An observational study in Influenza, sponsored by Sanofi. Completed at 10 sites in Korea, Republic of. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by Sanofi · Observational
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.
2,215 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 675 is above the median of 300 across 305 observational studies indexed under Influenza, Human.
Browse Influenza, Human studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Suspension for injection in a pre-filled syringe Injection intramuscular
Also known as: Quadrivalent influenza vaccine (split-virion, inactivated) - QIV
Number of participants with solicited injection site or systemic reactions
Percentage of participants reporting * injection site reactions: pain, erythema, swelling, induration, ecchymosis * systemic reactions: fever, headache, malaise, myalgia, shivering
Time frame: 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
Time frame: Up to Day 28
Number of participants with serious adverse events (SAEs)
Percentage of participants with SAEs, including AESIs, throughout the study
Time frame: Up to Day 28
Plan to share: Yes — 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
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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