Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 76 of 97 for:    "Dengue Hemorrhagic Fever"

Dengue Effectiveness Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03803618
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 23, 2019
Sponsor:
Collaborators:
Sanofi Pasteur (funding agency)
Research Institute of Tropical Medicine
Information provided by (Responsible Party):
University of the Philippines

Brief Summary:
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.

Condition or disease
Dengue Severe Dengue Virologically Confirmed Dengue

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effectiveness of the Tetravalent Dengue Vaccine, CYD-TDV (Dengvaxia®) in the Philippines
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Group/Cohort
Case
Control



Primary Outcome Measures :
  1. hospitalized and/or severe virologically confirmed dengue [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Any leftover sera will be used for future studies and stored at UPM-NIH for fifteen (15) years after the end of this study. Future studies using the sera will undergo appropriate ethical reviews as required. After this period, specimens will be destroyed according to local guidelines. Additional consent will be obtained from the parent for storage and future use of these samples. Only the Principal Investigator and designated study personnel will have access to these specimens.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803618


Contacts
Layout table for location contacts
Contact: Michelle C. Ylade, MD, MSc 6322545205 mcylade@up.edu.ph
Contact: Kristal An C. Agrupis, MD 6322545205 agrupiskristalan@gmail.com

Locations
Layout table for location information
Philippines
Cebu Provincial Hospital - Balamban Recruiting
Balamban, Cebu, Philippines
Contact: Leidenia I. Castro, MD         
Cebu Provincial Hospital - Bogo Recruiting
Bogo City, Cebu, Philippines
Contact: Leidenia I. Castro, MD         
Cebu Provincial Hospital - Danao Recruiting
Danao, Cebu, Philippines
Contact: Leidenia I. Castro         
Eversley Childs Sanitarium and General Hospital Recruiting
Mandaue City, Cebu, Philippines
Contact: Leidenia I. Castro, MD         
Sponsors and Collaborators
University of the Philippines
Sanofi Pasteur (funding agency)
Research Institute of Tropical Medicine
Investigators
Layout table for investigator information
Principal Investigator: Anna Lena L. Lopez, MD UP- National Institutes of Health, Institute of Child Health and Human Development

Layout table for additonal information
Responsible Party: University of the Philippines
ClinicalTrials.gov Identifier: NCT03803618     History of Changes
Other Study ID Numbers: UPM REB 2017-0237
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Dengue
Severe Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral