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

NCT07282795 | Not Yet Recruiting FDA Drug

• 2 other identifiers: FIM00018U1111-1331-8205
• Study Type: observational
• Target: 670
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers; Influenza Immunization

Keywords

Flu; Efluelda®

Outcome Measures

Primary Outcomes (9)

• Occurrence of solicited injected site reactions.

  Number of participants experiencing solicited injection site reactions

  Up to 7 days after vaccination

• Occurrence of solicited systemic reactions

  Number of participants experiencing solicited systemic reactions

  Up to 7 days after vaccination

• Occurrence of unsolicited Adverse Events (AE)

  Number of participants experiencing AEs

  From vaccination to Visit 2 (up to approximately 42 days)

• Occurrence of unsolicited Adverse Drug Reactions (ADR)

  Number of participants experiencing ADRs

  From vaccination to Visit 2 (up to approximately 42 days)

• Occurrence of unexpected Adverse Events (AE)

  Number of participants experiencing unexpected AEs

  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

  From vaccination to participant's last contact (up to approximately 42 days)

• Occurrence of Serious Adverse Events (SAE)

  Number of participants experiencing SAEs

  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

  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

  From vaccination to participant's last contact (up to approximately 42 days)

Study Arms (1)

Efluelda® Vaccination Group

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

Biological: Efluelda® Pre-filled syringe

Interventions

Efluelda® Pre-filled syringe BIOLOGICAL

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

Efluelda® Vaccination Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 22, 2029
• Study Completion (Estimated): March 20, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share