Last updated: 07/16/2020 11:10:05

Study to evaluate the incidence, clinical characteristics and economic burden of dengue in Brazilian children

GSK study ID
112994
See study documents
Clinicaltrials.gov ID
NCT01391819
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An epidemiological study to evaluate the incidence, clinical characteristics and economic burden of dengue in Brazilian children
Trial description: 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).
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Incidence of all laboratory-confirmed symptomatic dengue infection

Timeframe: At Year 1 (2012)

Incidence of all laboratory-confirmed symptomatic dengue infection

Timeframe: At Year 2 (2013)

Incidence of all laboratory-confirmed symptomatic dengue infection

Timeframe: At Year 3 (2014)

Secondary outcomes:

Proportion of subjects with prevalence of past dengue infection (dengue seroprevalence) at enrollment

Timeframe: At Day 0 (At enrollment)

Proportion of subjects with primary asymptomatic dengue infection

Timeframe: 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

Timeframe: From Year 0 to Year 3

Incidence of all laboratory-confirmed or probable symptomatic dengue infection

Timeframe: At Year 1 (2012)

Incidence of all laboratory-confirmed or probable symptomatic dengue infection

Timeframe: At Year 2 (2013)

Incidence of all laboratory-confirmed or probable symptomatic dengue infection

Timeframe: At Year 3 (2014)

Number of dengue infection cases by virus type (DENV)

Timeframe: From Day 0 to Year 3

Number of primary laboratory confirmed symptomatic dengue infection cases

Timeframe: At Year 1 (2012)

Number of primary laboratory confirmed symptomatic dengue infection cases

Timeframe: At Year 2 (2013)

Number of primary laboratory confirmed symptomatic dengue infection cases

Timeframe: At Year 3 (2014)

Number of secondary laboratory confirmed symptomatic dengue infection cases

Timeframe: At Year 1 (2012)

Number of secondary laboratory confirmed symptomatic dengue infection cases

Timeframe: At Year 2 (2013)

Number of secondary laboratory confirmed symptomatic dengue infection cases

Timeframe: At Year 3 (2014)

Number of working days missed of primary care giver 1 of subjects with laboratory confirmed symptomatic dengue cases

Timeframe: From 21 up to 35 days post laboratory confirmed dengue onset

Number of working days missed of primary care giver 2 of subjects with laboratory confirmed symptomatic dengue cases

Timeframe: From 21 up to 35 days post laboratory confirmed dengue onset

Number of laboratory confirmed dengue infection cases associated with caregiver absenteeism

Timeframe: From 21 up to 35 days post laboratory confirmed dengue onset

Number of school days missed by subjects

Timeframe: From 21 up to 35 days post laboratory confirmed dengue onset

Number of laboratory confirmed dengue infection cases associated with subjects absenteeism

Timeframe: From 21 up to 35 days post laboratory confirmed dengue onset

Number of subjects with serious adverse events (SAEs)

Timeframe: From Day 0 to Year 3

Number of symptomatic dengue laboratory confirmed cases associated with hospitalization direct medical resource

Timeframe: From Day 0 to Year 3

Number of hospitalization days due to laboratory confirmed dengue cases

Timeframe: From Day 0 to Year 3

Number of dengue infection episodes - clinical symptom since onset of suspected dengue cases: Temperature

Timeframe: From Day 0 to Year 3

Number of dengue infection episodes with any temperature interval since onset of suspected dengue cases, among laboratory confirmed dengue cases

Timeframe: From Day 0 to Year 3

Number of laboratory confirmed dengue episodes associated with clinical symptoms

Timeframe: From Day 0 to Year 3

Number of hospitalization days due to suspected dengue cases

Timeframe: From Day 0 to Year 3

Dengue infection episodes related temperature

Timeframe: From Day 0 to Year 3

Number of dengue episodes with any temperature interval

Timeframe: From Day 0 to Year 3

Number of dengue episodes associated with clinical symptoms

Timeframe: From Day 0 to Year 3

Interventions:
  • Other: Data collection
  • Procedure/surgery: Blood sample collection
    • Enrollment:
    2117
    Primary completion date:
    2015-30-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Coelho I, Haguinet F, Colares JK, Coelho Z, Araújo F, Schwarcz WD, Duarte A, 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. 103(1):100-111.
    Medical condition
    Dengue
    Product
    SB763310
    Collaborators
    Not applicable
    Study date(s)
    September 2011 to January 2015
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    5 - 13 years
    Accepts healthy volunteers
    Yes
    • 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 planning to move from the study area during the two school years following enrollment.
    • Child in care.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Fortaleza, Ceará, Brazil, 60430 160
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2015-30-01
    Actual study completion date
    2015-30-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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