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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Terminated

Conditions

Dengue
Dengue Vaccines

Treatments

Procedure: Blood sample collection

Study type

Interventional

Funder types

Industry

Identifiers

NCT02766088
200318

Details and patient eligibility

About

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.

Enrollment

1,750 patients

Sex

All

Ages

6 months to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,750 participants in 1 patient group

Total Group
Experimental group
Description:
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches might be considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
Treatment:
Procedure: Blood sample collection

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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