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
1 other identifier
interventional
2,004
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2019
CompletedResults Posted
Study results publicly available
July 7, 2020
CompletedJuly 7, 2020
June 1, 2020
3.1 years
October 5, 2015
June 16, 2020
June 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group
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).
From first visit to last visit (approximatively 2 years per subject)
Secondary Outcomes (10)
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)
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)
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 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)
- +5 more secondary outcomes
Study Arms (1)
AFI Group
EXPERIMENTALPopulation living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years will be considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consent (and assent if applicable) to participate in the study.
Interventions
Blood samples will be collected during the Suspected Dengue First Visit. All study subjects with AFI (fever \[body temperature ≥ 38°C/≥ 100.4°F\] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart) should be seen at a designated study hospital/clinic by the study physician. The Suspected Dengue First Visit should be scheduled within 7 days from the onset of fever (Days 2-7) and should ideally take place on the second day of fever (Day 2).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- Ministry of Health, Sri Lankacollaborator
Study Sites (1)
GSK Investigational Site
Colombo, Sri Lanka
Related Publications (1)
Tissera H, Samaraweera P, de Boer M, Gandhi S, Malvaux L, Mehta S, Palihawadana P, Vantomme V, Paris R, Schmidt A. The Burden of Acute Febrile Illness Attributable to Dengue Virus Infection in Sri Lanka: A Single-Center 2-Year Prospective Cohort Study (2016-2019). Am J Trop Med Hyg. 2021 Nov 1;106(1):160-167. doi: 10.4269/ajtmh.21-0604.
PMID: 34724624DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
October 5, 2015
First Posted
October 7, 2015
Study Start
June 1, 2016
Primary Completion
June 28, 2019
Study Completion
June 28, 2019
Last Updated
July 7, 2020
Results First Posted
July 7, 2020
Record last verified: 2020-06