PLSPH/PES, >5/>3
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, PLSPH/PES, <3/1
40
0.6%
9
0.1%
1
0%
1
0%
24
0.1%
5-19Y, PLSPH/PES, 4-5/1
32
0.5%
8
0.1%
0
0%
1
0%
23
0.1%
5-19Y, PLSPH/PES, >5/1
31
0.5%
1
0%
0
0%
3
0.1%
42
0.2%
5-19Y, PLSPH/PES, <3/2
24
0.4%
13
0.2%
0
0%
2
0.1%
88
0.4%
5-19Y, PLSPH/PES, 4-5/2
74
1.2%
25
0.4%
5
0.1%
13
0.5%
421
1.9%
5-19Y, PLSPH/PES, >5/2
103
1.6%
36
0.6%
7
0.1%
15
0.6%
507
2.3%
5-19Y, PLSPH/PES, <3/3
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, PLSPH/PES, 4-5/3
7
0.1%
0
0%
0
0%
0
0%
7
0%
5-19Y, PLSPH/PES, >5/3
30
0.5%
2
0%
0
0%
0
0%
17
0.1%
5-19Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, PLSPH/PES, >5/>3
0
0%
0
0%
0
0%
0
0%
0
0%
20+Y, PLSPH/PES, <3/1
18
0.3%
0
0%
0
0%
0
0%
40
0.2%
20+Y, PLSPH/PES, 4-5/1
7
0.1%
0
0%
0
0%
0
0%
27
0.1%
20+Y, PLSPH/PES, >5/1
5
0.1%
0
0%
0
0%
0
0%
33
0.2%
20+Y, PLSPH/PES, <3/2
43
0.7%
3
0%
0
0%
1
0%
273
1.3%
20+Y, PLSPH/PES, 4-5/2
57
0.9%
4
0.1%
3
0%
0
0%
516
2.4%
20+Y, PLSPH/PES, >5/2
28
0.4%
6
0.1%
2
0%
3
0.1%
463
2.1%
20+Y, PLSPH/PES, <3/3
0
0%
0
0%
0
0%
0
0%
0
0%
20+Y, PLSPH/PES, 4-5/3
0
0%
0
0%
0
0%
0
0%
14
0.1%
20+Y, PLSPH/PES, >5/3
13
0.2%
0
0%
0
0%
0
0%
36
0.2%
20+Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
0
0%
0
0%
20+Y, PLSPH/PES, >5/>3
0
0%
0
0%
0
0%
0
0%
0
0%
27. Secondary Outcome
Title Number of Subjects Living in the Same House at Survey 4
Description The malaria prevention and risk factors characteristics were: Number of persons living in the same part of the house (PLSPH) among persons enrolled in the study (PES), in the following combinations: < y/x (less than [<] y PLSPH among x PES), y-z/x (y to z PLSPH among x PES), > z/x (more than [>] z PLSPH among x PES), y-z/> x (y to z PLSPH among more than [>] x PES), > z/> x (more than [>] z PLSPH among more than [>] x PES, or missing information). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 453 158 36 68 1684
6M-4Y, PLSPH/PES, <3/1
28
0.4%
21
0.3%
2
0%
7
0.3%
42
0.2%
6M-4Y, PLSPH/PES, 4-5/1
24
0.4%
14
0.2%
4
0.1%
5
0.2%
74
0.3%
6M-4Y, PLSPH/PES, >5/1
18
0.3%
7
0.1%
1
0%
5
0.2%
59
0.3%
6M-4Y, PLSPH/PES, <3/2
27
0.4%
18
0.3%
3
0%
10
0.4%
74
0.3%
6M-4Y, PLSPH/PES, 4-5/2
30
0.5%
23
0.4%
3
0%
13
0.5%
184
0.9%
6M-4Y, PLSPH/PES, >5/2
25
0.4%
12
0.2%
4
0.1%
12
0.5%
338
1.6%
6M-4Y, PLSPH-PES, <3/3
0
0%
0
0%
1
0%
0
0%
1
0%
6M-4Y, PLSPH/PES, 4-5/3
1
0%
1
0%
0
0%
1
0%
9
0%
6M-4Y, PLSPH/PES, >5/3
14
0.2%
7
0.1%
2
0%
1
0%
62
0.3%
6M-4Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
0
0%
1
0%
6M-4Y, PLSPH/PES, >5/>3
1
0%
0
0%
0
0%
0
0%
4
0%
5-19Y, PLSPH/PES, <3/1
36
0.6%
5
0.1%
2
0%
2
0.1%
17
0.1%
5-19Y, PLSPH/PES, 4-5/1
35
0.5%
11
0.2%
1
0%
2
0.1%
23
0.1%
5-19Y, PLSPH/PES, >5/1
4
0.1%
2
0%
2
0%
1
0%
7
0%
5-19Y, PLSPH/PES, <3/2
13
0.2%
5
0.1%
2
0%
0
0%
10
0%
5-19Y, PLSPH/PES, 4-5/2
27
0.4%
8
0.1%
3
0%
3
0.1%
65
0.3%
5-19Y, PLSPH/PES, >5/2
31
0.5%
10
0.2%
3
0%
4
0.2%
149
0.7%
5-19Y, PLSPH/PES, <3/3
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, PLSPH/PES, 4-5/3
5
0.1%
1
0%
0
0%
0
0%
12
0.1%
5-19Y, PLSPH/PES, >5/3
42
0.7%
9
0.1%
3
0%
1
0%
38
0.2%
5-19Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
0
0%
2
0%
5-19Y, PLSPH/PES, >5/>3
5
0.1%
0
0%
0
0%
0
0%
5
0%
20+Y, PLSPH/PES, <3/1
4
0.1%
0
0%
0
0%
20
0.8%
20+Y, PLSPH/PES, 4-5/1
4
0.1%
0
0%
0
0%
8
0.3%
20+Y, PLSPH/PES, >5/1
1
0%
0
0%
0
0%
10
0.4%
20+Y, PLSPH/PES, <3/2
23
0.4%
0
0%
0
0%
81
3.4%
20+Y, PLSPH/PES, 4-5/2
26
0.4%
2
0%
0
0%
119
5%
20+Y, PLSPH/PES, >5/2
15
0.2%
1
0%
0
0%
191
8%
20+Y, PLSPH/PES, <3/3
1
0%
0
0%
0
0%
3
0.1%
20+Y, PLSPH/PES, 4-5/3
2
0%
0
0%
1
0%
3
0.1%
20+Y, PLSPH/PES, >5/3
11
0.2%
1
0%
0
0%
67
2.8%
20+Y, PLSPH/PES, 4-5/>3
0
0%
0
0%
0
0%
1
0%
20+Y, PLSPH/PES, >5/>3
0
0%
0
0%
0
0%
5
0.2%
28. Secondary Outcome
Title Mean Number of Subjects Living in the Same House at Survey 1
Description The malaria prevention and risk factors characteristics were the following: the mean and standard deviation of the number of persons living in the same part of the house (PLSPH). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 786 258 81 188 5088
6M-4Y, PLSPH
6.4
(4.83)
6.3
(4.23)
6.5
(3.98)
5.8
(2.14)
6.5
(4.28)
5-19Y, PLSPH
6.9
(4.55)
6.6
(3.53)
5.9
(1.91)
6.5
(3.04)
7.1
(4.69)
20+Y, PLSPH
6.1
(4.15)
7.4
(5.21)
6.2
(2.99)
6.3
(4.24)
29. Secondary Outcome
Title Mean Number of Subjects Living in the Same House at Survey 2
Description The malaria prevention and risk factors characteristics were the following: the mean and standard deviation of the number of persons living in the same part of the house (PLSPH). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 740 229 101 119 5222
6M-4Y, PLSPH
5.1
(2.90)
5.0
(2.17)
5.1
(2.34)
5.4
(2.62)
5.8
(2.66)
5-19Y, PLSPH
5.5
(2.64)
6.1
(2.78)
5.9
(1.89)
5.9
(2.81)
6.2
(2.78)
20+Y, PLSPH
4.7
(3.35)
6.5
(3.24)
7.8
(3.27)
5.3
(2.56)
5.4
(2.64)
30. Secondary Outcome
Title Mean Number of Subjects Living in the Same House at Survey 3
Description The malaria prevention and risk factors characteristics were the following: the mean and standard deviation of the number of persons living in the same part of the house (PLSPH). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 791 268 92 130 5119
6M-4Y, PLSPH
5.1
(2.73)
5.4
(2.74)
5.1
(3.40)
5.0
(2.43)
5.6
(2.48)
5-19Y, PLSPH
5.9
(3.25)
5.1
(2.04)
5.5
(1.85)
5.8
(2.06)
6.0
(2.42)
20+Y, PLSPH
4.5
(2.16)
5.9
(3.23)
5.4
(1.14)
6.5
(2.89)
5.4
(2.77)
31. Secondary Outcome
Title Mean Number of Subjects Living in the Same House at Survey 4
Description The malaria prevention and risk factors characteristics were the following: the mean and standard deviation of the number of persons living in the same part of the house (PLSPH). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 453 158 36 68 1684
6M-4Y, PLSPH
5.4
(3.12)
5.1
(3.73)
5.5
(3.50)
5.2
(3.24)
6.6
(3.33)
5-19Y, PLSPH
6.5
(4.55)
6.1
(3.95)
6.3
(3.13)
6.8
(4.28)
7.3
(3.70)
20+Y, PLSPH
5.0
(2.94)
6.3
(2.22)
5.0
(0.00)
6.6
(3.96)
32. Secondary Outcome
Title Number of Subjects by Localisation and Type of Location at Survey 1
Description The malaria prevention and risk factors characteristics were the following: localisation categories (i.e.: rural, urban, semi-rural or missing) and Type of Location (i.e.: Large city: >1 million habitants; Small city: >50000 & < 1 million habitants; Town: > 10000 and < 50000 habitants; Countryside: < 10000 habitants or missing type of location). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 786 258 81 188 5088
6M-4Y, rural
309
4.8%
136
2.1%
45
0.7%
106
4.4%
1415
6.5%
6M-4Y, urban
39
0.6%
22
0.3%
10
0.2%
11
0.5%
803
3.7%
6M-4Y, semi-rural
25
0.4%
12
0.2%
3
0%
2
0.1%
262
1.2%
6M-4Y, missing - localisation
0
0%
0
0%
0
0%
0
0%
0
0%
6M-4Y, large city
18
0.3%
14
0.2%
7
0.1%
7
0.3%
355
1.6%
6M-4Y, small city
0
0%
0
0%
0
0%
0
0%
18
0.1%
6M-4Y, town
44
0.7%
16
0.2%
5
0.1%
6
0.3%
644
3%
6M-4Y, countryside
311
4.9%
140
2.2%
46
0.7%
106
4.4%
1463
6.8%
5-19Y, rural
225
3.5%
55
0.9%
16
0.3%
51
2.1%
688
3.2%
5-19Y, urban
50
0.8%
13
0.2%
4
0.1%
5
0.2%
350
1.6%
5-19Y, semi-rural
19
0.3%
3
0%
3
0%
2
0.1%
128
0.6%
5-19Y, missing - localisation
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, large city
25
0.4%
5
0.1%
4
0.1%
4
0.2%
162
0.7%
5-19Y, small city
1
0%
0
0%
0
0%
0
0%
7
0%
5-19Y, town
43
0.7%
11
0.2%
2
0%
3
0.1%
282
1.3%
5-19Y, countryside
225
3.5%
55
0.9%
17
0.3%
51
2.1%
715
3.3%
5-19Y, missing - type of localisation
0
0%
0
0%
0
0%
0
0%
1
0%
20+Y, rural
89
1.4%
12
0.2%
10
0.2%
923
38.5%
20+Y, urban
26
0.4%
3
0%
0
0%
370
15.4%
20+Y, semi-rural
4
0.1%
2
0%
1
0%
147
6.1%
20+Y, missing - localisation
0
0%
0
0%
0
0%
1
0%
20+Y, large city
16
0.2%
3
0%
0
0%
181
7.5%
20+Y, small city
0
0%
0
0%
0
0%
9
0.4%
20+Y, town
14
0.2%
2
0%
1
0%
299
12.5%
20+Y, countryside
89
1.4%
12
0.2%
10
0.2%
951
39.6%
20+Y, missing - type of localisation
0
0%
0
0%
0
0%
1
0%
33. Secondary Outcome
Title Number of Subjects by Localisation and Type of Location at Survey 2
Description The malaria prevention and risk factors characteristics were the following: localisation categories (i.e.: rural, urban, semi-rural) and Type of Location (i.e.: Large city: >1 million habitants; Small city: >50000 & < 1 million habitants; Town: > 10000 and < 50000 habitants; Countryside: < 10000 habitants). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 740 229 101 119 5222
6M-4Y, rural
212
3.3%
120
1.9%
51
0.8%
60
2.5%
1377
6.4%
6M-4Y, urban
44
0.7%
16
0.2%
14
0.2%
15
0.6%
995
4.6%
6M-4Y, semi-rural
27
0.4%
12
0.2%
2
0%
1
0%
251
1.2%
6M-4Y, large city
10
0.2%
4
0.1%
5
0.1%
6
0.3%
374
1.7%
6M-4Y, small city
0
0%
0
0%
0
0%
0
0%
6
0%
6M-4Y, town
34
0.5%
12
0.2%
9
0.1%
9
0.4%
632
2.9%
6M-4Y, countryside
239
3.7%
132
2.1%
53
0.8%
61
2.5%
1611
7.5%
5-19Y, rural
237
3.7%
48
0.7%
17
0.3%
25
1%
583
2.7%
5-19Y, urban
72
1.1%
22
0.3%
11
0.2%
10
0.4%
472
2.2%
5-19Y, semi-rural
24
0.4%
1
0%
1
0%
1
0%
103
0.5%
5-19Y, large city
15
0.2%
5
0.1%
2
0%
7
0.3%
172
0.8%
5-19Y, small city
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, town
57
0.9%
17
0.3%
9
0.1%
3
0.1%
305
1.4%
5-19Y, countryside
261
4.1%
49
0.8%
18
0.3%
26
1.1%
680
3.1%
20+Y, rural
94
1.5%
6
0.1%
2
0%
6
0.3%
769
3.6%
20+Y, urban
26
0.4%
4
0.1%
3
0%
1
0%
515
2.4%
20+Y, semi-rural
4
0.1%
0
0%
0
0%
0
0%
157
0.7%
20+Y, large city
6
0.1%
2
0%
0
0%
1
0%
191
0.9%
20+Y, small city
0
0%
0
0%
0
0%
0
0%
5
0%
20+Y, town
20
0.3%
2
0%
3
0%
0
0%
330
1.5%
20+Y, countryside
98
1.5%
6
0.1%
2
0%
6
0.3%
915
4.2%
34. Secondary Outcome
Title Number of Subjects by Localisation and Type of Location at Survey 3
Description The malaria prevention and risk factors characteristics were the following: localisation categories (i.e.: rural, urban, semi-rural) and Type of Location (i.e.: Large city: >1 million habitants; Small city: >50000 & < 1 million habitants; Town: > 10000 and < 50000 habitants; Countryside: < 10000 habitants). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 791 268 92 130 5119
6M-4Y, rural
234
3.7%
146
2.3%
65
1%
82
3.4%
1531
7.1%
6M-4Y, urban
30
0.5%
11
0.2%
5
0.1%
5
0.2%
881
4.1%
6M-4Y, semi-rural
15
0.2%
4
0.1%
4
0.1%
4
0.2%
176
0.8%
6M-4Y, large city
7
0.1%
3
0%
1
0%
3
0.1%
386
1.8%
6M-4Y, small city
0
0%
0
0%
0
0%
0
0%
2
0%
6M-4Y, town
23
0.4%
9
0.1%
4
0.1%
2
0.1%
541
2.5%
6M-4Y, countryside
249
3.9%
149
2.3%
69
1.1%
86
3.6%
1659
7.7%
5-19Y, rural
283
4.4%
78
1.2%
9
0.1%
28
1.2%
645
3%
5-19Y, urban
42
0.7%
12
0.2%
4
0.1%
7
0.3%
404
1.9%
5-19Y, semi-rural
16
0.2%
4
0.1%
0
0%
0
0%
80
0.4%
5-19Y, large city
12
0.2%
2
0%
2
0%
2
0.1%
182
0.8%
5-19Y, small city
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, town
30
0.5%
10
0.2%
2
0%
5
0.2%
241
1.1%
5-19Y, countryside
299
4.7%
82
1.3%
9
0.1%
28
1.2%
705
3.3%
20+Y, rural
147
2.3%
8
0.1%
5
0.1%
3
0.1%
868
4%
20+Y, urban
23
0.4%
3
0%
0
0%
1
0%
430
2%
20+Y, semi-rural
1
0%
2
0%
0
0%
0
0%
104
0.5%
20+Y, large city
15
0.2%
0
0%
0
0%
0
0%
185
0.9%
20+Y, small city
0
0%
0
0%
0
0%
0
0%
1
0%
20+Y, town
8
0.1%
3
0%
0
0%
1
0%
273
1.3%
20+Y, countryside
148
2.3%
10
0.2%
5
0.1%
3
0.1%
943
4.4%
35. Secondary Outcome
Title Number of Subjects by Localisation and Type of Location at Survey 4
Description The malaria prevention and risk factors characteristics were the following: localisation categories (i.e.: rural, urban, semi-rural) and Type of Location (i.e.: Large city: >1 million habitants; Small city: >50000 & < 1 million habitants; Town: > 10000 and < 50000 habitants; Countryside: < 10000 habitants). Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 453 158 36 68 1684
6M-4Y, rural
153
2.4%
102
1.6%
20
0.3%
53
2.2%
536
2.5%
6M-4Y, urban
15
0.2%
1
0%
0
0%
1
0%
312
1.4%
6M-4Y, semi-rural
0
0%
0
0%
0
0%
0
0%
0
0%
6M-4Y, large city
0
0%
0
0%
0
0%
0
0%
0
0%
6M-4Y, small city
0
0%
0
0%
0
0%
0
0%
0
0%
6M-4Y, town
15
0.2%
1
0%
0
0%
1
0%
311
1.4%
6M-4Y, countryside
153
2.4%
102
1.6%
20
0.3%
53
2.2%
537
2.5%
5-19Y, rural
184
2.9%
49
0.8%
14
0.2%
11
0.5%
186
0.9%
5-19Y, urban
14
0.2%
2
0%
2
0%
2
0.1%
142
0.7%
5-19Y, semi-rural
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, large city
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, small city
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, town
14
0.2%
2
0%
2
0%
2
0.1%
141
0.7%
5-19Y, countryside
184
2.9%
49
0.8%
14
0.2%
11
0.5%
187
0.9%
20+Y, rural
85
1.3%
4
0.1%
1
0%
352
14.7%
20+Y, urban
2
0%
0
0%
0
0%
156
6.5%
20+Y, semi-rural
0
0%
0
0%
0
0%
0
0%
20+Y, large city
0
0%
0
0%
0
0%
0
0%
20+Y, small city
0
0%
0
0%
0
0%
0
0%
20+Y, town
2
0%
0
0%
0
0%
155
6.5%
20+Y, countryside
85
1.3%
4
0.1%
1
0%
353
14.7%
36. Secondary Outcome
Title Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1
Description The malaria prevention and risk factors characteristics were the following: Main house construction material (MHCM) walls and MHCM floor. MHCM walls data were assessed for the following sub-categories: mud, brick, cement/plaster, cement/paint, other and missing. MHCM floor data were assessed for the following sub-categories: natural floor, rudimentary floor, parquet polished wood, vinyl or asphalt strips, ceramic tiles, cement, carpet, missing. Note: Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 786 258 81 188 5088
6M-4Y, MHCM walls - mud
97
1.5%
62
1%
34
0.5%
84
3.5%
869
4%
6M-4Y, MHCM walls - brick
190
3%
76
1.2%
12
0.2%
12
0.5%
504
2.3%
6M-4Y, MHCM walls - cement/plaster
41
0.6%
16
0.2%
7
0.1%
11
0.5%
383
1.8%
6M-4Y, MHCM walls - cement/paint
29
0.5%
12
0.2%
5
0.1%
11
0.5%
408
1.9%
6M-4Y, MHCM walls - other
16
0.2%
4
0.1%
0
0%
1
0%
316
1.5%
6M-4Y, MHCM floor - natural floor
197
3.1%
100
1.6%
42
0.7%
83
3.5%
1079
5%
6M-4Y, MHCM floor - rudimentary floor
0
0%
0
0%
0
0%
0
0%
3
0%
6M-4Y, MHCM floor - parquet polished wood
0
0%
0
0%
0
0%
0
0%
2
0%
6M-4Y, MHCM floor - vinyl/asphalt strips
0
0%
0
0%
0
0%
0
0%
4
0%
6M-4Y, MHCM floor - ceramic tiles
0
0%
1
0%
0
0%
0
0%
30
0.1%
6M-4Y, MHCM floor - cement
170
2.7%
69
1.1%
16
0.3%
33
1.4%
1309
6.1%
6M-4Y, MHCM floor - carpet
6
0.1%
0
0%
0
0%
3
0.1%
53
0.2%
5-19Y, MHCM walls - mud
89
1.4%
29
0.5%
13
0.2%
48
2%
424
2%
5-19Y, MHCM walls - brick
119
1.9%
23
0.4%
3
0%
4
0.2%
223
1%
5-19Y, MHCM walls - cement/plaster
43
0.7%
8
0.1%
4
0.1%
5
0.2%
168
0.8%
5-19Y, MHCM walls - cement/paint
30
0.5%
4
0.1%
3
0%
1
0%
186
0.9%
5-19Y, MHCM walls - other
13
0.2%
7
0.1%
0
0%
0
0%
165
0.8%
5-19Y, MHCM walls - missing
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, MHCM floor - natural floor
146
2.3%
46
0.7%
12
0.2%
48
2%
511
2.4%
5-19Y, MHCM floor - rudimentary floor
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, MHCM floor - parquet polished wood
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, MHCM floor - vinyl/asphalt strips
0
0%
0
0%
0
0%
0
0%
2
0%
5-19Y, MHCM floor - ceramic tiles
0
0%
1
0%
0
0%
0
0%
14
0.1%
5-19Y, MHCM floor - cement
146
2.3%
24
0.4%
11
0.2%
10
0.4%
607
2.8%
5-19Y, MHCM floor - carpet
2
0%
0
0%
0
0%
0
0%
30
0.1%
5-19Y, MHCM floor - missing
0
0%
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM walls - mud
43
0.7%
7
0.1%
9
0.1%
548
22.8%
20+Y, MHCM walls - brick
43
0.7%
2
0%
0
0%
337
14%
20+Y, MHCM walls - cement/plaster
12
0.2%
5
0.1%
1
0%
192
8%
20+Y, MHCM walls - cement/paint
16
0.2%
3
0%
0
0%
217
9%
20+Y, MHCM walls - other
5
0.1%
0
0%
1
0%
146
6.1%
20+Y, MHCM walls - missing
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM floor - natural floor
64
1%
5
0.1%
8
0.1%
690
28.8%
20+Y, MHCM floor - rudimentary floor
0
0%
0
0%
0
0%
2
0.1%
20+Y, MHCM floor - parquet polished wood
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM floor - vinyl/asphalt strips
0
0%
0
0%
0
0%
2
0.1%
20+Y, MHCM floor - ceramic tiles
0
0%
0
0%
0
0%
13
0.5%
20+Y, MHCM floor - cement
55
0.9%
11
0.2%
3
0%
705
29.4%
20+Y, MHCM floor - carpet
0
0%
1
0%
0
0%
27
1.1%
20+Y, MHCM floor - missing
0
0%
0
0%
0
0%
1
0%
37. Secondary Outcome
Title Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2
Description The malaria prevention and risk factors characteristics were the following: Main house construction material (MHCM) walls and MHCM floor. MHCM walls data were assessed for the following sub-categories: mud, brick, cement/plaster, cement/paint, other. MHCM floor data were assessed for the following sub-categories: natural floor, rudimentary floor, parquet polished wood, vinyl or asphalt strips, ceramic tiles, cement, carpet. Note: Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 740 229 101 119 5222
6M-4Y, MHCM walls - mud
49
0.8%
30
0.5%
15
0.2%
29
1.2%
1010
4.7%
6M-4Y, MHCM walls - brick
163
2.5%
81
1.3%
34
0.5%
31
1.3%
458
2.1%
6M-4Y, MHCM walls - cement/plaster
33
0.5%
14
0.2%
8
0.1%
8
0.3%
472
2.2%
6M-4Y, MHCM walls - cement/paint
32
0.5%
15
0.2%
4
0.1%
2
0.1%
393
1.8%
6M-4Y, MHCM walls - other
6
0.1%
8
0.1%
6
0.1%
6
0.3%
290
1.3%
6M-4Y, MHCM floor - natural floor
194
3%
97
1.5%
45
0.7%
53
2.2%
1145
5.3%
6M-4Y, MHCM floor - rudimentary floor
0
0%
0
0%
0
0%
0
0%
2
0%
6M-4Y, MHCM floor - parquet polished wood
0
0%
0
0%
1
0%
0
0%
6
0%
6M-4Y, MHCM floor - vinyl/asphalt strips
0
0%
0
0%
0
0%
0
0%
15
0.1%
6M-4Y, MHCM floor - ceramic tiles
0
0%
1
0%
0
0%
1
0%
40
0.2%
6M-4Y, MHCM floor - cement
84
1.3%
50
0.8%
20
0.3%
22
0.9%
1357
6.3%
6M-4Y, MHCM floor - carpet
5
0.1%
0
0%
1
0%
0
0%
58
0.3%
5-19Y, MHCM walls - mud
79
1.2%
20
0.3%
11
0.2%
21
0.9%
445
2.1%
5-19Y, MHCM walls - brick
155
2.4%
26
0.4%
11
0.2%
7
0.3%
191
0.9%
5-19Y, MHCM walls - cement/plaster
51
0.8%
15
0.2%
2
0%
4
0.2%
207
1%
5-19Y, MHCM walls - cement/paint
34
0.5%
5
0.1%
1
0%
0
0%
182
0.8%
5-19Y, MHCM walls - other
14
0.2%
5
0.1%
4
0.1%
4
0.2%
133
0.6%
5-19Y, MHCM floor - natural floor
207
3.2%
42
0.7%
17
0.3%
26
1.1%
508
2.3%
5-19Y, MHCM floor - rudimentary floor
1
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, MHCM floor - parquet polished wood
0
0%
0
0%
1
0%
0
0%
5
0%
5-19Y, MHCM floor - vinyl/asphalt strips
0
0%
0
0%
0
0%
0
0%
10
0%
5-19Y, MHCM floor - ceramic tiles
0
0%
0
0%
0
0%
0
0%
26
0.1%
5-19Y, MHCM floor - cement
117
1.8%
29
0.5%
11
0.2%
9
0.4%
587
2.7%
5-19Y, MHCM floor - carpet
8
0.1%
0
0%
0
0%
1
0%
22
0.1%
20+Y, MHCM walls - mud
26
0.4%
5
0.1%
1
0%
5
0.2%
520
2.4%
20+Y, MHCM walls - brick
69
1.1%
2
0%
0
0%
0
0%
302
1.4%
20+Y, MHCM walls - cement/plaster
7
0.1%
0
0%
1
0%
1
0%
258
1.2%
20+Y, MHCM walls - cement/paint
15
0.2%
0
0%
0
0%
0
0%
215
1%
20+Y, MHCM walls - other
7
0.1%
3
0%
3
0%
1
0%
146
0.7%
20+Y, MHCM floor - natural floor
88
1.4%
7
0.1%
2
0%
5
0.2%
653
3%
20+Y, MHCM floor - rudimentary floor
0
0%
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM floor - parquet polished wood
0
0%
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM floor - vinyl/asphalt strips
0
0%
0
0%
1
0%
0
0%
4
0%
20+Y, MHCM floor - ceramic tiles
1
0%
0
0%
0
0%
0
0%
15
0.1%
20+Y, MHCM floor - cement
34
0.5%
3
0%
2
0%
2
0.1%
732
3.4%
20+Y, MHCM floor - carpet
1
0%
0
0%
0
0%
0
0%
35
0.2%
38. Secondary Outcome
Title Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3
Description The malaria prevention and risk factors characteristics were the following: Main house construction material (MHCM) walls and MHCM floor. MHCM walls data were assessed for the following sub-categories: mud, brick, cement/plaster, cement/paint, other. MHCM floor data were assessed for the following sub-categories: natural floor, rudimentary floor, ceramic tiles, cement, carpet. Note: Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 791 268 92 130 5119
6M-4Y, MHCM walls - mud
65
1%
42
0.7%
19
0.3%
33
1.4%
969
4.5%
6M-4Y, MHCM walls - brick
143
2.2%
91
1.4%
41
0.6%
43
1.8%
485
2.2%
6M-4Y, MHCM walls - cement/plaster
23
0.4%
10
0.2%
10
0.2%
5
0.2%
350
1.6%
6M-4Y, MHCM walls - cement/paint
28
0.4%
12
0.2%
3
0%
5
0.2%
464
2.1%
6M-4Y, MHCM walls - other
20
0.3%
6
0.1%
1
0%
5
0.2%
320
1.5%
6M-4Y, MHCM floor - natural floor
188
2.9%
111
1.7%
54
0.8%
65
2.7%
1082
5%
6M-4Y, MHCM floor - rudimentary floor
0
0%
0
0%
0
0%
0
0%
4
0%
6M-4Y, MHCM floor - ceramic tiles
1
0%
0
0%
0
0%
0
0%
26
0.1%
6M-4Y, MHCM floor - cement
85
1.3%
49
0.8%
20
0.3%
25
1%
1406
6.5%
6M-4Y, MHCM floor - carpet
5
0.1%
1
0%
0
0%
1
0%
70
0.3%
5-19Y, MHCM walls - mud
90
1.4%
32
0.5%
4
0.1%
13
0.5%
432
2%
5-19Y, MHCM walls - brick
161
2.5%
42
0.7%
2
0%
12
0.5%
205
0.9%
5-19Y, MHCM walls - cement/plaster
38
0.6%
8
0.1%
1
0%
3
0.1%
136
0.6%
5-19Y, MHCM walls - cement/paint
41
0.6%
5
0.1%
2
0%
2
0.1%
214
1%
5-19Y, MHCM walls - other
11
0.2%
7
0.1%
4
0.1%
5
0.2%
142
0.7%
5-19Y, MHCM floor - natural floor
185
2.9%
67
1%
7
0.1%
24
1%
449
2.1%
5-19Y, MHCM floor - rudimentary floor
0
0%
1
0%
0
0%
0
0%
0
0%
5-19Y, MHCM floor - ceramic tiles
2
0%
0
0%
0
0%
0
0%
12
0.1%
5-19Y, MHCM floor - cement
149
2.3%
26
0.4%
6
0.1%
11
0.5%
636
2.9%
5-19Y, MHCM floor - carpet
5
0.1%
0
0%
0
0%
0
0%
32
0.1%
20+Y, MHCM walls - mud
46
0.7%
3
0%
4
0.1%
3
0.1%
520
2.4%
20+Y, MHCM walls - brick
90
1.4%
4
0.1%
0
0%
0
0%
298
1.4%
20+Y, MHCM walls - cement/plaster
10
0.2%
0
0%
1
0%
0
0%
188
0.9%
20+Y, MHCM walls - cement/paint
15
0.2%
1
0%
0
0%
0
0%
228
1.1%
20+Y, MHCM walls - other
10
0.2%
5
0.1%
0
0%
1
0%
168
0.8%
20+Y, MHCM floor - natural floor
124
1.9%
9
0.1%
4
0.1%
3
0.1%
651
3%
20+Y, MHCM floor - rudimentary floor
0
0%
0
0%
0
0%
0
0%
2
0%
20+Y, MHCM floor - ceramic tiles
0
0%
1
0%
0
0%
0
0%
12
0.1%
20+Y, MHCM floor - cement
46
0.7%
3
0%
1
0%
1
0%
699
3.2%
20+Y, MHCM floor - carpet
1
0%
0
0%
0
0%
0
0%
38
0.2%
39. Secondary Outcome
Title Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4
Description The malaria prevention and risk factors characteristics were the following: Main house construction material (MHCM) walls and MHCM floor. MHCM walls data were assessed for the following sub-categories: mud, brick, cement/plaster, cement/paint, other. MHCM floor data were assessed for the following sub-categories: natural floor, rudimentary floor, vinyl or asphalt strips, ceramic tiles, cement, carpet. Note: Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 453 158 36 68 1684
6M-4Y, MHCM walls - mud
33
0.5%
14
0.2%
2
0%
14
0.6%
127
0.6%
6M-4Y, MHCM walls - brick
92
1.4%
76
1.2%
17
0.3%
33
1.4%
231
1.1%
6M-4Y, MHCM walls - cement/plaster
23
0.4%
8
0.1%
1
0%
2
0.1%
120
0.6%
6M-4Y, MHCM walls - cement/paint
6
0.1%
2
0%
0
0%
1
0%
81
0.4%
6M-4Y, MHCM walls - other
14
0.2%
3
0%
0
0%
4
0.2%
289
1.3%
6M-4Y, MHCM floor - natural floor
97
1.5%
76
1.2%
15
0.2%
37
1.5%
267
1.2%
6M-4Y, MHCM floor - rudimentary floor
0
0%
1
0%
0
0%
0
0%
0
0%
6M-4Y, MHCM floor - vinyl/asphalt strips
0
0%
0
0%
0
0%
0
0%
2
0%
6M-4Y, MHCM floor - ceramic tiles
0
0%
1
0%
0
0%
0
0%
16
0.1%
6M-4Y, MHCM floor - cement
70
1.1%
23
0.4%
5
0.1%
16
0.7%
541
2.5%
6M-4Y, MHCM floor - carpet
1
0%
2
0%
0
0%
1
0%
22
0.1%
5-19Y, MHCM walls - mud
40
0.6%
4
0.1%
0
0%
2
0.1%
36
0.2%
5-19Y, MHCM walls - brick
114
1.8%
27
0.4%
9
0.1%
5
0.2%
78
0.4%
5-19Y, MHCM walls - cement/plaster
24
0.4%
11
0.2%
4
0.1%
1
0%
52
0.2%
5-19Y, MHCM walls - cement/paint
13
0.2%
4
0.1%
1
0%
0
0%
30
0.1%
5-19Y, MHCM walls - other
7
0.1%
5
0.1%
2
0%
5
0.2%
132
0.6%
5-19Y, MHCM floor - natural floor
105
1.6%
27
0.4%
9
0.1%
6
0.3%
96
0.4%
5-19Y, MHCM floor - rudimentary floor
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, MHCM floor - vinyl/asphalt strips
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, MHCM floor - ceramic tiles
0
0%
0
0%
0
0%
0
0%
9
0%
5-19Y, MHCM floor - cement
89
1.4%
24
0.4%
7
0.1%
7
0.3%
214
1%
5-19Y, MHCM floor - carpet
4
0.1%
0
0%
0
0%
0
0%
8
0%
20+Y, MHCM walls - mud
18
0.3%
0
0%
1
0%
76
3.2%
20+Y, MHCM walls - brick
52
0.8%
1
0%
0
0%
171
7.1%
20+Y, MHCM walls - cement/plaster
13
0.2%
2
0%
0
0%
70
2.9%
20+Y, MHCM walls - cement/paint
1
0%
0
0%
0
0%
38
1.6%
20+Y, MHCM walls - other
3
0%
1
0%
0
0%
153
6.4%
20+Y, MHCM floor - natural floor
50
0.8%
1
0%
0
0%
201
8.4%
20+Y, MHCM floor - rudimentary floor
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM floor - vinyl/asphalt strips
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM floor - ceramic tiles
0
0%
0
0%
0
0%
8
0.3%
20+Y, MHCM floor - cement
37
0.6%
3
0%
1
0%
287
12%
20+Y, MHCM floor - carpet
0
0%
0
0%
0
0%
10
0.4%
40. Secondary Outcome
Title Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 1
Description The malaria prevention and risk factors characteristics were the following: main house construction material (MHCM) roof, windows/eaves, nets. MHCM roof data were assessed for the following sub-categories: grass/palm, iron sheet, tiles, other, missing. MHCM windows/eaves data were assessed for the following sub-categories: closed, open, partially open, missing. MHCM nets data were assessed for the following sub-categories: nets not present, nets present on all windows, nets present on some windows, missing. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 786 258 81 188 5088
6M-4Y, MHCM roof - grass/palm
112
1.7%
53
0.8%
22
0.3%
44
1.8%
453
2.1%
6M-4Y, MHCM roof - iron sheet
231
3.6%
109
1.7%
35
0.5%
74
3.1%
1980
9.2%
6M-4Y, MHCM roof - tiles
0
0%
0
0%
0
0%
0
0%
7
0%
6M-4Y, MHCM roof - other
30
0.5%
8
0.1%
1
0%
1
0%
40
0.2%
6M-4Y, MHCM windows/eaves - closed
193
3%
93
1.4%
31
0.5%
77
3.2%
1467
6.8%
6M-4Y, MHCM windows/eaves - open
76
1.2%
33
0.5%
17
0.3%
20
0.8%
486
2.2%
6M-4Y, MHCM windows/eaves - partially open
104
1.6%
44
0.7%
10
0.2%
22
0.9%
527
2.4%
6M-4Y, MHCM windows/eaves - missing
0
0%
0
0%
0
0%
0
0%
0
0%
6M-4Y, MHCM, nets - not present
322
5%
157
2.4%
54
0.8%
91
3.8%
1795
8.3%
6M-4Y, MHCM, nets - present on all windows
26
0.4%
6
0.1%
1
0%
21
0.9%
450
2.1%
6M-4Y, MHCM, nets - present on some windows
25
0.4%
7
0.1%
3
0%
7
0.3%
235
1.1%
5-19Y, MHCM roof - grass/palm
88
1.4%
19
0.3%
7
0.1%
28
1.2%
212
1%
5-19Y, MHCM roof - iron sheet
193
3%
48
0.7%
16
0.3%
30
1.3%
944
4.4%
5-19Y, MHCM roof - tiles
0
0%
0
0%
0
0%
0
0%
2
0%
5-19Y, MHCM roof - other
13
0.2%
4
0.1%
0
0%
0
0%
8
0%
5-19Y, MHCM roof - missing
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, MHCM windows/eaves - closed
154
2.4%
44
0.7%
14
0.2%
38
1.6%
669
3.1%
5-19Y, MHCM windows/eaves - open
71
1.1%
16
0.2%
5
0.1%
9
0.4%
233
1.1%
5-19Y, MHCM windows/eaves - partially open
69
1.1%
11
0.2%
4
0.1%
11
0.5%
264
1.2%
5-19Y, MHCM windows/eaves - missing
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, MHCM, nets - not present
256
4%
63
1%
21
0.3%
42
1.8%
853
3.9%
5-19Y, MHCM, nets - present on all windows
22
0.3%
6
0.1%
1
0%
11
0.5%
197
0.9%
5-19Y, MHCM, nets - present on some windows
16
0.2%
2
0%
1
0%
5
0.2%
116
0.5%
5-19Y, MHCM, nets - missing
0
0%
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM roof - grass/palm
31
0.5%
5
0.1%
3
0%
280
11.7%
20+Y, MHCM roof - iron sheet
84
1.3%
12
0.2%
8
0.1%
1117
46.5%
20+Y, MHCM roof - tiles
0
0%
0
0%
0
0%
6
0.3%
20+Y, MHCM roof - other
4
0.1%
0
0%
0
0%
37
1.5%
20+Y, MHCM roof - missing
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM windows/eaves - closed
65
1%
8
0.1%
5
0.1%
798
33.3%
20+Y, MHCM windows/eaves - open
25
0.4%
5
0.1%
2
0%
291
12.1%
20+Y, MHCM windows/eaves - partially open
29
0.5%
4
0.1%
4
0.1%
351
14.6%
20+Y, MHCM windows/eaves - missing
0
0%
0
0%
0
0%
1
0%
20+Y, MHCM, nets - not present
107
1.7%
12
0.2%
7
0.1%
1081
45%
20+Y, MHCM, nets - present on all windows
8
0.1%
3
0%
2
0%
223
9.3%
20+Y, MHCM, nets - present on some windows
4
0.1%
2
0%
2
0%
136
5.7%
20+Y, MHCM, nets - missing
0
0%
0
0%
0
0%
1
0%
41. Secondary Outcome
Title Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2
Description The malaria prevention and risk factors characteristics were the following: main house construction material (MHCM) roof, windows/eaves, nets. MHCM roof data were assessed for the following sub-categories: grass/palm, iron sheet, tiles, other. MHCM windows/eaves data were assessed for the following sub-categories: closed, open, partially open. MHCM nets data were assessed for the following sub-categories: nets not present, nets present on all windows, nets present on some windows. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 740 229 101 119 5222
6M-4Y, MHCM roof - grass/palm
52
0.8%
32
0.5%
16
0.3%
23
1%
509
2.4%
6M-4Y, MHCM roof - iron sheet
201
3.1%
102
1.6%
46
0.7%
50
2.1%
2092
9.7%
6M-4Y, MHCM roof - tiles
0
0%
0
0%
0
0%
0
0%
1
0%
6M-4Y, MHCM roof - other
30
0.5%
14
0.2%
5
0.1%
3
0.1%
21
0.1%
6M-4Y, MHCM windows/eaves - closed
97
1.5%
54
0.8%
30
0.5%
39
1.6%
1411
6.5%
6M-4Y, MHCM windows/eaves - open
88
1.4%
45
0.7%
20
0.3%
19
0.8%
669
3.1%
6M-4Y, MHCM windows/eaves - partially open
98
1.5%
49
0.8%
17
0.3%
18
0.8%
543
2.5%
6M-4Y, MHCM, nets - not present
242
3.8%
136
2.1%
62
1%
66
2.8%
1843
8.5%
6M-4Y, MHCM, nets - present on all windows
26
0.4%
6
0.1%
4
0.1%
8
0.3%
626
2.9%
6M-4Y, MHCM, nets - present on some windows
15
0.2%
6
0.1%
1
0%
2
0.1%
154
0.7%
5-19Y, MHCM roof - grass/palm
76
1.2%
15
0.2%
3
0%
13
0.5%
207
1%
5-19Y, MHCM roof - iron sheet
241
3.8%
54
0.8%
26
0.4%
23
1%
940
4.3%
5-19Y, MHCM roof - tiles
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, MHCM roof - other
16
0.2%
2
0%
0
0%
0
0%
11
0.1%
5-19Y, MHCM windows/eaves - closed
159
2.5%
36
0.6%
16
0.3%
14
0.6%
610
2.8%
5-19Y, MHCM windows/eaves - open
85
1.3%
24
0.4%
6
0.1%
17
0.7%
294
1.4%
5-19Y, MHCM windows/eaves - partially open
89
1.4%
11
0.2%
7
0.1%
5
0.2%
254
1.2%
5-19Y, MHCM, nets - not present
290
4.5%
65
1%
23
0.4%
28
1.2%
793
3.7%
5-19Y, MHCM, nets - present on all windows
36
0.6%
5
0.1%
3
0%
6
0.3%
296
1.4%
5-19Y, MHCM, nets - present on some windows
7
0.1%
1
0%
3
0%
2
0.1%
69
0.3%
20+Y, MHCM roof - grass/palm
30
0.5%
3
0%
1
0%
2
0.1%
276
1.3%
20+Y, MHCM roof - iron sheet
80
1.2%
7
0.1%
4
0.1%
5
0.2%
1144
5.3%
20+Y, MHCM roof - tiles
1
0%
0
0%
0
0%
0
0%
2
0%
20+Y, MHCM roof - other
13
0.2%
0
0%
0
0%
0
0%
19
0.1%
20+Y, MHCM windows/eaves - closed
49
0.8%
6
0.1%
3
0%
4
0.2%
732
3.4%
20+Y, MHCM windows/eaves - open
42
0.7%
3
0%
2
0%
2
0.1%
372
1.7%
20+Y, MHCM windows/eaves - partially open
33
0.5%
1
0%
0
0%
1
0%
337
1.6%
20+Y, MHCM, nets - not present
115
1.8%
9
0.1%
3
0%
4
0.2%
1033
4.8%
20+Y, MHCM, nets - present on all windows
5
0.1%
0
0%
2
0%
3
0.1%
320
1.5%
20+Y, MHCM, nets - present on some windows
4
0.1%
1
0%
0
0%
0
0%
88
0.4%
42. Secondary Outcome
Title Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 3
Description The malaria prevention and risk factors characteristics were the following: main house construction material (MHCM) roof, windows/eaves, nets. MHCM roof data were assessed for the following sub-categories: grass/palm, iron sheet, tiles, other. MHCM windows/eaves data were assessed for the following sub-categories: closed, open, partially open. MHCM nets data were assessed for the following sub-categories: nets not present, nets present on all windows, nets present on some windows. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 791 268 92 130 5119
6M-4Y, MHCM roof - grass/palm
55
0.9%
35
0.5%
12
0.2%
26
1.1%
464
2.1%
6M-4Y, MHCM roof - iron sheet
214
3.3%
125
1.9%
60
0.9%
63
2.6%
2111
9.8%
6M-4Y, MHCM roof - tiles
0
0%
0
0%
0
0%
1
0%
9
0%
6M-4Y, MHCM roof - other
10
0.2%
1
0%
2
0%
1
0%
4
0%
6M-4Y, MHCM windows/eaves - closed
164
2.6%
82
1.3%
38
0.6%
57
2.4%
1352
6.3%
6M-4Y, MHCM windows/eaves - open
86
1.3%
67
1%
28
0.4%
30
1.3%
845
3.9%
6M-4Y, MHCM windows/eaves - partially open
29
0.5%
12
0.2%
8
0.1%
4
0.2%
391
1.8%
6M-4Y, MHCM, nets - not present
244
3.8%
149
2.3%
63
1%
84
3.5%
1918
8.9%
6M-4Y, MHCM, nets - present on all windows
21
0.3%
10
0.2%
6
0.1%
4
0.2%
532
2.5%
6M-4Y, MHCM, nets - present on some windows
14
0.2%
2
0%
5
0.1%
3
0.1%
138
0.6%
5-19Y, MHCM roof - grass/palm
76
1.2%
16
0.2%
1
0%
5
0.2%
186
0.9%
5-19Y, MHCM roof - iron sheet
264
4.1%
77
1.2%
12
0.2%
30
1.3%
940
4.3%
5-19Y, MHCM roof - tiles
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, MHCM roof - other
1
0%
1
0%
0
0%
0
0%
2
0%
5-19Y, MHCM windows/eaves - closed
165
2.6%
58
0.9%
9
0.1%
18
0.8%
593
2.7%
5-19Y, MHCM windows/eaves - open
143
2.2%
26
0.4%
2
0%
16
0.7%
357
1.7%
5-19Y, MHCM windows/eaves - partially open
33
0.5%
10
0.2%
2
0%
1
0%
179
0.8%
5-19Y, MHCM, nets - not present
290
4.5%
83
1.3%
13
0.2%
28
1.2%
818
3.8%
5-19Y, MHCM, nets - present on all windows
31
0.5%
9
0.1%
0
0%
4
0.2%
261
1.2%
5-19Y, MHCM, nets - present on some windows
20
0.3%
2
0%
0
0%
3
0.1%
50
0.2%
20+Y, MHCM roof - grass/palm
45
0.7%
1
0%
2
0%
2
0.1%
259
1.2%
20+Y, MHCM roof - iron sheet
123
1.9%
12
0.2%
3
0%
2
0.1%
1123
5.2%
20+Y, MHCM roof - tiles
0
0%
0
0%
0
0%
0
0%
9
0%
20+Y, MHCM roof - other
3
0%
0
0%
0
0%
0
0%
11
0.1%
20+Y, MHCM windows/eaves - closed
112
1.7%
9
0.1%
4
0.1%
1
0%
715
3.3%
20+Y, MHCM windows/eaves - open
49
0.8%
2
0%
1
0%
3
0.1%
483
2.2%
20+Y, MHCM windows/eaves - partially open
10
0.2%
2
0%
0
0%
0
0%
204
0.9%
20+Y, MHCM, nets - not present
153
2.4%
12
0.2%
4
0.1%
4
0.2%
1052
4.9%
20+Y, MHCM, nets - present on all windows
11
0.2%
0
0%
0
0%
0
0%
262
1.2%
20+Y, MHCM, nets - present on some windows
7
0.1%
1
0%
1
0%
0
0%
88
0.4%
43. Secondary Outcome
Title Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 4
Description The malaria prevention and risk factors characteristics were the following: main house construction material (MHCM) roof, windows/eaves, nets. MHCM roof data were assessed for the following sub-categories: grass/palm, iron sheet, other. MHCM windows/eaves data were assessed for the following sub-categories: closed, open, partially open. MHCM nets data were assessed for the following sub-categories: nets not present, nets present on all windows, nets present on some windows. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 453 158 36 68 1684
6M-4Y, MHCM roof - grass/palm
51
0.8%
29
0.5%
6
0.1%
17
0.7%
161
0.7%
6M-4Y, MHCM roof - iron sheet
111
1.7%
67
1%
14
0.2%
28
1.2%
673
3.1%
6M-4Y, MHCM roof - other
6
0.1%
7
0.1%
0
0%
9
0.4%
14
0.1%
6M-4Y, MHCM windows/eaves - closed
124
1.9%
58
0.9%
13
0.2%
34
1.4%
725
3.4%
6M-4Y, MHCM windows/eaves - open
15
0.2%
13
0.2%
1
0%
5
0.2%
66
0.3%
6M-4Y, MHCM windows/eaves - partially open
29
0.5%
32
0.5%
6
0.1%
15
0.6%
57
0.3%
6M-4Y, MHCM, nets - not present
156
2.4%
95
1.5%
16
0.3%
51
2.1%
712
3.3%
6M-4Y, MHCM, nets - present on all windows
8
0.1%
1
0%
2
0%
2
0.1%
79
0.4%
6M-4Y, MHCM, nets - present on some windows
4
0.1%
7
0.1%
2
0%
1
0%
57
0.3%
5-19Y, MHCM roof - grass/palm
55
0.9%
10
0.2%
1
0%
2
0.1%
51
0.2%
5-19Y, MHCM roof - iron sheet
134
2.1%
37
0.6%
13
0.2%
9
0.4%
276
1.3%
5-19Y, MHCM roof - other
9
0.1%
4
0.1%
2
0%
2
0.1%
1
0%
5-19Y, MHCM windows/eaves - closed
139
2.2%
32
0.5%
11
0.2%
9
0.4%
292
1.4%
5-19Y, MHCM windows/eaves - open
24
0.4%
8
0.1%
4
0.1%
1
0%
17
0.1%
5-19Y, MHCM windows/eaves - partially open
35
0.5%
11
0.2%
1
0%
3
0.1%
19
0.1%
5-19Y, MHCM, nets - not present
162
2.5%
41
0.6%
14
0.2%
13
0.5%
276
1.3%
5-19Y, MHCM, nets - present on all windows
17
0.3%
5
0.1%
2
0%
0
0%
25
0.1%
5-19Y, MHCM, nets - present on some windows
19
0.3%
5
0.1%
0
0%
0
0%
27
0.1%
20+Y, MHCM roof - grass/palm
27
0.4%
0
0%
1
0%
98
4.1%
20+Y, MHCM roof - iron sheet
56
0.9%
4
0.1%
0
0%
394
16.4%
20+Y, MHCM roof - other
4
0.1%
0
0%
1
0%
16
0.7%
20+Y, MHCM windows/eaves - closed
64
1%
4
0.1%
1
0%
421
17.5%
20+Y, MHCM windows/eaves - open
9
0.1%
0
0%
0
0%
33
1.4%
20+Y, MHCM windows/eaves - partially open
14
0.2%
0
0%
0
0%
54
2.3%
20+Y, MHCM, nets - not present
74
1.2%
4
0.1%
1
0%
438
18.3%
20+Y, MHCM, nets - present on all windows
7
0.1%
0
0%
0
0%
32
1.3%
20+Y, MHCM, nets - present on some windows
6
0.1%
0
0%
0
0%
38
1.6%
44. Secondary Outcome
Title Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 1
Description The malaria prevention and risk factors characteristics were the following: Main source of drinking water (MSDW): bottled water, closed water source (piped water, tube well, dug well, protected well), open water source (unprotected well, spring water, rainwater, tanker truck, surface water), missing; and Presence of electricity (PE): Yes, No, missing. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 1) Medium PD Group (Survey 1) High PD Group (Survey 1) Very High PD Group (Survey 1) Neg PD Group (Survey 1)
Arm/Group Description Subjects from Survey 1 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1 not infected with P.falciparum.
Measure Participants 786 258 81 188 5088
6M-4Y, MSDW - bottled water
1
0%
0
0%
0
0%
0
0%
22
0.1%
6M-4Y, MSDW - closed water source
246
3.8%
111
1.7%
28
0.4%
49
2%
1637
7.6%
6M-4Y, MSDW - open water source
126
2%
59
0.9%
30
0.5%
70
2.9%
821
3.8%
6M-4Y, PE - Yes
66
1%
24
0.4%
7
0.1%
13
0.5%
780
3.6%
6M-4Y, PE - No
307
4.8%
146
2.3%
51
0.8%
106
4.4%
1700
7.9%
5-19Y, MSDW - bottled water
1
0%
0
0%
0
0%
0
0%
9
0%
5-19Y, MSDW - closed water source
182
2.8%
41
0.6%
13
0.2%
19
0.8%
767
3.5%
5-19Y, MSDW - open water source
111
1.7%
30
0.5%
10
0.2%
39
1.6%
390
1.8%
5-19Y, MSDW - missing
0
0%
0
0%
0
0%
0
0%
1
0%
5-19Y, PE - Yes
48
0.7%
13
0.2%
4
0.1%
4
0.2%
384
1.8%
5-19Y, PE - No
246
3.8%
58
0.9%
19
0.3%
54
2.3%
782
3.6%
5-19Y, PE - missing
0
0%
0
0%
0
0%
0
0%
1
0%
20+Y, MSDW - bottled water
1
0%
0
0%
0
0%
12
0.5%
20+Y, MSDW - closed water source
82
1.3%
10
0.2%
4
0.1%
943
39.3%
20+Y, MSDW - open water source
36
0.6%
7
0.1%
7
0.1%
485
20.2%
20+Y, MSDW - missing
0
0%
0
0%
0
0%
1
0%
20+Y, PE - Yes
18
0.3%
5
0.1%
1
0%
397
16.5%
20+Y, PE - No
101
1.6%
12
0.2%
10
0.2%
1043
43.5%
20+Y, PE - missing
0
0%
0
0%
0
0%
1
0%
45. Secondary Outcome
Title Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 2
Description The malaria prevention and risk factors characteristics were the following: Main source of drinking water (MSDW): bottled water, closed water source (piped water, tube well, dug well, protected well), open water source (unprotected well, spring water, rainwater, tanker truck, surface water); and Presence of electricity (PE): Yes, No. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 2) Medium PD Group (Survey 2) High PD Group (Survey 2) Very High PD Group (Survey 2) Neg PD Group (Survey 2)
Arm/Group Description Subjects from Survey 2 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2 not infected with P.falciparum.
Measure Participants 740 229 101 119 5222
6M-4Y, MSDW - bottled water
1
0%
0
0%
0
0%
0
0%
4
0%
6M-4Y, MSDW - closed water source
207
3.2%
93
1.4%
44
0.7%
42
1.8%
1784
8.3%
6M-4Y, MSDW - open water source
75
1.2%
55
0.9%
23
0.4%
34
1.4%
835
3.9%
6M-4Y, PE - Yes
49
0.8%
18
0.3%
9
0.1%
9
0.4%
824
3.8%
6M-4Y, PE - No
234
3.7%
130
2%
58
0.9%
67
2.8%
1799
8.3%
5-19Y, MSDW - bottled water
1
0%
0
0%
0
0%
0
0%
3
0%
5-19Y, MSDW - closed water source
229
3.6%
45
0.7%
22
0.3%
21
0.9%
760
3.5%
5-19Y, MSDW - open water source
103
1.6%
26
0.4%
7
0.1%
15
0.6%
395
1.8%
5-19Y, PE - Yes
60
0.9%
12
0.2%
11
0.2%
4
0.2%
366
1.7%
5-19Y, PE - No
273
4.3%
59
0.9%
18
0.3%
32
1.3%
792
3.7%
20+Y, MSDW - bottled water
0
0%
0
0%
0
0%
0
0%
4
0%
20+Y, MSDW - closed water source
87
1.4%
7
0.1%
4
0.1%
1
0%
987
4.6%
20+Y, MSDW - open water source
37
0.6%
3
0%
1
0%
6
0.3%
450
2.1%
20+Y, PE - Yes
23
0.4%
4
0.1%
2
0%
1
0%
436
2%
20+Y, PE - No
101
1.6%
6
0.1%
3
0%
6
0.3%
1005
4.6%
46. Secondary Outcome
Title Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 3
Description The malaria prevention and risk factors characteristics were the following: Main source of drinking water (MSDW): bottled water, closed water source (piped water, tube well, dug well, protected well), open water source (unprotected well, spring water, rainwater, tanker truck, surface water); and Presence of electricity (PE): Yes, No. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 3) Medium PD Group (Survey 3) High PD Group (Survey 3) Very High PD Group (Survey 3) Neg PD Group (Survey 3)
Arm/Group Description Subjects from Survey 3 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3 not infected with P.falciparum.
Measure Participants 791 268 92 130 5119
6M-4Y, MSDW - bottled water
0
0%
0
0%
0
0%
1
0%
26
0.1%
6M-4Y, MSDW - closed water source
185
2.9%
97
1.5%
37
0.6%
53
2.2%
1613
7.5%
6M-4Y, MSDW - open water source
94
1.5%
64
1%
37
0.6%
37
1.5%
949
4.4%
6M-4Y, PE - Yes
36
0.6%
25
0.4%
8
0.1%
11
0.5%
775
3.6%
6M-4Y, PE - No
243
3.8%
136
2.1%
66
1%
80
3.3%
1813
8.4%
5-19Y, MSDW - bottled water
0
0%
1
0%
0
0%
0
0%
13
0.1%
5-19Y, MSDW - closed water source
214
3.3%
51
0.8%
6
0.1%
23
1%
715
3.3%
5-19Y, MSDW - open water source
127
2%
42
0.7%
7
0.1%
12
0.5%
401
1.9%
5-19Y, PE - Yes
56
0.9%
19
0.3%
5
0.1%
7
0.3%
348
1.6%
5-19Y, PE - No
285
4.5%
75
1.2%
8
0.1%
28
1.2%
781
3.6%
20+Y, MSDW - bottled water
0
0%
0
0%
0
0%
0
0%
15
0.1%
20+Y, MSDW - closed water source
101
1.6%
8
0.1%
2
0%
1
0%
884
4.1%
20+Y, MSDW - open water source
70
1.1%
5
0.1%
3
0%
3
0.1%
503
2.3%
20+Y, PE - Yes
19
0.3%
3
0%
0
0%
1
0%
386
1.8%
20+Y, PE - No
152
2.4%
10
0.2%
5
0.1%
3
0.1%
1016
4.7%
47. Secondary Outcome
Title Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 4
Description The malaria prevention and risk factors characteristics were the following: Main source of drinking water (MSDW): bottled water, closed water source (piped water, tube well, dug well, protected well), open water source (unprotected well, spring water, rainwater, tanker truck, surface water); and Presence of electricity (PE): Yes, No. Data were collected across centers from subjects between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. Results were presented per the following P. falciparum parasite density status subgroups: Low, Medium, High, Very high, and Negative (Neg).
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Low PD Group (Survey 4) Medium PD Group (Survey 4) High PD Group (Survey 4) Very High PD Group (Survey 4) Neg PD Group (Survey 4)
Arm/Group Description Subjects from Survey 4 with low P. falciparum parasite density (PD), (less than [<] 2500 parasites per microliter [parasites/μL]. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with medium P. falciparum parasite density (PD), (2500 - 9999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with high P. falciparum parasite density (PD), (10000 - 19999 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 with very high P. falciparum parasite density (PD), (greater than or equal to [≥] 20000 parasites/μL). Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4 not infected with P.falciparum.
Measure Participants 453 158 36 68 1684
6M-4Y, MSDW - bottled water
0
0%
0
0%
0
0%
0
0%
1
0%
6M-4Y, MSDW - closed water source
139
2.2%
79
1.2%
15
0.2%
38
1.6%
656
3%
6M-4Y, MSDW - open water source
29
0.5%
24
0.4%
5
0.1%
16
0.7%
191
0.9%
6M-4Y, PE - Yes
20
0.3%
5
0.1%
0
0%
3
0.1%
384
1.8%
6M-4Y, PE - No
148
2.3%
98
1.5%
20
0.3%
51
2.1%
464
2.1%
5-19Y, MSDW - bottled water
0
0%
0
0%
0
0%
0
0%
0
0%
5-19Y, MSDW - closed water source
155
2.4%
38
0.6%
12
0.2%
9
0.4%
247
1.1%
5-19Y, MSDW - open water source
43
0.7%
13
0.2%
4
0.1%
4
0.2%
81
0.4%
5-19Y, PE - Yes
23
0.4%
8
0.1%
3
0%
4
0.2%
161
0.7%
5-19Y, PE - No
175
2.7%
43
0.7%
13
0.2%
9
0.4%
167
0.8%
20+Y, MSDW - bottled water
0
0%
0
0%
0
0%
1
0%
20+Y, MSDW - closed water source
69
1.1%
2
0%
1
0%
391
16.3%
20+Y, MSDW - open water source
18
0.3%
2
0%
0
0%
116
4.8%
20+Y, PE - Yes
9
0.1%
2
0%
0
0%
206
8.6%
20+Y, PE - No
78
1.2%
2
0%
1
0%
302
12.6%
48. Secondary Outcome
Title Number of Subjects With Malaria Prevention Measures (MPM) at Each Survey
Description The malaria prevention measures (MPM) data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for each Survey. The MPM results include the following categories: Use of Mosquito coils over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM) or Use of indoor residual spray- no spray (Uirs-no spray): the number of months ago for each Uirs-nM sub-categories is defined using the following [x Months]. Not all Uirs-nM sub-categories were analyzed in each survey.
Time Frame At each Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Arm/Group Description Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
Measure Participants 6401 6411 6400 2399
[6M-4Y], UMc > 7D, Yes
433
6.8%
398
6.2%
348
5.4%
239
10%
[6M-4Y], UMc > 7D, Missing/No
2767
43.2%
2799
43.6%
2845
44.5%
954
39.8%
[6M-4Y], UIs > 7D, Yes
101
1.6%
60
0.9%
48
0.8%
27
1.1%
[6M-4Y], UIs > 7D, Missing/No
3099
48.4%
3137
48.9%
3145
49.1%
1166
48.6%
[6M-4Y], UCR > 7D, Yes
4
0.1%
5
0.1%
24
0.4%
20
0.8%
[6M-4Y], UCR > 7D, Missing/No
3196
49.9%
3192
49.8%
3169
49.5%
1173
48.9%
[6M-4Y], UTR > 7D, Yes
7
0.1%
9
0.1%
0
0%
2
0.1%
[6M-4Y], UTR > 7D, Missing/No
3193
49.9%
3188
49.7%
3193
49.9%
1191
49.6%
[6M-4Y], Una >7D, Yes
2663
41.6%
2726
42.5%
2778
43.4%
905
37.7%
[6M-4Y], Una >7D, Missing/No
537
8.4%
471
7.3%
415
6.5%
288
12%
[6M-4Y], Uirs past 12M, Yes
59
0.9%
15
0.2%
7
0.1%
3
0.1%
[6M-4Y], Uirs past 12M, Missing/No
3141
49%
3182
49.6%
3186
49.8%
1190
49.6%
[6M-4Y], Uirs-nM [1 Month]
9
0.1%
1
0%
1
0%
0
0%
[6M-4Y], Uirs-nM [11 Months]
1
0%
[6M-4Y], Uirs-nM [12 Months]
5
0.1%
1
0%
2
0%
[6M-4Y], Uirs-nM [10 Months]
1
0%
[6M-4Y], Uirs-nM [2 Months]
6
0.1%
3
0%
1
0%
[6M-4Y], Uirs-nM [3 Months]
21
0.3%
5
0.1%
3
0%
1
0%
[6M-4Y], Uirs-nM [4 Months]
9
0.1%
2
0%
1
0%
[6M-4Y], Uirs-nM [5 Months]
1
0%
2
0%
[6M-4Y], Uirs-nM [6 Months]
6
0.1%
[6M-4Y], Uirs-nM [7 Months]
1
0%
1
0%
[6M-4Y], Uirs-nM [9 Months]
1
0%
[6M-4Y], Uirs-nM [no spray]
3141
49%
3182
49.6%
3186
49.8%
1190
49.6%
[5-19Y], UMc > 7D, Yes
227
3.5%
209
3.3%
180
2.8%
127
5.3%
[5-19Y], UMc > 7D, Missing/No
1386
21.6%
1418
22.1%
1432
22.4%
479
20%
[5-19Y], UIs > 7D, Yes
45
0.7%
32
0.5%
20
0.3%
10
0.4%
[5-19Y], UIs > 7D, Missing/No
1568
24.5%
1595
24.9%
1592
24.9%
596
24.8%
[5-19Y], UCR > 7D, Yes
4
0.1%
2
0%
12
0.2%
7
0.3%
[5-19Y], UCR > 7D, Missing/No
1609
25.1%
1625
25.3%
1600
25%
599
25%
[5-19Y], UTR > 7D, Yes
3
0%
3
0%
0
0%
2
0.1%
[5-19Y], UTR > 7D, Missing/No
1610
25.1%
1624
25.3%
1612
25.2%
604
25.2%
[5-19Y], Una >7D, Yes
1336
20.9%
1381
21.5%
1401
21.9%
460
19.2%
[5-19Y], Una >7D, Missing/No
277
4.3%
246
3.8%
211
3.3%
146
6.1%
[5-19Y], Uirs past 12M, Yes
24
0.4%
8
0.1%
3
0%
1
0%
[5-19Y], Uirs past 12M, Missing/No
1589
24.8%
1619
25.2%
1609
25.1%
605
25.2%
[5-19Y], Uirs-nM [1 Month]
2
0%
1
0%
1
0%
[5-19Y], Uirs-nM [11 Months]
1
0%
[5-19Y], Uirs-nM [12 Months]
2
0%
1
0%
1
0%
[5-19Y], Uirs-nM [2 Months]
1
0%
2
0%
0
0%
[5-19Y], Uirs-nM [3 Months]
13
0.2%
3
0%
0
0%
0
0%
[5-19Y], Uirs-nM [4 Months]
2
0%
0
0%
1
0%
[5-19Y], Uirs-nM [5 Months]
0
0%
1
0%
[5-19Y], Uirs-nM [6 Months]
4
0.1%
[5-19Y], Uirs-nM [7 Months]
0
0%
0
0%
[5-19Y], Uirs-nM [9 Months]
0
0%
[5-19Y], Uirs-nM [no spray]
1589
24.8%
1619
25.2%
1609
25.1%
605
25.2%
[Y20+], UMc > 7D, Yes
196
3.1%
199
3.1%
167
2.6%
117
4.9%
[Y20+], UMc > 7D, Missing/No
1392
21.7%
1388
21.6%
1428
22.3%
483
20.1%
[Y20+], UIs > 7D, Yes
46
0.7%
30
0.5%
28
0.4%
11
0.5%
[Y20+], UIs > 7D, Missing/No
1542
24.1%
1557
24.3%
1567
24.5%
589
24.5%
[Y20+], UCR > 7D, Yes
0
0%
4
0.1%
12
0.2%
12
0.5%
[Y20+], UCR > 7D, Missing/No
1588
24.8%
1583
24.7%
1583
24.7%
588
24.5%
[Y20+], UTR > 7D, Yes
4
0.1%
4
0.1%
0
0%
0
0%
[Y20+], UTR > 7D, Missing/No
1584
24.7%
1583
24.7%
1595
24.9%
600
25%
[Y20+], Una >7D, Yes
1346
21%
1350
21%
1392
21.8%
460
19.2%
[Y20+], Una >7D, Missing/No
242
3.8%
237
3.7%
203
3.2%
140
5.8%
[Y20+], Uirs past 12M, Yes
32
0.5%
7
0.1%
2
0%
2
0.1%
[Y20+], Uirs past 12M, Missing/No
1556
24.3%
1580
24.6%
1593
24.9%
598
24.9%
[Y20+], Uirs-nM [1 Month]
7
0.1%
0
0%
0
0%
[Y20+], Uirs-nM [11 Months]
0
0%
[Y20+], Uirs-nM [12 Months]
3
0%
0
0%
1
0%
[Y20+], Uirs-nM [10 Months]
1
0%
[Y20+], Uirs-nM [2 Months]
4
0.1%
1
0%
1
0%
[Y20+], Uirs-nM [3 Months]
8
0.1%
3
0%
1
0%
0
0%
[Y20+], Uirs-nM [4 Months]
6
0.1%
2
0%
0
0%
[Y20+], Uirs-nM [5 Months]
1
0%
1
0%
[Y20+], Uirs-nM [6 Months]
2
0%
[Y20+], Uirs-nM [7 Months]
1
0%
0
0%
[Y20+], Uirs-nM [9 Months]
0
0%
[Y20+], Uirs-nM [no spray]
1556
24.3%
1580
24.6%
1593
24.9%
598
24.9%
49. Secondary Outcome
Title Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 1
Description Data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 1. The other Plasmodium species assessed were: P. Malaria, P. Vivax, P. Ovale. Infection were determined using a blood smear slide, and categorized according positive (Pos) and negative (Neg) results.
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Overall Study Group (6M-4Y) (Survey 1) Overall Study Group (5-19Y) (Survey 1) Overall Study Group (20Y+) (Survey 1)
Arm/Group Description Subjects from Survey 1, aged between and including 6 months (6M) to 4 years (4Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1, aged 5 to 19 years (5-19Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 1, aged 20 years or older (20Y+), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
Measure Participants 3200 1613 1588
P.Malariae, Pos
19
0.3%
21
0.3%
1
0%
P.Malariae, Neg
3181
49.7%
1592
24.8%
1587
24.8%
P.Vivax, Pos
0
0%
0
0%
0
0%
P.Vivax, Neg
3200
50%
1613
25.1%
1588
24.8%
P.Ovale, Pos
3
0%
1
0%
0
0%
P.Ovale, Neg
3197
49.9%
1612
25.1%
1588
24.8%
50. Secondary Outcome
Title Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 2
Description Data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 2. The other Plasmodium species assessed were: P. Malaria, P. Vivax, P. Ovale. Infection were determined using a blood smear slide, and categorized according positive (Pos) and negative (Neg) results.
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Overall Study Group (6M-4Y) (Survey 2) Overall Study Group (5-19Y) (Survey 2) Overall Study Group (20Y+) (Survey 2)
Arm/Group Description Subjects from Survey 2, aged between and including 6 months (6M) to 4 years (4Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2, aged 5 to 19 years (5-19Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 2, aged 20 years or older (20Y+), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
Measure Participants 3197 1627 1587
P.Malariae, Pos
32
0.5%
27
0.4%
2
0%
P.Malariae, Neg
3165
49.4%
1600
24.9%
1585
24.8%
P.Vivax, Pos
0
0%
0
0%
0
0%
P.Vivax, Neg
3197
49.9%
1627
25.4%
1587
24.8%
P.Ovale, Pos
6
0.1%
3
0%
2
0%
P.Ovale, Neg
3191
49.8%
1624
25.3%
1585
24.8%
51. Secondary Outcome
Title Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 3
Description Data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 3. The other Plasmodium species assessed were: P. Malaria, P. Vivax, P. Ovale. Infection were determined using a blood smear slide, and categorized according positive (Pos) and negative (Neg) results.
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Overall Study Group (6M-4Y) (Survey 3) Overall Study Group (5-19Y) (Survey 3) Overall Study Group (20Y+) (Survey 3)
Arm/Group Description Subjects from Survey 3, aged between and including 6 months (6M) to 4 years (4Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3, aged 5 to 19 years (5-19Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 3, aged 20 years or older (20Y+), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
Measure Participants 3193 1612 1595
P.Malariae, Pos
48
0.7%
27
0.4%
0
0%
P.Malariae, Neg
3145
49.1%
1585
24.7%
1595
24.9%
P.Vivax, Pos
0
0%
0
0%
0
0%
P.Vivax, Neg
3193
49.9%
1612
25.1%
1595
24.9%
P.Ovale, Pos
6
0.1%
4
0.1%
1
0%
P.Ovale, Neg
3187
49.8%
1608
25.1%
1594
24.9%
52. Secondary Outcome
Title Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 4
Description Data were collected across centers from subjects with age between and including: 6M-4Y, 5-19 Y and 20Y+, for Survey 4. The other Plasmodium species assessed were: P. Malaria, P. Vivax, P. Ovale. Infection were determined using a blood smear slide, and categorized according positive (Pos) and negative (Neg) results.
Time Frame At Survey visit

Outcome Measure Data

Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) Cohort, which included all evaluable subjects for whom at least one laboratory result of blood sample was available at the survey visit.
Arm/Group Title Overall Study Group (6M-4Y) (Survey 4) Overall Study Group (5-19Y) (Survey 4) Overall Study Group (20Y+) (Survey 4)
Arm/Group Description Subjects from Survey 4, aged between and including 6 months (6M) to 4 years (4Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4, aged 5 to 19 years (5-19Y), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects from Survey 4, aged 20 years or older (20Y+), enrolled in catchment areas of study 110021 (NCT00866619), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy.
Measure Participants 1193 606 600
P.Malariae, Pos
32
0.5%
28
0.4%
0
0%
P.Malariae, Neg
1161
18.1%
578
9%
600
9.4%
P.Vivax, Pos
0
0%
0
0%
0
0%
P.Vivax, Neg
1193
18.6%
606
9.4%
600
9.4%
P.Ovale, Pos
3
0%
3
0%
1
0%
P.Ovale, Neg
1190
18.6%
603
9.4%
599
9.4%
53. Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedure for Each Survey
Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Capillary blood sampling was the only invasive procedure involved in this study. SAEs related to this procedure were recorded at the Survey visit.
Time Frame At each Survey visit

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total cohort, which included all subjects enrolled in the study.
Arm/Group Title Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Arm/Group Description Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
Measure Participants 6404 6414 6400 2400
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%

Adverse Events

Time Frame Capillary blood sampling was the only invasive procedure involved in this study. Serious adverse events (SAEs) related to this procedure were recorded at each survey visit.
Adverse Event Reporting Description Anticipated and unanticipated adverse events symptoms were not collected in the study.
Arm/Group Title Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Arm/Group Description Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.
All Cause Mortality
Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/6404 (0%) 0/6414 (0%) 0/6400 (0%) 0/2400 (0%)
Serious Adverse Events
Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/6404 (0%) 0/6414 (0%) 0/6400 (0%) 0/2400 (0%)
Other (Not Including Serious) Adverse Events
Overall Study Group (Survey 1) Overall Study Group (Survey 2) Overall Study Group (Survey 3) Overall Study Group (Survey 4)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email GSKClinicalSupportHD@gsk.com
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01190202
Other Study ID Numbers:
  • 114001
First Posted:
Aug 27, 2010
Last Update Posted:
Aug 18, 2020
Last Verified:
Aug 1, 2020