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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dengue Fever
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Malaysia
  • Selangor
    • Serdang, Selangor, Malaysia, 43400
      • Universiti Putra Malaysia
      • Contact: Study Contact; Phone Number: +603-9769 1000; Email: zamberi@upm.edu.my
      • Principal Investigator: Zamberi Sekawi, Dr
  • Wilayah Persekutuan Kuala Lumpur
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
      • universiti malaya
      • Contact: Study Contact; Phone Number: +60379493641; Email: sfaridah@ummc.edu.my
      • Principal Investigator: Sharifah Faridah binti Syed Omar, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No Intervention; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Mosquito-Borne Diseases; Dengue
• Other Study ID Numbers: TAK-003-5001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No