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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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Biological
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Republic of Korea
Centum Family Medicine Clinic
RECRUITING
Busan
House ENT clinic
RECRUITING
Busan
Yoon Jae Woong Neurosurgery Clinic
RECRUITING
Busan
Daol Union Clinic
RECRUITING
Daegu
Dr. Jang's Family Medicine Clinic
RECRUITING
Daegu
Jeon Junha Internal Medicine
RECRUITING
Daegu
Kintex Dream Internal Medicine Clinic
RECRUITING
Goyang-si
Kim's gutease internal medicine
RECRUITING
Gunpo
Cheongna Healthy Internal Medicine Clinic
RECRUITING
Incheon
Sae Seongmo Clinic
RECRUITING
Incheon
Yul otolaryngology
RECRUITING
Incheon
Hallym University Sacred Kangnam Hospital
RECRUITING
Seoul
Hangang Internal Medicine Clinic
RECRUITING
Seoul
Kim Mijin Medical Clinic
RECRUITING
Seoul
YK Family Medicine clinic
RECRUITING
Seoul
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2026-09-17
Estimated Completion Date: 2029-03-20
Participants
Target number of participants: 670
Treatments
Efluelda® Vaccination Group
Adults aged 65 years of age or older will receive 1 dose of Efluelda® vaccination intramuscularly on Day 1
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov