Clinical trial NCT02766088: 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
Official title: A Cohort Study to Assess the Burden of Dengue Illness in Household Members From Selected Communities in Southeast Asia and Latin America
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dengue
Dengue Vaccines
Keywords: Dengue
Household
Southeast Asia
Latin America
Surveillance
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-05-09
Enrollment: 1750
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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).
* 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.

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.

Primary outcomes:
measure: Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site
timeFrame: From Day 0 to Month 24 (study end)
Secondary outcomes:
measure: Number of Subjects With DENV-type Specific Confirmed Symptomatic DENV Infection
timeFrame: From Day 0 to Month 24 (study end)
measure: Incidence Proportion of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in Mexico
timeFrame: From Day 0 to Month 24 (study end)
measure: Incidence Percentage of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in the Philippines.
timeFrame: From Day 0 to Month 24 (study end)
measure: Incidence Proportion of Probable Symptomatic Dengue Infection During the Study Period.
timeFrame: From Day 0 to Month 24 (study end)
measure: Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
timeFrame: At Day 0
measure: Percentage of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
timeFrame: At Day 0
measure: Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
timeFrame: From Day 0 to Month 24 (study end)
measure: Number of Suspected Dengue Cases With Severity Criteria Characteristics
timeFrame: From Day 0 to Month 24 (study end)
measure: Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure
timeFrame: From Day 0 to Month 24 (study end)
Other outcomes:
Locations:
city: Zapopan
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: DeAntonio R, Amaya-Tapia G, Ibarra-Nieto G, Huerta G, Damaso S, Guignard A, de Boer M. 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.
citation: 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 Oct 29;15(5):213-222. doi: 10.2478/abm-2021-0027. eCollection 2021 Oct.