Clinical trial NCT01751139: An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil
Official title: An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Endemic Regions of Brazil
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dengue
Keywords: Endemic regions
Brazil
Incidence
Surveillance
Dengue
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Tropical Disease Foundation
name: Goncalo Moniz Research Center
name: Evandro Chagas Research Institute, Bio-Manguinhos Technology and Immunology Institute
First posted: 2012-12-17
Enrollment: 3300
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.

Detailed description: The aim of this study is to generate dengue disease burden data including estimates of incidence rates, prevalence data and the clinical presentation of dengue across different age groups.

The study will be conducted in at least three cities: Rio de Janeiro, Salvador, and Manaus. This study will also prepare potential sites for future clinical trials, by setting up the logistics and training staff on site to enroll a cohort of subjects perform dengue surveillance and other study procedures.

Households will be randomly selected from communities where a registry system is implemented. All individuals in the household will be eligible for participating in the study. This study will be sponsored by GSK and co-funded by GSK and Fiocruz. As study sponsor, GSK will delegate some activities to Fiocruz, according to the provisions in their Cooperative Research and Development Agreement (CRADA).

Eligibility criteria: Inclusion Criteria:

* Written, signed or thumb-printed informed consent (and assent when applicable) must be obtained from the subject or subject's parent(s)/legally acceptable representative(s) (LAR(s)). If the subject/subject's parent(s)/LAR(s) are illiterate the consent form will be countersigned by a witness.
* Male or female at least 6 months of age at the time of enrollment.
* Subject and/or subject's parent(s)/LAR(s) who the study staff believes can comply with the requirements of the protocol.
* Subject who plans, at the time of enrollment, to remain at same residence/study area during their study participation period).

Exclusion Criteria:

* Child in care.
* Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement.
* Terminal illness or severe mental incapacity.

Primary outcomes:
measure: Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year
timeFrame: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
Secondary outcomes:
measure: Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year
timeFrame: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
measure: Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
timeFrame: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
measure: Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
timeFrame: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
measure: Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
timeFrame: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
measure: Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
timeFrame: From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)
measure: Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
timeFrame: From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)
measure: Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall
timeFrame: At the first visit of the first year
measure: Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
timeFrame: At the first visit of the first year
measure: Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
timeFrame: At the first visit of the first year
measure: Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
timeFrame: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
measure: Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
timeFrame: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
measure: Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
timeFrame: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
measure: Number of Suspected Dengue Cases With Severity Criteria
timeFrame: From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)
measure: Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure
timeFrame: From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: GSK Investigational Site
state: Amazonas
city: Salvador
country: Brazil
facility: GSK Investigational Site
state: Bahía
city: Natal
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Norte
city: Campinas
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: de Aguiar DF, de Barros ENC, Ribeiro GS, Brasil P, Mourao MPG, Luz K, Aoki FH, Freitas ARR, Calvet GA, Oliveira E, Branco BF, Abreu A, Cheuvart B, Guignard A, de Boer M, Duarte AC, Borges MB, de Noronha TG. A prospective, multicentre, cohort study to assess the incidence of dengue illness in households from selected communities in Brazil (2014-2018). Int J Infect Dis. 2021 Jul;108:443-453. doi: 10.1016/j.ijid.2021.04.062. Epub 2021 Apr 21.