Dengue, Dengue Fever, Severe Dengue, Virologically-confirmed Dengue
Conditions
Brief summary
This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline.
Detailed description
This is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among Philippine children who are eligible to receive dengue vaccine during the DOH Mass Dengue Vaccination. Additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among Philippine children who received the Dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum IgG for the assessment of dengue seroprevalence at the population level. We will enroll children who are residents of selected areas in Region 7, Philippines. Children should be eligible to participate in the Department of Health mass dengue vaccination. They will be prospectively venipunctured for baseline dengue serologic status. The blood samples will be stored for serologic testing using neutralization tests and commercial IgG tests. Children in the cohort will be followed up, and those who present with \<5 days of fever will be identified and blood drawn for dengue LAMP and RT-PCR.
Interventions
None listed
Sponsors
Department of Health, Philippines
World Health Organization
Research Institute for Tropical Medicine, Philippines
University of North Carolina
La Jolla Institute for Allergy & Immunology
International Vaccine Institute
University of the Philippines
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Provide signed informed consent and assent (as applicable) * Be a child belonging to the specified age group and resident of the targeted communities of the DOH dengue mass immunization * Be eligible to receive dengue vaccine during the DOH dengue mass immunization in 2017
Exclusion criteria
* Any subject whose parent/guardian refuse to provide informed consent and/or assent * Children who do not belong to the specified age groups and not residents of the targeted communities * Children \<9 years old * Children with history of bleeding disorder * Any subject previously enrolled in a dengue vaccine clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| virologically-confirmed dengue (VCD) | 5 years | The primary outcome measure is virologically confirmed dengue by RT-PCR |
Outcome results
None listed