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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Dengue Fever Arbovirus Infections Dengue Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universiti Malaya, Kuala Lumpur, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

No exclusion criteria will be applied for this study.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: 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 outcomes

Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Acronym: PRIME-Q

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Apr 29, 2024
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting