Epidemiology Study of Malaria Transmission Intensity in Africa

• ClinicalTrials.gov Identifier: NCT01190202
• Recruitment Status: Completed
• First Posted: August 27, 2010
• Last Update Posted: September 30, 2015
• Sponsor: GlaxoSmithKline
• 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.

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

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