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Can a booster shot keep teens safe from meningitis?

NCT ID NCT04936685

Vaccine Sponsor: Sanofi Pasteur, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether booster doses of the MenACYW vaccine, given years after the first shot, keep children and teens protected against meningococcal disease. Researchers will measure antibody levels in the blood before and after the booster to see if the immune system responds strongly. The study includes about 209 healthy participants who received the vaccine as toddlers. The goal is to understand how long protection lasts and whether additional doses are safe and effective.

What this could mean

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

Active substance
MenACYW conjugate vaccine (MenQuadfi)
What this could lead to
If it works, this could show that booster doses keep teens protected against meningococcal disease for years after their first shots.
What could go wrong
This is an early-stage study with a small group, so results may not apply to everyone. The vaccine could also cause side effects like pain or fever.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

209 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Dec 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.

Ages

6 to 7 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: * Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2) * Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures * Covered by health insurance, if required by local regulations Exclusion Criteria: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically * At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease) * Personal history of Guillain-Barré syndrome (GBS) * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 (Group 1 and 3) and of Meningococcal B vaccine * Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study * The above information is not intended to contain all considerations relevant to a patient's 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 immunisation

Contacts and locations

Locations

  • Investigational Site Number : 2460001

    Helsinki, 00100, Finland

  • Investigational Site Number : 2460002

    Jarvenpaa, 04400, Finland

  • Investigational Site Number : 2460003

    Pori, 28100, Finland

  • Investigational Site Number : 2460004

    Kokkola, 67100, Finland

  • Investigational Site Number : 2460006

    Helsinki, 00930, Finland

  • Investigational Site Number : 2460007

    Oulu, 90220, Finland

  • Investigational Site Number : 2460008

    Tampere, 33100, Finland

  • Investigational Site Number : 2460009

    Espoo, 02230, Finland

  • Investigational Site Number : 2460010

    Turku, 20520, Finland

  • Investigational Site Number : 2760001

    Bramsche, 49565, Germany

  • Investigational Site Number : 2760002

    Mönchengladbach, 41236, Germany

  • Investigational Site Number : 2760003

    Tauberbischofsheim, 97941, Germany

  • Investigational Site Number : 2760004

    Erfurt, 99086, Germany

  • Investigational Site Number : 2760006

    Schönau am Königssee, 83471, Germany

  • Investigational Site Number : 2760007

    Bretten, 75015, Germany

  • Investigational Site Number : 2760008

    Mönchengladbach, 41236, Germany

  • Investigational Site Number : 2760009

    Goch, 47574, Germany

  • Investigational Site Number : 2760011

    Bönnigheim, 74357, Germany

  • Investigational Site Number : 2760015

    Hamburg, 22415, Germany

  • Investigational Site Number : 3480001

    Budapest, 1188, Hungary

  • Investigational Site Number : 3480002

    Budapest, 1042, Hungary

  • Investigational Site Number : 3480005

    Miskolc, 3527, Hungary

  • Investigational Site Number : 3480006

    Székesfehérvár, 8000, Hungary

  • Investigational Site Number : 7240001

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number : 7240002

    Madrid, 28007, Spain

  • Investigational Site Number : 7240003

    Seville, 41014, Spain

  • Investigational Site Number : 7240006

    Santiago de Compostela, Galicia [Galicia], 15706, Spain

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