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

N/ANot Yet RecruitingNCT07282795

Sanofi670 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

670

Conditions

Influenza Immunization Healthy Volunteers

Interventions

Efluelda® Pre-filled syringeBIOLOGICAL

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

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® 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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Outcomes

Primary Outcomes

Occurrence of solicited injected site reactions.

Number of participants experiencing solicited injection site reactions

Time frame: Up to 7 days after vaccination

Occurrence of solicited systemic reactions

Number of participants experiencing solicited systemic reactions

Time frame: Up to 7 days after vaccination

Occurrence of unsolicited Adverse Events (AE)

Number of participants experiencing AEs

Time frame: From vaccination to Visit 2 (up to approximately 42 days)

Occurrence of unsolicited Adverse Drug Reactions (ADR)

Number of participants experiencing ADRs

Time frame: From vaccination to Visit 2 (up to approximately 42 days)

Occurrence of unexpected Adverse Events (AE)

Number of participants experiencing unexpected AEs