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

Recruiting

• Conditions: Dengue Fever
• Interventions: Other: No Intervention

• Registration Number: NCT06388785
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-29
• Study Start: 2024-09-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2027-05-08
• Study Completion: 2027-05-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

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Exclusion Criteria

No exclusion criteria will be applied for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
QDENGA Vaccinated	No Intervention	Participants who have received QDENGA vaccine will be prospectively surveyed and regularly contacted to obtain data for up to 15 months post-vaccination.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	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 Outcome Measures

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

Trial Locations

Locations (2)

Universiti Putra Malaysia; 🇲🇾 Serdang, Selangor, Malaysia

Universiti Malaya; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia