Clinical trial NCT05406180: Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) in Subjects Aged 3 Years Old and Above
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-06-06
Enrollment: 675
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 3 years old and above will be enrolled after receipt of one dose of VaxigripTetra inj. during a routine health care visit. Subjects will be enrolled on the day of vaccination and will be followed-up for one vaccination whatever their age at enrolment. Therefore, in case of the subjects under 9 years old (between 3 to 8 years of age), who may receive two doses depending on their previous influenza vaccination history, only one dose (either first or second vaccination) for each subject will be accounted for the study. The planned duration of each subject's participation in the study will be 21 to 28 days.

Planned number of subjects: 670 subjects aged 3 years old and above Planned number of country: 1 (Republic of Korea) Planned number of sites: 10

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.


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

Primary outcomes:
measure: Number of participants with solicited injection site or systemic reactions
timeFrame: Up to 7 days after vaccination
measure: Number of participants with unsolicited adverse events
timeFrame: Up to Day 28
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Donghae-si
country: Korea, Republic of
facility: Site 009
state: Kangwon
city: Changwon
country: Korea, Republic of
facility: Site 011
city: Gwangju
country: Korea, Republic of
facility: Site 012
city: Gyeonggi-do
country: Korea, Republic of
facility: Site 003
city: Gyeonggi-do
country: Korea, Republic of
facility: Site 005
city: Gyeonggi-do
country: Korea, Republic of
facility: Site 010
city: Incheon
country: Korea, Republic of
facility: Site 004
city: Incheon
country: Korea, Republic of
facility: Site 007
city: Incheon
country: Korea, Republic of
facility: Site 008
city: Seoul
country: Korea, Republic of
facility: Site 002
Study officials:
References:
citation: Lim S, Li X, Syrkina O, Fournier M. Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea. Infect Dis Ther. 2022 Oct;11(5):2035-2043. doi: 10.1007/s40121-022-00685-x. Epub 2022 Sep 7.