Clinical trial NCT02251704: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Official title: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Malaria Vaccines
Keywords: Malaria
MTI
Surveillance study
Africa
RTS,S/AS01
Epidemiology
Plasmodium falciparum
Malaria control interventions
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: The PATH Malaria Vaccine Initiative (MVI)
First posted: 2014-09-29
Enrollment: 54112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects' whose parent(s)/Legally Acceptable Representative(s) \[LAR(s)\], in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female 6 months to \<10 years of age at the time of survey.
* Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.

Exclusion Criteria:

* Child in care.
* Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.

Primary outcomes:
measure: Number of subjects infected with P. falciparum parasitaemia (using microscopy)
timeFrame: From Day 0 to Year 10
measure: Number of subjects using malaria control interventions
timeFrame: From Day 0 to Year 10
Secondary outcomes:
measure: Number of subjects by demography and medical history characteristics
timeFrame: From Day 0 to Year 10
measure: Number of subjects infected with Plasmodium species other than P. falciparum (using microscopy)
timeFrame: From Day 0 to Year 10
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
timeFrame: From Day 0 to Year 10
measure: Number of subjects using anti-malarial therapy in the 14 days prior to the visit
timeFrame: From Day 0 to Year 10
measure: Number of subjects with measured fever at the visit
timeFrame: From Day 0 to Year 10
measure: Number of subjects with reported fever in the 24 hours prior to the visit
timeFrame: From Day 0 to Year 10
measure: Number of subjects demonstrating care seeking behaviour
timeFrame: From Day 0 to Year 10
measure: Number of subjects in each geo-referenced segment
timeFrame: From Day 0 to Year 10
measure: Number of subjects experiencing risk factors
timeFrame: From Day 0 to Year 10
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: GSK Investigational Site
city: Ouagadougou
country: Burkina Faso
facility: GSK Investigational Site
city: Kintampo
country: Ghana
facility: GSK Investigational Site
city: Navrongo
country: Ghana
facility: GSK Investigational Site
city: Kisumu
country: Kenya
facility: GSK Investigational Site
city: Kisumu
country: Kenya
facility: GSK Investigational Site
city: Nairobi
country: Kenya
facility: GSK Investigational Site
city: Chikwawa
country: Malawi
facility: GSK Investigational Site
city: Mangochi
country: Malawi
facility: GSK Investigational Site
city: Dakar
country: Senegal
facility: GSK Investigational Site
city: Dakar
country: Senegal
facility: GSK Investigational Site
city: Amani Tanga
country: Tanzania
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: