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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05832333
• Collaborator: (none)
• Enrollment: 682
• Locations: 12
• Actual Duration (Months): 28.1
• Patients Per Site: 56.8
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: VaxigripTetra®

Detailed Description

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

Study Design

• Study Type: Observational
• Actual Enrollment: 682 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 5, 2019
• Actual Primary Completion Date: Feb 7, 2022
• Actual Study Completion Date: Feb 7, 2022

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 35 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 003	Gangwon-do		Korea, Republic of
2	Site 002	Gwangju		Korea, Republic of
3	Site 004	Gyeonggi-do		Korea, Republic of
4	Site 005	Gyeonggi-do		Korea, Republic of
5	Site 008	Gyeonggi-do		Korea, Republic of
6	Site 011	Gyeonggi-do		Korea, Republic of
7	Site 015	Gyeonggi-do		Korea, Republic of
8	Site 006	Gyeongsangnam-do		Korea, Republic of
9	Site 010	Gyeongsangnam-do		Korea, Republic of
10	Site 009	Seoul		Korea, Republic of
11	Site 012	Seoul		Korea, Republic of
12	Site 014	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: NCT05832333
• Other Study ID Numbers: GQM00015
• First Posted: Apr 27, 2023
• Last Update Posted: Apr 27, 2023
• Last Verified: Apr 1, 2023

• 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 Apr 27, 2023