Post-marketing Surveillance Study for the Safety of Efluelda® 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

2026-01-30

Study Completion Date

2029-03-20

Brief Summary

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To objective of this study is to investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda® in adults aged 65 years or older under routine clinical practice, as per approved indications This is an open-label, multi-center, observational active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Regulation on the Operation of Risk Management Plans".

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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Influenza Immunization Healthy Volunteers

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Efluelda® Vaccination Group

Adults aged 65 years of age or older will receive 1 dose of Efluelda® vaccination intramuscularly on Day 1

Efluelda® Pre-filled syringe

Intervention Type BIOLOGICAL

Pharmaceutical Form:

Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration

Interventions

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Efluelda® Pre-filled syringe

Pharmaceutical Form:

Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration

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® on the day of enrollment according to the approved local product label

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

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