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New meningitis vaccine shows promise for infants in major trial

NCT ID NCT06284915

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new meningitis vaccine (MenACYW) in 840 healthy infants and toddlers. The goal was to see if it works as well as an existing vaccine (Nimenrix) when given as two shots at 6 and 12 months of age. The trial measured immune response and monitored safety to support a simplified vaccination schedule.

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

840 people

The number who actually took part.

Started

Mar 2024

Finished

Nov 2025

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 14 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 6 to 7 months on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history, physical examination and judgment of the Investigator Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * 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 study (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 * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention(s) used in the study or to a product containing any of the same substances * Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * Receipt of any vaccine (including COVID-19) and Meningococcal B vaccines) in the 4 weeks preceding the first and second study intervention administration or planned receipt of any vaccine (including COVID-19 and Meningococcal B vaccines) in the 4 weeks following any study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study interventions. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. * Previous vaccination against meningococcal A, C, W, or Y disease with either the trial vaccine or another vaccine (i.e., mono- or quadrivalent meningococcal conjugate vaccine) containing serogroups A, C, Y, or W.

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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 : 2030002

    České Budějovice, 370 06, Czechia

  • Investigational Site Number : 2080005

    Hjørring, 9800, Denmark

  • Investigational Site Number : 2460003

    Kokkola, 67100, Finland

  • Investigational Site Number : 2760009

    Worms, 67550, Germany

  • Investigational Site Number : 6160001

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

  • Investigational Site Number : 6420001

    Bucharest, 011025, Romania

  • Investigational Site Number : 6420003

    Bucharest, 021105, Romania

  • Investigational Site Number: 2030001

    České Budějovice, Czechia

  • Investigational Site Number: 2030005

    Prague, Czechia

  • Investigational Site Number: 2080001

    Zeeland, Denmark

  • Investigational Site Number: 2080002

    Odense, Denmark

  • Investigational Site Number: 2080004

    Aarhus, Denmark

  • Investigational Site Number: 2080006

    Herlev, Denmark

  • Investigational Site Number: 2080007

    Aalborg, Denmark

  • Investigational Site Number: 2460002

    Helsinki, Finland

  • Investigational Site Number: 2460004

    Tampere, Finland

  • Investigational Site Number: 2460005

    Espoo, Finland

  • Investigational Site Number: 2460006

    Jaarvenpa, Finland

  • Investigational Site Number: 2460007

    Oulu, Finland

  • Investigational Site Number: 2460011

    Helsinki, Finland

  • Investigational Site Number: 2460012

    Turku, Finland

  • Investigational Site Number: 2760001

    Mönchengladbach, Germany

  • Investigational Site Number: 2760003

    Hürth, Germany

  • Investigational Site Number: 2760004

    Herxheim, Germany

  • Investigational Site Number: 2760005

    Schönau am Königssee, Germany

  • Investigational Site Number: 2760007

    Erfurt, Germany

  • Investigational Site Number: 2760008

    Schweigen-Rechtenbach, Germany

  • Investigational Site Number: 2760010

    Wolfsburg, Germany

  • Investigational Site Number: 2760011

    Mönchengladbach, Germany

  • Investigational Site Number: 6160002

    Wroclaw, Poland

  • Investigational Site Number: 6160003

    Bydgoszcz, Poland

  • Investigational Site Number: 6160004

    Łomianki, Poland

  • Investigational Site Number: 6160007

    Torun, Poland

  • Investigational Site Number: 6160008

    Bydgoszcz, Poland

  • Investigational Site Number: 6160010

    Wroclav, Poland

  • Investigational Site Number: 6160011

    Siemianowice Śląskie, Poland

  • Investigational Site Number: 6160012

    Luboń, Poland

  • Investigational Site Number: 6160014

    Trzebnica, Poland

  • Investigational Site Number: 6160015

    Krakow, Poland

  • Investigational Site Number: 6160016

    Łęczna, Poland

  • Investigational Site Number: 6160017

    Bydgoszcz, Poland

  • Investigational Site Number: 6160021

    Krakow, Poland

  • Investigational Site Number: 6160022

    Warsaw, Poland

  • Investigational Site Number: 6420002

    Bucharest, Romania

  • Investigational Site Number: 6420005

    Calarasi, Romania

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