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

NCT06694025 | Not Yet Recruiting FDA Drug

• 2 other identifiers: QHD00024U1111-1251-6083
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda Tetra in adults aged 65 years or older under routine clinical practice, as per approved indications. 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 (Healthy Volunteers); Immunization

Outcome Measures

Primary Outcomes (5)

• Occurrence of solicited (pre-listed in the participant's diary card [DC] and case report form) injection site and systemic reactions

  From baseline up to 7 days after vaccination

• Occurrence of unsolicited AEs and ADRs

  From baseline up to Visit 2 (28-35 days) after vaccination

• Occurrence of unexpected AEs and ADRs

  From baseline up to participant's last contact after vaccination (36-42 days)

• Occurrence of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)

  From baseline up to participant's last contact after vaccination (36-42 days)

• Occurrence of AE of special interest (AESI)

  From baseline up to participant's last contact after vaccination (36-42 days)

Study Arms (1)

Efluelda group

A single dose of 0.7 mL is administered as approved by MFDS.

Biological: Efluelda Tetra Pre-filled syringe

Interventions

Efluelda Tetra Pre-filled syringe BIOLOGICAL

Suspension for injection in a pre-filled syringe

Efluelda 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 Tetra as per routine healthcare visits and according to approved local product labeling, at study centers (general hospitals or clinics located in Korea).

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 Tetra 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number : 001

Seoul, Seoul-teukbyeolsi, 07441, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)