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.