Sanofi
English

Recruiting

NCT07621653

Meningococcal Immunization

Healthy Volunteers

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

+ 6 Weeks and - 55 year(s)

Study targets participants aged from 6 Weeks to 55 year(s)

All gender

This study targets all gender participants

N/A

not applicable

706 participants

Study involves a large group of participants

9 locations

Available in numerous locations

Study Overview

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 Criteria

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.

Updated on August 2026. Study ID: NCT07621653