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

Epidemiology Study of Malaria Transmission Intensity in Africa

Request patient level data

GSK study ID

114001

See study documents

Clinicaltrials.gov ID

NCT01190202

See results summary

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Study complete

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

Primary completion date:

2013-20-12

Observational study model:

Not applicable

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

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

Showing 1 - 6 of 8 Results

Study documents

Clinical study report

Available language(s): English

Download document(s)

Scientific result summary

Available language(s): English

Download document(s)

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

Results overview

Results posted on ClinicalTrials.gov

Recruitment status

Study complete

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

Participate in clinical trial

Access to clinical trial data by researchers

Visit website