Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
NCT ID: NCT02251704
Last Updated: 2025-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
54115 participants
INTERVENTIONAL
2014-10-22
2024-07-06
Brief Summary
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Detailed Description
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By taking into account variations in malaria transmission intensity (MTI) and malaria control intervention coverage, it enabled a more complete assessment of the benefits and risks of the vaccine introduction, and thereby provided greater insight into the potential vaccine impact in EPI-MAL-002/-003 by adjusting incidence data for overall changes in transmission and other malaria control intervention coverage, and assisted in the generalisation of results to other populations.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Survey 1 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 1.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Survey 2 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 2.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Survey 3 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 3.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Survey 4 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 4.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Survey 5 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 5.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Survey 6 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 6.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Survey 7 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 7.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Survey 8 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 8.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Survey 9 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 9.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Survey 10 Group
Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 10.
Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Interventions
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Assessment of body temperature
Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.
Blood sampling
Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
Eligibility Criteria
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Inclusion Criteria
* A male or female aged 6 months to under 10 years at the time of the survey.
* Signed informed consent or thumb-printed and witnessed informed consent was obtained from the parent(s)/LAR(s) of the child.
Exclusion Criteria
* Had current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
6 Months
9 Years
ALL
Yes
Sponsors
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The PATH Malaria Vaccine Initiative (MVI)
OTHER
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Nouna, , Burkina Faso
GSK Investigational Site
Ouagadougou, , Burkina Faso
GSK Investigational Site
Kintampo, , Ghana
GSK Investigational Site
Navrongo, , Ghana
GSK Investigational Site
Kisumu, , Kenya
GSK Investigational Site
Kisumu, , Kenya
GSK Investigational Site
Nairobi, , Kenya
GSK Investigational Site
Chikwawa, , Malawi
GSK Investigational Site
Mangochi, , Malawi
GSK Investigational Site
Dakar, , Senegal
GSK Investigational Site
Dakar, , Senegal
GSK Investigational Site
Amani, , Tanzania
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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116682
Identifier Type: -
Identifier Source: org_study_id
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