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Clinical Trials in South Korea / NCT07621653
Recruiting Observational

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 · tracked via the Priya Life Science South Korea tracker
Sponsor
Sanofi
Phase
Observational
Started
2026-07-01
Last updated
2026-07-29

Condition(s) studied

Meningococcal ImmunizationHealthy Volunteers

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Weeks
Max age
55 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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)

Trial sites (9)

FacilityCityRegionStatus
Investigational Site Number: 410009 Busan South Korea Recruiting
Investigational Site Number: 410011 Daegu South Korea Recruiting
Investigational Site Number: 410003 Goyang South Korea Recruiting
Investigational Site Number: 410008 Gwangju South Korea Recruiting
Investigational Site Number: 410010 Hanam South Korea Recruiting
Investigational Site Number: 410006 Iksan South Korea Recruiting
Investigational Site Number: 410005 Seongnam South Korea Recruiting
Investigational Site Number: 410004 Seoul South Korea Recruiting
Investigational Site Number: 410007 Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07621653 on ClinicalTrials.gov ↗ ← All trials in South Korea