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New meningitis vaccine shows promise for toddlers in phase 3 trial

NCT ID NCT03890367

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tested a new vaccine (MenACYW) in 707 healthy toddlers aged 12-23 months. The vaccine aims to protect against four types of meningococcal bacteria that can cause meningitis and sepsis. Researchers compared the new vaccine to two existing vaccines (Nimenrix and NeisVac-C) to see if it works as well or better. The study measured immune responses and safety.

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 (meningococcal vaccine)
What this could lead to
If successful, this could provide a new option to protect toddlers against four types of meningococcal bacteria, potentially offering better or equal protection compared to current vaccines.
What could go wrong
This trial is already completed, so results are known. However, the new vaccine may not prove superior to existing ones, and like all vaccines, it can cause side effects such as injection site reactions 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

707 people

The number who actually took part.

Started

Sep 2019

Finished

Oct 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

12 to 23 months

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 12 to 23 months on the day of the first study visit ("12 to 23 months" means from the 12th month after birth to the day before the 24th month after birth). * Informed consent form (ICF) had been signed and dated by the parent(s)/legally acceptable representative(s) and by an independent witness if required by local regulations. * Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures. Exclusion criteria: * Participation in the 4 weeks (28 days) preceding the study vaccination or planned participation during the present study period in another clinical study 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 prior to Visit 2 except for influenza vaccination, which might be received at least 2 weeks before or after study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B 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 study or to a vaccine containing any of the same substances . * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine. * Personal history of Guillain-Barré syndrome. * Thrombocytopenia, as reported by the parent/ legally acceptable representative or suspected thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion. * Chronic illness 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 \>= 38.0 degree Celsius). 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 a 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 2080001

    Aarhus, 8200, Denmark

  • Investigational Site Number 2080002

    Hvidovre, 2650, Denmark

  • Investigational Site Number 2080003

    Odense, 5000, Denmark

  • Investigational Site Number 2460001

    Tampere, 33100, Finland

  • Investigational Site Number 2460002

    Turku, 20520, Finland

  • Investigational Site Number 2460003

    Pori, 28100, Finland

  • Investigational Site Number 2460004

    Jarvenpaa, 04400, Finland

  • Investigational Site Number 2460005

    Helsinki, 00100, Finland

  • Investigational Site Number 2460006

    Espoo, 02230, Finland

  • Investigational Site Number 2460007

    Oulu, 90220, Finland

  • Investigational Site Number 2460008

    Kokkola, 67100, Finland

  • Investigational Site Number 2460010

    Seinäjoki, 60100, Finland

  • Investigational Site Number 2760002

    Erfurt, 99086, Germany

  • Investigational Site Number 2760003

    Mönchengladbach, 41236, Germany

  • Investigational Site Number 2760004

    Bramsche, 49565, Germany

  • Investigational Site Number 2760005

    Mönchengladbach, 41236, Germany

  • Investigational Site Number 2760006

    Schönau, 83471, Germany

  • Investigational Site Number 2760007

    Hürth, 50354, Germany

  • Investigational Site Number 2760008

    Schwaigern, 74193, Germany

  • Investigational Site Number 2760009

    Schweigen, 76889, Germany

  • Investigational Site Number 2760010

    Tuttlingen, 78532, Germany

  • Investigational Site Number 2760011

    Mannheim, 68161, Germany

  • Investigational Site Number 2760012

    Wolfsburg, 38448, Germany

  • Investigational Site Number 2760013

    Itzehoe, 25524, Germany

  • Investigational Site Number 2760015

    Bönnigheim, 74357, Germany

  • Investigational Site Number 2760017

    Hamburg, 22415, Germany

  • Investigational Site Number 2760018

    Tauberbischofsheim, 97941, Germany

  • Investigational Site Number 2760019

    Bretten, 75015, Germany

  • Investigational Site Number 2760020

    Herxheim, 76863, Germany

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