An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Endemic Regions of Brazil
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3,300
- 试验地点
- 6
- 主要终点
- Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year
研究概览
简要总结
The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year
时间窗: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
Incidence rate (IR) of laboratory-confirmed symptomatic dengue infection (lab-conf.) with 95% Confidence Interval (CI) for each year and overall, calculated as the incidence rate per 1000 person-years : numerator = number of all lab-conf. cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) confirmed symptomatic dengue infection or subject's withdrawal, whichever came first. Lab-conf. case defined as follows: Dengue virus identification through RT-qPCR on acute serum sample or Dengue virus NS1 positive on acute serum sample through Enzyme-linked Immunosorbent Assay (ELISA) or Anti-Dengue Immunoglobulin type M (IgM) seroconversion between acute and convalescent serum samples through ELISA. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.
次要结局
- Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year(At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years)
- Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall(At the first visit of the first year)
- Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year(At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years)
- Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases(From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject))
- Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment(At the first visit of the first year)
- Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year(At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years)
- Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year(At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years)
- Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases(From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject))
- Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender(At the first visit of the first year)
- 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(At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years)
- 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(At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years)
- Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure(From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject))
- 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(At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years)
- Number of Suspected Dengue Cases With Severity Criteria(From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject))