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Meningitis, MeningococcalPhase 2NCT05087056

Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

A Phase 2 study testing MenABCWY vaccine in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 30 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. Read more about this study

Who is it for?
Ages 11 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Meningitis, Meningococcal
What is being tested?
MenABCWY vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
30 sitesin 2 countries
Study dates
18 Nov 2021to 10 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Participants or/and 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 participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
  • Written informed assent obtained from the participant (if applicable) prior to performing any study specific procedure.
  • A male or female between, and including, 11 and 14 years of age (i.e. 14 years + 364 days) at the time of the first vaccination.
  • Healthy participants as established by medical history, physical examination and clinical judgment of the investigator before entering into the study.
  • Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, hysterectomy, bilateral-salpingectomy or bilateral ovariectomy.
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  • Female participants of childbearing potential may be enrolled in the study, if the participant:
  • has practiced adequate contraception for 30 days prior to first vaccination, and
  • has a negative pregnancy test* on the day of vaccination, and
  • has agreed to follow adequate contraception for 30 days before each of the 2 subsequent vaccinations and for 30 days after each vaccination * Urine samples for pregnancy testing will be collected from female participants of childbearing potential at Visit 1, Visit 3 and Visit 5 prior to the vaccination.

Who cannot join

  • 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 within 60 days of enrolment.
  • Progressive, unstable or uncontrolled clinical conditions.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  • Any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures. History of febrile convulsions should not lead to exclusion.
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  • 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 within 90 days prior to study vaccination. This will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum 20 mg/day for paediatric participants. Inhaled and topical steroids are allowed.
  • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
  • 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 vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study period.
  • Previous vaccination with any meningococcal (MenB or MenACWY) vaccine at any time prior to informed consent/ assent (as applicable) with the exception of meningococcal C (conjugated or polysaccharide) vaccination, if the last dose of MenC was received at ≤24 months of age.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of study vaccine/product or planned administration before the next blood sampling visit.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine/product dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum of 20 mg/day for paediatric participants. 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.
  • Pregnant or lactating female.
  • Female planning to become pregnant / planning to discontinue contraceptive precautions during the windows reported in the inclusion criterion.
  • History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator.
  • Any study personnel or immediate dependants, family, or household members.

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States24 sites

  • GSK Investigational Site

    Austin, Texas, 75024

  • GSK Investigational Site

    Binghamton, New York, 13905-1118

  • GSK Investigational Site

    Birmingham, Alabama, 35205

  • GSK Investigational Site

    Charleston, South Carolina, 29414-5834

  • GSK Investigational Site

    Charlotte, North Carolina, 28226

  • GSK Investigational Site

    Endwell, New York, 13850

  • GSK Investigational Site

    Galveston, Texas, 77555 1115

  • GSK Investigational Site

    Grand Island, Nebraska, 68803

  • GSK Investigational Site

    Gresham, Oregon, 97030

  • GSK Investigational Site

    Haughton, Louisiana, 71037

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Layton, Utah, 84037

  • GSK Investigational Site

    Lincoln, Nebraska, 68510

  • GSK Investigational Site

    Macon, Georgia, 31210

  • GSK Investigational Site

    Miami, Florida, 33156-7397

  • GSK Investigational Site

    Miami, Florida, 33173

  • GSK Investigational Site

    Missoula, Montana, 59804

  • GSK Investigational Site

    Missoula, Montana, 80216

  • GSK Investigational Site

    Nicholasville, Kentucky, 40517

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Tucson, Arizona, 85745-2696

  • GSK Investigational Site

    Valparaiso, Indiana, 84088

  • GSK Investigational Site

    Ventura, California, 93003

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20016

Other trials in United States

Germany6 sites

  • GSK Investigational Site

    Bramsche, 49565

  • GSK Investigational Site

    Herxheim, 76863

  • GSK Investigational Site

    Leipzig, 16269

  • GSK Investigational Site

    Mannheim, 68309

  • GSK Investigational Site

    Schönau, Bavaria, 83471

  • GSK Investigational Site

    Schweigen-Rechtenbach, 76889

Other trials in Germany

About this study

Official title: A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

Being tested
MenABCWY vaccine, Placebo
Keywords
MenABCWY, Safety, Tolerability, Immunogenicity, Healthy adolescents, Invasive meningococcal disease
Medical subject headings
Meningitis, Meningococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MenABCWY vaccineCombination product

    Two doses of the MenABCWY vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, on a 0-, 24-month schedule in the ABCWY-24 Group, and a 0-, 48-month schedule in the ABCWY-48 Group.

  • PlaceboCombination product

    Single dose of Placebo (saline solution in pre-filled syringe), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1441 in the ABCWY-24 Group, and at Day 721 in the ABCWY-48 Group.

Study groups in NCT05087056
Study groupRoleWhat they receive
ABCWY-24 GroupExperimentalParticipants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 721, 1 dose of Placebo at Day 1441.
Receives: Combination Product: MenABCWY vaccine; Combination Product: Placebo
ABCWY-48 GroupExperimentalParticipants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 1441, 1 dose of Placebo at Day 721.
Receives: Combination Product: MenABCWY vaccine; Combination Product: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains

    The immune response to 2 doses of the MenABCWY vaccine administered on a 0-, 24-month schedule, and a 0-, 48-month schedule is evaluated against each N. meningitidis serogroup B indicator strains.

    Measured: At Baseline (Day 1)

  2. Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains

    The immune response to 2 doses of the MenABCWY vaccine administered on a 0-, 24-month schedule, and a 0-, 48-month schedule is evaluated against each N. meningitidis serogroup B indicator strains.

    Measured: At 1 month after the second dose of MenABCWY (Day 751 for the ABCWY-24 Group and Day 1471 for the ABCWY-48 Group)

  3. Percentage of participants with solicited administration site events

    The solicited administration site events include pain, redness, swelling and induration. Redness, swelling, and induration are summarized according to defined severity grading scales: None (0 to 24mm); Mild (25 to 50mm); Moderate (51 to 100mm); Severe (>100mm). Injection site pain is summarized according to "mild", "moderate" or "severe".

    Measured: During the 7 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441)

  4. Percentage of participants with solicited systemic events

    The solicited systemic events include fever, headache, nausea, myalgia, arthralgia and fatigue. Fever is defined as body temperature 38.0°C (100.4°F). The preferred location for measuring temperature in this study is the oral route. Solicited systemic events (except fever) are summarized according to "mild", "moderate" or "severe".

    Measured: During the 7 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441)

  5. Percentage of participants with any unsolicited adverse events (AEs) including all serious adverse events (SAEs), AEs leading to withdrawal, adverse events of special interest (AESIs) and medically attended AEs

    An unsolicited AE is an AE that was not included in a list of solicited events and must have been spontaneously communicated by a participant/participant's parent(s)/ Legally Acceptable Representative(s) who has signed the informed consent. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject or is an abnormal pregnancy outcome. AESIs are predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterise and understand it. Medically attended AEs are symptoms or illnesses requiring a hospitalisation, or an emergency room visit, or visit to/by a health care provider.

    Measured: During the 30 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441)

  6. Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject or is an abnormal pregnancy outcome. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterise and understand it. Medically attended AEs are symptoms or illnesses requiring a hospitalisation, or an emergency room visit, or visit to/by a health care provider.

    Measured: During the 6 months (including the day of vaccination) following the first vaccination (Vaccine administered at Day 1)

  7. Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject or is an abnormal pregnancy outcome. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterise and understand it. Medically attended AEs are symptoms or illnesses requiring a hospitalisation, or an emergency room visit, or visit to/by a health care provider.

    Measured: During the 6 months (including the day of vaccination) following the second vaccination (Vaccine administered at Day 721)

Secondary outcomes (2)

  1. Percentage of participants with hSBA titers ≥ LLOQ for N. meningitidis serogroups A, C, W and Y

    The immune response to 1 and 2 doses of the MenABCWY vaccine administered on a 0-, 24-month schedule, and a 0-, 48-month schedule is evaluated against N. meningitidis serogroups A, C, W and Y.

    Measured: At Baseline (Day 1), 1 month after the first dose of MenABCWY (Day 31) and 1 month after second dose of MenABCWY (Day 751 for the ABCWY-24 Group and Day 1471 for the ABCWY-48 Group)

  2. Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains and for serogroups A, C, W and Y

    The antibody persistence at 25 months after the second dose of the MenABCWY vaccine administered on a 0-, 24-month schedule is evaluated against each N. meningitidis serogroup B indicator strains and serogroups A, C, W and Y.

    Measured: At 25 months after the second dose of MenABCWY (Day 1471 for the ABCWY-24 Group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2021
  2. Study start18 Nov 2021
  3. Primary completion10 Mar 2027 (estimated)
  4. Study completion10 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05087056
Sponsor's protocol ID
215344
Other IDs
2021-001670-33
Status last verified
Sep 2026
First submitted
8 Oct 2021
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MenABCWY vaccine in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains (time frame: At Baseline (Day 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05087056.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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