Clinical trial NCT05832333: Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra®) in Subjects Aged 6 to 35 Months
Official title: Post-marketing Surveillance Study for the Use of VaxigripTetra®, a Quadrivalent Influenza Vaccine Administered Via Intramuscular Route in Subjects Aged 6 to 35 Months in Republic of Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-04-27
Enrollment: 682
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged 6 to 35 months will be enrolled after receipt of one dose of VaxigripTetra® during a routine health care visit.

Participants will be enrolled on the day of vaccination (first or second vaccination) and will be followed-up for only one vaccination.

Planned number of subjects: 670 subjects aged 6 to 35 months Planned number of country: 1 (Republic of Korea) Planned number of sites: 12

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Occurence of solicited injection site or systemic reactions
timeFrame: Up to 7 days after vaccination
measure: Occurence of unsolicited adverse events (AEs)
timeFrame: Up to 21(+7) days after vaccination
measure: Occurrence of serious adverse events (SAEs) throughout the study participation
timeFrame: Up to 21(+7) days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Gangwon-do
country: Korea, Republic of
facility: Site 003
city: Gwangju
country: Korea, Republic of
facility: Site 002
city: Gyeonggi-do
country: Korea, Republic of
facility: Site 004
city: Gyeonggi-do
country: Korea, Republic of
facility: Site 005
city: Gyeonggi-do
country: Korea, Republic of
facility: Site 008
city: Gyeonggi-do
country: Korea, Republic of
facility: Site 011
city: Gyeonggi-do
country: Korea, Republic of
facility: Site 015
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Site 006
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Site 010
city: Seoul
country: Korea, Republic of
facility: Site 009
city: Seoul
country: Korea, Republic of
facility: Site 012
city: Seoul
country: Korea, Republic of
facility: Site 014
Study officials:
References: