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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

RecruitingN/A

Sponsor: Sanofi

Conditions: Meningococcal Immunization, Healthy Volunteers

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

Countries: South Korea

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 overview

Sex: ALL

Age: 6 Weeks to 55 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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.

Locations (9)

Busan, South Korea
Daegu, South Korea
Goyang, South Korea
Gwangju, South Korea
Hanam, South Korea
Iksan, South Korea
Seongnam, South Korea
Seoul, South Korea
Seoul, South Korea