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

NCT05406180 | Completed

• 1 other identifier: GQM13
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 10

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

VaxigripTetra inj. BIOLOGICAL

Suspension for injection in a pre-filled syringe Injection intramuscular

Also known as: Quadrivalent influenza vaccine (split-virion, inactivated) - QIV

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (10)

Site 009

Donghae-si, Gangwon-do, South Korea

Location

Site 011

Changwon, South Korea

Location

Site 012

Gwangju, South Korea

Location

Site 003

Gyeonggi-do, South Korea

Location

Site 005

Gyeonggi-do, South Korea

Location

Site 010

Gyeonggi-do, South Korea

Location

Site 004

Incheon, South Korea

Location

Site 007

Incheon, South Korea

Location

Site 008

Incheon, South Korea

Location

Site 002

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36070176 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 6, 2022
• Study Start: October 10, 2018
• Primary Completion: December 27, 2019
• Study Completion: December 27, 2019
• Last Updated: June 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (10)