Last updated: 04/10/2025 05:42:20

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

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GSK study ID
205232
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Clinicaltrials.gov ID
NCT02285777
EudraCT ID
2015-001030-16
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, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
Trial description: This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be invited at the time of their last study visit to participate in this extension study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Percentages of subjects without bactericidal activity at 1:4 dilution against each US Neisseria meningitides (N. meningitidis) serogroup B strain at 1 month after the 3-dose vaccination series.

Timeframe: At Month 7 (1 month after the 3-dose vaccination series)

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 3-dose vaccination series.

Timeframe: At Month 10 (4 months after the 3-dose vaccination series)

Percentages of subjects without bactericidal activity at 1:8 dilution against each US N. meningitidis serogroup B strain at 1 and 4 months after the 3-dose vaccination series.

Timeframe: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Percentages of US N. meningitidis serogroup B strains killed at 1:4 and 1:8 dilutions at 1 and 4 months after the 3-dose vaccination series

Timeframe: At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥1:8 at 1 and 4 months after the 3-dose vaccination series

Timeframe: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

HT-hSBA Geometric Mean Titers (GMTs) against the N. meningitidis serogroup B test strains

Timeframe: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Percentages of subjects with HT-hSBA titers against N. meningitidis serogroup B test strains ≥ Lower Limit of Quantitation (LLQ) at 1 month after the 3-dose vaccination series.

Timeframe: At Month 7 (1 month after the 3-dose vaccination series)

Percentages of subjects with HT-hSBA titers against N. meningitidis serogroup B test strains ≥ LLQ at 4 months after the 3-dose vaccination series

Timeframe: At Month 10 (4 months after the 3-dose vaccination series)

Percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series.

Timeframe: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series.

Timeframe: At months 7 and 10 (1 and 4 months after 3-dose vaccination series)

Percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series.

Timeframe: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

HT-hSBA GMTs against N. meningitidis serogroups A, C, W and Y.

Timeframe: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Percentages of subjects with HT-hSBA titers against the N. meningitidis serogroup A, C, W and Y ≥ LLQ at 1 month after the 3- dose vaccination series

Timeframe: At Month 7 (1 month after the 3-dose vaccination series)

Percentages of subjects with HT-hSBA titers against the N. meningitidis serogroup A, C, W and Y ≥ LLQ at 4 months after the 3-dose vaccination series

Timeframe: At Month 10 (4 months after the 3-dose vaccination series)

Percentage of subjects with two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C,W and Y at 1 and 4 months after the 3-dose vaccination series.

Timeframe: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Percentage of subjects with three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series.

Timeframe: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Percentage of subjects with four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series.

Timeframe: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series

Timeframe: At Month 7 (1 month after the 3-dose vaccination series)

Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series

Timeframe: At Month 10 (4 months after the 3-dose vaccination series)

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series

Timeframe: At Month 7 (1 month after the 3-dose vaccination series)

Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series

Timeframe: At Month 10 (4 months after the 3-dose vaccination series)

Number of subjects reporting any solicited local or systemic Adverse Events (AEs)

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

Number of subjects reporting any unsolicited AEs

Timeframe: Day 1 to Day 30 after any vaccination

Number of subjects reporting any serious adverse events (SAEs), medically-attended AEs and AEs leading to premature withdrawal.

Timeframe: During the entire study period (from Day 0 up to Month 10)

Interventions:
  • Biological/vaccine: Meningococcal ABCWY
  • Biological/vaccine: Placebo
    • Enrollment:
    189
    Primary completion date:
    2015-26-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Welsch A et al. (2018) Breadth of coverage against a panel of 110 invasive disease isolates, immunogenicity and safety for 2 and 3 doses of an investigational MenABCWY vaccine in US adolescents - Results from a randomized, controlled, observer-blind phase II study. Vaccine.. 36(35):5309-5317.
    Medical condition
    Meningococcal disease
    Product
    GSK3536819A
    Collaborators
    Not applicable
    Study date(s)
    December 2014 to June 2015
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    10 - 19 years
    Accepts healthy volunteers
    No
    • Adolescents who completed V102_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).
    • Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.
    • History of any meningococcal vaccine administration other than vaccination given in the parent V102_16 protocol.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Adolescents who completed V102_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).
    Exclusion criteria:
    • Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.
    • History of any meningococcal vaccine administration other than vaccination given in the parent V102_16 protocol.

    Trial location(s)

    Location
    Status
    Contact us
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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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    Protocol
    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
    2015-26-03
    Actual study completion date
    2015-11-06

    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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