Last updated: 07/13/2021 06:30:08
An epidemiological surveillance study to evaluate the incidence of dengue in Brazil
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: An epidemiological surveillance study to evaluate the incidence of dengue in endemic regions of Brazil
Trial description: The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
To estimate the incidence of laboratory-confirmed symptomatic dengue infection (all DENV types)
Timeframe: At the end of every year/season
Secondary outcomes:
To estimate the incidence of DENV-type specific primary laboratory-confirmed symptomatic dengue infection
Timeframe: Every year/season
To estimate the incidence of DENV-type specific secondary laboratory-confirmed symptomatic dengue infection
Timeframe: Every year/season
To estimate the incidence of primary symptomatic dengue infection (including laboratory-confirmed and probable cases)
Timeframe: Every year/season
To estimate the incidence of secondary symptomatic dengue infection (including laboratory-confirmed and probable cases)
Timeframe: Every year/season
To estimate the prevalence of previous dengue infection(s) (dengue seroprevalence) at baseline
Timeframe: 4 years (Day 0 – Month 48)
To estimate the incidence of primary inapparent dengue infection
Timeframe: Every year/season
To estimate the severity of symptoms of symptomatic dengue (using the 2009 WHO guidelines)
Timeframe: 4 years (Day 0 – Month 48)
Interventions:
Procedure/surgery: Blood sample collection
Other: Data collection
Enrollment:
3300
Observational study model:
Not applicable
Primary completion date:
2018-20-12
Time perspective:
Not applicable
Clinical publications:
de Aguiar DF, de Barros EN, Ribeiro GS, Brasil P, Mourao MPG, Luz K, Aoki FH, Freitas ARR, Calvet GA, Oliveira E, Branco BF, Abreu A, Cheuvart B, Guignard A, de Boer M, Duarte AC, Borges MB, de Noronha TG. A prospective, multicentre, cohort study to assess the incidence of dengue illness in households from selected communities in Brazil (2014−2018). Int J Infect Dis. 108:443-453. doi: 10.1016/j.ijid.2021.04.062.
Medical condition
Dengue
Product
SB763310
Collaborators
Foundation of Tropical Medicine, Goncalo Moniz research center, Evandro Chagas Research Institute, Bio-Manguinhos Technology and Immunology Institute
Study date(s)
February 2014 to December 2018
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6+ years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
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.
Exclusion criteria:
- 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.
Child in care.
Trial location(s)
Location
GSK Investigational Site
Natal, Rio Grande do Norte, Brazil, 59025-050
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 21040-900
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2018-20-12
Actual study completion date
2018-20-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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