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Recruiting 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

— Observational Meningococcal Immunization Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine.
Who it may be relevant to
Registry conditions: Meningococcal Immunization, Healthy Volunteers. Basic parameters: 6 Weeks — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Biological Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine
    This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Primary outcome measures

  • Number of participants with solicited injection site and systemic reactions [Time frame: Up to 7 days after vaccination]
  • Number of participants with unsolicited non-serious Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including unexpected AEs and ADRs [Time frame: Up to 30 days after vaccination]
  • Number of participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), and Serious Adverse Drug Reactions (SADRs) [Time frame: From Day 01 up to the end of the study (approximately 44 days after inclusion in individuals aged 2-55 years; approximately 4 months in infants aged 6 months to <24 months; approximately 13 months in infants aged 6 weeks to <6 months)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

South Korea · 9 centers
  • Investigational Site Number: 410009 — Busan
  • Investigational Site Number: 410011 — Daegu
  • Investigational Site Number: 410003 — Goyang
  • Investigational Site Number: 410008 — Gwangju
  • Investigational Site Number: 410010 — Hanam
  • Investigational Site Number: 410006 — Iksan
  • Investigational Site Number: 410005 — Seongnam
  • Investigational Site Number: 410004 — Seoul
  • … and 1 more center

Identifiers

NCT: NCT07621653 · MEQ00085 · U1111-1317-8004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗