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

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-06

Study Completion Date

2015-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil

NCT01751139

Dengue

TERMINATED NA

This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia

NCT02766088

Dengue Dengue Vaccines

TERMINATED NA

A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia

NCT02570152

Dengue

COMPLETED NA

Diagnosis and Characterization of Dengue Fever in Children

NCT00946218

Dengue Fever

COMPLETED

Dengue Vaccine Strategy in Children Aged 9 to 17 Years in the French Caribbean

NCT04839757

Dengue Vaccination Seroprevalence +1 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prospective cohort study.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dengue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study cohort

Children age 5 to 13 years at the time of enrollment, selected from schools in Fortaleza.

Group Type OTHER

Data collection

Intervention Type OTHER

Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection.

Blood sample collection

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Data collection

Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection.

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes