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    Clinical Trial Results:
    Phase 3b, Open label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults from 18 to 50 Years of Age and to Collect Blood Donations to Develop Vaccines against Neisseria meningitidis

    Summary
    EudraCT number
    		 2014-002972-95
    Trial protocol
    		 PL  
    Global end of trial date
    24 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Feb 2016
    First version publication date
    18 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V72_74
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02305446
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma Services A.G.
    Sponsor organisation address
    Fabrikstrasse 2, Basel, Switzerland, 4056
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish a control sera panel using pre and post-vaccination blood donations to be used as a reference in SBA test. To assess the safety of two doses of rMenB+OMV NZ in healthy adult subjects.
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations, including the European Directive 2001/20/EC, Novartis codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    55
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at one site in Poland from December 2014 to February 2015.

    Pre-assignment
    Screening details
    		 All enrolled subjects were included in the trial and assigned to the same treatment group.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 rMenB+OMV NZ
    Arm description
    		 Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (group B) multicomponent recombinant adsorbed vaccine
    Investigational medicinal product code
    Other name
    rMenB+OMV NZ
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.

    Number of subjects in period 1
    		rMenB+OMV NZ
    Started
    55
    Completed
    54
    Not completed
    1
         Adverse Event
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    rMenB+OMV NZ
    Reporting group description
    		 Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule.

    Reporting group values
    		 rMenB+OMV NZ Total
    Number of subjects
    		 55 55
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 27.2 ( 6.932 ) -
    Gender categorical
    Units: Subjects
        Female
    		 27 27
        Male
    		 28 28

    End points

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    End points reporting groups
    Reporting group title
    rMenB+OMV NZ
    Reporting group description
    		 Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule.

    Subject analysis set title
    All Enrolled Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All screened subjects who provide informed consent and provide demographic and/or other baseline screening measurements, regardless of the subject’s vaccination status in the trial, and receive a subject ID.

    Subject analysis set title
    Unsolicited Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed Set with post-vaccination unsolicited adverse event data.

    Primary: 1. Number of Subjects Reporting Unsolicited AEs

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    End point title
    		 1. Number of Subjects Reporting Unsolicited AEs [1]
    End point description
    Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination. Analysis were evaluated on the Unsolicited Safety Set.
    End point type
    Primary
    End point timeframe
    From day 1 to day 7 after each vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses not applicable.
    End point values
    		 rMenB+OMV NZ
    Number of subjects analysed
    55
    Units: Number of subjects
        Any SAEs (vaccination 1)
    0
        Any SAEs (vaccination 2)
    0
        At least possibly related SAEs (vaccination 1)
    0
        At least possibly related SAEs (vaccination 2)
    0
        AEs leading to premature withdrawal (vaccination1)
    0
        AEs leading to premature withdrawal (vaccination2)
    0
        Medically attended AEs (vaccination 1)
    0
        Medically attended AEs (vaccination 2)
    0
        AESIs (AEs of Special Interest) (vaccination 1)
    0
        AESIs (AEs of Special Interest) (vaccination 2)
    0
    No statistical analyses for this end point

    Other pre-specified: 2. Number of Adult Volunteers Whose Blood Can be Used as a Reference in SBA Test.

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    End point title
    		 2. Number of Adult Volunteers Whose Blood Can be Used as a Reference in SBA Test.
    End point description
    The number of identified healthy adult volunteers with pre and post-vaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test. The analysis was performed on the all enrolled dataset.
    End point type
    Other pre-specified
    End point timeframe
    Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2.
    End point values
    		 rMenB+OMV NZ
    Number of subjects analysed
    55
    Units: Number of Subjects
        Study Day 1 Blood Sample
    55
        Postvaccination 2 Blood Sample
    50
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Safety was assessed from the day of first vaccination (Day 1) until and inclusive the day of study termination (pre-planned at Day 91).
    Adverse event reporting additional description
    The analyses for unsolicited adverse events were done on the safety population. This study collects: throughout the study, any SAEs, AEs leading to withdrawal, AESI and medically attended AEs.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    rMenB+OMV NZ
    Reporting group description
    		 Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Statistical analyses not applicable.
    Serious adverse events
    		 rMenB+OMV NZ
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 55 (1.82%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    multiple sclerosis
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 rMenB+OMV NZ
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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