Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Dengue

Treatments

Other: Data collection

Procedure: Blood sample collection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01391819

112994

Details and patient eligibility

About

The aim of this study is to establish an active surveillance in order to generate dengue disease burden estimates including incidence rates, prevalence data, clinical presentation and cost of illness in Forteleza (Brazil).

Full description

Prospective cohort study.

The study period initially planned to be two years, is extended by one year to cover one additional dengue season.

Enrollment

2,117 patients

Sex

All

Ages

5 to 13 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female between 5 and 13 years of age (including children at least 5 years of age and excluding children who reached their fourteenth birthday) at the time of enrollment.
Written informed consent (and assent when applicable).
Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol (e.g. willingness to do a hospital visit in case of dengue suspicion, willingness to attend the study hospital return for follow-up visits, able to observe for signs of dengue, understand how to take a temperature, etc).
Subjects who plan to attend one of the study schools for two school years following enrollment.

Exclusion criteria

Subjects planning to move from the study area during the two school years following enrollment.
Child in care.
Enrollment in another study that would conflict with the current study.