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

Recruiting

• Conditions: Immunization; Influenza (Healthy Volunteers)
• Interventions: Biological: Efluelda Tetra Pre-filled syringe

• Registration Number: NCT06694025
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Study Start: 2025-10-01
• Primary Completion: 2030-12-05
• Study Completion: 2030-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 670

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 Tetra 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Efluelda group	Efluelda Tetra Pre-filled syringe	A single dose of 0.7 mL is administered as approved by MFDS.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Investigational Site Number : 001; 🇰🇷 Seoul, Korea, Republic of