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

Completed

• Conditions: Influenza

• Registration Number: NCT05832333
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2019-10-05
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07
• Status Verified: 2023-04
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Study First Posted: 2023-04-27
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 682

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of serious adverse events (SAEs) throughout the study participation	Up to 21(+7) days after vaccination	Percentage of participants with SAEs, including AESIs, throughout the study
Occurence of 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 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
Occurence of unsolicited adverse events (AEs)	Up to 21(+7) days after vaccination	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 (12)

Site 006; 🇰🇷 Gyeongsangnam-do, Korea, Republic of

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

Site 002; 🇰🇷 Gwangju, Korea, Republic of

Site 003; 🇰🇷 Gangwon-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 015; 🇰🇷 Gyeonggi-do, Korea, Republic of

Site 011; 🇰🇷 Gyeonggi-do, Korea, Republic of

Site 009; 🇰🇷 Seoul, Korea, Republic of

Site 014; 🇰🇷 Seoul, Korea, Republic of

Site 012; 🇰🇷 Seoul, Korea, Republic of