Epidemiology Study of Malaria Transmission Intensity in Africa

NCT ID: NCT01190202

Last Updated: 2020-08-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-14

Study Completion Date

2013-12-20

Brief Summary

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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

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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.

Conditions

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Malaria Malaria Vaccines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Study Groups

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Overall Study Group (Survey 1)

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.

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick

Assessment of body temperature

Intervention Type PROCEDURE

Assessment of axial body temperature with a digital thermometer

Overall Study Group (Survey 2)

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.

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick

Assessment of body temperature

Intervention Type PROCEDURE

Assessment of axial body temperature with a digital thermometer

Overall Study Group (Survey 3)

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.

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick

Assessment of body temperature

Intervention Type PROCEDURE

Assessment of axial body temperature with a digital thermometer

Overall Study Group (Survey 4)

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.

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

Capillary blood samples collected by finger/heel prick

Assessment of body temperature

Intervention Type PROCEDURE

Assessment of axial body temperature with a digital thermometer

Interventions

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Blood sampling

Capillary blood samples collected by finger/heel prick

Intervention Type PROCEDURE

Assessment of body temperature

Assessment of axial body temperature with a digital thermometer

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The PATH Malaria Vaccine Initiative (MVI)

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Ouagadougou, , Burkina Faso

Site Status

GSK Investigational Site

Lambaréné, , Gabon

Site Status

GSK Investigational Site

Kintampo, , Ghana

Site Status

GSK Investigational Site

Kumasi, , Ghana

Site Status

GSK Investigational Site

Kisumu, , Kenya

Site Status

GSK Investigational Site

Lilongwe, , Malawi

Site Status

GSK Investigational Site

Dar es Salaam, , Tanzania

Site Status

GSK Investigational Site

Korogwe, Tanga, , Tanzania

Site Status

Countries

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Burkina Faso Gabon Ghana Kenya Malawi Tanzania

References

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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.

Reference Type BACKGROUND
PMID: 29078773 (View on PubMed)

Other Identifiers

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114001

Identifier Type: -

Identifier Source: org_study_id

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