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

NCT04707391 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2131712019-004982-42
• Study Type: interventional
• Target: 1,250
• Locations: 4 countries
• Sites: 69

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

Keywords

Neisseria meningitidis; Meningococcal disease

Outcome Measures

Primary Outcomes (9)

• Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline

  Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ.

  At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline)

• Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline

  Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ.

  At 1 month after the first vaccination (i.e., Day 31) compared to Day 1 (Baseline)

• Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group

  Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.

  During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group

• Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group

  Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.

  During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group

• Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group

  Assessed solicited systemic events include fever \[body temperature \>= 38.0°C (celsius) /100.4°F (Fahrenheit)\], nausea, fatigue, myalgia, arthralgia, headache.

  During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group

• Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group

  Assessed solicited systemic events include fever \[body temperature \>= 38.0°C/100.4°F\], nausea, fatigue, myalgia, arthralgia, headache.

  During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group

• Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs)

  Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-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 characterize and understand it. An MAE is defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.

  During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group

• Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) Following Vaccination at Day 181 for ABCWY Group

  Any AE-untoward medical occurrence in a patient/clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-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 characterize and understand it.

  During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group

• Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs

  SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were assessed throughout the study period are reported in this outcome measure.

  From Day 1 to Day 361 (throughout the study period)

Secondary Outcomes (10)

• Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination

  At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)

• Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination

  1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])

• hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination

  At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)

• hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination

  1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])

• Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination

  At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) compared to baseline (Day 1)

Study Arms (2)

ABCWY Group

EXPERIMENTAL

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.

Combination Product: MenABCWY vaccine; Combination Product: Placebo

ACWY Group

ACTIVE COMPARATOR

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

Biological: MenACWY vaccine; Combination Product: MenB vaccine

Interventions

MenABCWY vaccine COMBINATION_PRODUCT

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

ABCWY Group

Placebo COMBINATION_PRODUCT

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

ABCWY Group

MenACWY vaccine BIOLOGICAL

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

Also known as: Menveo

ACWY Group

MenB vaccine 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.

Also known as: Bexsero

ACWY Group

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).
• 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.
• Written or witnessed/thumb printed informed assent obtained from participants below the legal age of consent prior to performance of any study specific procedure.
• 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.
• 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.
• 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, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or post-menopause.
• 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.

You may not qualify if:

• 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 enrollment.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product.
• 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.
• Progressive, unstable or uncontrolled clinical conditions
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
• 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).
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• 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.
• 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).
• Previous vaccination with 2 or more doses of MenACWY vaccine.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (69)

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

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GSK Investigational Site

Banning, California, 92220, United States

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GSK Investigational Site

Chula Vista, California, 91911, United States

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GSK Investigational Site

West Covina, California, 91790, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20017, United States

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GSK Investigational Site

Miami, Florida, 33126, United States

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GSK Investigational Site

Miami, Florida, 33135, United States

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GSK Investigational Site

Port Orange, Florida, 32127, United States

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GSK Investigational Site

Atlanta, Georgia, 30338, United States

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GSK Investigational Site

Columbus, Georgia, 31904, United States

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GSK Investigational Site

Sandy Springs, Georgia, 30328, United States

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GSK Investigational Site

Meridian, Idaho, 83642, United States

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GSK Investigational Site

Champaign, Illinois, 61822, United States

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GSK Investigational Site

Quincy, Illinois, 62301, United States

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GSK Investigational Site

Louisville, Kentucky, 40291, United States

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GSK Investigational Site

Boston, Massachusetts, 02114, United States

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GSK Investigational Site

Fall River, Massachusetts, 02725, United States

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GSK Investigational Site

Methuen, Massachusetts, 01844, United States

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GSK Investigational Site

Roslindale, Massachusetts, 02135, United States

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GSK Investigational Site

Grosse Pointe Woods, Michigan, 48236, United States

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GSK Investigational Site

Biloxi, Mississippi, 39531, United States

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GSK Investigational Site

Albuquerque, New Mexico, 87102, United States

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GSK Investigational Site

Syracuse, New York, 13210, United States

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GSK Investigational Site

Fayetteville, North Carolina, 28304, United States

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GSK Investigational Site

Raleigh, North Carolina, 27612, United States

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GSK Investigational Site

Wilmington, North Carolina, 28401, United States

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GSK Investigational Site

Cranberry Township, Pennsylvania, 16066, United States

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GSK Investigational Site

Monongahela, Pennsylvania, 15063, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15025, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15217, United States

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GSK Investigational Site

Warwick, Rhode Island, 02886-6110, United States

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GSK Investigational Site

Charleston, South Carolina, 29406, United States

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GSK Investigational Site

Greenville, South Carolina, 29607, United States

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GSK Investigational Site

Austin, Texas, 78745, United States

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GSK Investigational Site

Beaumont, Texas, 77706, United States

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GSK Investigational Site

Carrollton, Texas, 75010, United States

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GSK Investigational Site

Dallas, Texas, 75251, United States

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GSK Investigational Site

Houston, Texas, 77055, United States

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GSK Investigational Site

Katy, Texas, 77450, United States

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GSK Investigational Site

Longview, Texas, 75605, United States

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GSK Investigational Site

Plano, Texas, 75024, United States

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GSK Investigational Site

The Woodlands, Texas, 77381-3527, United States

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GSK Investigational Site

Kaysville, Utah, 84037, United States

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GSK Investigational Site

Layton, Utah, 84041, United States

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GSK Investigational Site

Roy, Utah, 84067, United States

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GSK Investigational Site

Syracuse, Utah, 84075, United States

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GSK Investigational Site

Seattle, Washington, 98105, United States

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GSK Investigational Site

CABA, Buenos Aires, C1222, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, Buenos Aires, C1425AWK, Argentina

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GSK Investigational Site

Mar del Plata, Buenos Aires, B7600FYH, Argentina

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GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

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GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, T4000NWB, Argentina

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GSK Investigational Site

Buenos Aires, 1426, Argentina

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GSK Investigational Site

Buenos Aires, C1428, Argentina

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GSK Investigational Site

Córdoba, 5000, Argentina

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GSK Investigational Site

Río Cuarto, 5800, Argentina

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GSK Investigational Site

Coffs Harbour, New South Wales, 2450, Australia

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GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

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GSK Investigational Site

Kanwal, New South Wales, 2259, Australia

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GSK Investigational Site

Maroubra, New South Wales, 2035, Australia

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GSK Investigational Site

Taringa, Queensland, 4068, Australia

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GSK Investigational Site

Tarragindi, Queensland, 4121, Australia

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GSK Investigational Site

Clayton, Victoria, 3168, Australia

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GSK Investigational Site

Parkville, Victoria, 3052, Australia

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GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

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GSK Investigational Site

Guelph, Ontario, N1H 1B1, Canada

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GSK Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

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GSK Investigational Site

Toronto, Ontario, M9V 4B4, Canada

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Related Publications (1)

• 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.

  PMID: 39722560 DERIVED

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningococcal Infections

Interventions

Meningococcal Vaccines; 4CMenB vaccine

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: January 25, 2021
• Primary Completion: May 3, 2023
• Study Completion: September 29, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

AR (9); US (48); CA (3); AU (9)