Last updated: 01/05/2022 09:30:07
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Occurrence of Acute febrile illness (AFI) due to Laboratory Confirmed Dengue (LCD).
Timeframe: At Month 24 (from Visit 1 to Visit 2)
Secondary outcomes:
Occurrence of AFI due to non-LCD.
Timeframe: At Month 24 (from Visit 1 to Visit 2)
Occurrence of AFI due to LCD by DENV type, study site, and age group.
Timeframe: At Month 24 (from Visit 1 to Visit 2)
Interventions:
Procedure/surgery: Blood sample collection
Enrollment:
2004
Observational study model:
Not applicable
Primary completion date:
2019-28-06
Time perspective:
Not applicable
Clinical publications:
Tissera H, Samaraweera P, de Boer M, Gandhi S, Malvaux L, Mehta S, Palihawadana P, Vantomme V, Paris R, Schmidt A. CLI_DPIV-021_The Burden of Acute Febrile Dengue Illness attributable to Dengue Virus Infection in Sri Lanka: A Single-Center 2-Year Prospective Cohort Study (2016–2019)_(JXT). Am J Trop Med Hyg. 2021;
DOI: http://dx.doi.org/ doi:10.4269/ajtmh.21-0604
Medical condition
Dengue
Product
GSK2863178A
Collaborators
Ministry of Health, Sri Lanka
Study date(s)
June 2016 to June 2019
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6 months - 50 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.).
Exclusion criteria:
- 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.
Child in care.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2019-28-06
Actual study completion date
2019-28-06
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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Access to clinical trial data by researchers
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