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New 5-in-1 meningitis shot could protect kids from five strains at once

NCT ID NCT06647407

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new pentavalent meningococcal vaccine (MenPenta) that aims to protect against five types of meningococcal bacteria (A, B, C, W, Y) in healthy children, toddlers, and infants. Researchers will compare it to existing licensed vaccines and check how well it works when given alone or with routine childhood shots. The trial involves 750 participants across three age groups and will monitor immune response and side effects for up to 19 months.

What this could mean

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

Active substance
Pentavalent Meningococcal ABCYW vaccine (MenPenta)
What this could lead to
If successful, this could lead to a single vaccine that protects against five major types of meningococcal disease, simplifying childhood immunization schedules.
What could go wrong
This is an early-phase study (phase 1/2) with only 750 participants, so results may not confirm broad effectiveness or safety. The vaccine may not produce a strong enough immune response in all age groups.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 750 people

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

Started

Nov 2024

Expected to finish

May 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

56 days to 9 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 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion * For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 Kg and in both cases medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement 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 since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants) * History of any meningitis infection, confirmed either clinically, serologically, or microbiologically * At high risk of meningococcal infection during the study * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Individual with active tuberculosis * History of Guillain-Barré syndrome * For Stage 3 infants: History of intussusception * Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine * For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination NOTE: 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 immunization

Contacts and locations

Locations

  • Hospital das Clínicas da Universidade Federal de Minas Gerais- Site Number : 0760001

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Investigational Site Number : 2030003

    Jindřichův Hradec, 377 01, Czechia

  • Investigational Site Number : 2030004

    Ostrava, 700 30, Czechia

  • Investigational Site Number : 2030007

    Pilsen, 301 00, Czechia

  • Investigational Site Number : 2030008

    Prague, 180 00, Czechia

  • Investigational Site Number : 2030009

    Prague, 180 00, Czechia

  • Investigational Site Number : 2080002

    Hvidovre, 2650, Denmark

  • Investigational Site Number : 2080003

    Odense, 5000, Denmark

  • Investigational Site Number : 2460001

    Helsinki, 00100, Finland

  • Investigational Site Number : 2460002

    Seinäjoki, 60100, Finland

  • Investigational Site Number : 2460004

    Oulu, 90220, Finland

  • Investigational Site Number : 2460005

    Jarvenpaa, 04400, Finland

  • Investigational Site Number : 2460006

    Espoo, 02230, Finland

  • Investigational Site Number : 2460007

    Tampere, 33100, Finland

  • Investigational Site Number : 2460008

    Helsinki, 00290, Finland

  • Investigational Site Number : 2760003

    Wolfsburg, 38448, Germany

  • Investigational Site Number : 2760004

    Schönau am Königssee, 83471, Germany

  • Investigational Site Number : 2760005

    Krefeld, 47799, Germany

  • Investigational Site Number : 2760006

    Hürth, 50354, Germany

  • Investigational Site Number : 2760007

    Hürth, 50354, Germany

  • Investigational Site Number : 2760008

    Herxheim, 76863, Germany

  • Investigational Site Number : 2760009

    Mönchengladbach, 41236, Germany

  • Investigational Site Number : 3400001

    San Pedro Sula, Honduras

  • Investigational Site Number : 3400002

    Tegucigalpa, 11101, Honduras

  • Investigational Site Number : 3400003

    Tegucigalpa, 11101, Honduras

  • Investigational Site Number : 6160001

    Lodz, Lódzkie, 91-347, Poland

  • Investigational Site Number : 6160002

    Warsaw, Masovian Voivodeship, 02-793, Poland

  • Investigational Site Number : 6160003

    Warsaw, Masovian Voivodeship, 02-647, Poland

  • Investigational Site Number : 6160004

    Siemianowice Śląskie, Silesian Voivodeship, 41-103, Poland

  • Investigational Site Number : 6160005

    Trzebnica, Lower Silesian Voivodeship, 55-100, Poland

  • Investigational Site Number : 6160006

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-090, Poland

  • Investigational Site Number : 7240004

    Madrid, 28938, Spain

  • Investigational Site Number : 7240007

    Seville, Sevilla, 41013, Spain

  • Investigational Site Number : 7240009

    Madrid, 28041, Spain

  • Investigational Site Number : 8260004

    Exeter, Devon, EX2 5DW, United Kingdom

  • Investigational Site Number : 8260007

    London, England, E1 1BB, United Kingdom

  • Investigational Site Number : 8260009

    London, England, SW17 0QT, United Kingdom

  • Investigational Site Number : 8260010

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • Private Practice - Dr. Nelson Rosário- Site Number : 0760004

    Curitiba, Paraná, 80810-100, Brazil

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