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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05406180
• Collaborator: (none)
• Enrollment: 675
• Locations: 10
• Actual Duration (Months): 14.6
• Patients Per Site: 67.5
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: VaxigripTetra inj.

Study Design

• Study Type: Observational
• Actual Enrollment: 675 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 10, 2018
• Actual Primary Completion Date: Dec 27, 2019
• Actual Study Completion Date: Dec 27, 2019

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. Number of participants with serious adverse events (SAEs) [Up to Day 28]

   Percentage of participants with SAEs, including AESIs, throughout the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 009	Donghae-si	Kangwon	Korea, Republic of
2	Site 011	Changwon		Korea, Republic of
3	Site 012	Gwangju		Korea, Republic of
4	Site 003	Gyeonggi-do		Korea, Republic of
5	Site 005	Gyeonggi-do		Korea, Republic of
6	Site 010	Gyeonggi-do		Korea, Republic of
7	Site 004	Incheon		Korea, Republic of
8	Site 007	Incheon		Korea, Republic of
9	Site 008	Incheon		Korea, Republic of
10	Site 002	Seoul		Korea, Republic of

Sponsors and Collaborators

• Sanofi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT05406180
• Other Study ID Numbers: GQM13
• First Posted: Jun 6, 2022
• Last Update Posted: Jun 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Influenza, Human; Vaccines

Study Results

No Results Posted as of Jun 6, 2022