An observational study in Dengue Fever, sponsored by Takeda. Active, not recruiting at 2 sites in Malaysia. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Takeda · Observational
The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever.
No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate.
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 595 across 78 observational studies indexed under Dengue.
Browse Dengue studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who have received the QDENGA vaccine in Malaysia and provided informed consent to participate in the active surveillance and data collection will be included in the study.
Exclusion Criteria:
No exclusion criteria will be applied for this study.
Participants who have received QDENGA vaccine will be prospectively surveyed and regularly contacted to obtain data for up to 15 months post-vaccination.
Other: No Intervention
This is a non-interventional study.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant administered a studied drug and which does not necessarily have to have a causal relationship with the vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a studied drug, whether or not the event is considered causally related to the use of the product. An SAE is any untoward medical occurrence that at any dose: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Time frame: From 14 days after first vaccination up to 15 months
Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP)
Number of participants who require hospitalization for severe dengue diagnosed by HCP will be reported.
Time frame: From 14 days after first vaccination up to 15 months
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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