Meningococcal ImmunizationNCT07621653
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
An observational study of Meningococcal Immunization and Healthy Volunteers, run by Sanofi at 9 sites in South Korea.
Trial summary
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)*. Read more about this study
- Who is it for?
- Ages 6 weeks to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Immunization, Healthy Volunteers
- What is being tested?
- Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine
- Type of treatment
- Vaccines
- How many people
- 706 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 1 Jul 2026to 23 Nov 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This is a multi-center, observational cohort active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Standard for Re-examination of New Drugs". This is a single country study which will be conducted only in Korea with a target number of 706 participants. Investigators will recruit participants until the targeted number of participants (as contracted with the sponsor) has been obtained; each participant will be assigned an identification number in the order of enrollment.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
9 sites in 1 country
South Korea9 sites, 9 recruiting
- Recruiting
Investigational Site Number: 410009
Busan, 49408
- Recruiting
Investigational Site Number: 410011
Daegu, 41794
- Recruiting
Investigational Site Number: 410003
Goyang, 10234
- Recruiting
Investigational Site Number: 410008
Gwangju, 61665
- Recruiting
Investigational Site Number: 410010
Hanam, 12919
- Recruiting
Investigational Site Number: 410006
Iksan, 54639
- Recruiting
Investigational Site Number: 410005
Seongnam, 13558
- Recruiting
Investigational Site Number: 410004
Seoul, 06132
- Recruiting
Investigational Site Number: 410007
Seoul, 06614
About this study
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.
- Conditions
- Meningococcal Immunization, Healthy Volunteers
- Being tested
- Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate VaccineBiological
Also called MenQuadfi®
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Participants aged 6 weeks to 55 years old | Participants vaccinated with MenQuadfi® for the first time as per ordinary healthcare setting at the day of inclusion Receives: Biological: Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jul 2026
- Primary completion23 Nov 2027 (estimated)
- Study completion23 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal ImmunizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 706 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621653
- Sponsor's protocol ID
- MEQ00085
- Other IDs
- U1111-1317-8004
- Status last verified
- Jul 2026
- First submitted
- 26 May 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org