Influenza
Conditions
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.
Interventions
BIOLOGICALVaxigripTetra inj.
Suspension for injection in a pre-filled syringe Injection intramuscular
Sponsors
Sanofi
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with solicited injection site or systemic reactions | 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 | 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 |
| Number of participants with serious adverse events (SAEs) | Up to Day 28 | Percentage of participants with SAEs, including AESIs, throughout the study |
Countries
South Korea
Outcome results
None listed