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

See if I qualify

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 Identifier	NCT03803618
Sponsor	University of the Philippines
Last Modified on	24 January 2021

How understandable was the trial content above?

Hard to understand

Easy to understand

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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

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.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

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

Learn more

Step 3 Enroll in the clinical study

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.

Learn more

Step 4 Get your study results

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

Learn more

Similar trials to consider

Browse trials for

fever

vaccination

dengue fever

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

Dengue Effectiveness Study in the Philippines