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

NCT07621653 | Recruiting

• 2 other identifiers: MEQ00085U1111-1317-8004
• Study Type: observational
• Target: 706
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Meningococcal Immunization; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

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

Interventions

Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine BIOLOGICAL

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Also known as: MenQuadfi®

Participants aged 6 weeks to 55 years old

Eligibility Criteria

• Age: 6 Weeks - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (9)

Investigational Site Number: 410009

Busan, 49408, South Korea

RECRUITING

Investigational Site Number: 410011

Daegu, 41794, South Korea

RECRUITING

Investigational Site Number: 410003

Goyang, 10234, South Korea

RECRUITING

Investigational Site Number: 410008

Gwangju, 61665, South Korea

RECRUITING

Investigational Site Number: 410010

Hanam, 12919, South Korea

RECRUITING

Investigational Site Number: 410006

Iksan, 54639, South Korea

RECRUITING

Investigational Site Number: 410005

Seongnam, 13558, South Korea

RECRUITING

Investigational Site Number: 410004

Seoul, 06132, South Korea

RECRUITING

Investigational Site Number: 410007

Seoul, 06614, South Korea

RECRUITING

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 23, 2027
• Study Completion (Estimated): November 23, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

KR (9)