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This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia

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ClinicalTrials.gov Identifier: NCT02766088
Recruitment Status : Completed
First Posted : May 9, 2016
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to describe the burden of DENV illness among household members aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.

Condition or disease Intervention/treatment Phase
Dengue Procedure: Blood sample collection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 850 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Cohort Study to Assess the Burden of Dengue Illness in Household Members From Selected Communities in Southeast Asia and Latin America
Actual Study Start Date : July 14, 2016
Actual Primary Completion Date : December 14, 2018
Actual Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: Prospective
3000 subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia.
Procedure: Blood sample collection
All participants will have an enrolment visit with collection of a blood sample and a termination contact/visit. Participants or their parents/guardians will be contacted weekly or every two weeks to monitor the occurrence of febrile episodes. Additional visits will be made if febrile episodes occur. In case of dengue suspicion, a blood sample will be collected.




Primary Outcome Measures :
  1. Number of subjects with symptomatic Dengue fever virus (DENV) infection (all DENV types), as confirmed through Real time quantitative polymerase chain reaction (RTqPCR). [ Time Frame: During the study period (Months 0 through 12 and 0 through 24, depending on the study site). ]

Secondary Outcome Measures :
  1. Number of subjects with symptomatic DENV infection as confirmed by DENV type specific tests. [ Time Frame: During the study period (Months 0 through 12 and 0 through 24, depending on the study site). ]
  2. Number of subjects with virologically confirmed (by RTqPCR or non-structural protein 1 [NS1] tests) symptomatic DENV infection (based on serological evidence). [ Time Frame: During the study period (Months 0 through 12 and 0 through 24, depending on the study site). ]
  3. Number of seropositive subjects for anti-DENV Immunoglobulin G (IgG) at enrolment (indicative of past DENV infection). [ Time Frame: During the study period (Months 0 through 12 and 0 through 24, depending on the study site). ]
  4. Number of subjects with any dengue-specific symptoms, by severity. [ Time Frame: During the study period (Months 0 through 12 and 0 through 24, depending on the study site). ]


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Ages Eligible for Study:   6 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written and signed informed consent (and assent if the subject is below the legal age of consent) obtained from the subject/from subject's parent(s)/LAR(s). For a subject below the legal age of consent is, his/her signature will be obtained on the informed assent form, if applicable.
  • A male or female between, and including 6 months and 50 years of age at the time of enrolment (Subjects become ineligible on their 51st birthday).
  • Subject and/or the subject's parent(s)/LAR(s) who the investigator believes can comply with the requirements of the protocol (e.g., willingness to go to the hospital/healthcare centre for visit(s) in case of acute febrile illness, able to observe the signs of dengue and to understand how to take and report body temperature, etc).
  • Subject who plans, at the time of enrolment, to remain at same residence/study area during the one or two year study period (as applicable).
  • Household should be reachable by phone (residence phone or mobile phone). Note: Pregnant or lactating female or female planning to become pregnant can be recruited into the study.

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 or severe mental incapacity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766088


Locations
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Mexico
GSK Investigational Site
Zapopan, Jalisco, Mexico, 45170
Philippines
GSK Investigational Site
Muntinlupa, Philippines
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02766088     History of Changes
Other Study ID Numbers: 200318
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Keywords provided by GlaxoSmithKline:
Dengue
Household
Southeast Asia
Latin America
Surveillance
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral