An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil

GlaxoSmithKline (GSK)

Status: Terminated

Conditions: Dengue

Treatments: Procedure: Blood sample collection; Other: Data collection

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01751139

116606

Details and patient eligibility

About

The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.

Full description

The aim of this study is to generate dengue disease burden data including estimates of incidence rates, prevalence data and the clinical presentation of dengue across different age groups.

The study will be conducted in at least three cities: Rio de Janeiro, Salvador, and Manaus. This study will also prepare potential sites for future clinical trials, by setting up the logistics and training staff on site to enroll a cohort of subjects perform dengue surveillance and other study procedures.

Households will be randomly selected from communities where a registry system is implemented. All individuals in the household will be eligible for participating in the study. This study will be sponsored by GSK and co-funded by GSK and Fiocruz. As study sponsor, GSK will delegate some activities to Fiocruz, according to the provisions in their Cooperative Research and Development Agreement (CRADA).

Enrollment: 3,300 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written, signed or thumb-printed informed consent (and assent when applicable) must be obtained from the subject or subject's parent(s)/legally acceptable representative(s) (LAR(s)). If the subject/subject's parent(s)/LAR(s) are illiterate the consent form will be countersigned by a witness.
• Male or female at least 6 months of age at the time of enrollment.
• Subject and/or subject's parent(s)/LAR(s) who the study staff believes can comply with the requirements of the protocol.
• Subject who plans, at the time of enrollment, to remain at same residence/study area during their study participation 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 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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3,300 participants in 1 patient group

Total Group

Other group

Description:

Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.

Treatment:

Procedure: Blood sample collection

Other: Data collection