A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dengue
- Sponsor
- GlaxoSmithKline
- Enrollment
- 2004
- Locations
- 1
- Primary Endpoint
- Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.
Detailed Description
This study aims to estimate the burden of dengue illness in selected sites South Asia and to prepare sites for the conduct of future vaccine efficacy trials. Operational goals include: * Build long-term collaboration with sites in dengue-endemic regions of South Asia where the incidence of clinical dengue illness can be studied. * Establish dengue surveillance cohorts that can be followed long-term. * Establish operational feasibility of future Phase III studies with regard to recruitment, case capture and sampling procedures. * Prepare sites for participation in Phase III clinical endpoint studies.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject and/or subject's parent(s)/legally acceptable representative(s) (LAR\[s\]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit\[s\] in case of AFI, able to observe the signs of dengue and to understand how to take and report body temperature, etc.).
- •Signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/LAR(s) at the hospital/clinic or during a home visit. If the subject/subject's parent(s)/LAR(s) are illiterate, the informed consent form (ICF) (or informed assent form \[IAF\] when applicable) will be countersigned by an impartial witness.
- •Subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child.
- •Male or female aged between and including 6 months and 50 years at the time of enrolment.
- •Subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study 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 based on investigator's judgement.
- •Mental incapacity based on investigator's judgement.
Outcomes
Primary Outcomes
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group
Time Frame: From first visit to last visit (approximatively 2 years per subject)
The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD) OR date of last contact OR date of death. An AFI due to LCD was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°Celsius \[C\]/≥ 100.4°Farhenheit \[F\] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue through dengue Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F).
Secondary Outcomes
- Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group.(From first visit to last visit (approximatively 2 years per subject))
- Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD(At each day during the 7-day period following the onset of each episode of AFI due to LCD)
- Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD(At each day during the 7-day period following the onset of each episode of AFI due to non-LCD)
- Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD(At each day during the 7-day period following the onset of each episode of AFI due to non-LCD)
- Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure(From first visit to last visit (approximatively 2 years per subject))
- Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group(From first visit to last visit (approximatively 2 years per subject))
- Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group(From first visit to last visit (approximatively 2 years per subject))
- Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group(From first visit to last visit (approximatively 2 years per subject))
- Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group(From first visit to last visit (approximatively 2 years per subject))
- Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD.(At each day during the 7-day period following the onset of each episode of AFI due to LCD)