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NCT03465254 Clinical Trial

Dengue Serostatus Study in the Philippines

Dengue Clinical Trial

Official title:
Effect of Baseline Dengue Serostatus Among Tetravalent Dengue Vaccine CYDTDV (Dengvaxia®) Recipients on Subsequent Virologically Confirmed Dengue in the Philippines

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03465254
Other study ID # UPM REB 2016-435-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 2016
Est. completion date June 2023

Study information
Verified date May 2023
Source University of the Philippines
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2996
Est. completion date June 2023
Est. primary completion date October 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 14 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (7)
Lead Sponsor Collaborator
University of the Philippines Department of Health, Philippines, International Vaccine Institute, La Jolla Institute for Allergy & Immunology, Research Institute for Tropical Medicine, Philippines, University of North Carolina, World Health Organization

Outcome
Type Measure Description Time frame Safety issue
Primary virologically-confirmed dengue (VCD) The primary outcome measure is virologically confirmed dengue by RT-PCR 5 years
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