A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia
PRIME-Q
Post-vaccination Surveillance for Monitoring the Adverse Events Following Immunisation With QDENGA in a Real-world Setting in Malaysia (PRIME-Q)
1 other identifier
observational
2,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2024
CompletedFirst Posted
Study publicly available on registry
April 29, 2024
CompletedStudy Start
First participant enrolled
September 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 8, 2027
June 12, 2025
June 1, 2025
2.6 years
April 25, 2024
June 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From 14 days after first vaccination up to 15 months
Secondary Outcomes (1)
Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP)
From 14 days after first vaccination up to 15 months
Study Arms (1)
QDENGA Vaccinated
Participants who have received QDENGA vaccine will be prospectively surveyed and regularly contacted to obtain data for up to 15 months post-vaccination.
Interventions
Eligibility Criteria
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.
You may qualify if:
- Participants who have received at least one dose of QDENGA vaccine in Malaysia during the study period.
- Participants or their legally authorized representative (LARs) with a functioning phone number.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (2)
Universiti Malaya
Kuala Lumpur, Kuala Lumpur, 50603, Malaysia
Universiti Putra Malaysia
Serdang, Selangor, 43400, Malaysia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2024
First Posted
April 29, 2024
Study Start
September 26, 2024
Primary Completion (Estimated)
May 8, 2027
Study Completion (Estimated)
May 8, 2027
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.