Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra®) in Subjects Aged 6 to 35 Months

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

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: VaxigripTetra®

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 682

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do, Korea, Republic of
    • Site 003
  • Gwangju, Korea, Republic of
    • Site 002
  • Gyeonggi-do, Korea, Republic of
    • Site 005
  • Gyeonggi-do, Korea, Republic of
    • Site 004
  • Gyeonggi-do, Korea, Republic of
    • Site 008
  • Gyeonggi-do, Korea, Republic of
    • Site 011
  • Gyeonggi-do, Korea, Republic of
    • Site 015
  • Gyeongsangnam-do, Korea, Republic of
    • Site 006
  • Gyeongsangnam-do, Korea, Republic of
    • Site 010
  • Seoul, Korea, Republic of
    • Site 009
  • Seoul, Korea, Republic of
    • Site 012
  • Seoul, Korea, Republic of
    • Site 014

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of solicited injection site or systemic reactions	Percentage of participants reporting; injection site reactions: pain, erythema, swelling, induration, ecchymosis; systemic reactions for infants and toddlers ≤ 23 months: fever, vomiting ,crying abnormal, drowsiness, appetite lost, irritability; systemic reactions for children aged 2 to 3 years: fever, headache, malaise, myalgia, shivering	Up to 7 days after vaccination
Occurence of unsolicited adverse events (AEs)	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 21(+7) days after vaccination
Occurrence of serious adverse events (SAEs) throughout the study participation	Percentage of participants with SAEs, including AESIs, throughout the study	Up to 21(+7) days after vaccination

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2019
• Primary Completion (Actual): February 7, 2022
• Study Completion (Actual): February 7, 2022

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

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: GQM00015

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