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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04707391
Ethics application status
Date submitted
11/01/2021
Date registered
13/01/2021
Date last updated
2/09/2021

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
Combination Product - MenABCWY vaccine
Combination Product - Placebo
Other interventions - MenACWY vaccine
Combination Product - MenB vaccine

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.

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.


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

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

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.

Intervention code [1] 0 0
Combination Product
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 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 second MenABCWY vaccine and after the single MenACWY vaccine - 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
Timepoint [1] 0 0
At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group)
Primary outcome [2] 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 first MenABCWY vaccine and after the single MenACWY vaccine - 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.
Timepoint [2] 0 0
At 1 month after the first vaccination (i.e., Day 31)
Primary outcome [3] 0 0
Percentages of participants with solicited administration site events - 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
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
Percentages of participants with solicited administration site events - 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.
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
Percentages of participants with solicited systemic events - Assessed solicited systemic events include fever [body temperature = 38.0°C/100.4°F], nausea, fatigue, myalgia, arthralgia, headache.
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
Percentages of participants with solicited systemic events - Assessed solicited systemic events include fever [body temperature = 38.0°C/100.4°F], nausea, fatigue, myalgia, arthralgia, headache
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
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) - 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.
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
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) - Any unsolicited AEs, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs are evaluated
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
Percentages of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs - SAEs, AEs leading to withdrawal, AESIs and medically attended AEs are assessed throughout the study period
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 and second MenABCWY vaccine and after the single MenACWY vaccine - 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
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, Day 211 for ABCWY group [second dose])
Secondary outcome [2] 0 0
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 - 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.
Timepoint [2] 0 0
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])
Secondary outcome [3] 0 0
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 - 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).
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
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 - 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
Timepoint [4] 0 0
At Day 1 and Day 211
Secondary outcome [5] 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 vaccine - 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.
Timepoint [5] 0 0
At Day 211
Secondary outcome [6] 0 0
GMTs against each serogroup B indicator strains at day 1, 1 month after second MenABCWY vaccine - 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
Timepoint [6] 0 0
At Day 1 and Day 211
Secondary outcome [7] 0 0
GMRs against each serogroup B indicator strains at 1 month after second dose of MenABCWY vaccine - 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).
Timepoint [7] 0 0
At Day 211 versus 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 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.
Minimum age
15 Years
Maximum age
25 Years
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Taringa
Recruitment postcode(s) [1] 0 0
4068 - Taringa
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario

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

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT04707391
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
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04707391