Last updated: 04/11/2025 06:41:20

Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents

Request patient level data
GSK study ID
205215
See study documents
Clinicaltrials.gov ID
NCT02212457
See results summary
EudraCT ID
2013-002451-15
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 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GSK Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK Meningococcal group B vaccine, in Healthy Adolescents
Trial description: The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)

Secondary outcomes:

hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)

Percentages of subjects with hSBA titers ≥LLQ against N. meningitidis serogroups A, C, W and y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)

hSBA GMTs against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0, 11 month schedule.

Timeframe: At 1 Month after the last vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group, Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)

Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)

hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.

Timeframe: At 1 month after last vaccination (Month 7)

Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 7)

Percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0_11 month schedule.

Timeframe: At 1 month after second vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group , Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)

hSBA GMTs against serogroups A, C, W and Y and serogroup B test strains at all the relevant time points for all schedules.

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain for all schedules.

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M14459 B strain for all schedules.

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M07-0241084 B strain for all schedules.

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against 96217 B strain for all schedules.

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against A human serogroup for all schedules.

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against C human serogroup for all schedules.

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against W human serogroup for all schedules.

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against Y human serogroup for all schedules.

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test Strains for all schedules.

Timeframe: At Month 2, Month 3, Month 7 and Month 13

The area under the curve (AUC) for percentage of subjects with hSBA titers ≥LLQ for all serogroups and strains.

Timeframe: From Month 0 to Month 13

Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination.

Timeframe: Within 30 minutes after vaccination

Number of participants reporting any unsolicited AEs within 30 minutes after vaccination.

Timeframe: Within 30 minutes after vaccination

Number of participants reporting unsolicited AEs from Day 1 to Day 30 after any vaccination.

Timeframe: Day 1 through Day 30 after any vaccination

Number of participants reporting any solicited local or systemic adverse events (AEs) and other indicators of reactogenicity from Day 1 to Day 7.

Timeframe: At Day 1 (6 hours) to Day 7 after vaccination

Number of participants reporting any serious AE (SAE), medically attended AEs (MAAEs), AEs leading to premature withdrawal

Timeframe: During the entire study period (Month 0 to Month 13)

Interventions:
  • Biological/vaccine: Bexsero
  • Other: Saline Placebo
  • Biological/vaccine: Havrix
  • Biological/vaccine: MenABCWY
    • Enrollment:
    1063
    Primary completion date:
    2015-22-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Timo Vesikari, Jerzy Brzostek, Anitta Ahonen, Marita Paassilta, Ewa Majda-Stanislawska, Leszek Szenborn, Miia Virta, Robert Clifford, Teresa Jackowska, Murray Kimmel, Ilaria Bindi, Pavitra Keshavan, Paola Pedotti, Daniela Toneatto. Immunogenicity and safety of different schedules of the meningococcal ABCWY vaccine, with assessment of long-term antibody persistence and booster responses – results from two phase 2b randomized trials in adolescents. Hum Vaccin Immunother. 2021;ePub. DOI: http://dx.doi.org/ http://dx.doi.org/10.1080/21645515.2021.1968214
    Medical condition
    Infections, Meningococcal
    Product
    GSK3536819A, GSK3536829A
    Collaborators
    Not applicable
    Study date(s)
    August 2014 to March 2016
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    10 - 18 years
    Accepts healthy volunteers
    Yes
    • 1.) Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment.
    • 2.)Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
    • 1.) Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
    • 2.) Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 1.) Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment. 2.)Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts). 3.)Female subjects of childbearing potential must have a negative urine preganancy test.
    Exclusion criteria:
    • 1.) Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines. 2.) Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Augusta, Kansas, United States, 67010
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bellevue, Nebraska, United States, 68005
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Binghamton, New York, United States, 13901
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29414
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44122
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dayton, Ohio, United States, 45406
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 32 Results

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    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
    2015-22-05
    Actual study completion date
    2016-03-03

    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website