Status:
COMPLETED
Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) in Subjects Aged 3 Years Old and Above
Lead Sponsor:
Sanofi
Conditions:
Influenza
Eligibility:
All Genders
3+ years
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 su...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
October 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 27 2019
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT05406180
Start Date
October 10 2018
End Date
December 27 2019
Last Update
June 6 2022
Active Locations (10)
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1
Site 009
Donghae-si, Gangwon-do, South Korea
2
Site 011
Changwon, South Korea
3
Site 012
Gwangju, South Korea
4
Site 003
Gyeonggi-do, South Korea