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NCT05406180 Clinical Trial

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

Influenza Clinical Trial

Official title:
Postmarketing Surveillance Study for Use of Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) Administered Via the Intramuscular Route in Subjects Aged 3 Years Old and Above in the Republic of Korea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05406180
Other study ID # GQM13
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2018
Est. completion date December 27, 2019

Study information
Verified date May 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 675
Est. completion date December 27, 2019
Est. primary completion date December 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• VaxigripTetra inj.
Suspension for injection in a pre-filled syringe Injection intramuscular

Locations
Country Name City State
Korea, Republic of Site 011 Changwon
Korea, Republic of Site 009 Donghae-si Kangwon
Korea, Republic of Site 012 Gwangju
Korea, Republic of Site 003 Gyeonggi-do
Korea, Republic of Site 005 Gyeonggi-do
Korea, Republic of Site 010 Gyeonggi-do
Korea, Republic of Site 004 Incheon
Korea, Republic of Site 007 Incheon
Korea, Republic of Site 008 Incheon
Korea, Republic of Site 002 Seoul

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Number of participants with serious adverse events (SAEs) Percentage of participants with SAEs, including AESIs, throughout the study Up to Day 28
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