MalariaNCT01190202
Epidemiology Study of Malaria Transmission Intensity in Africa
A study testing Blood sampling and Assessment of body temperature in people with Malaria and Malaria Vaccines, run by GlaxoSmithKline at 8 sites in 6 countries.
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). Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria Vaccines
- What is being tested?
- Blood sampling and Assessment of body temperature
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,618 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 14 Mar 2011to 20 Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Child in care.
- Previous or current participation in any malaria vaccine trial.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Tanzania2 sites
GSK Investigational Site
Dar es Salaam
GSK Investigational Site
Korogwe, Tanga
About this study
Official title: 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).
Read the 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.
- Conditions
- Malaria, Malaria Vaccines
- Being tested
- Blood sampling, Assessment of body temperature
- Keywords
- Malaria, Plasmodium falciparum
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Capillary blood samples collected by finger/heel prick
Assessment of body temperatureProcedure or surgery
Assessment of axial body temperature with a digital thermometer
| Study group | Role | What they receive |
|---|---|---|
| Overall Study Group (Survey 1) | Experimental | 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. Receives: Procedure: Blood sampling; Procedure: Assessment of body temperature |
| Overall Study Group (Survey 2) | Experimental | 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. Receives: Procedure: Blood sampling; Procedure: Assessment of body temperature |
| Overall Study Group (Survey 3) | Experimental | 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. Receives: Procedure: Blood sampling; Procedure: Assessment of body temperature |
| Overall Study Group (Survey 4) | Experimental | 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. Receives: Procedure: Blood sampling; Procedure: Assessment of body temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At each Survey visit
Secondary outcomes (52)
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.
Measured: At each Survey visit
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.
Measured: During the survey period (approximatively 1 year)
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.
Measured: During the survey period (approximatively 1 year)
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.
Measured: During the survey period (approximatively 1 year)
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.
Measured: During the survey period (approximatively 1 year)
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.
Measured: During the survey period (approximatively 1 year)
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).
Measured: During the 14 day-period before the malaria treatment
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).
Measured: During the 14 day-period before the malaria treatment
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).
Measured: During the 14 day-period before the malaria treatment
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: In the last 24 hours or at the survey visit
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).
Measured: During the survey period (approximatively 1 year)
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).
Measured: During the survey period (approximatively 1 year)
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).
Measured: During the survey period (approximatively 1 year)
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).
Measured: During the survey period (approximatively 1 year)
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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).
Measured: At Survey visit
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.
Measured: At each Survey visit
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.
Measured: At Survey visit
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.
Measured: At Survey visit
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.
Measured: At Survey visit
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.
Measured: At Survey visit
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.
Measured: At each Survey visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study start14 Mar 2011
- Primary completion20 Dec 2013
- Study completion20 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 21,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190202
- Sponsor's protocol ID
- 114001
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2010
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
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, Pircon 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.
PubMed 29078773
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT01190202
- Acronym / sponsor ID
- 114001
- Conditions
- Malaria, Malaria Vaccines
- Keywords
- Malaria, Plasmodium falciparum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,618 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI)
- Study start
- 14 Mar 2011 (actual)
- Primary completion
- 20 Dec 2013 (actual)
- Study completion
- 20 Dec 2013 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Overall Study Group (Survey 1) | Experimental | Procedure: Blood sampling, Procedure: Assessment of body temperatureSubjects 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. |
| Overall Study Group (Survey 2) | Experimental | Procedure: Blood sampling, Procedure: Assessment of body temperatureSubjects 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. |
| Overall Study Group (Survey 3) | Experimental | Procedure: Blood sampling, Procedure: Assessment of body temperatureSubjects 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. |
| Overall Study Group (Survey 4) | Experimental | Procedure: Blood sampling, Procedure: Assessment of body temperatureSubjects 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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Child in care.
- Previous or current participation in any malaria vaccine trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingCapillary blood samples collected by finger/heel prick | Procedure or surgery | Overall Study Group (Survey 1), Overall Study Group (Survey 2), Overall Study Group (Survey 3), Overall Study Group (Survey 4) |
| Assessment of body temperatureAssessment of axial body temperature with a digital thermometer | Procedure or surgery | Overall Study Group (Survey 1), Overall Study Group (Survey 2), Overall Study Group (Survey 3), Overall Study Group (Survey 4) |
Primary outcome
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.
52 secondary outcomes
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
Number of Subjects With Anemia and Severe Anemia for Each Survey
Time frame: 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)
Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density
Time frame: 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)
Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density
Time frame: 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
Mean Number of Days With Malaria Treatment at Survey 2
Time frame: 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
Mean Number of Days With Malaria Treatment at Survey 4
Time frame: 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
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
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
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
Mean Number of Days With Fever at Survey 1
Time frame: 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)
Mean Number of Days With Fever at Survey 3
Time frame: 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)
Axillary Temperature at Visit in Survey 1
Time frame: At Survey visit
Axillary Temperature at Visit in Survey 2
Time frame: At Survey visit
Axillary Temperature at Visit in Survey 3
Time frame: At Survey visit
Axillary Temperature at Visit in Survey 4
Time frame: At Survey visit
Number of Subjects Living in the Same House at Survey 1
Time frame: At Survey visit
Number of Subjects Living in the Same House at Survey 2
Time frame: At Survey visit
Number of Subjects Living in the Same House at Survey 3
Time frame: At Survey visit
Number of Subjects Living in the Same House at Survey 4
Time frame: At Survey visit
Mean Number of Subjects Living in the Same House at Survey 1
Time frame: At Survey visit
Mean Number of Subjects Living in the Same House at Survey 2
Time frame: At Survey visit
Mean Number of Subjects Living in the Same House at Survey 3
Time frame: At Survey visit
Mean Number of Subjects Living in the Same House at Survey 4
Time frame: At Survey visit
Number of Subjects by Localisation and Type of Location at Survey 1
Time frame: At Survey visit
Number of Subjects by Localisation and Type of Location at Survey 2
Time frame: At Survey visit
Number of Subjects by Localisation and Type of Location at Survey 3
Time frame: At Survey visit
Number of Subjects by Localisation and Type of Location at Survey 4
Time frame: At Survey visit
Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1
Time frame: At Survey visit
Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2
Time frame: At Survey visit
Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3
Time frame: At Survey visit
Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4
Time frame: 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
Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2
Time frame: At Survey visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29078773Drakeley 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, Pircon 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.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Assessment of body temperature in people with Malaria and Malaria Vaccines, run by GlaxoSmithKline at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Ghana, Tanzania, Burkina Faso, Gabon, Kenya and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey (time frame: At each Survey visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01190202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.