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

NCT ID: NCT05087056

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2027-02-05

Brief 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.

Conditions

Meningitis, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ABCWY-24 Group

Participants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 721, 1 dose of Placebo at Day 1441.

Group Type: EXPERIMENTAL

MenABCWY vaccine

Intervention Type: COMBINATION_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.

Placebo

Intervention Type: COMBINATION_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.

ABCWY-48 Group

Participants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 1441, 1 dose of Placebo at Day 721.

Group Type: EXPERIMENTAL

MenABCWY vaccine

Intervention Type: COMBINATION_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.

Placebo

Intervention Type: COMBINATION_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.

Interventions

MenABCWY vaccine

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.

Intervention Type: COMBINATION_PRODUCT

Placebo

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

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 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.
• 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Ventura, California, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Macon, Georgia, United States

GSK Investigational Site

Valparaiso, Indiana, United States

GSK Investigational Site

Nicholasville, Kentucky, United States

GSK Investigational Site

Haughton, Louisiana, United States

GSK Investigational Site

Missoula, Montana, United States

GSK Investigational Site

Missoula, Montana, United States

GSK Investigational Site

Grand Island, Nebraska, United States

GSK Investigational Site

Lincoln, Nebraska, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Binghamton, New York, United States

GSK Investigational Site

Endwell, New York, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Gresham, Oregon, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Kingsport, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Galveston, Texas, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

Bramsche, , Germany

GSK Investigational Site

Herxheim, , Germany

GSK Investigational Site

Leipzig, , Germany

GSK Investigational Site

Mannheim, , Germany

GSK Investigational Site

Schönau am Königssee, , Germany

GSK Investigational Site

Schweigen-Rechtenbach, , Germany

Countries

United States; Germany

Other Identifiers

2021-001670-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

215344

Identifier Type: -

Identifier Source: org_study_id