Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) in Subjects Aged 3 Years Old and Above

Sanofi

Status: Completed

Conditions: Influenza

Treatments: Biological: VaxigripTetra inj.

Study type: Observational

Funder types: Industry

Identifiers

NCT05406180

GQM13

Details and patient eligibility

About

The objective is to describe the safety profile after 1 dose of VaxigripTetra inj. administered in subjects aged 3 years old and above under routine clinical practice.

The planned duration of each subject's participation in the study will be 21 to 28 days.

Enrollment: 675 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 3 years and above on the day of enrollment
• For subjects aged 3 to 18 years: Informed consent form has been signed and dated by the parent or other legally acceptable representative.
• For subjects 19 years and above: Informed consent form has been signed and dated by the subject.
• Receipt of one dose of VaxigripTetra inj. (on the day of inclusion) as part of routine clinical practice according to the approved local product insert

Exclusion criteria

• 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