Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
This study is currently recruiting participants.
Verified April 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01391819
First received: July 8, 2011
Last updated: April 25, 2013
Last verified: April 2013
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Dengue Virus Infection |
Other: Data collection Procedure: Blood sample collection |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | An Epidemiological Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of laboratory-confirmed symptomatic dengue infection [ Time Frame: Three years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of past dengue infections [ Time Frame: At least three years ] [ Designated as safety issue: No ]
- Occurrence of asymptomatic primary dengue infection [ Time Frame: At least three years ] [ Designated as safety issue: No ]
- Occurrence of symptomatic dengue infection by virus type [ Time Frame: At least three years ] [ Designated as safety issue: No ]
- Occurrence of symptomatic and primary asymptomatic dengue infection by age category [ Time Frame: At least three years ] [ Designated as safety issue: No ]
- Occurrence of primary symptomatic dengue infections [ Time Frame: At least three years ] [ Designated as safety issue: No ]
- Occurrence of secondary symptomatic dengue infections [ Time Frame: At least three years ] [ Designated as safety issue: No ]
- Symptoms of symptomatic dengue infection [ Time Frame: At least three years ] [ Designated as safety issue: No ]
- Direct medical resource utilization and indirect resource utilization associated with symptomatic dengue infection [ Time Frame: At least three years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Study cohort
Children age 5 to 13 years at the time of enrollment, selected from schools in Fortaleza.
|
Other: Data collection
Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection.
Procedure: 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.
|
Detailed Description:
Prospective cohort study.
The study period initially planned to be two years, is extended by one year to cover one additional dengue season.
Eligibility| Ages Eligible for Study: | 5 Years to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391819
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| Brazil | |
| GSK Investigational Site | Recruiting |
| Fortaleza, Ceará, Brazil, 60430 160 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01391819 History of Changes |
| Other Study ID Numbers: | 112994 |
| Study First Received: | July 8, 2011 |
| Last Updated: | April 25, 2013 |
| Health Authority: | Brazil: Agência Nacional de Vigilância Sanitária (ANVISA) |
Keywords provided by GlaxoSmithKline:
|
Brazil Incidence Dengue virus Dengue Dengue infection |
Additional relevant MeSH terms:
|
Dengue Virus Diseases Arbovirus Infections Flavivirus Infections |
Flaviviridae Infections RNA Virus Infections Hemorrhagic Fevers, Viral |
ClinicalTrials.gov processed this record on May 21, 2013