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.
Study Type
OBSERVATIONAL
Enrollment
2,000
This is a non-interventional study.
Universiti Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia
RECRUITINGUniversiti Putra Malaysia
Serdang, Selangor, Malaysia
RECRUITINGNumber 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
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