Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine

NCT ID: NCT04707391

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2023-09-29

Brief Summary

The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.

Conditions

Meningitis, Meningococcal

Study Design

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

Study Groups

ABCWY Group

Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.

Group Type: EXPERIMENTAL

MenABCWY vaccine

Intervention Type: COMBINATION_PRODUCT

2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.

Placebo

Intervention Type: COMBINATION_PRODUCT

1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group

ACWY Group

Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.

Group Type: ACTIVE_COMPARATOR

MenACWY vaccine

Intervention Type: BIOLOGICAL

1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group

MenB vaccine

Intervention Type: COMBINATION_PRODUCT

2 doses of MenB vaccine administered intramuscularly on Day 181 and Day 211 to participants in ACWY group. MenB vaccine is a non-investigational medical product (NIMP) in this study and is administered only in compliance with standard of care.

Interventions

MenABCWY vaccine

2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.

Intervention Type: COMBINATION_PRODUCT

Placebo

1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group

Intervention Type: COMBINATION_PRODUCT

MenACWY vaccine

1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group

Intervention Type: BIOLOGICAL

MenB vaccine

2 doses of MenB vaccine administered intramuscularly on Day 181 and Day 211 to participants in ACWY group. MenB vaccine is a non-investigational medical product (NIMP) in this study and is administered only in compliance with standard of care.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Menveo; Bexsero

Eligibility Criteria

Inclusion Criteria

1. Participants and/or participants' parents/LARs, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).

2. Written or witnessed/thumb printed informed consent obtained from the participant/participant's parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.

3. Written or witnessed/thumb printed informed assent obtained from participants below the legal age of consent prior to performance of any study specific procedure.

4. Previous vaccination with 1 dose of MenACWY vaccine at an age of 10 years or older, with an interval of at least 4 years between the previous MenACWY vaccine and enrollment (informed consent and assent [as applicable]) into this study.

5. A male or female between, and including, 15 and 25 years of age (i.e., 25 years and 364 days) at the time of the first vaccination.

6. Healthy participants as established by medical history, physical examination, and clinical judgment of the investigator before entering into the study.

7. Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or post-menopause.

8. Female participants of childbearing potential may be enrolled in the study, if the participant:

• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test* on the day of vaccination, and
• has agreed to continue adequate contraception during the entire intervention period and for 30 days after completion of the vaccination series.

Exclusion Criteria

1. Current or previous, confirmed or suspected disease caused by N. meningitidis.

2. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrollment.

3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product.

4. Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study.

5. Progressive, unstable or uncontrolled clinical conditions

6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

7. Abnormal function or modification of the immune system resulting from:

• Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
• Systemic administration of corticosteroids (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to study vaccination until the following post vaccination blood sample. This will mean prednisone ≥20 mg/day (for adult participants and ≥0.5 mg/kg/day with maximum ≥20 mg/day for pediatric 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 (e.g., infliximab).

8. Any neuroinflammatory (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion.

9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

10. Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study vaccine(s)/product during the period beginning 30 days before the first dose of study vaccine(s)/product (Day -29 to Day 1), or planned use during the study period.

11. Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable (according to the participant's age).

12. Previous vaccination with 2 or more doses of MenACWY vaccine.

13. Administration/planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before any dose of study vaccine(s)/product until the following post-vaccination blood sample.

14. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to any vaccine/product dose until the following post-vaccination blood sample. For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants and ≥0.5 mg/kg/day with maximum ≥20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.

15. 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).

16. Child in care.

17. Pregnant or lactating female.

18. Female planning to become pregnant or planning to discontinue contraceptive precautions.

19. History of/current chronic alcohol and/or drug abuse.

20. Involvement in the study as a study staff member or being immediate dependents, family, or household member of a study staff member.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Banning, California, United States

GSK Investigational Site

Chula Vista, California, United States

GSK Investigational Site

West Covina, 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

Port Orange, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Columbus, Georgia, United States

GSK Investigational Site

Sandy Springs, Georgia, United States

GSK Investigational Site

Meridian, Idaho, United States

GSK Investigational Site

Champaign, Illinois, United States

GSK Investigational Site

Quincy, Illinois, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Fall River, Massachusetts, United States

GSK Investigational Site

Methuen, Massachusetts, United States

GSK Investigational Site

Roslindale, Massachusetts, United States

GSK Investigational Site

Grosse Pointe Woods, Michigan, United States

GSK Investigational Site

Biloxi, Mississippi, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Fayetteville, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Cranberry Township, Pennsylvania, United States

GSK Investigational Site

Monongahela, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Warwick, Rhode Island, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Beaumont, Texas, United States

GSK Investigational Site

Carrollton, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Katy, Texas, United States

GSK Investigational Site

Longview, Texas, United States

GSK Investigational Site

Plano, Texas, United States

GSK Investigational Site

The Woodlands, Texas, United States

GSK Investigational Site

Kaysville, Utah, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

Roy, Utah, United States

GSK Investigational Site

Syracuse, Utah, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

CABA, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, Argentina

GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Córdoba, , Argentina

GSK Investigational Site

Río Cuarto, , Argentina

GSK Investigational Site

Coffs Harbour, New South Wales, Australia

GSK Investigational Site

Darlinghurst, New South Wales, Australia

GSK Investigational Site

Kanwal, New South Wales, Australia

GSK Investigational Site

Maroubra, New South Wales, Australia

GSK Investigational Site

Taringa, Queensland, Australia

GSK Investigational Site

Tarragindi, Queensland, Australia

GSK Investigational Site

Clayton, Victoria, Australia

GSK Investigational Site

Parkville, Victoria, Australia

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Guelph, Ontario, Canada

GSK Investigational Site

Sarnia, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

Countries

United States; Argentina; Australia; Canada

References

Nolan T, Bhusal C, Hoberman A, Llapur CJ, Voloshyna O, Fink E, Gentile A, Wallace G, Richmond PC, Domachowske JB, Mzolo T, Lattanzi M, Toneatto D; BOOST Study Group. Immunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults Who Had Previously Received a Meningococcal ACWY Vaccine: A Phase 3, Randomized Controlled Clinical Study. Clin Infect Dis. 2025 Apr 30;80(4):752-760. doi: 10.1093/cid/ciae622.

Reference Type: DERIVED

PMID: 39722560 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-004982-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

213171

Identifier Type: -

Identifier Source: org_study_id