Overview

This trial has been completed.

Condition dengue
Treatments data collection, blood sample collection
Sponsor GlaxoSmithKline
Start date September 2011
End date January 2015
Trial size 2117 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
Primary purpose other
Masking no masking
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
Number of laboratory confirmed symptomatic dengue infection cases
time frame: At Year 1 (2012)
Number of laboratory confirmed symptomatic dengue infection cases
time frame: At Year 2 (2013)
Number of laboratory confirmed symptomatic dengue infection cases
time frame: At Year 3 (2014)

Secondary Outcomes

Measure
Number of subjects with Immunoglobulin type G (IgG) antibodies against dengue
time frame: From Day 0 to Year 3
Number of subjects with asymptomatic dengue primary infection
time frame: From Day 0 to Year 3
Number of subjects with laboratory confirmed and probable dengue cases
time frame: From Year 0 to Year 3
Number of dengue infection cases by virus type
time frame: From Day 0 to Year 3
Number of primary laboratory confirmed symptomatic dengue infection cases
time frame: From Day 0 to Year 3
Number of secondary laboratory confirmed symptomatic dengue infection cases
time frame: From Day 0 to Year 3
Number of working days missed of primary care giver 1 and 2
time frame: Up to Day 35 post laboratory confirmed dengue onset
Caregiver absenteeism associated with subject dengue illness
time frame: Up to Day 35 post laboratory confirmed dengue onset
Number of school days missed by subjects
time frame: Up to Day 35 post laboratory confirmed dengue onset
Subjects absenteeism associated with dengue illness
time frame: Up to Day 35 post laboratory confirmed dengue onset
Number of subjects with serious adverse events (SAEs)
time frame: From Day 0 to Year 3
Direct medical resource associated with suspected dengue cases
time frame: From Day 0 to Year 3
Number of hospitalization days due to suspected dengue cases
time frame: From Day 0 to Year 3
Dengue infection episodes related temperature
time frame: From Day 0 to Year 3
Number of dengue episodes with any temperature interval
time frame: From Day 0 to Year 3
Number of dengue episodes associated with clinical symptoms
time frame: From Day 0 to Year 3

Eligibility Criteria

All 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 March 2017.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.