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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

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ClinicalTrials.gov Identifier: NCT02570152
Recruitment Status : Recruiting
First Posted : October 7, 2015
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
Ministry of Health, Sri Lanka
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE October 5, 2015
First Posted Date  ICMJE October 7, 2015
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE June 1, 2016
Estimated Primary Completion Date July 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Occurrence of Acute febrile illness (AFI) due to Laboratory Confirmed Dengue (LCD). [ Time Frame: At Month 24 (from Visit 1 to Visit 2) ]
An AFI due to LCD was confirmed if all of the following criteria were met: • Fever (body temperature ≥ 38°C/≥ 100.4°F) recorded or reported on ≥ 2 consecutive calendar days, measured at least twice, at least 812 hours apart, • Laboratory confirmation of dengue through dengue RT-qPCR on the acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) • Dengue RT-qPCR result on the acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) is valid and for dengue.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02570152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • Occurrence of AFI due to non-LCD. [ Time Frame: At Month 24 (from Visit 1 to Visit 2) ]
    An AFI due to non-LCD was confirmed if all of the following criteria were met: • Fever (body temperature ≥ 38°C/≥ 100.4°F) recorded or reported on ≥ 2 consecutive calendar days, measured at least twice, at least 812 hours apart, and • Dengue RT-qPCR result on the acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) is (valid but) negative for dengue.
  • Occurrence of AFI due to LCD by DENV type, study site, and age group. [ Time Frame: At Month 24 (from Visit 1 to Visit 2) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Dengue
Intervention  ICMJE Procedure: Blood sample collection
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).
Study Arms  ICMJE Experimental: AFI Group
Population 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.
Intervention: Procedure: Blood sample collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2017)
2000
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2015)
5000
Estimated Study Completion Date  ICMJE July 29, 2019
Estimated Primary Completion Date July 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Listed Location Countries  ICMJE India,   Sri Lanka
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02570152
Other Study ID Numbers  ICMJE 200274
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Ministry of Health, Sri Lanka
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP