NCT01190202

Brief Summary

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,618

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

March 14, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2013

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

August 18, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

August 26, 2010

Results QC Date

September 29, 2017

Last Update Submit

August 5, 2020

Conditions

MalariaMalaria Vaccines

Keywords

MalariaPlasmodium falciparum

Outcome Measures

Primary Outcomes (1)

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

    The Overall parasite prevalence (PP) data were collected across centers from subjects aged between and including: 6 months to 4 Years (6M-4Y), 5 to 19 Years (5-19 Y) and 20 Years or older (20Y+), for each Survey. The number of subjects P. Falciparum parasitemia infected among the number of subjects with known result for P.falciparum parasitemia test was tabulated.

    At each Survey visit

Secondary Outcomes (52)

  • Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey

    At each Survey visit

  • Number of Subjects With Anemia and Severe Anemia for Each Survey

    During the survey period (approximatively 1 year)

  • Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density

    During the survey period (approximatively 1 year)

  • Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density

    During the survey period (approximatively 1 year)

  • Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density

    During the survey period (approximatively 1 year)

  • +47 more secondary outcomes

Study Arms (4)

Overall Study Group (Survey 1)

EXPERIMENTAL

Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.

Procedure: Blood samplingProcedure: Assessment of body temperature

Overall Study Group (Survey 2)

EXPERIMENTAL

Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.

Procedure: Blood samplingProcedure: Assessment of body temperature

Overall Study Group (Survey 3)

EXPERIMENTAL

Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.

Procedure: Blood samplingProcedure: Assessment of body temperature

Overall Study Group (Survey 4)

EXPERIMENTAL

Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study.

Procedure: Blood samplingProcedure: Assessment of body temperature

Interventions

Blood samplingPROCEDURE

Capillary blood samples collected by finger/heel prick

Overall Study Group (Survey 1)Overall Study Group (Survey 2)Overall Study Group (Survey 3)Overall Study Group (Survey 4)
Assessment of body temperaturePROCEDURE

Assessment of axial body temperature with a digital thermometer

Overall Study Group (Survey 1)Overall Study Group (Survey 2)Overall Study Group (Survey 3)Overall Study Group (Survey 4)

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Written informed consent obtained from the subject/from the parent(s)/ Legally Acceptable Representative(s) of the subject.

You may not qualify if:

  • Child in care.
  • Previous or current participation in any malaria vaccine trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

GSK Investigational Site

Ouagadougou, Burkina Faso

Location

GSK Investigational Site

Lambaréné, Gabon

Location

GSK Investigational Site

Kintampo, Ghana

Location

GSK Investigational Site

Kumasi, Ghana

Location

GSK Investigational Site

Kisumu, Kenya

Location

GSK Investigational Site

Lilongwe, Malawi

Location

GSK Investigational Site

Dar es Salaam, Tanzania

Location

GSK Investigational Site

Korogwe, Tanga, Tanzania

Location

Related Publications (1)

  • Drakeley C, Abdulla S, Agnandji ST, Fernandes JF, Kremsner P, Lell B, Mewono L, Bache BE, Mihayo MG, Juma O, Tanner M, Tahita MC, Tinto H, Diallo S, Lompo P, D'Alessandro U, Ogutu B, Otieno L, Otieno S, Otieno W, Oyieko J, Asante KP, Dery DB, Adjei G, Adeniji E, Atibilla D, Owusu-Agyei S, Greenwood B, Gesase S, Lusingu J, Mahende C, Mongi R, Segeja M, Adjei S, Agbenyega T, Agyekum A, Ansong D, Bawa JT, Boateng HO, Dandalo L, Escamilla V, Hoffman I, Maenje P, Martinson F, Carter T, Leboulleux D, Kaslow DC, Usuf E, Pircon JY, Bahmanyar ER. Longitudinal estimation of Plasmodium falciparum prevalence in relation to malaria prevention measures in six sub-Saharan African countries. Malar J. 2017 Oct 27;16(1):433. doi: 10.1186/s12936-017-2078-3.

    PMID: 29078773BACKGROUND

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
GSKClinicalSupportHD@gsk.com
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2010

First Posted

August 27, 2010

Study Start

March 14, 2011

Primary Completion

December 20, 2013

Study Completion

December 20, 2013

Last Updated

August 18, 2020

Results First Posted

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

IPD for this study will be made available via the Clinical Study Data Request site.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
More information

Locations

BU(1)GH(2)KE(1)TA(2)MA(1)GA(1)