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Dengue Effectiveness Study in the Philippines

CompletedN/A

Sponsor: University of the Philippines

Conditions: Dengue, Severe Dengue, Virologically Confirmed Dengue

Countries: Philippines

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.

Eligibility overview

Sex: ALL

Age: 9 Years to 14 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility 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

Locations (4)

Balamban, Cebu, Philippines
Bogo, Cebu, Philippines
Danao, Cebu, Philippines
Mandaue City, Cebu, Philippines