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

NCT07282795 — Recruiting, 670 participants, Sanofi

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Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe, a High-dose Trivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea

Registry	NCT07282795
Status	Recruiting
Study type	Observational
Enrollment	670 (Estimated)
Sponsor	Sanofi (Industry)
Conditions	Influenza Immunization, Healthy Volunteers
Interventions	Efluelda® Pre-filled syringe (Biological)
Dates	start 2026-09-17, primary completion 2029-02-22 (estimated), completion 2029-03-20 (estimated), first posted 2025-12-15, last updated 2026-10-20
Locations	15 sites in South Korea

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Efluelda® Vaccination Group		Biological: Efluelda® Pre-filled syringe	Adults aged 65 years of age or older will receive 1 dose of Efluelda® vaccination intramuscularly on Day 1

Efluelda® Pre-filled syringe (Biological): Pharmaceutical Form: Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration

+Outcome measures

Primary outcomes

Occurrence of solicited injected site reactions. [Up to 7 days after vaccination]: Number of participants experiencing solicited injection site reactions
Occurrence of solicited systemic reactions [Up to 7 days after vaccination]: Number of participants experiencing solicited systemic reactions
Occurrence of unsolicited Adverse Events (AE) [From vaccination to Visit 2 (up to approximately 42 days)]: Number of participants experiencing AEs
Occurrence of unsolicited Adverse Drug Reactions (ADR) [From vaccination to Visit 2 (up to approximately 42 days)]: Number of participants experiencing ADRs
Occurrence of unexpected Adverse Events (AE) [From vaccination to participant's last contact (up to approximately 42 days)]: Number of participants experiencing unexpected AEs
Occurrence of unexpected Adverse Drug Reactions (ADR) [From vaccination to participant's last contact (up to approximately 42 days)]: Number of participants experiencing unexpected ADRs
Occurrence of Serious Adverse Events (SAE) [From vaccination to participant's last contact (up to approximately 42 days)]: Number of participants experiencing SAEs
Occurrence of unexpected Serious Adverse Drug Reactions (SADR) [From vaccination to participant's last contact (up to approximately 42 days)]: Number of participants experiencing unexpected SADRs
Occurrence of Adverse Event of Special Interest (AESI) [From vaccination to participant's last contact (up to approximately 42 days)]: Number of participants experiencing AESIs

+Eligibility

Sex: All, ages: 65 Years to any, accepts healthy volunteers

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.

+Locations (15)

Facility	City	Country	Status
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
Jeon Junha Internal Medicine	Daegu	South Korea	Recruiting
Daol Union Clinic	Daegu	South Korea	Recruiting
Sae Seongmo Clinic	Incheon	South Korea	Recruiting
Cheongna Healthy Internal Medicine Clinic	Incheon	South Korea	Recruiting
Yul otolaryngology	Incheon	South Korea	Recruiting
Hangang Internal Medicine Clinic	Seoul	South Korea	Recruiting
Kim Mijin Medical Clinic	Seoul	South Korea	Recruiting
YK Family Medicine clinic	Seoul	South Korea	Recruiting
Hallym University Sacred Kangnam Hospital	Seoul	South Korea	Recruiting