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Recruiting NCT07621653

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

Conditions: Meningococcal Immunization, Healthy Volunteers

Sex: All
Ages: 6 Weeks – 55 Years
Healthy volunteers: Yes
Enrollment: 706
Sponsor: Sanofi

Location: Investigational Site Number: 410009 Busan

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07621653). StuddyBuddy aggregates publicly available trial information.