Dengue Effectiveness Study in the Philippines

NCT03803618 | Completed DMC

• 1 other identifier: UPM REB 2017-0237
• Study Type: observational
• Target: 2,081
• Locations: 1 country
• Sites: 4

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.

Conditions

Dengue; Severe Dengue; Virologically Confirmed Dengue

Outcome Measures

Primary Outcomes (1)

• hospitalized and / or severe virologically confirmed dengue

  The primary outcome are children who are hospitalized and/or severe virologically confirmed dengue

  5 years

Study Arms (2)

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

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Philippines: lead
• Sanofi Pasteur, a Sanofi Company: collaborator
• Research Institute for Tropical Medicine, Philippines: collaborator

Study Sites (4)

Cebu Provincial Hospital - Balamban

Balamban, Cebu, Philippines

Location

Cebu Provincial Hospital - Bogo

Bogo, Cebu, Philippines

Location

Cebu Provincial Hospital - Danao

Danao, Cebu, Philippines

Location

Eversley Childs Sanitarium and General Hospital

Mandaue City, Cebu, Philippines

Location

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.

MeSH Terms

Conditions

Dengue; Severe Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Jacqueline L. Deen, MD

  UPM - NIH, Institute of Child Health and Human Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: September 1, 2017
• Primary Completion: November 30, 2022
• Study Completion: April 30, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

PH (4)