Monitoring adverse events of the QDENGA vaccine in Malaysia
Post-vaccination Surveillance for Monitoring the Adverse Events Following Immunisation With QDENGA in a Real-world Setting in Malaysia (PRIME-Q)
This study is looking to see what health issues people in Malaysia experience after getting the QDENGA vaccine for dengue fever.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 2 sites (Kuala Lumpur, Kuala Lumpur and 1 other locations) |
| Trial ID | NCT06388785 on ClinicalTrials.gov |
What this trial studies
This study aims to collect data on the adverse events experienced by individuals who have received the QDENGA vaccine for dengue fever in Malaysia. It will focus on identifying the types and frequency of medical problems following vaccination, as well as the number of vaccinated individuals who require hospitalization due to severe dengue fever. The study is observational and does not involve administering any vaccines, as it relies on data from participants who have already been vaccinated. Participants will be asked to provide information about their health status post-vaccination.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have received at least one dose of the QDENGA vaccine in Malaysia.
Not a fit: Patients who have not been vaccinated with the QDENGA vaccine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the safety profile of the QDENGA vaccine and improve patient care for those vaccinated.
How similar studies have performed: While this study is observational and focuses on monitoring adverse events, similar studies on vaccine safety have shown success in providing valuable data for improving vaccine protocols.
Eligibility criteria
Show full inclusion / exclusion criteria
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 exclusion criteria will be applied for this study.
Where this trial is running
Kuala Lumpur, Kuala Lumpur and 1 other locations
- Universiti Malaya — Kuala Lumpur, Kuala Lumpur, Malaysia (Recruiting)
- Universiti Putra Malaysia — Serdang, Selangor, Malaysia (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.