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

N/ANot Yet RecruitingNCT06694025

Sanofi670 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

670

Conditions

Immunization Influenza (Healthy Volunteers)

Interventions

Efluelda Tetra Pre-filled syringeBIOLOGICAL

Suspension for injection in a pre-filled syringe

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Investigational Site Number : 001

Seoul, Seoul-teukbyeolsi, South Korea

Outcomes

Primary Outcomes

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

Time frame: From baseline up to 7 days after vaccination

Occurrence of unsolicited AEs and ADRs

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

Occurrence of unexpected AEs and ADRs

Time frame: 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)

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

Occurrence of AE of special interest (AESI)

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

Central Contacts

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

CONTACT

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

Data from ClinicalTrials.gov

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