Dengue Effectiveness Study in the Philippines

May 16, 2023 updated by: University of the Philippines

Effectiveness of the Tetravalent Dengue Vaccine, CYD-TDV (Dengvaxia®) in the Philippines

This is an observational study that aims to determine the effectiveness of a tetravalent dengue vaccine (CYD-TDV) when given through a community-based immunization program against hospitalized and /or severe virologically confirmed dengue.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a matched case-control study. Cases will be children who are admitted with a clinical suspicion of dengue at the study hospitals and were eligible to have received the dengue vaccine during the mass immunization. The outcome of interest is hospitalized and/or severe virologically-confirmed dengue and the exposure is receipt of the dengue vaccine. Each case will be matched to two controls who were also eligible to have received the dengue vaccine and lives in the same area as the case. Cases and controls will be matched by age and sex.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2081

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Philippines
    • Cebu
      • Balamban, Cebu, Philippines
        • Cebu Provincial Hospital - Balamban
      • Bogo City, Cebu, Philippines
        • Cebu Provincial Hospital - Bogo
      • Danao, Cebu, Philippines
        • Cebu Provincial Hospital - Danao
      • Mandaue City, Cebu, Philippines
        • Eversley Childs Sanitarium and General Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals to be enrolled in the study as probable cases will be admitted patients in the hospital study sites who are residents of the area, eligible to have received the dengue vaccine at the time of the initiation of community-based dengue vaccination program, and suspected to have dengue.

Description

Inclusion Criteria:

CASE-CONTROL STUDIES

  • For a suspected case to be enrolled in the study, he/she should:

    • Provide signed informed consent and assent (as applicable)
    • Be within the age group eligible to receive the dengue vaccine at the time of mass vaccination (i.e. no condition that would have made him/her ineligible for dengue vaccination)
    • Be admitted in any of the participating hospitals for suspected dengue
    • Have ≤5 days history of fever.
    • For the case to be included in the analysis, the participant must meet all the inclusion criteria above plus have virologically-confirmed dengue infection by RT-PCR

  • For controls to be recruited into the study, he/she should:

    • Provide signed informed consent and assent (as applicable)
    • Be age and sex-matched to the case
    • Be from the same community as the matched case
    • Be eligible to have received dengue vaccine during the community-based dengue immunization campaign in 2017 (i.e. no condition that would have made him/her ineligible for dengue vaccination)
    • Have had no episode of clinically-diagnosed or laboratory-confirmed dengue fever from the start of the community -based dengue immunization campaign to the focal time (the date of onset of dengue fever in the matched case)
    • Should not have been previously recruited as a control.

Exclusion Criteria:

• Any subject whose parent/guardian refuse to provide informed consent and/or assent.

  • In addition, the following conditions automatically exclude children from the dengue mass immunization:

    • Children <9 years or adults older than 45 years of age
    • Anyone who is allergic or has had an allergic reaction to a prior dose or to any component of the dengue vaccine
    • Recipient of blood product in the last 3 months
    • Immunocompromised individuals, due to but not limited to genetic defects, HIV infection, or therapies that affect the immune system such as high-dose corticosteroids or chemotherapy
    • Recipient of any vaccine within the past month
    • History of bleeding disorder
    • Pregnant or breastfeeding women
    • Enrolled in dengue vaccine Phase 3 clinical study

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Confirmed dengue case
Dengue cases who are 9-14 years old during the dengue mass vaccination program in Cebu with <5 days history of fever, admitted in the participating hospitals with dengue virus confirmation by RT-PCR
Control
Age and sex matched neighborhood controls

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
hospitalized and / or severe virologically confirmed dengue
Time Frame: 5 years
The primary outcome are children who are hospitalized and/or severe virologically confirmed dengue
5 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the Philippines

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi Pasteur, a Sanofi Company
Research Institute for Tropical Medicine, Philippines

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacqueline L. Deen, MD, UPM - NIH, Institute of Child Health and Human Development

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPM REB 2017-0237

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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