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

GSK study ID
200274
See study documents
Clinicaltrials.gov ID
NCT02570152
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2019-28-06
    Observational study model:
    Not applicable
    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:

      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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Colombo, Sri Lanka, 10620
    Status
    Study Complete
    Contact us

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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