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

Sanofi

Status

Begins enrollment in 7 months

Conditions

Influenza (Healthy Volunteers)

Immunization

Treatments

Biological: Efluelda Tetra Pre-filled syringe

Study type

Observational

Funder types

Industry

Identifiers

NCT06694025

U1111-1251-6083 (Registry Identifier)

QHD00024 (Other Identifier)

Details and patient eligibility

About

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.

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 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