Post‑marketing safety check of MenQuadfi in children and adults in Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study monitors the safety of MenQuadfi when given in routine clinical practice in Korea, focusing on adverse drug reactions that may appear beyond the approved labeling. It includes participants from infancy through early adulthood and aims to capture both known and unexpected reactions. Data are collected as part of standard vaccination experiences, with informed consent obtained from participants or their guardians. The study analyzes ADRs in the context of approved indications and local labeling.

Why it matters

Who can join: the full rules

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.

Where it's running

• Investigational Site Number: 410009
  Busan, South Korea Recruiting
• Investigational Site Number: 410011
  Daegu, South Korea Recruiting
• Investigational Site Number: 410003
  Goyang, South Korea Recruiting
• Investigational Site Number: 410008
  Gwangju, South Korea Recruiting
• Investigational Site Number: 410010
  Hanam, South Korea Recruiting
• Investigational Site Number: 410006
  Iksan, South Korea Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.