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

Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe, a High-dose Quadrivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06694025

Enrollment

670

Registered

2024-11-19

Start date

2026-10-01

Completion date

2028-01-31

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunization, Influenza (Healthy Volunteers)

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.

Interventions

BIOLOGICALEfluelda Tetra Pre-filled syringe

Suspension for injection in a pre-filled syringe

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

South Korea

Contacts

Primary ContactTrial Transparency email recommended (Toll free for US & Canada)

Contact-US@sanofi.com800-633-1610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026