Last updated: 07/17/2024 17:00:06
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: A cohort study to assess the burden of dengue illness in household members from selected communities in Southeast Asia and Latin America
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects with symptomatic Dengue fever virus (DENV) infection (all DENV types), as confirmed through Real time quantitative polymerase chain reaction (RTqPCR).
Timeframe: During the study period (Months 0 through 12 and 0 through 24, depending on the study site).
Secondary outcomes:
Number of subjects with symptomatic DENV infection as confirmed by DENV type specific tests.
Timeframe: During the study period (Months 0 through 12 and 0 through 24, depending on the study site).
Number of subjects with virologically confirmed (by RTqPCR or non-structural protein 1 [NS1] tests) symptomatic DENV infection (based on serological evidence).
Timeframe: During the study period (Months 0 through 12 and 0 through 24, depending on the study site).
Number of seropositive subjects for anti-DENV Immunoglobulin G (IgG) at enrolment (indicative of past DENV infection).
Timeframe: During the study period (Months 0 through 12 and 0 through 24, depending on the study site).
Number of subjects with any dengue-specific symptoms, by severity.
Timeframe: During the study period (Months 0 through 12 and 0 through 24, depending on the study site).
Interventions:
Enrollment:
1750
Primary completion date:
2018-14-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Rodrigo DeAntonio, Gerardo Amaya-Tapia, Gabriela Ibarra-Nieto, Gloria Huerta, Silvia Damaso, Adrienne Guignard, Melanie de Boer. et al. Incidence of dengue illness in Mexican people aged 6 months to 50 years old: A prospective cohort study conducted in Jalisco. PLoS One. 2021 May 5;16(5):e0250253. doi: 10.1371/journal. pone.0250253. eCollection 2021.
Capeding MR, de Boer M, Damaso S, Guignard A. Assessing the burden of dengue among household members in Alaminos, Laguna, the Philippines: a prospective cohort study. Asian Biomed (Res Rev News). 2021;15(5):213-222. DOI: http://dx.doi.org/ 10.2478/abm-2021-0027
Medical condition
Dengue
Product
SB763310
Collaborators
Not applicable
Study date(s)
July 2016 to December 2018
Type
Interventional
Phase
n/a
Participation criteria
Sex
Female & Male
Age
6 months - 50 years
Accepts healthy volunteers
Yes
- 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).
- 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:
- 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.
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.
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)
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
Other
Actual primary completion date
2018-14-12
Actual study completion date
2018-14-12
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website