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)

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)

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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