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Trial record 42 of 48 for:    ( Map: Gabon )

Epidemiology Study of Malaria Transmission Intensity in Africa

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ClinicalTrials.gov Identifier: NCT01190202
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
The PATH Malaria Vaccine Initiative (MVI)
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date August 26, 2010
First Posted Date August 27, 2010
Last Update Posted Date September 30, 2015
Study Start Date March 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2010)
  • Occurrence of Plasmodium falciparum parasitemia during the first year [ Time Frame: At year 1 ]
  • Occurrence of P. falciparum parasitemia during the second year [ Time Frame: At year 2 ]
  • Occurrence of P. falciparum parasitemia during the third year [ Time Frame: At year 3 ]
  • Occurrence of P. falciparum parasitemia during the fourth year [ Time Frame: At year 4 ]
Original Primary Outcome Measures
 (submitted: August 26, 2010)
  • Occurrence of Plasmodium falciparum parasitemia [ Time Frame: At epoch 1 (year 1) ]
  • Occurrence of P. falciparum parasitemia [ Time Frame: At epoch 2 (year 2) ]
  • Occurrence of P. falciparum parasitemia [ Time Frame: At epoch 3 (year 3) ]
  • Occurrence of P. falciparum parasitemia [ Time Frame: At epoch 4 (year 4) ]
Change History Complete list of historical versions of study NCT01190202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 27, 2010)
  • Occurrence of P. falciparum parasitemia [ Time Frame: At years 1, 2, 3 and 4 ]
  • Occurrence of anemia [ Time Frame: At years 1, 2, 3 and 4 ]
  • Occurrence of anti-malarial therapy [ Time Frame: At years 1, 2, 3 and 4 ]
  • Occurrence of fever [ Time Frame: At years 1, 2, 3 and 4 ]
  • Occurrence of each risk factor [ Time Frame: At years 1, 2, 3 and 4 ]
  • Occurrence of malaria prevention measures [ Time Frame: At years 1, 2, 3 and 4 ]
  • Occurrence of other Plasmodium parasitemia [ Time Frame: At years 1, 2, 3 and 4 ]
Original Secondary Outcome Measures
 (submitted: August 26, 2010)
  • Occurrence of P. falciparum parasitemia [ Time Frame: At epochs 1, 2, 3 and 4 (years 1, 2, 3 and 4) ]
  • Occurrence of anemia [ Time Frame: At epochs 1, 2, 3 and 4 (years 1, 2, 3 and 4) ]
  • Occurrence of anti-malarial therapy [ Time Frame: At epochs 1, 2, 3 and 4 (years 1, 2, 3 and 4) ]
  • Occurrence of fever [ Time Frame: At epochs 1, 2, 3 and 4 (years 1, 2, 3 and 4) ]
  • Occurrence of each risk factor [ Time Frame: At epochs 1, 2, 3 and 4 (years 1, 2, 3 and 4) ]
  • Occurrence of malaria prevention measures [ Time Frame: At epochs 1, 2, 3 and 4 (years 1, 2, 3 and 4) ]
  • Occurrence of other Plasmodium parasitemia [ Time Frame: At epochs 1, 2, 3 and 4 (years 1, 2, 3 and 4) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiology Study of Malaria Transmission Intensity in Africa
Official Title Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
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).
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.

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood
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.
Condition Malaria
Intervention
  • 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
Study Groups/Cohorts Subjects
Subjects at least 6 months of age, enrolled in catchment areas of study 110021 (NCT00866619).
Interventions:
  • Procedure: Blood sampling
  • Procedure: Assessment of body temperature
Publications * 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, Pirçon 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 13, 2014)
13380
Original Estimated Enrollment
 (submitted: August 26, 2010)
25600
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Gabon,   Burkina Faso,   Ghana,   Kenya,   Malawi,   Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number NCT01190202
Other Study ID Numbers 114001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators The PATH Malaria Vaccine Initiative (MVI)
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2015