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AzTrials

Meningitis, MeningococcalPhase 3NCT04707391

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

A Phase 3 study testing MenABCWY vaccine, MenACWY vaccine and MenB vaccine in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 69 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Meningitis, Meningococcal
What is being tested?
MenABCWY vaccine, MenACWY vaccine and MenB vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,250 participants
Where
69 sitesin 4 countries
Study dates
25 Jan 2021to 29 Sep 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • Child in care.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of/current chronic alcohol and/or drug abuse.
  • Involvement in the study as a study staff member or being immediate dependents, family, or household member of a study staff member.

Trial locations and contacts

69 sites in 4 countries.

69 sites in 4 countries

United States48 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87102

  • GSK Investigational Site

    Atlanta, Georgia, 30338

  • GSK Investigational Site

    Austin, Texas, 78745

  • GSK Investigational Site

    Banning, California, 92220

  • GSK Investigational Site

    Beaumont, Texas, 77706

  • GSK Investigational Site

    Biloxi, Mississippi, 39531

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Carrollton, Texas, 75010

  • GSK Investigational Site

    Champaign, Illinois, 61822

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Chula Vista, California, 91911

  • GSK Investigational Site

    Columbus, Georgia, 31904

  • GSK Investigational Site

    Cranberry Township, Pennsylvania, 16066

  • GSK Investigational Site

    Dallas, Texas, 75251

  • GSK Investigational Site

    Fall River, Massachusetts, 02725

  • GSK Investigational Site

    Fayetteville, North Carolina, 28304

  • GSK Investigational Site

    Greenville, South Carolina, 29607

  • GSK Investigational Site

    Grosse Pointe Woods, Michigan, 48236

  • GSK Investigational Site

    Houston, Texas, 77055

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Katy, Texas, 77450

  • GSK Investigational Site

    Kaysville, Utah, 84037

  • GSK Investigational Site

    Layton, Utah, 84041

  • GSK Investigational Site

    Longview, Texas, 75605

  • GSK Investigational Site

    Louisville, Kentucky, 40291

  • GSK Investigational Site

    Meridian, Idaho, 83642

  • GSK Investigational Site

    Methuen, Massachusetts, 01844

  • GSK Investigational Site

    Miami, Florida, 33126

  • GSK Investigational Site

    Miami, Florida, 33135

  • GSK Investigational Site

    Monongahela, Pennsylvania, 15063

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15025

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15217

  • GSK Investigational Site

    Plano, Texas, 75024

  • GSK Investigational Site

    Port Orange, Florida, 32127

  • GSK Investigational Site

    Quincy, Illinois, 62301

  • GSK Investigational Site

    Raleigh, North Carolina, 27612

  • GSK Investigational Site

    Roslindale, Massachusetts, 02135

  • GSK Investigational Site

    Roy, Utah, 84067

  • GSK Investigational Site

    Sandy Springs, Georgia, 30328

  • GSK Investigational Site

    Seattle, Washington, 98105

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Syracuse, Utah, 84075

  • GSK Investigational Site

    The Woodlands, Texas, 77381-3527

  • GSK Investigational Site

    Warwick, Rhode Island, 02886-6110

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20017

  • GSK Investigational Site

    West Covina, California, 91790

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

Other trials in United States

Argentina9 sites

  • GSK Investigational Site

    Buenos Aires, 1426

  • GSK Investigational Site

    Buenos Aires, C1428

  • GSK Investigational Site

    CABA, Buenos Aires, C1222

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, Buenos Aires, C1425AWK

  • GSK Investigational Site

    Córdoba, 5000

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, B7600FYH

  • GSK Investigational Site

    Río Cuarto, 5800

  • GSK Investigational Site

    San Miguel de Tucumán, Tucumán Province, T4000IHE

  • GSK Investigational Site

    San Miguel de Tucumán, Tucumán Province, T4000NWB

Other trials in Argentina

Australia9 sites

  • GSK Investigational Site

    Clayton, Victoria, 3168

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Darlinghurst, New South Wales, 2010

  • GSK Investigational Site

    Kanwal, New South Wales, 2259

  • GSK Investigational Site

    Maroubra, New South Wales, 2035

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Parkville, Victoria, 3052

  • GSK Investigational Site

    Taringa, Queensland, 4068

  • GSK Investigational Site

    Tarragindi, Queensland, 4121

Other trials in Australia

Canada3 sites

  • GSK Investigational Site

    Guelph, Ontario, N1H 1B1

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    Toronto, Ontario, M9V 4B4

Other trials in Canada

About this study

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

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.

Being tested
MenABCWY vaccine, Placebo, MenACWY vaccine, MenB vaccine
Keywords
Neisseria meningitidis, Meningococcal disease
Medical subject headings
Meningitis, Meningococcal, Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MenABCWY vaccineCombination product

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

  • PlaceboCombination product

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

  • MenACWY vaccineBiological

    Also called Menveo

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

  • MenB vaccineCombination product

    Also called Bexsero

    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.

Study groups in NCT04707391
Study groupRoleWhat they receive
ABCWY GroupExperimentalParticipants 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.
Receives: Combination Product: MenABCWY vaccine; Combination Product: Placebo
ACWY GroupActive comparatorParticipants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Receives: Biological: MenACWY vaccine; Combination Product: MenB vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

Secondary outcomes (10)

  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 MenABCWY Vaccination and After the Single MenACWY Vaccination

    The immune response to MenABCWY vaccine after the first dose and single dose of MenACWY vaccine was evaluated by measuring the percentage of participants with hSBA titers >= LLOQ against each of the serogroups A, C, W and Y.

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

  2. 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

    The immune response to MenABCWY vaccine after the second dose was evaluated by measuring the percentage of participants with hSBA titers >= LLOQ against each of the serogroups A, C, W and Y.

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

  3. 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

    The immune response to MenABCWY after first dose and single dose of MenACWY vaccine was 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 associated 2-sided 95% confidence intervals were calculated.

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

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

    The immune response to MenABCWY after second dose was 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 associated 2-sided 95% confidence intervals were calculated.

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

  5. 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

    The immune response to MenABCWY vaccine after first and single dose of MenACWY vaccine are 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 GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.

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

  6. Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination

    The immune response to MenABCWY vaccine after second dose are 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 GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.

    Measured: At 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) compared to baseline (Day 1)

  7. 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

    The immune response to MenABCWY vaccine after second dose was evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively).

    Measured: At Day 1 and at Day 211

  8. 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

    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, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). 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.

    Measured: At Day 211 compared to baseline (Day 1)

  9. GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination

    The immune response to MenABCWY vaccine after the second dose was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) in terms of GMTs at baseline (Day 1) and 1 month after second MenABCWY vaccination.

    Measured: At Day 1 and at Day 211

  10. GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination

    The immune response to MenABCWY vaccine after second dose was evaluated by measuring the human serum bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.

    Measured: At Day 211 compared to baseline (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start25 Jan 2021
  3. Primary completion3 May 2023
  4. Study completion29 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04707391
Sponsor's protocol ID
213171
Other IDs
2019-004982-42, 2019
Status last verified
Jun 2024
First submitted
11 Jan 2021
Last updated
3 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • 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.

    PubMed 39722560

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenABCWY vaccine, MenACWY vaccine and MenB vaccine in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 69 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Argentina, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04707391, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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