Clinical trial NCT04707391: Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis, Meningococcal
Keywords: Neisseria meningitidis
Meningococcal disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 1250
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline)
measure: 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
timeFrame: At 1 month after the first vaccination (i.e., Day 31) compared to Day 1 (Baseline)
measure: Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group
timeFrame: During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
measure: Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group
timeFrame: During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group
measure: Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group
timeFrame: During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group
measure: Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group
timeFrame: During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group
measure: 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)
timeFrame: During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
measure: 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
timeFrame: During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group
measure: Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs
timeFrame: From Day 1 to Day 361 (throughout the study period)
Secondary outcomes:
measure: 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
timeFrame: At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)
measure: 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
timeFrame: 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])
measure: 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
timeFrame: At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)
measure: hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination
timeFrame: 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])
measure: 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
timeFrame: At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) compared to baseline (Day 1)
measure: Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination
timeFrame: At 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) compared to baseline (Day 1)
measure: Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination
timeFrame: At Day 1 and at Day 211
measure: 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 Vaccination
timeFrame: At Day 211 compared to baseline (Day 1)
measure: GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination
timeFrame: At Day 1 and at Day 211
measure: GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination
timeFrame: At Day 211 compared to baseline (Day 1)
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Banning
country: United States
facility: GSK Investigational Site
state: California
city: Chula Vista
country: United States
facility: GSK Investigational Site
state: California
city: West Covina
country: United States
facility: GSK Investigational Site
state: California
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Port Orange
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Columbus
country: United States
facility: GSK Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: GSK Investigational Site
state: Georgia
city: Meridian
country: United States
facility: GSK Investigational Site
state: Idaho
city: Champaign
country: United States
facility: GSK Investigational Site
state: Illinois
city: Quincy
country: United States
facility: GSK Investigational Site
state: Illinois
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Methuen
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Roslindale
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Grosse Pointe Woods
country: United States
facility: GSK Investigational Site
state: Michigan
city: Biloxi
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cranberry Township
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Monongahela
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Beaumont
country: United States
facility: GSK Investigational Site
state: Texas
city: Carrollton
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Katy
country: United States
facility: GSK Investigational Site
state: Texas
city: Longview
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: The Woodlands
country: United States
facility: GSK Investigational Site
state: Texas
city: Kaysville
country: United States
facility: GSK Investigational Site
state: Utah
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Roy
country: United States
facility: GSK Investigational Site
state: Utah
city: Syracuse
country: United States
facility: GSK Investigational Site
state: Utah
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Caba
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: GSK Investigational Site
state: Tucumán
city: San Miguel de Tucumán
country: Argentina
facility: GSK Investigational Site
state: Tucumán
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: Rio Cuarto
country: Argentina
facility: GSK Investigational Site
city: Coffs Harbour
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Kanwal
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Maroubra
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Taringa
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Tarragindi
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Guelph
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
Study officials:
References: