Epidemiology Study of Malaria Transmission Intensity in Africa

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Malaria; Malaria Vaccines

Treatments: Procedure: Blood sampling; Procedure: Assessment of body temperature

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01190202

114001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21,618 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

21,618 participants in 4 patient groups

Overall Study Group (Survey 1)

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling

Procedure: Assessment of body temperature

Overall Study Group (Survey 2)

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling

Procedure: Assessment of body temperature

Overall Study Group (Survey 3)

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling

Procedure: Assessment of body temperature

Overall Study Group (Survey 4)

Experimental group

Description:

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.

Treatment:

Procedure: Blood sampling

Procedure: Assessment of body temperature