Last updated: 08/05/2020 09:10:09

Epidemiology Study of Malaria Transmission Intensity in Africa

GSK study ID
114001
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Trial description: 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).
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for each Survey

Timeframe: At each Survey visit

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

Timeframe: At each Survey visit

Number of subjects with anemia and severe anemia for each Survey

Timeframe: During the survey period (approximatively 1 year)

Number of Subjects With Anti-malarial Therapy in Survey 1, according to parasite density

Timeframe: During the survey period (approximatively 1 year)

Number of Subjects With Anti-malarial Therapy in Survey 2, according to parasite density

Timeframe: During the survey period (approximatively 1 year)

Number of Subjects With Anti-malarial Therapy in Survey 3, according to parasite density

Timeframe: During the survey period (approximatively 1 year)

Number of Subjects With Anti-malarial Therapy in Survey 4, according to parasite density

Timeframe: During the survey period (approximatively 1 year)

Mean number of Days with Malaria Treatment at Survey 1

Timeframe: During the 14 day-period before the malaria treatment

Mean number of Days with Malaria Treatment at Survey 2

Timeframe: During the 14 day-period before the malaria treatment

Mean number of Days with Malaria Treatment at Survey 3

Timeframe: During the 14 day-period before the malaria treatment

Mean number of Days with Malaria Treatment at Survey 4

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: In the last 24 hours or at the survey visit

Mean number of Days with Fever at Survey 1

Timeframe: During the survey period (approximatively 1 year)

Mean number of Days with Fever at Survey 2

Timeframe: During the survey period (approximatively 1 year)

Mean number of Days with Fever at Survey 3

Timeframe: During the survey period (approximatively 1 year)

Mean number of Days with Fever at Survey 4

Timeframe: During the survey period (approximatively 1 year)

Axillary temperature at visit in Survey 1

Timeframe: At Survey visit

Axillary temperature at visit in Survey 2

Timeframe: At Survey visit

Axillary temperature at visit in Survey 3

Timeframe: At Survey visit

Axillary temperature at visit in Survey 4

Timeframe: At Survey visit

Number of subjects living in the same house at Survey 1

Timeframe: At Survey visit

Number of subjects living in the same house at Survey 2

Timeframe: At Survey visit

Number of subjects living in the same house at Survey 3

Timeframe: At Survey visit

Number of subjects living in the same house at Survey 4

Timeframe: At Survey visit

Mean number of subjects living in the same house at Survey 1

Timeframe: At Survey visit

Mean number of subjects living in the same house at Survey 2

Timeframe: At Survey visit

Mean number of subjects living in the same house at Survey 3

Timeframe: At Survey visit

Mean number of subjects living in the same house at Survey 4

Timeframe: At Survey visit

Number of subjects by localisation and type of location at Survey 1

Timeframe: At Survey visit

Number of subjects by localisation and type of location at Survey 2

Timeframe: At Survey visit

Number of subjects by localisation and type of location at Survey 3

Timeframe: At Survey visit

Number of subjects by localisation and type of location at Survey 4

Timeframe: At Survey visit

Number of subjects by house construction material regarding walls and floor at Survey 1

Timeframe: At Survey visit

Number of subjects by house construction material regarding walls and floor at Survey 2

Timeframe: At Survey visit

Number of subjects by house construction material regarding walls and floor at Survey 3

Timeframe: At Survey visit

Number of subjects by house construction material regarding walls and floor at Survey 4

Timeframe: At Survey visit

Number of subjects classified by house construction material regarding roof, window/eaves and nets at Survey 1

Timeframe: At Survey visit

Number of subjects classified by house construction material regarding roof, window/eaves and nets at Survey 2

Timeframe: At Survey visit

Number of subjects classified by house construction material regarding roof, window/eaves and nets at Survey 3

Timeframe: At Survey visit

Number of subjects classified by house construction material regarding roof, window/eaves and nets at Survey 4

Timeframe: At Survey visit

Number of subjects classified by house information regarding main source of the drinking water and presence of electricity at Survey 1

Timeframe: At Survey visit

Number of subjects classified by house information regarding main source of the drinking water and presence of electricity at Survey 2

Timeframe: At Survey visit

Number of subjects classified by house information regarding main source of the drinking water and presence of electricity at Survey 3

Timeframe: At Survey visit

Number of subjects classified by house information regarding main source of the drinking water and presence of electricity at Survey 4

Timeframe: At Survey visit

Number of subjects with malaria prevention measures (MPM) at each survey

Timeframe: At each Survey visit

Number of subjects with Plasmodium species other than P. falciparum at Survey 1

Timeframe: At Survey visit

Number of subjects with Plasmodium species other than P. falciparum at Survey 2

Timeframe: At Survey visit

Number of subjects with Plasmodium species other than P. falciparum at Survey 3

Timeframe: At Survey visit

Number of subjects with Plasmodium species other than P. falciparum at Survey 4

Timeframe: At Survey visit

Number of subjects with serious adverse events (SAEs) related to study procedure for each survey

Timeframe: At each Survey visit

Interventions:
Procedure/surgery: Blood sampling
Procedure/surgery: Assessment of body temperature
Enrollment:
21618
Observational study model:
Not applicable
Primary completion date:
2013-20-12
Time perspective:
Not applicable
Clinical publications:
Drakeley C et al. (2017) Longitudinal estimation of Plasmodium falciparum prevalence in relation to malaria prevention measures in six sub-Saharan African countries. Malar J. 16(1):433.
Medical condition
Malaria
Product
SB257049
Collaborators
The PATH Malaria Vaccine Initiative (MVI)
Study date(s)
March 2011 to December 2013
Type
Interventional
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
6+ years
Accepts healthy volunteers
Yes
  • 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.
  • Child in care.
  • Previous or current participation in any malaria vaccine trial.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Dar-es-Salaam, Tanzania
Status
Study Complete
Location
GSK Investigational Site
Kintampo, Ghana
Status
Study Complete
Location
GSK Investigational Site
Kisumu, Kenya
Status
Study Complete
Location
GSK Investigational Site
Korogwe, Tanga, Tanzania
Status
Study Complete
Location
GSK Investigational Site
Kumasi, Ghana
Status
Study Complete
Location
GSK Investigational Site
Lambaréné, Gabon
Status
Study Complete
Location
GSK Investigational Site
Lilongwe, Malawi
Status
Study Complete
Location
GSK Investigational Site
Ouagadougou 01, Burkina Faso
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2013-20-12
Actual study completion date
2013-20-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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