<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02251704</url>
  </required_header>
  <id_info>
    <org_study_id>116682</org_study_id>
    <nct_id>NCT02251704</nct_id>
  </id_info>
  <brief_title>Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa</brief_title>
  <official_title>Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The PATH Malaria Vaccine Initiative (MVI)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003&#xD;
      studies, enrolling from the same health and demographic surveillance system (HDSS) (or&#xD;
      equivalent system) populations. The co-primary objectives are to produce longitudinal&#xD;
      estimates of parasite prevalence in humans, and record malaria control measures usage in&#xD;
      areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will involve up to 10 annual cross sectional surveys during malaria peak&#xD;
      transmission with possible further extension, dependent on the duration of the EPI-MAL-002&#xD;
      and EPI-MAL-003 studies. Surveys will provide point estimates of parasite prevalence and&#xD;
      subsequently a longitudinal assessment of the level of endemicity in each area covered by&#xD;
      EPI-MAL-002 and EPI-MAL-003. This study will be conducted in parallel to EPI-MAL-002 and&#xD;
      EPI-MAL-003 in order to assess parasite prevalence and malaria control measures before&#xD;
      (EPI-MAL-002) and after (EPI-MAL-003) vaccine introduction.&#xD;
&#xD;
      By taking into account variations in malaria transmission intensity (MTI) and malaria control&#xD;
      intervention coverage, it will enable a more complete assessment of the benefits and risks of&#xD;
      the vaccine introduction, and thereby more insight into the potential vaccine impact in&#xD;
      EPI-MAL-002/-003, by adjusting incidence data for overall changes in transmission and other&#xD;
      malaria control intervention coverage, and assist generalisation of results to other&#xD;
      populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 22, 2014</start_date>
  <completion_date type="Anticipated">August 5, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 5, 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects infected with P. falciparum parasitaemia (using microscopy)</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Infection with P. falciparum determined using a blood smear slide and determined using microscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects using malaria control interventions</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Malaria control interventions are mosquito net usage (including insecticide-treated nets [ITN] and long lasting insecticidal nets [LLIN]), indoor residual spraying (IRS), seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi), and artemisinin-based combination therapy (ACT) therapy received within the last 14 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects by demography and medical history characteristics</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Parameters used to assess this outcome were gender, age and medical history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects infected with Plasmodium species other than P. falciparum (using microscopy)</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Infection with Plasmodium species other than P. falciparum determined using a blood smear slide and microscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with uptake and timing of the third dose of DTP/HepB/Hib pentavalent and the first dose of the measles EPI vaccines</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Vaccination record of receipt of dose 3 of the DTP/HepB/Hib pentavalent and the first dose of the measles EPI vaccines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects using anti-malarial therapy in the 14 days prior to the visit</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Any anti-malarial therapy received in the last 14 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with measured fever at the visit</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Any measured fever at time of visit (axillary temperature greater than or equal to [≥] 37.5 degrees Celsius [°C])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with reported fever in the 24 hours prior to the visit</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Any reported fever occurring in the last 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects demonstrating care seeking behaviour</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Visits to health providers following reported fever or malaria in the previous 14 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects in each geo-referenced segment</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Positioning of the subject's residence is attributed to a segment with a unique ID from the grid referencing study area map in which the subject resides, where necessary, grouping small geographically proximate villages so that each segment has at least 10 study subjects to avoid personally identifiable information (PII), and proceeding as far as geographically appropriate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects experiencing risk factors</measure>
    <time_frame>From Day 0 to Year 10</time_frame>
    <description>Malaria risk factors are rural/urban area, construction material for the house, floor and roof, type of eaves (open/closed), use of electricity and water source (distance from and type)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">54000</enrollment>
  <condition>Malaria</condition>
  <condition>Malaria Vaccines</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects 6 months to &lt;10 years of age enrolled in HDSS catchment areas at the sites participating in the EPI-MAL-002 and EPI-MAL-003 studies of the candidate malaria vaccine RTS,S/AS01E in sub-Saharan Africa.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Assessment of body temperature</intervention_name>
    <description>Axillary body temperature of all subjects recorded by a digital thermometer at the time of survey.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects' whose parent(s)/Legally Acceptable Representative(s) [LAR(s)], in the&#xD;
             opinion of the investigator, can and will comply with the requirements of the&#xD;
             protocol.&#xD;
&#xD;
          -  A male or female 6 months to &lt;10 years of age at the time of survey.&#xD;
&#xD;
          -  Signed informed consent or thumb-printed and witnessed informed consent obtained from&#xD;
             the parent(s)/LAR(s) of the child.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child in care.&#xD;
&#xD;
          -  Current active participation in any trial involving administration of an&#xD;
             investigational malaria vaccine or malaria drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>US GSK Clinical Trials Call Center</last_name>
    <phone>877-379-3718</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>EU GSK Clinical Trials Call Center</last_name>
    <phone>+44 (0) 20 89904466</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nouna</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ouagadougou</city>
        <zip>2208</zip>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kintampo</city>
        <country>Ghana</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Kwaku Poku Asante</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Navrongo</city>
        <country>Ghana</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Abraham Rexford Oduro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kisumu</city>
        <zip>40100</zip>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Simon Kariuki</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kisumu</city>
        <zip>40100</zip>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Bernhards Ogutu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kisumu</city>
        <zip>40102</zip>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Walter Otieno</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Blantyre 3</city>
        <country>Malawi</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Dianne Janette Terlouw</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mangochi</city>
        <country>Malawi</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Kenneth Maleta</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dakar</city>
        <zip>12500</zip>
        <country>Senegal</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dakar</city>
        <zip>16556</zip>
        <country>Senegal</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tanga</city>
        <country>Tanzania</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
    <country>Ghana</country>
    <country>Kenya</country>
    <country>Malawi</country>
    <country>Senegal</country>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malaria</keyword>
  <keyword>MTI</keyword>
  <keyword>Surveillance study</keyword>
  <keyword>Africa</keyword>
  <keyword>RTS,S/AS01</keyword>
  <keyword>Epidemiology</keyword>
  <keyword>Plasmodium falciparum</keyword>
  <keyword>Malaria control interventions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02251704
org study id: 116682
nct id: NCT02251704
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003
      studies, enrolling from the same health and demographic surveillance system (HDSS) (or
      equivalent system) populations. The co-primary objectives are to produce longitudinal
      estimates of parasite prevalence in humans, and record malaria control measures usage in
      areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.
This study will involve up to 10 annual cross sectional surveys during malaria peak
      transmission with possible further extension, dependent on the duration of the EPI-MAL-002
      and EPI-MAL-003 studies. Surveys will provide point estimates of parasite prevalence and
      subsequently a longitudinal assessment of the level of endemicity in each area covered by
      EPI-MAL-002 and EPI-MAL-003. This study will be conducted in parallel to EPI-MAL-002 and
      EPI-MAL-003 in order to assess parasite prevalence and malaria control measures before
      (EPI-MAL-002) and after (EPI-MAL-003) vaccine introduction.

      By taking into account variations in malaria transmission intensity (MTI) and malaria control
      intervention coverage, it will enable a more complete assessment of the benefits and risks of
      the vaccine introduction, and thereby more 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 assist generalisation of results to other
      populations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of subjects infected with P. falciparum parasitaemia (using microscopy)
time frame: From Day 0 to Year 10
description: Infection with P. falciparum determined using a blood smear slide and determined using microscopy
measure: Number of subjects using malaria control interventions
time frame: From Day 0 to Year 10
description: Malaria control interventions are mosquito net usage (including insecticide-treated nets [ITN] and long lasting insecticidal nets [LLIN]), indoor residual spraying (IRS), seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi), and artemisinin-based combination therapy (ACT) therapy received within the last 14 days
measure: Number of subjects by demography and medical history characteristics
time frame: From Day 0 to Year 10
description: Parameters used to assess this outcome were gender, age and medical history
measure: Number of subjects infected with Plasmodium species other than P. falciparum (using microscopy)
time frame: From Day 0 to Year 10
description: Infection with Plasmodium species other than P. falciparum determined using a blood smear slide and microscopy
measure: Number of subjects with uptake and timing of the third dose of DTP/HepB/Hib pentavalent and the first dose of the measles EPI vaccines
time frame: From Day 0 to Year 10
description: Vaccination record of receipt of dose 3 of the DTP/HepB/Hib pentavalent and the first dose of the measles EPI vaccines
measure: Number of subjects using anti-malarial therapy in the 14 days prior to the visit
time frame: From Day 0 to Year 10
description: Any anti-malarial therapy received in the last 14 days
measure: Number of subjects with measured fever at the visit
time frame: From Day 0 to Year 10
description: Any measured fever at time of visit (axillary temperature greater than or equal to [≥] 37.5 degrees Celsius [°C])
measure: Number of subjects with reported fever in the 24 hours prior to the visit
time frame: From Day 0 to Year 10
description: Any reported fever occurring in the last 24 hours
measure: Number of subjects demonstrating care seeking behaviour
time frame: From Day 0 to Year 10
description: Visits to health providers following reported fever or malaria in the previous 14 days
measure: Number of subjects in each geo-referenced segment
time frame: From Day 0 to Year 10
description: Positioning of the subject's residence is attributed to a segment with a unique ID from the grid referencing study area map in which the subject resides, where necessary, grouping small geographically proximate villages so that each segment has at least 10 study subjects to avoid personally identifiable information (PII), and proceeding as far as geographically appropriate
measure: Number of subjects experiencing risk factors
time frame: From Day 0 to Year 10
description: Malaria risk factors are rural/urban area, construction material for the house, floor and roof, type of eaves (open/closed), use of electricity and water source (distance from and type)
arm group label: Study Group
arm group type: Other
description: Subjects 6 months to <10 years of age enrolled in HDSS catchment areas at the sites participating in the EPI-MAL-002 and EPI-MAL-003 studies of the candidate malaria vaccine RTS,S/AS01E in sub-Saharan Africa.
intervention type: Procedure
intervention name: Blood sampling
description: Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
arm group label: Study Group
intervention type: Diagnostic Test
intervention name: Assessment of body temperature
description: Axillary body temperature of all subjects recorded by a digital thermometer at the time of survey.
arm group label: Study Group
criteria: 
gender: All
minimum age: 6 Months
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
last name: US GSK Clinical Trials Call Center
phone: 877-379-3718
email: GSKClinicalSupportHD@gsk.com
last name: EU GSK Clinical Trials Call Center
phone: +44 (0) 20 89904466
email: GSKClinicalSupportHD@gsk.com
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
contact backup: 
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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investigator: 
facility: 
status: Recruiting
contact: 
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investigator: 
facility: 
status: Recruiting
contact: 
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investigator: 
facility: 
status: Recruiting
contact: 
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investigator: 
facility: 
status: Recruiting
contact: 
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facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
country: Burkina Faso
country: Ghana
country: Kenya
country: Malawi
country: Senegal
country: Tanzania
responsible party type: Sponsor
mesh term: Malaria
sharing ipd: No