Last updated: 04/11/2025 07:12:16

Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

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GSK study ID
205231
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Clinicaltrials.gov ID
NCT02140762
EudraCT ID
Not applicable
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 Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
Trial description: Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.

Timeframe: One month after the second vaccination (month 3)

Secondary outcomes:

Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.

Timeframe: Four months after the second vaccination (month 6)

Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination

Timeframe: One month after the second vaccination (month 3)

Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.

Timeframe: Four months after the second vaccination (month 6)

Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject

Timeframe: Baseline, one month after second vaccination (month 3)

Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject

Timeframe: Baseline, four months after second vaccination (month 6)

Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series

Timeframe: One month after the second vaccination (month 3)

Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series

Timeframe: Four months after the second vaccination (month 6)

hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains

Timeframe: One month after the second vaccination (month 3)

HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains

Timeframe: Four months after the second vaccination (month 6)

hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y

Timeframe: One month after the second vaccination (month 3)

HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y

Timeframe: Four months after the second vaccination (month 6)

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.

Timeframe: At baseline(day 1) and One month after the second vaccination (month 3)

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series

Timeframe: At Baseline and One month after the second vaccination (month 3)

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.

Timeframe: Four months after the second vaccination (month 6)

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.

Timeframe: Four months after the second vaccination (month 6)

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.

Timeframe: Four months after the second vaccination (month 6)

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series

Timeframe: Four months after the second vaccination (month 6)

Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series

Timeframe: One month after the second vaccination (month 3)

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series

Timeframe: One month after the second vaccination (month 3)

Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.

Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.

Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.

Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.

Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.

Timeframe: At Month 3 and Month 6 (one and four months after 2 doses of vaccination)

Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.

Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)

Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)

Timeframe: From day 1 (6 hours) until day 7 after any vaccination

Number of Subjects Reporting Unsolicited AEs.

Timeframe: From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.

Interventions:
  • Biological/vaccine: MenABCWY
  • Other: Placebo
  • Biological/vaccine: MenACWY
    • Enrollment:
    305
    Primary completion date:
    2014-19-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Meningococcal
    Product
    GSK3536819A
    Collaborators
    Not applicable
    Study date(s)
    May 2014 to February 2015
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    10 - 18 Years
    Accepts healthy volunteers
    Yes
    • Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.
    • Female subjects of childbearing potential must have a negative urine pregnancy test.
    • Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.
    • Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.

      • Female subjects of childbearing potential must have a negative urine pregnancy test.
    Exclusion criteria:

      Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.

      • Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44121
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Huntsville, Alabama, United States, 35802
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jonesboro, Arkansas, United States, 72401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Melbourne, Florida, United States, 32934
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newton, Kansas, United States, 67114
    Status
    Study Complete
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    Study documents

    Study report synopsis
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2014-19-11
    Actual study completion date
    2015-16-02

    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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