Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VaxigripTetra inj. | Biological | Suspension for injection in a pre-filled syringe Injection intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with solicited injection site or systemic reactions | Percentage of participants reporting
| 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 | Up to Day 28 |
| Number of participants with serious adverse events (SAEs) | Percentage of participants with SAEs, including AESIs, throughout the study | Up to Day 28 |
Not provided
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
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
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 009 | Donghae-si | Gangwon-do | South Korea | |||
| Site 011 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36070176 | Derived | 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. |
Not provided
Not provided
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.vivli.org
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Changwon |
| South Korea |
| Site 012 | Gwangju | South Korea |
| Site 003 | Gyeonggi-do | South Korea |
| Site 005 | Gyeonggi-do | South Korea |
| Site 010 | Gyeonggi-do | South Korea |
| Site 004 | Incheon | South Korea |
| Site 007 | Incheon | South Korea |
| Site 008 | Incheon | South Korea |
| Site 002 | Seoul | South Korea |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided