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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Dengue

Treatments: Procedure: Blood sample collection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02570152

200274

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,004 patients

Sex: All

Ages: 6 months to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,004 participants in 1 patient group

AFI Group

Experimental group

Description:

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.

Treatment:

Procedure: Blood sample collection