Dengue Effectiveness Study in the Philippines (NCT03803618) | Clinical Trial Compass
CompletedNot Applicable
Dengue Effectiveness Study in the Philippines
Philippines2,081 participantsStarted 2017-09-01
Plain-language 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.
Who can participate
Age range9 Years – 14 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 excl…
What they're measuring
1
hospitalized and / or severe virologically confirmed dengue