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One shot to rule them all? new vaccine targets five meningococcal strains in infants

NCT ID NCT05082285

Vaccine Sponsor: GlaxoSmithKline 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 combination vaccine designed to protect healthy infants against five types of meningococcal bacteria (A, B, C, W, and Y) that can cause serious infections like meningitis. Over 700 infants received different doses or combinations of the vaccine to check safety and immune response. The goal is to see if this combined shot can offer broad protection with fewer injections.

What this could mean

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

Active substance
Meningococcal combined ABCWY vaccine
What this could lead to
If successful, this vaccine could protect infants against five types of meningococcal bacteria with fewer shots, reducing the risk of serious infections like meningitis.
What could go wrong
This is an early phase 2 trial, so the vaccine may not prove effective enough or could cause side effects. Results in infants may differ from older 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

726 people

The number who actually took part.

Started

Nov 2021

Finished

Mar 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

55 to 89 days

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: * Participants' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. * Healthy participants as established by medical history and clinical examination before entering into the study. * A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination. * Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg. Exclusion Criteria: Medical conditions * Current or previous, confirmed or suspected disease caused by N. meningitidis. * Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth. * Progressive, unstable or uncontrolled clinical conditions. * Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures. * Congenital or peripartum disorders resulting in a chronic condition * Major congenital defects, as assessed by the investigator. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s). * Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study. * Abnormal function or modification of the immune system resulting from: * Autoimmune disorders or immunodeficiency syndromes. * Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed. * Administration of antineoplastic and immunomodulating agents or radiotherapy from birth. * Administration of long-acting immune-modifying drugs at any time during the study period. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant therapy * Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines from birth, or planned use during the study period. * Previous vaccination with any meningococcal vaccine. * Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed. Prior/Concurrent clinical study experience * Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device). Other exclusions * Child in care. * Study personnel as an immediate family or household member. * For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.

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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.

Infections, meningococcal

Contacts and locations

Locations

  • GSK Investigational Site

    Santo Domingo Este, Dominican Republic

  • GSK Investigational Site

    Espoo, 02230, Finland

  • GSK Investigational Site

    Helsinki, 00100, Finland

  • GSK Investigational Site

    Jarvenpaa, 04400, Finland

  • GSK Investigational Site

    Kokkola, 67100, Finland

  • GSK Investigational Site

    Oulu, 90220, Finland

  • GSK Investigational Site

    Seinäjoki, 60100, Finland

  • GSK Investigational Site

    Gilching, 82205, Germany

  • GSK Investigational Site

    Schönau am Königssee, 83471, Germany

  • GSK Investigational Site

    San Pedro Sula, 21101, Honduras

  • GSK Investigational Site

    Bydgoszcz, 85-048, Poland

  • GSK Investigational Site

    Krakow, 30-348, Poland

  • GSK Investigational Site

    Krakow, 30-644, Poland

  • GSK Investigational Site

    Luboń, 62-030, Poland

  • GSK Investigational Site

    Siemianowice Śląskie, 41-103, Poland

  • GSK Investigational Site

    Torun, 87-100, Poland

  • GSK Investigational Site

    Trzebnica, 55-100, Poland

  • GSK Investigational Site

    Warsaw, 02-647, Poland

  • GSK Investigational Site

    Wroclaw, 50368, Poland

  • GSK Investigational Site

    Parow Valley, 7505, South Africa

  • GSK Investigational Site

    Soweto Gauteng, 2013, South Africa

  • GSK Investigational Site

    Almería, 04120, Spain

  • GSK Investigational Site

    Burgos, 09006, Spain

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Madrid, 28222, Spain

  • GSK Investigational Site

    Marbella, 29600, Spain

  • GSK Investigational Site

    Málaga, 29004, Spain

  • GSK Investigational Site

    Santiago de Compostela, 15706, Spain

  • GSK Investigational Site

    Seville, 41013, Spain

  • GSK Investigational Site

    Exeter, EX2 5DW, United Kingdom

  • GSK Investigational Site

    Oxford, OX3 7LE, United Kingdom

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