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