Post-market safety check of Efluelda in older adults after a flu vaccination

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multi-center observational study conducted in Korea to monitor adverse events and adverse drug reactions following Efluelda administration in adults 65 years and older under real-world conditions. Participants receive one dose and are followed for about 28 to 35 days, with a possible extension if a study visit is missed. The trial uses standard healthcare settings and follows local risk management regulations. Data collected reflect safety in routine use rather than experimental conditions. No efficacy outcomes are the primary focus.

Why it matters

Who can join: the full rules

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

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it's running

• Kintex Dream Internal Medicine Clinic
  Goyang-si, Gyeonggi-do, South Korea Recruiting
• Kim's gutease internal medicine
  Gunpo, Gyeonggi-do, South Korea Recruiting
• House ENT clinic
  Busan, South Korea Recruiting
• Yoon Jae Woong Neurosurgery Clinic
  Busan, South Korea Recruiting
• Centum Family Medicine Clinic
  Busan, South Korea Recruiting
• Dr. Jang's Family Medicine Clinic
  Daegu, South Korea Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.