Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra®) in Subjects Aged 6 to 35 Months

Sanofi

Status: Completed

Conditions: Influenza

Treatments: Biological: VaxigripTetra®

Study type: Observational

Funder types: Industry

Identifiers

NCT05832333

GQM00015

Details and patient eligibility

About

Multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in Korea under routine clinical practices.

Full description

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

Enrollment: 682 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 6 to 35 months on the day of enrolment
• Informed consent form has been signed and dated by the parent or other legally acceptable representative
• Receipt of one dose of VaxigripTetra® on the day of inclusion in routine practice according to the approved local product insert

Exclusion criteria

• Participation at the time of study enrolment (or in the 4 weeks preceding the enrolment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure