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Korea launches safety watch on meningitis vaccine MenQuadfi

NCT ID NCT07621653

Vaccine Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study will monitor the safety of the MenQuadfi vaccine in 706 people aged 6 weeks to 55 years in South Korea. Researchers will track side effects like injection-site reactions and serious adverse events as the vaccine is used in real-world clinics. The goal is to confirm the vaccine's safety profile outside of controlled trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MenQuadfi (meningococcal groups A, C, Y, W polysaccharide tetanus toxoid conjugate vaccine)
What this could lead to
If successful, this study will confirm that MenQuadfi is safe for routine use in Korea, helping protect against serious meningococcal disease.
What could go wrong
This is an observational safety study, not a test of effectiveness. It may not detect rare side effects due to its size and real-world setting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 706 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

6 weeks to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

meningococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers Meningococcal immunization

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number: 410003

    RECRUITING

    Goyang, 10234, South Korea

  • Investigational Site Number: 410004

    RECRUITING

    Seoul, 06132, South Korea

  • Investigational Site Number: 410005

    RECRUITING

    Seongnam, 13558, South Korea

  • Investigational Site Number: 410006

    RECRUITING

    Iksan, 54639, South Korea

  • Investigational Site Number: 410007

    RECRUITING

    Seoul, 06614, South Korea

  • Investigational Site Number: 410008

    RECRUITING

    Gwangju, 61665, South Korea

  • Investigational Site Number: 410009

    RECRUITING

    Busan, 49408, South Korea

  • Investigational Site Number: 410010

    RECRUITING

    Hanam, 12919, South Korea

  • Investigational Site Number: 410011

    RECRUITING

    Daegu, 41794, South Korea

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