Influenza ImmunizationNCT07282795
Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe
An observational study of Influenza Immunization and Healthy Volunteers, run by Sanofi at 15 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Immunization, Healthy Volunteers
- What is being tested?
- Efluelda® Pre-filled syringe
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 670 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 17 Sep 2026to 20 Mar 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Investigators will recruit participants after vaccination with Efluelda® as per routine healthcare visits and according to approved local product labeling, at study centers (general hospitals or clinics located in South Korea). 600 evaluable participants will be included and will include male and female adults aged 65 years and older.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
15 sites in 1 country
South Korea15 sites, 15 recruiting
- Recruiting
House ENT clinic
Busan, 47715
- Recruiting
Yoon Jae Woong Neurosurgery Clinic
Busan, 47765
- Recruiting
Centum Family Medicine Clinic
Busan, 48059
- Recruiting
Dr. Jang's Family Medicine Clinic
Daegu, 41586
- Recruiting
Jeon Junha Internal Medicine
Daegu, 41925
- Recruiting
Daol Union Clinic
Daegu, 42242
- Recruiting
Kintex Dream Internal Medicine Clinic
Goyang-si, Gyeonggi-do, 10390
- Recruiting
Kim's gutease internal medicine
Gunpo, Gyeonggi-do, 15865
- Recruiting
Sae Seongmo Clinic
Incheon, 21021
- Recruiting
Cheongna Healthy Internal Medicine Clinic
Incheon, 22736
- Recruiting
Yul otolaryngology
Incheon, 22758
- Recruiting
Hangang Internal Medicine Clinic
Seoul, 05264
- Recruiting
Kim Mijin Medical Clinic
Seoul, 06216
- Recruiting
YK Family Medicine clinic
Seoul, 06544
- Recruiting
Hallym University Sacred Kangnam Hospital
Seoul, 07441
About this study
Official title: 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
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.
- Conditions
- Influenza Immunization, Healthy Volunteers
- Being tested
- Efluelda® Pre-filled syringe
- Keywords
- Flu, Efluelda®
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efluelda® Pre-filled syringeBiological
Pharmaceutical Form:
Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| Efluelda® Vaccination Group | Adults aged 65 years of age or older will receive 1 dose of Efluelda® vaccination intramuscularly on Day 1 Receives: Biological: Efluelda® Pre-filled syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited injected site reactions.
Number of participants experiencing solicited injection site reactions
Measured: Up to 7 days after vaccination
Occurrence of solicited systemic reactions
Number of participants experiencing solicited systemic reactions
Measured: Up to 7 days after vaccination
Occurrence of unsolicited Adverse Events (AE)
Number of participants experiencing AEs
Measured: From vaccination to Visit 2 (up to approximately 42 days)
Occurrence of unsolicited Adverse Drug Reactions (ADR)
Number of participants experiencing ADRs
Measured: From vaccination to Visit 2 (up to approximately 42 days)
Occurrence of unexpected Adverse Events (AE)
Number of participants experiencing unexpected AEs
Measured: From vaccination to participant's last contact (up to approximately 42 days)
Occurrence of unexpected Adverse Drug Reactions (ADR)
Number of participants experiencing unexpected ADRs
Measured: From vaccination to participant's last contact (up to approximately 42 days)
Occurrence of Serious Adverse Events (SAE)
Number of participants experiencing SAEs
Measured: From vaccination to participant's last contact (up to approximately 42 days)
Occurrence of unexpected Serious Adverse Drug Reactions (SADR)
Number of participants experiencing unexpected SADRs
Measured: From vaccination to participant's last contact (up to approximately 42 days)
Occurrence of Adverse Event of Special Interest (AESI)
Number of participants experiencing AESIs
Measured: From vaccination to participant's last contact (up to approximately 42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start17 Sep 2026
- Primary completion22 Feb 2029 (estimated)
- Study completion20 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza ImmunizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282795
- Sponsor's protocol ID
- FIM00018
- Other IDs
- U1111-1331-8205
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org