A Cohort Study to Assess the Burden of Dengue Illness in Household Members From Selected Communities in Southeast Asia and Latin America
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1,750
- Locations
- 3
- Primary Endpoint
- Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Total Group
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches might be considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
Intervention: Blood sample collection (Procedure)
Outcomes
Primary Outcomes
Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site
Time Frame: From Day 0 to Month 24 (study end)
Incidence percentage of RT-qPCR confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period \]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.
Secondary Outcomes
- Incidence Percentage of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in the Philippines.(From Day 0 to Month 24 (study end))
- Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits(From Day 0 to Month 24 (study end))
- Number of Suspected Dengue Cases With Severity Criteria Characteristics(From Day 0 to Month 24 (study end))
- Incidence Proportion of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in Mexico(From Day 0 to Month 24 (study end))
- 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.(At Day 0)
- Number of Subjects With DENV-type Specific Confirmed Symptomatic DENV Infection(From Day 0 to Month 24 (study end))
- Incidence Proportion of Probable Symptomatic Dengue Infection During the Study Period.(From Day 0 to Month 24 (study end))
- 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.(At Day 0)
- Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure(From Day 0 to Month 24 (study end))