Last updated: 07/17/2024 17:25:42

Combined Study – Phase 3b MenB Long Term Persistence in Adolescents

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GSK study ID
205218
See study documents
Clinicaltrials.gov ID
NCT02446743
See results summary
EudraCT ID
2017-000093-11
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Assess the Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningococcal B Recombinant Vaccine and the Response to a Third Dose in Adolescents and Young Adult Subjects who Previously Participated in Parent Studies V72_41 (NCT01423084) and V72P10 (NCT00661713), Compared to Naïve Healthy Controls
Trial description: The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents [who previously participated in parent studies V72_41 (NCT0142384) and V72P10 (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with rMenB+OMV NZ
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Percentage of subjects with Human Serum Bactericidal Activity (hSBA)≥1:4

Timeframe: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).

Percentage of subjects with hSBA≥1:5

Timeframe: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).

Percentage of subjects with hSBA titers≥1:5 in parent studies-V72P10 and V72_41

Timeframe: At one month after last vaccination in parent studies- V72P10 (Month 7) and V72_41 (Month 2)

Percentage of subjects with hSBA≥1:8

Timeframe: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).

Percentage of subjects with hSBA≥1:16

Timeframe: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).

hSBA Geometric Mean Titers (GMTs) after the last dose of rMenB+OMV NZ vaccination in the parent study.

Timeframe: Group 3B: 1 month after the last rMenB+OMV NZ vaccination in parent study and Day 1(prior to booster dose); Group B_0_1: Day 1(prior to first dose)

Geometric Mean Ratios (GMRs) of GMTs after the last dose of rMenB+OMV NZ Vaccination in the Parent Study versus Day 1.

Timeframe: Group 3B: 1 month after the last vaccination in parent study and Day 1 (prior to booster dose)

Number of subjects with solicited local and systemic AEs.

Timeframe: 7 days (including the day of vaccination) after each vaccination

Number of subjects with any unsolicited adverse events (AEs).

Timeframe: 30 days (including the day of vaccination) after each vaccination.

Number of subjects with any SAEs, AEs leading to withdrawal and medically attended AEs.

Timeframe: Group 3B: from Day 1 to Day 31 (study termination visit) and Group B_0_1: from Day 1 to Day 61 (study termination visit)

Secondary outcomes:

Percentage of subjects with hSBA ≥1:4 after booster dose/first vaccination of rMenB+OMV NZ.

Timeframe: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.

Percentage of subjects with hSBA ≥1:5 after booster dose/first vaccination of rMenB+OMV NZ.

Timeframe: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.

Percentage of subjects with hSBA ≥1:8 after booster dose/first vaccination of rMenB+OMV NZ

Timeframe: Group 3B : 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.

Percentage of subjects with hSBA ≥1:16 after booster dose/first vaccination of rMenB+OMV NZ

Timeframe: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.

hSBA Geometric Mean Titers prior to booster/first dose of vaccination & post booster/first dose of vaccination.

Timeframe: Group 3B subjects: Day 1(pre-booster dose) and 30 days post-booster dose. Group B_0_1: Day 1 (pre-first dose) and 30 days post-first dose.

Geometric mean ratio (GMRs) of GMTs after booster dose/first rMenB+OMV NZ vaccination versus day 1.

Timeframe: At Day 31 (30 days post booster dose/first dose of vaccination) versus Day 1 (prior to booster dose/first dose of vaccination).

Percentages of subjects with at least 4-fold increase in hSBA titers pre vaccination compared to one month post-booster/first rMenB+OMV NZ vaccination

Timeframe: Group 3B: 1 month after booster dose; Group B_0_1: 1 month after first vaccination

Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ

Timeframe: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.

Percentage of subjects with hSBA ≥1:5 after booster dose/second vaccination of rMenB+OMV NZ

Timeframe: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose."

Percentage of subjects with hSBA ≥1:8 after booster dose/second vaccination of rMenB+OMV NZ

Timeframe: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.

Percentage of subjects with hSBA ≥1:16 after booster dose/second vaccination of rMenB+OMV NZ

Timeframe: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose

hSBA Geometric Mean Titers prior to booster/second dose of vaccination & post booster/second dose of vaccination.

Timeframe: Group 3B: Day 1 (pre-booster dose) and 3, 7 and 30 days after third dose booster; Group B_0_1: Pre 2nd dose and at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose.

Geometric Mean Ratios (GMRs) of GMTs after booster/second vaccination versus before booster/second vaccination.

Timeframe: Group 3B: Day 1 and 30 days after third dose booster; Group B_0_1: 30 days post-first dose and at 30 days post-second dose

Percentages of Subjects with at Least Four-fold Increase in hSBA Titers Pre-booster/Second dose vaccination- compared to 3, 7 and 30 Days Post- booster/Second Vaccination

Timeframe: Group 3B: at 3, 7 and 30 days after third dose booster; Group B_0_1: at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose

Percentage of subjects with hSBA ≥1:4 after second vaccination of rMenB+OMV NZ

Timeframe: At Day 61 (30 days post second dose of vaccination.)

Percentage of subjects with hSBA ≥1:5 after second vaccination of rMenB+OMV NZ

Timeframe: At Day 61 (30 days post second dose of vaccination.)

Percentage of subjects with hSBA ≥1:8 after second vaccination of rMenB+OMV NZ.

Timeframe: At Day 61 (30 days post second vaccination)

Percentage of subjects with hSBA ≥1:16 after second vaccination of rMenB+OMV NZ.

Timeframe: At Day 61 (30 days post second vaccination)

hSBA Geometric Mean Titers (GMTs) after second vaccination of rMenB+OMV NZ.

Timeframe: At Day 1 & Day 61 (30 days post second dose of vaccination)

Geometric mean ratio (GMRs) of GMTs one month post second vaccination versus pre vaccination at Day 1

Timeframe: At Day 1 & Day 61 (30 days post 2nd vaccination)

Percentages of Subjects with at Least Four-fold Increase in hSBA Titers at pre-First Vaccination compared to One Month Post-Second Vaccination

Timeframe: At Day 61 (30 days post second dose of vaccination)

Interventions:
  • Biological/vaccine: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)
    • Enrollment:
    531
    Primary completion date:
    2016-23-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Nolan T et al. (2019) Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine. Vaccine. 37(9):1209-1218.
    Medical condition
    Infections, Meningococcal
    Product
    GSK3536829A
    Collaborators
    Not applicable
    Study date(s)
    November 2015 to September 2016
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    15 - 24 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Inclusion Criterion for follow-on subjects:
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion Criteria:

      • Inclusion Criterion for follow-on subjects:
      • Individuals who participated to Study V72_41 or V72P10 and have completed vaccination with rMenB+OMV NZ according to a 2-dose schedule Inclusion Criterion for naïve subjects:
      • Individuals of 15 through 21 years of age on the day of informed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72_41.
      • 17 through 24 years of age on the day of informed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72P10. Inclusion Criteria for all subjects:
      • Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
      • Individuals who can comply with study procedures including follow-up.
      • Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method . Exclusion Criteria for all subjects Exclusion Criterion for follow-on subjects:
      • Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study. Exclusion Criterion for naïve subjects:
      • Received any other Meningococcal group B vaccines prior to enrolment in this study. Exclusion Criteria for all subjects:
      • Progressive, unstable or uncontrolled clinical conditions.
      • Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study.
      • Abnormal function of the immune system.
      • Received immunoglobulins or any blood products within 180 days prior to informed consent and assent as applicable (according to the subject’s age).
      • Received an investigational or non-registered medicinal product within 30 days prior to informed consent and assent as applicable (according to the subject’s age).
      • Study personnel as an immediate family or household member.
      • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
      • Positive results at the urine pregnancy test performed before study vaccination.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Carlton, Victoria, Australia, 3010
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newmarket, Ontario, Canada, L3Y5G8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Truro, Nova Scotia, Canada, B2N1L2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sudbury, Ontario, Canada, P3E1H5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Santiago, Chile, 8380453
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M9V 4B4
    Status
    Study Complete
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    Study documents

    Protocol
    Available language(s): English
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    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2016-23-09
    Actual study completion date
    2016-23-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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