Postmarketing Surveillance Study for Use of Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) Administered Via the Intramuscular Route in Subjects Aged 3 Years Old and Above in the Republic of Korea
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Sanofi
- Enrollment
- 675
- Locations
- 10
- Primary Endpoint
- Number of participants with serious adverse events (SAEs)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of participants with serious adverse events (SAEs)
Time Frame: Up to Day 28
Percentage of participants with SAEs, including AESIs, throughout the study
Number of participants with solicited injection site or systemic reactions
Time Frame: Up to 7 days after vaccination
Percentage of participants reporting * injection site reactions: pain, erythema, swelling, induration, ecchymosis * systemic reactions: fever, headache, malaise, myalgia, shivering
Number of participants with unsolicited adverse events
Time Frame: Up to Day 28
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