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

NCT05832333 | Completed

• 1 other identifier: GQM00015
• Study Type: observational
• Target: 682
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

VaxigripTetra® BIOLOGICAL

Suspension for injection Injection intramuscular

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

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (12)

Site 003

Gangwon-do, South Korea

Location

Site 002

Gwangju, South Korea

Location

Site 004

Gyeonggi-do, South Korea

Location

Site 005

Gyeonggi-do, South Korea

Location

Site 008

Gyeonggi-do, South Korea

Location

Site 011

Gyeonggi-do, South Korea

Location

Site 015

Gyeonggi-do, South Korea

Location

Site 006

Gyeongsangnam-do, South Korea

Location

Site 010

Gyeongsangnam-do, South Korea

Location

Site 009

Seoul, South Korea

Location

Site 012

Seoul, South Korea

Location

Site 014

Seoul, South Korea

Location

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: April 11, 2023
• First Posted: April 27, 2023
• Study Start: October 5, 2019
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (12)