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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by GlaxoSmithKline
Sponsor:
Collaborators:
Instituto de Pesquisa Evandro Chagas
Bio-Manguinhos, Fiocruz, Brazil
Fundaao de Medicina Tropical
Centro de Pesquisas Goncalo Moniz - CPqGM
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01751139
First received: December 13, 2012
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Dengue
Procedure: Blood sample collection
Other: Data collection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Endemic Regions of Brazil

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To estimate the incidence of laboratory-confirmed symptomatic dengue infection (all DENV types) [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To estimate the incidence of DENV-type specific laboratory-confirmed and probable symptomatic dengue infection by study site, gender, age-group, and previous dengue exposure (primary or secondary) [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]
  • To estimate the prevalence of previous dengue infection(s) (dengue seroprevalence) at baseline [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]
  • To estimate the incidence of primary inapparent dengue infection [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]
  • To estimate the severity of symptoms of symptomatic dengue (using the 2009 WHO guidelines) [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study cohort
Subjects 6 months of age and older who live in the selected study sites in Brazil.
Procedure: Blood sample collection
Blood samples will be collected at each of the three scheduled study visits (Day 0, Month 6 and Month 12) and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue infection diagnosis.
Other: Data collection
Diary logs will be issued to all subjects at Day 0 and Month 6, as required. Any completed diary logs will be verified, as applicable. Subjects will be given a diary log in the event of the occurrence of a symptom that may be associated with suspected dengue.

Detailed 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).

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 investigator 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 the one 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 or severe mental incapacity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751139

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Brazil
GSK Investigational Site Recruiting
Manaus, Amazonas, Brazil, 69040000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Rio de Janeiro, Brazil, 21040-900
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Instituto de Pesquisa Evandro Chagas
Bio-Manguinhos, Fiocruz, Brazil
Fundaao de Medicina Tropical
Centro de Pesquisas Goncalo Moniz - CPqGM
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01751139     History of Changes
Other Study ID Numbers: 116606
Study First Received: December 13, 2012
Last Updated: August 7, 2014
Health Authority: Brazil: CONEP - National Committee for Research Ethics

Keywords provided by GlaxoSmithKline:
Endemic regions
Brazil
Incidence
Surveillance
Dengue

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on August 18, 2014