Dengue Effectiveness Study in the Philippines

  • STATUS
    Recruiting
  • End date
    Nov 24, 2022
  • participants needed
    380
  • sponsor
    University of the Philippines
Updated on 24 January 2021
fever
vaccination
dengue fever

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.

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 the mass immunization. The outcome of interest is hospitalized and/or severe virologically-confirmed dengue and the exposure is receipt of the dengue vaccine. Each case will be matched to two controls who were also eligible to have received the dengue vaccine and lives in the same area as the case. Cases and controls will be matched by age and sex.

Details
Condition dengue fever, Dengue, Severe Dengue, Virologically Confirmed Dengue
Clinical Study IdentifierNCT03803618
SponsorUniversity of the Philippines
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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