Dengue Serostatus Study in the Philippines

May 16, 2023 updated by: University of the Philippines

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

2996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children in selected study areas in Region 7, aged 9-14 years old who are considered eligible to be included in the DOH dengue mass vaccination

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort
Recruited members of the cohort are children aged 9-14 years old and eligible to receive the dengue vaccine at the time of the initiation of community-based dengue immunization program of the Department of Health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
virologically-confirmed dengue (VCD)
Time Frame: 5 years
The primary outcome measure is virologically confirmed dengue by RT-PCR
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Philippines

Collaborators

World Health Organization
University of North Carolina
International Vaccine Institute
Department of Health, Philippines
Research Institute for Tropical Medicine, Philippines
La Jolla Institute for Allergy & Immunology

Investigators

  • Principal Investigator: Jacqueline L. Deen, MD, UPM-NIH, Institute of Child Health and Human Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

October 31, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPM REB 2016-435-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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