Status:
COMPLETED
Dengue Effectiveness Study in the Philippines
Lead Sponsor:
University of the Philippines
Collaborating Sponsors:
Sanofi Pasteur, a Sanofi Company
Research Institute for Tropical Medicine, Philippines
Conditions:
Dengue
Severe Dengue
Eligibility:
All Genders
9-14 years
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...
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 th...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
2081 Patients enrolled
Trial Details
Trial ID
NCT03803618
Start Date
September 1 2017
End Date
April 30 2023
Last Update
May 17 2023
Active Locations (4)
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1
Cebu Provincial Hospital - Balamban
Balamban, Cebu, Philippines
2
Cebu Provincial Hospital - Bogo
Bogo, Cebu, Philippines
3
Cebu Provincial Hospital - Danao
Danao, Cebu, Philippines
4
Eversley Childs Sanitarium and General Hospital
Mandaue City, Cebu, Philippines