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Trial record 79 of 97 for:    "Dengue Hemorrhagic Fever"

Dengue Serostatus Study

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ClinicalTrials.gov Identifier: NCT03465254
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
Department of Health, Philippines
World Health Organization
Research Institute of Tropical Medicine
Information provided by (Responsible Party):
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.

Condition or disease
Dengue Severe Dengue Dengue Fever Virologically-confirmed Dengue

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.

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Study Type : Observational
Actual Enrollment : 2996 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Baseline Dengue Serostatus Among Tetravalent Dengue Vaccine CYDTDV (Dengvaxia®) Recipients on Subsequent Virologically Confirmed Dengue in the Philippines
Actual Study Start Date : November 2016
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

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.



Primary Outcome Measures :
  1. virologically-confirmed dengue (VCD) [ 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

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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
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
Criteria

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

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): NCT03465254


Sponsors and Collaborators
University of the Philippines
Department of Health, Philippines
World Health Organization
Research Institute of Tropical Medicine
Investigators
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Principal Investigator: Anna Lena L. Lopez, MD University of the Philippines-Manila, National Institutes of Health, Institute of Child Health and Human Development

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Responsible Party: University of the Philippines
ClinicalTrials.gov Identifier: NCT03465254     History of Changes
Other Study ID Numbers: UPM REB 2016-435-01
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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