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

Sanofi675 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

675

Conditions

Influenza

Interventions

VaxigripTetra inj.BIOLOGICAL

Suspension for injection in a pre-filled syringe Injection intramuscular

Eligibility

Sex: ALLMin age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Site 009

Donghae-si, Gangwon-do, South Korea

Site 011

Changwon, South Korea

Site 012

Gwangju, South Korea

Site 003

Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Number of participants with solicited injection site or systemic reactions

Percentage of participants reporting * injection site reactions: pain, erythema, swelling, induration, ecchymosis * systemic reactions: fever, headache, malaise, myalgia, shivering

Time frame: Up to 7 days after vaccination

Number of participants with unsolicited adverse events

Percentage of participants with unsolicited (spontaneously reported) injection site reactions occurring within 28 days after each injection and unsolicited systemic AEs between each injection and up to 28 days after the last injection

Time frame: Up to Day 28

Number of participants with serious adverse events (SAEs)

Percentage of participants with SAEs, including AESIs, throughout the study

Time frame: Up to Day 28

Data from ClinicalTrials.gov

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