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

Influenza Clinical Trial

Official title:

Post-marketing Surveillance Study for the Use of VaxigripTetra®, a Quadrivalent Influenza Vaccine Administered Via Intramuscular Route in Subjects Aged 6 to 35 Months in Republic of Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05832333
• Other study ID #: GQM00015
• Status: Completed
• Start date: October 5, 2019
• Est. completion date: February 7, 2022

Study information

• Verified date: April 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 682
• Est. completion date: February 7, 2022
• Est. primary completion date: February 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• VaxigripTetra®
Suspension for injection Injection intramuscular

Locations

Country	Name	City	State
Korea, Republic of	Site 003	Gangwon-do
Korea, Republic of	Site 002	Gwangju
Korea, Republic of	Site 004	Gyeonggi-do
Korea, Republic of	Site 005	Gyeonggi-do
Korea, Republic of	Site 008	Gyeonggi-do
Korea, Republic of	Site 011	Gyeonggi-do
Korea, Republic of	Site 015	Gyeonggi-do
Korea, Republic of	Site 006	Gyeongsangnam-do
Korea, Republic of	Site 010	Gyeongsangnam-do
Korea, Republic of	Site 009	Seoul
Korea, Republic of	Site 012	Seoul
Korea, Republic of	Site 014	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	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
Primary	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
Primary	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