DengueNCT03803618
Dengue Effectiveness Study in the Philippines
An observational study of Dengue and Severe Dengue, run by University of the Philippines at 4 sites in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue, Severe Dengue, Virologically Confirmed Dengue
- Type of treatment
- Vaccines
- How many people
- 2,081 participants
- Where
- 4 sitesPhilippines
- Study dates
- 1 Sep 2017to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Individuals to be enrolled in the study as probable cases will be admitted patients in the hospital study sites who are residents of the area, eligible to have received the dengue vaccine at the time of the initiation of community-based dengue vaccination program, and suspected to have dengue.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- Recipient of any vaccine within the past month
- History of bleeding disorder
- Pregnant or breastfeeding women
- Enrolled in dengue vaccine Phase 3 clinical study
Trial locations and contacts
4 sites in 1 country.
Philippines4 sites
Cebu Provincial Hospital - Balamban
Balamban, Cebu
Cebu Provincial Hospital - Bogo
Bogo, Cebu
Cebu Provincial Hospital - Danao
Danao, Cebu
Eversley Childs Sanitarium and General Hospital
Mandaue City, Cebu
About this study
Official title: Effectiveness of the Tetravalent Dengue Vaccine, CYD-TDV (Dengvaxia®) in the 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.
Read the 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 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.
- Conditions
- Dengue, Severe Dengue, Virologically Confirmed Dengue
- Medical subject headings
- Dengue, Severe Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed dengue case | Dengue cases who are 9-14 years old during the dengue mass vaccination program in Cebu with <5 days history of fever, admitted in the participating hospitals with dengue virus confirmation by RT-PCR | |
| Control | Age and sex matched neighborhood controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospitalized and / or severe virologically confirmed dengue
The primary outcome are children who are hospitalized and/or severe virologically confirmed dengue
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Sep 2017
- Primary completion30 Nov 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company, Research Institute for Tropical Medicine, Philippines
- Responsible party
- Sponsor
- Investigators
- Jacqueline L. Deen, MD, Principal investigator, UPM - NIH, Institute of Child Health and Human Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803618
- Sponsor's protocol ID
- UPM REB 2017-0237
- Status last verified
- May 2023
- First submitted
- 10 Jan 2019
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Tetravalent Dengue Vaccine, CYD-TDV (Dengvaxia®) in the Philippines
- ClinicalTrials.gov ID
- NCT03803618
- Acronym / sponsor ID
- UPM REB 2017-0237
- Conditions
- Dengue, Severe Dengue, Virologically Confirmed Dengue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,081 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company, Research Institute for Tropical Medicine, Philippines
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confirmed dengue case | – | –Dengue cases who are 9-14 years old during the dengue mass vaccination program in Cebu with <5 days history of fever, admitted in the participating hospitals with dengue virus confirmation by RT-PCR |
| Control | – | –Age and sex matched neighborhood controls |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Individuals to be enrolled in the study as probable cases will be admitted patients in the hospital study sites who are residents of the area, eligible to have received the dengue vaccine at the time of the initiation of community-based dengue vaccination program, and suspected to have dengue.
Key inclusion criteria (14 listed)
- CASE-CONTROL STUDIES
- For a suspected case to be enrolled in the study, he/she should:
- For controls to be recruited into the study, he/she should:
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hospitalized and / or severe virologically confirmed dengue
Time frame: 5 years
The primary outcome are children who are hospitalized and/or severe virologically confirmed dengue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline L. Deen, MD principal investigator
UPM - NIH, Institute of Child Health and Human Development
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue and Severe Dengue, run by University of the Philippines at 4 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospitalized and / or severe virologically confirmed dengue (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.