Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea

This surveillance is to investigate the safety profile of MenQuadfi®, when administered to participants aged 6 weeks to 55 years under the real-world clinical practice settings as per approved indications, including the Adverse Drug Reactions (ADRs)*.

*It includes ADRs that were not fully recognized in clinical practice, or unexpected ADRs which refer to those not listed in the approved drug labeling.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers; Meningococcal Immunization
• Intervention / Treatment: Biological: Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine

• Study Type: Observational
• Enrollment (Estimated): 706

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: Contact-US@sanofi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This is a multi-center, observational cohort active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Standard for Re-examination of New Drugs".

This is a single country study which will be conducted only in Korea with a target number of 706 participants.

Investigators will recruit participants until the targeted number of participants (as contracted with the sponsor) has been obtained; each participant will be assigned an identification number in the order of enrollment.

Description

Inclusion Criteria:

• Aged 6 weeks to 55 years on the day of MenQuadfi® vaccination
• Evidence of a personally signed and dated informed consent document indicating that the participant or their parent(s)/other legally acceptable representative(s), if applicable, have been informed of all pertinent aspects of the study
• Participants who have been vaccinated with MenQuadfi® for the first time as per ordinary healthcare setting at the day of inclusion in the study according to the approved local product label

Exclusion Criteria:

• Participating or planning participation in any other clinical studies investigating a vaccine, drug, medical device, or medical procedure at the time of the study enrolment (or in 4 weeks preceding the enrolment)
• Having a previous history of enrollment in this study (participants who have already been enrolled once in this study are not eligible for re-enrollment)
• Being applicable to contraindications in the approved local product label of MenQuadfi®; anyone with a known systemic hypersensitivity reaction to any component of this vaccine or after previous administration of the vaccine or a vaccine containing the same components

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants aged 6 weeks to 55 years old; Participants vaccinated with MenQuadfi® for the first time as per ordinary healthcare setting at the day of inclusion	Biological: Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine; This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.; Other Names: MenQuadfi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with solicited injection site and systemic reactions	Up to 7 days after vaccination
Number of participants with unsolicited non-serious Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including unexpected AEs and ADRs	Up to 30 days after vaccination
Number of participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), and Serious Adverse Drug Reactions (SADRs)	From Day 01 up to the end of the study (approximately 44 days after inclusion in individuals aged 2-55 years; approximately 4 months in infants aged 6 months to <24 months; approximately 13 months in infants aged 6 weeks to <6 months)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Estimated): May 27, 2026
• Primary Completion (Estimated): November 23, 2027
• Study Completion (Estimated): November 23, 2027

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MEQ00085; U1111-1317-8004 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org