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

NCT01391819 | Completed Results

• 1 other identifier: 112994
• Study Type: interventional
• Target: 2,117
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dengue

Keywords

Brazil; Incidence; Dengue virus; Dengue; Dengue infection

Outcome Measures

Primary Outcomes (3)

• Incidence of All Laboratory-confirmed Symptomatic Dengue Infection

  Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.

  At Year 1 (2012)

• Incidence of All Laboratory-confirmed Symptomatic Dengue Infection

  Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.

  At Year 2 (2013)

• Incidence of All Laboratory-confirmed Symptomatic Dengue Infection

  Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.

  At Year 3 (2014)

Secondary Outcomes (24)

• Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment

  At Day 0 (At enrollment)

• Proportion of Subjects With Primary Asymptomatic Dengue Infection

  From Day 0 to Year 3

• Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases

  From Year 0 to Year 3

• Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection

  At Year 1 (2012)

• Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection

  At Year 2 (2013)

Study Arms (1)

Study cohort

OTHER

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

Other: Data collection; Procedure: Blood sample collection

Interventions

Data collection OTHER

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

Study cohort

Blood sample collection 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.

Study cohort

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fortaleza, Ceará, 60430 160, Brazil

Location

Related Publications (1)

• C B Coelho I, Haguinet F, B Colares JK, C B Coelho Z, M C Araujo F, Dias Schwarcz W, Duarte AC, Borges B, Minguet C, Guignard A. Dengue Infection in Children in Fortaleza, Brazil: A 3-Year School-Based Prospective Cohort Study. Am J Trop Med Hyg. 2020 Jul;103(1):100-111. doi: 10.4269/ajtmh.19-0521. Epub 2020 Apr 23.

  PMID: 32342838 DERIVED

MeSH Terms

Conditions

Dengue

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: September 6, 2011
• Primary Completion: January 30, 2015
• Study Completion: January 30, 2015
• Last Updated: June 25, 2019
• Results First Posted: April 26, 2017

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)