Epidemiology Study of Malaria Transmission Intensity in Africa

This study has been completed.
Sponsor:
Collaborator:
The PATH Malaria Vaccine Initiative (MVI)
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01190202
First received: August 26, 2010
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Malaria
Procedure: Blood sampling
Procedure: Assessment of body temperature

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of Plasmodium falciparum parasitemia during the first year [ Time Frame: At year 1 ] [ Designated as safety issue: No ]
  • Occurrence of P. falciparum parasitemia during the second year [ Time Frame: At year 2 ] [ Designated as safety issue: No ]
  • Occurrence of P. falciparum parasitemia during the third year [ Time Frame: At year 3 ] [ Designated as safety issue: No ]
  • Occurrence of P. falciparum parasitemia during the fourth year [ Time Frame: At year 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of P. falciparum parasitemia [ Time Frame: At years 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
  • Occurrence of anemia [ Time Frame: At years 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
  • Occurrence of anti-malarial therapy [ Time Frame: At years 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
  • Occurrence of fever [ Time Frame: At years 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
  • Occurrence of each risk factor [ Time Frame: At years 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
  • Occurrence of malaria prevention measures [ Time Frame: At years 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
  • Occurrence of other Plasmodium parasitemia [ Time Frame: At years 1, 2, 3 and 4 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 13380
Study Start Date: March 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects
Subjects at least 6 months of age, enrolled in catchment areas of study 110021 (NCT00866619).
Procedure: Blood sampling
Capillary blood samples collected by finger/heel prick
Procedure: Assessment of body temperature
Assessment of axial body temperature with a digital thermometer

Detailed Description:

This study is a multicenter epidemiology study at centers that are participating in GSK's pivotal Phase III candidate malaria vaccine 110021 ( NCT00866619) trial and will involve 4 annual cross sectional surveys performed preferably at peak transmission.

There will be no study vaccine administered in this epidemiology study.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects at least 6 months of age will be enrolled in catchment areas of a Phase III trial of the candidate malaria vaccine in sub-Saharan Africa (study 110021 (NCT00866619)); participants of study 110021 are excluded from this epidemiology study.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Child in care.
  • Previous or current participation in any malaria vaccine trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190202

Locations
Burkina Faso
GSK Investigational Site
Ouagadougou 01, Burkina Faso
Gabon
GSK Investigational Site
Lambaréné, Gabon
Ghana
GSK Investigational Site
Kintampo, Ghana
GSK Investigational Site
Kumasi, Ghana
Kenya
GSK Investigational Site
Kisumu, Kenya
Malawi
GSK Investigational Site
Lilongwe, Malawi
Tanzania
GSK Investigational Site
Dar-es-Salaam, Tanzania
GSK Investigational Site
Korogwe, Tanga, Tanzania
Sponsors and Collaborators
GlaxoSmithKline
The PATH Malaria Vaccine Initiative (MVI)
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01190202     History of Changes
Other Study ID Numbers: 114001
Study First Received: August 26, 2010
Last Updated: July 3, 2014
Health Authority: Tanzania: Ministry of Health
Burkina Faso : Ministere de la Sante
Gabon : Ministere de la Sante et de l'Hygiene Publique
Kenya : Ministry of public health and sanitation
Ghana: Ministry of Health
Malawi : Ministry of Health and Population

Keywords provided by GlaxoSmithKline:
Malaria
Plasmodium falciparum

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 26, 2014