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New meningitis booster shows promise in phase 3 trial

NCT ID NCT04084769

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a booster dose of an experimental meningitis vaccine (MenACYW) in 570 healthy teens and adults who had received a meningitis vaccine 3-6 years earlier. The goal was to see if the booster could restore strong immunity against four types of meningococcal bacteria. Results will help determine if this vaccine can be used as a booster to maintain protection.

What this could mean

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

Active substance
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (MenACYW)
What this could lead to
If successful, this could provide a safe and effective booster option to maintain protection against meningococcal disease in adolescents and adults.
What could go wrong
This is a completed Phase 3 trial, so results are already in. However, the vaccine is still investigational and may not be approved or widely available. Side effects are possible, as with any vaccine.

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

570 people

The number who actually took part.

Started

Sep 2019

Finished

Sep 2020

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

13 to 26 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 \>= 13 to less than (\<) 26 years on the day of inclusion. * Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only) or study MET43 (MET43 Groups 1, 2, or 3 only). * For MET59 Group 2 only (Menveo vaccine-primed participants only; enrichment population): participants had a documented record of having received 1 dose of Menveo vaccine 3-6 years earlier either as part of a clinical trial or as routine vaccination. Participants who participated in MET50 Group 4 can be enrolled if they fulfill this criterion. * Participants aged 13 to \< 18 years: assent form had been signed and dated by the participant and informed consent form (ICF) had been signed and dated by the parent or guardian. * Participants aged \>=18 (or legal age of majority, if different from 18 years of age) to \< 26 years: ICF had been signed and dated by the participants. * Participant aged 13 to \< 18 years: both the participant and parent or guardian were able to attend all scheduled visits and complied with all trial procedures. * Participants aged \>=18 (or legal age of majority, if different from 18 years of age) to \< 26 years: able to attend all scheduled visits and complied with all trial procedures. Exclusion criteria: * Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile. * Participation 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. * Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine before Visit 3 (Day 30) except for influenza vaccination, which might be received at least 2 weeks before study investigational vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Receipt of any meningococcal vaccine including a licensed or investigational MenACWY vaccine or MenB vaccine since participation in study MET50 or MET43. * Menveo vaccine-primed participants only (enrichment group for Group 2): receipt of more than 1 dose of Menveo vaccine or vaccination with another licensed or investigational MenACWY vaccine or with a licensed or investigational MenB vaccine. * 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 travelling to countries with high endemic or epidemic disease). * 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. * Personal history of Guillain-Barré syndrome. * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination. * Verbal report of thrombocytopenia, contraindicating IM vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination. * Current alcohol abuse or drug addiction. * Chronic illness (e.g., Human immunodeficiency viruses, hepatitis B, hepatitis C) that, in the opinion of the investigator, was 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 \>= 100.4 degree Fahrenheit). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. The above information was not intended to contain all considerations relevant to a participant'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.

Meningococcal immunisation (healthy volunteers)

Contacts and locations

Locations

  • Investigational Site Number 6300001

    San Juan, 00981, Puerto Rico

  • Investigational Site Number 8400001

    Layton, Utah, 84041, United States

  • Investigational Site Number 8400002

    Lincoln, Nebraska, 68505, United States

  • Investigational Site Number 8400003

    Salt Lake City, Utah, 84107, United States

  • Investigational Site Number 8400004

    Lincoln, Nebraska, 68516, United States

  • Investigational Site Number 8400005

    San Diego, California, 92123-1881, United States

  • Investigational Site Number 8400007

    Salt Lake City, Utah, 84109, United States

  • Investigational Site Number 8400009

    Norman, Oklahoma, 73069, United States

  • Investigational Site Number 8400011

    Provo, Utah, 84064, United States

  • Investigational Site Number 8400012

    Birmingham, Alabama, 35205, United States

  • Investigational Site Number 8400013

    Bardstown, Kentucky, 40004, United States

  • Investigational Site Number 8400014

    Layton, Utah, 84041, United States

  • Investigational Site Number 8400015

    South Jordan, Utah, 84095, United States

  • Investigational Site Number 8400018

    Kingsport, Tennessee, 37660, United States

  • Investigational Site Number 8400022

    Salt Lake City, Utah, 84109, United States

  • Investigational Site Number 8400023

    Roy, Utah, 84067, United States

  • Investigational Site Number 8400024

    West Jordan, Utah, 84088-8865, United States

  • Investigational Site Number 8400027

    Lincoln, Nebraska, 68504, United States

  • Investigational Site Number 8400028

    South Euclid, Ohio, 44121, United States

  • Investigational Site Number 8400029

    Tullahoma, Tennessee, 37388, United States

  • Investigational Site Number 8400030

    Dayton, Ohio, 45414, United States

  • Investigational Site Number 8400031

    Kaysville, Utah, 84037, United States

  • Investigational Site Number 8400032

    Syracuse, Utah, 84075-9645, United States

  • Investigational Site Number 8400033

    Lexington, Kentucky, 40517, United States

  • Investigational Site Number 8400034

    Bridgeton, Missouri, 63044, United States

  • Investigational Site Number 8400036

    South Jordan, Utah, 84095, United States

  • Investigational Site Number 8400037

    Charlottesville, Virginia, 22903, United States

  • Investigational Site Number 8400038

    Erie, Pennsylvania, 16505, United States

  • Investigational Site Number 8400039

    Charleston, South Carolina, 29414, United States

  • Investigational Site Number 8400040

    Orem, Utah, 84057, United States

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