A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia

Dengue Fever Clinical Trial

— PRIME-Q  

Official title:

Post-vaccination Surveillance for Monitoring the Adverse Events Following Immunisation With QDENGA in a Real-world Setting in Malaysia (PRIME-Q)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388785
• Other study ID #: TAK-003-5001
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: May 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dengue
• Dengue Fever

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations

Country	Name	City	State
Malaysia	Universiti Malaya	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	Universiti Putra Malaysia	Serdang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From 14 days after first vaccination up to 15 months

External Links

•   To obtain more information about this study, click this link