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

Sanofi

Status

Not yet enrolling

Conditions

Healthy Volunteers

Influenza Immunization

Treatments

Biological: Efluelda® Pre-filled syringe

Study type

Observational

Funder types

Industry

Identifiers

NCT07282795

FIM00018

U1111-1331-8205 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

670 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

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