Dengue Fever
Conditions
Brief summary
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.
Interventions
OTHERNo Intervention
This is a non-interventional study.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants who have received at least one dose of QDENGA vaccine in Malaysia during the study period. 2. Participants or their legally authorized representative (LARs) with a functioning phone number.
Exclusion criteria
No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | From 14 days after first vaccination up to 15 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP) | From 14 days after first vaccination up to 15 months | Number of participants who require hospitalization for severe dengue diagnosed by HCP will be reported. |
Countries
Malaysia
Contacts
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed