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

Completed

• Conditions: Influenza

• Registration Number: NCT05406180
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-10
• Primary Completion: 2019-12-27
• Study Completion: 2019-12-27
• Status Verified: 2022-05
• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-31
• Last Update Submitted: 2022-05-31
• Study First Posted: 2022-06-06
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 675

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with serious adverse events (SAEs)	Up to Day 28	Percentage of participants with SAEs, including AESIs, throughout the study
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

Trial Locations

Locations (10)

Site 012; 🇰🇷 Gwangju, Korea, Republic of

Site 004; 🇰🇷 Incheon, Korea, Republic of

Site 007; 🇰🇷 Incheon, Korea, Republic of

Site 005; 🇰🇷 Gyeonggi-do, Korea, Republic of

Site 011; 🇰🇷 Changwon, Korea, Republic of

Site 008; 🇰🇷 Incheon, Korea, Republic of

Site 009; 🇰🇷 Donghae-si, Kangwon, Korea, Republic of

Site 003; 🇰🇷 Gyeonggi-do, Korea, Republic of

Site 010; 🇰🇷 Gyeonggi-do, Korea, Republic of

Site 002; 🇰🇷 Seoul, Korea, Republic of