Dengue Serostatus Study in the Philippines

Active, not recruiting

• Conditions: Dengue Fever; Dengue; Virologically-confirmed Dengue; Severe Dengue

• Registration Number: NCT03465254
• Lead Sponsor: University of the Philippines

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Primary Completion: 2022-10-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-17
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2996

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
virologically-confirmed dengue (VCD)	5 years	The primary outcome measure is virologically confirmed dengue by RT-PCR