An observational study in Dengue, Severe Dengue and Virologically Confirmed Dengue, sponsored by University of the Philippines. Completed at 4 sites in Philippines. Open to participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by University of the Philippines · Observational
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.
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.
65 studies on the registry are indexed under Severe Dengue; 5 are open to participants now.
This study's enrollment of 2,081 is above the median of 667 across 13 observational studies indexed under Severe Dengue.
Browse Severe Dengue studies →University of the Philippines is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Compared within Severe Dengue, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dengue. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
In addition, the following conditions automatically exclude children from the dengue mass immunization:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Age and sex matched neighborhood controls
hospitalized and / or severe virologically confirmed dengue
The primary outcome are children who are hospitalized and/or severe virologically confirmed dengue
Time frame: 5 years
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of the Philippines