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

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ClinicalTrials.gov Identifier: NCT04707391
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Meningitis, Meningococcal Combination Product: MenABCWY vaccine Combination Product: Placebo Biological: MenACWY vaccine Combination Product: MenB vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase IIIB, Randomized, Controlled, Observer-blind Study to Evaluate Safety and Immunogenicity of GSK's Meningococcal ABCWY Vaccine When Administered in Healthy Adolescents and Adults, Previously Primed With Meningococcal ACWY Vaccine
Actual Study Start Date : January 25, 2021
Estimated Primary Completion Date : April 23, 2023
Estimated Study Completion Date : April 23, 2023


Arm Intervention/treatment
Experimental: ABCWY Group
All participants in this group receive 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
2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.

Combination Product: Placebo
1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group

Active Comparator: ACWY Group
All participants in this group receive 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Biological: MenACWY vaccine
1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group
Other Name: Menveo

Combination Product: 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.
Other Name: Bexsero




Primary Outcome Measures :
  1. 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 second MenABCWY vaccine and after the single MenACWY vaccine [ Time Frame: At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) ]

    Immunogenicity of MenABCWY vaccine after its second dose compared to single dose of MenACWY vaccine, relative to baseline (Day 1) is assessed for each serogroups A, C, W and Y

    For each serogroup, the 4-fold rise is defined as:

    • a post-vaccination hSBA titer ≥ 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

  2. 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 first MenABCWY vaccine and after the single MenACWY vaccine [ Time Frame: At 1 month after the first vaccination (i.e., Day 31) ]
    Immunogenicity of MenABCWY vaccine after first dose compared to single dose of MenACWY vaccine, relative to baseline (Day 1) is measured. For the serogroups A, C, W, Y, evaluation of the 4-fold rise is defined as: a post-vaccination hSBA titer ≥ 16 for participants with a pre-vaccination hSBA titer <4; . a post-vaccination hSBA titer ≥ 4 times the Lower limit of quantitation (LLOQ) for participants with a prevaccination 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.

  3. Percentages of participants with solicited administration site events [ Time Frame: During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group ]
    Assessed solicited administrative site events include injection site pain, erythema, swelling, induration. Any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters

  4. Percentages of participants with solicited administration site events [ Time Frame: During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group ]
    Assessed solicited administrative site events include injection site pain, erythema, swelling, induration. Any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.

  5. Percentages of participants with solicited systemic events [ Time Frame: During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group ]
    Assessed solicited systemic events include fever [body temperature ≥ 38.0°C/100.4°F], nausea, fatigue, myalgia, arthralgia, headache.

  6. Percentages of participants with solicited systemic events [ Time Frame: During the 7 days (including day of vaccination) 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

  7. Percentages 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) [ Time Frame: During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY 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.

  8. Percentages 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) [ Time Frame: During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group ]
    Any unsolicited AEs, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs are evaluated

  9. Percentages of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs [ Time Frame: From Day 1 to Day 361 (throughout the study period) ]
    SAEs, AEs leading to withdrawal, AESIs and medically attended AEs are assessed throughout the study period


Secondary Outcome Measures :
  1. 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 and second MenABCWY vaccine and after the single MenACWY vaccine [ Time Frame: At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group, Day 211 for ABCWY group [second dose]) ]
    Immune response to MenABCWY vaccine after the first and second dose and single dose of MenACWY vaccine is evaluated by measuring the percentage of participants with hSBA titers ≥ LLOQ against each of the serogroups A, C, W and Y

  2. hSBA Geometric Mean Titers (GMTs) against serogroups A, C, W, and Y at day 1, 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine [ Time Frame: At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group, Day 211 for ABCWY group [second dose]) ]
    Immune response to MenABCWY after first and second dose and single dose of MenACWY vaccine is evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their 95% confidence intervals are calculated.

  3. Geometric mean ratios (GMRs) against serogroups A, C, W, and Y at 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine [ Time Frame: At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group, Day 211 for ABCWY group [second dose]) versus Day 1 ]
    Immune response to MenABCWY vaccine after first and second dose and single dose of MenACWY vaccine is evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMR (GMT after vaccination over GMT at baseline).

  4. Percentages of participants with hSBA titers ≥ LLOQ for each and all serogroup B indicator strains at day 1 and 1 month after the second dose of MenABCWY vaccine [ Time Frame: At Day 1 and Day 211 ]
    The immune response to MenABCWY vaccine after second dose is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains- M14459, M07-0241084, 96217and NZ98/254 in terms of percentage of participants with hSBA titers ≥ LLOQ

  5. Percentages of participants with 4-fold rise in hSBA titers against each N. meningitidis serogroup B indicator strains at 1 month after the second MenABCWY vaccine [ Time Frame: At Day 211 ]
    The immune response to MenABCWY after second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains M14459, M07-0241084, 96217and NZ98/254 compared to baseline (day 1) in terms of 4-fold rise in hSBA titers. For each of the serogroup B indicator strains, the 4-fold rise is defined as: a post-vaccination hSBA titer ≥16 for participants with a pre-vaccination hSBA titer <4; . a post-vaccination hSBA titer ≥ 4 times the LLOQ for participants with a prevaccination 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.

  6. GMTs against each serogroup B indicator strains at day 1, 1 month after second MenABCWY vaccine [ Time Frame: At Day 1 and Day 211 ]
    Immune response to MenABCWY vaccine after the second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B indicator strains M14459, M07-0241084, 96217and NZ98/254 in terms of GMTs at baseline (Day 1) and 1 month after second MenABCWY vaccination

  7. GMRs against each serogroup B indicator strains at 1 month after second dose of MenABCWY vaccine [ Time Frame: At Day 211 versus Day 1 ]
    Immune response to MenABCWY vaccine after second dose is evaluated by measuring the human serum bactericidal activity against each of the N. meningitidis serogroup B indicator strains- M14459, M07-0241084, 96217and NZ98/254 compared to baseline (Day 1) and expressed as GMR (GMT after vaccination over GMT at baseline).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 and not more than 6 years (intended as up to 6 years and 364 days) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707391


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Texas
GSK Investigational Site Recruiting
Houston, Texas, United States, 77055
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Oscar De Valle         
Argentina
GSK Investigational Site Recruiting
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1425AWK
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mercedes Deluca         
Australia, Queensland
GSK Investigational Site Recruiting
Taringa, Queensland, Australia, 4068
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ferdinandus de Looze         
Canada, Ontario
GSK Investigational Site Recruiting
Newmarket, Ontario, Canada, L3Y5G8
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sam Henein         
Sponsors and Collaborators
GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04707391    
Other Study ID Numbers: 213171
2019-004982-42 ( EudraCT Number )
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by GlaxoSmithKline:
Neisseria meningitidis
Meningococcal disease
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs