Epidemiology Study of Malaria Transmission Intensity in Africa

Malaria Clinical Trial

Official title:

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190202
• Other study ID #: 114001
• Status: Completed
• Phase: N/A
• Start date: March 14, 2011
• Est. completion date: December 20, 2013

Study information

• Verified date: August 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21618
• Est. completion date: December 20, 2013
• Est. primary completion date: December 20, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Malaria
• Malaria Vaccines

Intervention

Procedure:
• Blood sampling
Capillary blood samples collected by finger/heel prick
• Assessment of body temperature
Assessment of axial body temperature with a digital thermometer

Locations

Country	Name	City	State
Burkina Faso	GSK Investigational Site	Ouagadougou 01
Gabon	GSK Investigational Site	Lambaréné
Ghana	GSK Investigational Site	Kintampo
Ghana	GSK Investigational Site	Kumasi
Kenya	GSK Investigational Site	Kisumu
Malawi	GSK Investigational Site	Lilongwe
Tanzania	GSK Investigational Site	Dar-es-Salaam
Tanzania	GSK Investigational Site	Korogwe, Tanga

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	The PATH Malaria Vaccine Initiative (MVI)

Countries where clinical trial is conducted

Burkina Faso,  Gabon,  Ghana,  Kenya,  Malawi,  Tanzania, 

References & Publications (1)

Drakeley C, Abdulla S, Agnandji ST, Fernandes JF, Kremsner P, Lell B, Mewono L, Bache BE, Mihayo MG, Juma O, Tanner M, Tahita MC, Tinto H, Diallo S, Lompo P, D'Alessandro U, Ogutu B, Otieno L, Otieno S, Otieno W, Oyieko J, Asante KP, Dery DB, Adjei G, Adeniji E, Atibilla D, Owusu-Agyei S, Greenwood B, Gesase S, Lusingu J, Mahende C, Mongi R, Segeja M, Adjei S, Agbenyega T, Agyekum A, Ansong D, Bawa JT, Boateng HO, Dandalo L, Escamilla V, Hoffman I, Maenje P, Martinson F, Carter T, Leboulleux D, Kaslow DC, Usuf E, Pirçon JY, Bahmanyar ER. Longitudinal estimation of Plasmodium falciparum prevalence in relation to malaria prevention measures in six sub-Saharan African countries. Malar J. 2017 Oct 27;16(1):433. doi: 10.1186/s12936-017-2078-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey	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.	At each Survey visit
Secondary	Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey	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.	At each Survey visit
Secondary	Number of Subjects With Anemia and Severe Anemia for Each Survey	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.	During the survey period (approximatively 1 year)
Secondary	Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density	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.	During the survey period (approximatively 1 year)
Secondary	Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density	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.	During the survey period (approximatively 1 year)
Secondary	Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density	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.	During the survey period (approximatively 1 year)
Secondary	Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density	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.	During the survey period (approximatively 1 year)
Secondary	Mean Number of Days With Malaria Treatment at Survey 1	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).	During the 14 day-period before the malaria treatment
Secondary	Mean Number of Days With Malaria Treatment at Survey 2	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).	During the 14 day-period before the malaria treatment
Secondary	Mean Number of Days With Malaria Treatment at Survey 3	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).	During the 14 day-period before the malaria treatment
Secondary	Mean Number of Days With Malaria Treatment at Survey 4	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).	During the 14 day-period before the malaria treatment
Secondary	Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 1	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).	In the last 24 hours or at the survey visit
Secondary	Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 2	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).	In the last 24 hours or at the survey visit
Secondary	Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 3	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).	In the last 24 hours or at the survey visit
Secondary	Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 4	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).	In the last 24 hours or at the survey visit
Secondary	Mean Number of Days With Fever at Survey 1	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).	During the survey period (approximatively 1 year)
Secondary	Mean Number of Days With Fever at Survey 2	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).	During the survey period (approximatively 1 year)
Secondary	Mean Number of Days With Fever at Survey 3	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).	During the survey period (approximatively 1 year)
Secondary	Mean Number of Days With Fever at Survey 4	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).	During the survey period (approximatively 1 year)
Secondary	Axillary Temperature at Visit in Survey 1	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).	At Survey visit
Secondary	Axillary Temperature at Visit in Survey 2	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).	At Survey visit
Secondary	Axillary Temperature at Visit in Survey 3	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).	At Survey visit
Secondary	Axillary Temperature at Visit in Survey 4	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).	At Survey visit
Secondary	Number of Subjects Living in the Same House at Survey 1	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).	At Survey visit
Secondary	Number of Subjects Living in the Same House at Survey 2	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).	At Survey visit
Secondary	Number of Subjects Living in the Same House at Survey 3	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).	At Survey visit
Secondary	Number of Subjects Living in the Same House at Survey 4	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).	At Survey visit
Secondary	Mean Number of Subjects Living in the Same House at Survey 1	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).	At Survey visit
Secondary	Mean Number of Subjects Living in the Same House at Survey 2	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).	At Survey visit
Secondary	Mean Number of Subjects Living in the Same House at Survey 3	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).	At Survey visit
Secondary	Mean Number of Subjects Living in the Same House at Survey 4	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).	At Survey visit
Secondary	Number of Subjects by Localisation and Type of Location at Survey 1	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).	At Survey visit
Secondary	Number of Subjects by Localisation and Type of Location at Survey 2	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).	At Survey visit
Secondary	Number of Subjects by Localisation and Type of Location at Survey 3	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).	At Survey visit
Secondary	Number of Subjects by Localisation and Type of Location at Survey 4	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).	At Survey visit
Secondary	Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1	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).	At Survey visit
Secondary	Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2	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).	At Survey visit
Secondary	Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3	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).	At Survey visit
Secondary	Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4	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).	At Survey visit
Secondary	Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 1	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).	At Survey visit
Secondary	Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2	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).	At Survey visit
Secondary	Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 3	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).	At Survey visit
Secondary	Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 4	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).	At Survey visit
Secondary	Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 1	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).	At Survey visit
Secondary	Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 2	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).	At Survey visit
Secondary	Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 3	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).	At Survey visit
Secondary	Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 4	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).	At Survey visit
Secondary	Number of Subjects With Malaria Prevention Measures (MPM) at Each Survey	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.	At each Survey visit
Secondary	Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 1	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.	At Survey visit
Secondary	Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 2	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.	At Survey visit
Secondary	Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 3	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.	At Survey visit
Secondary	Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 4	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.	At Survey visit
Secondary	Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedure for Each Survey	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.	At each Survey visit