Clinical Trial: Epidemiology Study of Malaria Transmission Intensity in Africa

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Summary:

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.


Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • 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:

  • 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) ]


Current Secondary Outcome:

  • 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:

  • 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) ]


Information By: GlaxoSmithKline

Dates:
Date Received: August 26, 2010
Date Started: March 2011
Date Completion:
Last Updated: September 28, 2015
Last Verified: September 2015