Overview

This trial is active, not recruiting.

Condition dengue
Treatments data collection, blood sample collection
Sponsor GlaxoSmithKline
Start date September 2011
End date March 2015
Trial size 2000 participants
Trial identifier NCT01391819, 112994

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
Children age 5 to 13 years at the time of enrollment, selected from schools in Fortaleza.
data collection
Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection.
blood sample collection
A blood sample will be collected at each of the three scheduled study visits and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue diagnosis.

Primary Outcomes

Measure
Occurrence of laboratory-confirmed symptomatic dengue infection
time frame: Three years

Secondary Outcomes

Measure
Occurrence of past dengue infections
time frame: At least three years
Occurrence of asymptomatic primary dengue infection
time frame: At least three years
Occurrence of symptomatic dengue infection by virus type
time frame: At least three years
Occurrence of symptomatic and primary asymptomatic dengue infection by age category
time frame: At least three years
Occurrence of primary symptomatic dengue infections
time frame: At least three years
Occurrence of secondary symptomatic dengue infections
time frame: At least three years
Symptoms of symptomatic dengue infection
time frame: At least three years
Direct medical resource utilization and indirect resource utilization associated with symptomatic dengue infection
time frame: At least three years

Eligibility Criteria

Male or female participants from 5 years up to 13 years old.

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.

Additional Information

Official title An Epidemiological Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
Description Prospective cohort study. The study period initially planned to be two years, is extended by one year to cover one additional dengue season.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.