Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) in Subjects Aged 3 Years Old and Above

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: VaxigripTetra inj.

• Study Type: Observational
• Enrollment (Actual): 675

Contacts and Locations

Study Locations

• Korea, Republic of
  • Changwon, Korea, Republic of
    • Site 011
  • Gwangju, Korea, Republic of
    • Site 012
  • Gyeonggi-do, Korea, Republic of
    • Site 003
  • Gyeonggi-do, Korea, Republic of
    • Site 005
  • Gyeonggi-do, Korea, Republic of
    • Site 010
  • Incheon, Korea, Republic of
    • Site 004
  • Incheon, Korea, Republic of
    • Site 007
  • Incheon, Korea, Republic of
    • Site 008
  • Seoul, Korea, Republic of
    • Site 002
  • Kangwon
    • Donghae-si, Kangwon, Korea, Republic of
      • Site 009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): December 27, 2019
• Study Completion (Actual): December 27, 2019

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: GQM13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No