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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-14

Study Completion Date

2018-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Dengue Dengue Vaccines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Total Group

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.

Group Type EXPERIMENTAL

Blood sample collection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes