Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-10-01

Study Completion Date

2028-01-31

Brief Summary

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To investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda Tetra in adults aged 65 years or older under routine clinical practice, as per approved indications.

The study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.

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Detailed Description

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Conditions

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Immunization Influenza (Healthy Volunteers)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Efluelda group

A single dose of 0.7 mL is administered as approved by MFDS.

Efluelda Tetra Pre-filled syringe

Intervention Type BIOLOGICAL

Suspension for injection in a pre-filled syringe

Interventions

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Efluelda Tetra Pre-filled syringe

Suspension for injection in a pre-filled syringe

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged 65 years or older on the day of enrollment
* The informed consent form has been signed and dated
* Receipt of 1 dose of Efluelda Tetra on the day of enrollment according to the approved local product label

Exclusion Criteria

* Previous history of enrollment in this study
* Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes