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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04707391




Registration number
NCT04707391
Ethics application status
Date submitted
11/01/2021
Date registered
13/01/2021

Titles & IDs
Public title
Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine
Scientific 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
Secondary ID [1] 0 0
2019-004982-42
Secondary ID [2] 0 0
213171
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningitis, Meningococcal 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MenABCWY vaccine
Other interventions - Placebo
Treatment: Other - MenACWY vaccine
Other interventions - MenB vaccine

Experimental: 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.

Active comparator: ACWY Group - Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.


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

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

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

Other interventions: 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 code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline)
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
At 1 month after the first vaccination (i.e., Day 31) compared to Day 1 (Baseline)
Primary outcome [3] 0 0
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group
Timepoint [3] 0 0
During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
Primary outcome [4] 0 0
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group
Timepoint [4] 0 0
During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group
Primary outcome [5] 0 0
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group
Timepoint [5] 0 0
During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group
Primary outcome [6] 0 0
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group
Timepoint [6] 0 0
During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group
Primary outcome [7] 0 0
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)
Timepoint [7] 0 0
During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
Primary outcome [8] 0 0
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
Timepoint [8] 0 0
During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group
Primary outcome [9] 0 0
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs
Timepoint [9] 0 0
From Day 1 to Day 361 (throughout the study period)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)
Secondary outcome [4] 0 0
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination
Timepoint [4] 0 0
1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) compared to baseline (Day 1)
Secondary outcome [6] 0 0
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination
Timepoint [6] 0 0
At 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) compared to baseline (Day 1)
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
At Day 1 and at Day 211
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
At Day 211 compared to baseline (Day 1)
Secondary outcome [9] 0 0
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination
Timepoint [9] 0 0
At Day 1 and at Day 211
Secondary outcome [10] 0 0
GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination
Timepoint [10] 0 0
At Day 211 compared to baseline (Day 1)

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/09/2023
Sample size
Target
Accrual to date
Final
1250
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Kanwal
Recruitment hospital [4] 0 0
GSK Investigational Site - Maroubra
Recruitment hospital [5] 0 0
GSK Investigational Site - Taringa
Recruitment hospital [6] 0 0
GSK Investigational Site - Tarragindi
Recruitment hospital [7] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [8] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [9] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2035 - Maroubra
Recruitment postcode(s) [5] 0 0
4068 - Taringa
Recruitment postcode(s) [6] 0 0
4121 - Tarragindi
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Rhode Island
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Tucumán
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autonoma de Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Cordoba
Country [25] 0 0
Argentina
State/province [25] 0 0
Rio Cuarto
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04707391