Epidemiology Study of Malaria Transmission Intensity in Africa

August 5, 2020 updated by: GlaxoSmithKline

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

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).

Study Overview

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 Type

Interventional

Enrollment (Actual)

21618

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / 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.
Capillary blood samples collected by finger/heel prick
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.
Capillary blood samples collected by finger/heel prick
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.
Capillary blood samples collected by finger/heel prick
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.
Capillary blood samples collected by finger/heel prick
Assessment of axial body temperature with a digital thermometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey
Time Frame: 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.
At each Survey visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey
Time Frame: 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.
At each Survey visit
Number of Subjects With Anemia and Severe Anemia for Each Survey
Time Frame: 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.
During the survey period (approximatively 1 year)
Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density
Time Frame: 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.
During the survey period (approximatively 1 year)
Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density
Time Frame: 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.
During the survey period (approximatively 1 year)
Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density
Time Frame: 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.
During the survey period (approximatively 1 year)
Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density
Time Frame: 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.
During the survey period (approximatively 1 year)
Mean Number of Days With Malaria Treatment at Survey 1
Time Frame: 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).
During the 14 day-period before the malaria treatment
Mean Number of Days With Malaria Treatment at Survey 2
Time Frame: 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).
During the 14 day-period before the malaria treatment
Mean Number of Days With Malaria Treatment at Survey 3
Time Frame: 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).
During the 14 day-period before the malaria treatment
Mean Number of Days With Malaria Treatment at Survey 4
Time Frame: 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).
During the 14 day-period before the malaria treatment
Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 1
Time Frame: 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).
In the last 24 hours or at the survey visit
Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 2
Time Frame: 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).
In the last 24 hours or at the survey visit
Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 3
Time Frame: 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).
In the last 24 hours or at the survey visit
Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 4
Time Frame: 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).
In the last 24 hours or at the survey visit
Mean Number of Days With Fever at Survey 1
Time Frame: 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).
During the survey period (approximatively 1 year)
Mean Number of Days With Fever at Survey 2
Time Frame: 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).
During the survey period (approximatively 1 year)
Mean Number of Days With Fever at Survey 3
Time Frame: 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).
During the survey period (approximatively 1 year)
Mean Number of Days With Fever at Survey 4
Time Frame: 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).
During the survey period (approximatively 1 year)
Axillary Temperature at Visit in Survey 1
Time Frame: 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).
At Survey visit
Axillary Temperature at Visit in Survey 2
Time Frame: 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).
At Survey visit
Axillary Temperature at Visit in Survey 3
Time Frame: 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).
At Survey visit
Axillary Temperature at Visit in Survey 4
Time Frame: 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).
At Survey visit
Number of Subjects Living in the Same House at Survey 1
Time Frame: 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).
At Survey visit
Number of Subjects Living in the Same House at Survey 2
Time Frame: 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).
At Survey visit
Number of Subjects Living in the Same House at Survey 3
Time Frame: 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).
At Survey visit
Number of Subjects Living in the Same House at Survey 4
Time Frame: 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).
At Survey visit
Mean Number of Subjects Living in the Same House at Survey 1
Time Frame: 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).
At Survey visit
Mean Number of Subjects Living in the Same House at Survey 2
Time Frame: 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).
At Survey visit
Mean Number of Subjects Living in the Same House at Survey 3
Time Frame: 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).
At Survey visit
Mean Number of Subjects Living in the Same House at Survey 4
Time Frame: 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).
At Survey visit
Number of Subjects by Localisation and Type of Location at Survey 1
Time Frame: 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).

At Survey visit
Number of Subjects by Localisation and Type of Location at Survey 2
Time Frame: 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).

At Survey visit
Number of Subjects by Localisation and Type of Location at Survey 3
Time Frame: 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).

At Survey visit
Number of Subjects by Localisation and Type of Location at Survey 4
Time Frame: 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).

At Survey visit
Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1
Time Frame: 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).

At Survey visit
Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2
Time Frame: 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).

At Survey visit
Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3
Time Frame: 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).
At Survey visit
Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4
Time Frame: 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).

At Survey visit
Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 1
Time Frame: 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).

At Survey visit
Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2
Time Frame: 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).

At Survey visit
Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 3
Time Frame: 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).

At Survey visit
Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 4
Time Frame: 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).

At Survey visit
Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 1
Time Frame: 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).

At Survey visit
Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 2
Time Frame: 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).

At Survey visit
Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 3
Time Frame: 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).

At Survey visit
Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 4
Time Frame: 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).

At Survey visit
Number of Subjects With Malaria Prevention Measures (MPM) at Each Survey
Time Frame: 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.

At each Survey visit
Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 1
Time Frame: 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.

At Survey visit
Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 2
Time Frame: 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.

At Survey visit
Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 3
Time Frame: 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.

At Survey visit
Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 4
Time Frame: 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.

At Survey visit
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedure for Each Survey
Time Frame: 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.
At each Survey visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2011

Primary Completion (Actual)

December 20, 2013

Study Completion (Actual)

December 20, 2013

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 114001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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