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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-55
SponsorSanofi

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

706 Participants
are divided into 1 treatment group

Sponsors and collaborators