A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia (PRIME-Q)

Takeda

Status: Enrolling

Conditions: Dengue Fever

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06388785

TAK-003-5001

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10,000 participants in 1 patient group

QDENGA Vaccinated

Description:

Participants who have received QDENGA vaccine will be prospectively surveyed and regularly contacted to obtain data for up to 15 months post-vaccination.

Treatment:

Other: No Intervention