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
← catalyst calendarNCT07621653 · readout in 461 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
706estimated
Sites
9
Country
South Korea
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-01 | actual | When the study began enrolling |
| Primary completion | 2027-11-23 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-11-23 | estimated | The whole study's end, after follow-up |
| First posted | 2026-06-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Meningococcal Immunization
- Healthy Volunteers
Intervention
- Biological: Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine — also filed as MenQuadfi®
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with solicited injection site and systemic reactions
measured 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
measured 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)
measured 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)
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