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    Clinical Trial Results:
    A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults in Europe

    Summary
    EudraCT number
    		 2015-000596-27
    Trial protocol
    		 GB  
    Global end of trial date
    19 Jan 2018

    Results information
    Results version number
    		 v1
    This version publication date
    03 Feb 2019
    First version publication date
    03 Feb 2019
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VAC52150EBL2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02416453
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines & Prevention B.V.
    Sponsor organisation address
    Archimedesweg 4-6, Leiden, Netherlands, 2333 CN
    Public contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.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
    23 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jan 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the safety and tolerability of 3 vaccination schedules of Ad26 vector expressing the glycoprotein of the Ebola virus Mayinga variant (Ad26.ZEBOV) and Modified Vaccinia Ankara - Bavarian Nordic vector expressing the glycoproteins of Ebola virus, Sudan virus and Marburg virus and the nucleoprotein of Tai Forest virus (MVA-BN-Filo) administered intramuscularly (IM) as heterologous 2-dose regimens on Days 1 and 29, Days 1 and 57, or Days 1 and 85 (Groups 1 to 3).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations included measurement of vital signs, clinical laboratory tests (Hematology, serum chemistry and urinalysis), assessment of adverse events (AEs) including reactogenicity, physical examinations, and electrocardiograms (ECG).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 197
    Country: Number of subjects enrolled
    United Kingdom: 224
    Worldwide total number of subjects
    421
    EEA total number of subjects
    421
    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)
    418
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 421 subjects were enrolled and treated. Of the 421 subjects, 406 subjects were enrolled in groups 1 to 3 (30 subjects in cohort I, 376 subjects in cohort II & III) and 15 subjects in group 4.

    Period 1
    Period 1 title
    REGIMEN (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval
    Arm description
    		 Subjects received intramuscular (IM) injection of Ad26 vector expressing the glycoprotein of the Ebola virus Mayinga variant (Ad26.ZEBOV) at a dose of 5*10^10 viral particles (vp) as Dose 1 on Day 1, followed by Modified Vaccinia Ankara - Bavarian Nordic vector expressing the glycoproteins of Ebola virus, Sudan virus and Marburg virus and the nucleoprotein of Tai Forest virus (MVA-BN-Filo) at a dose of 1*10^8 infectious units (Inf.U) (nominal titer) as Dose 2 on Day 29 in an open-label fashion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 29.

    Arm title
    		 Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval
    Arm description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57 in an open-label fashion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57.

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1.

    Arm title
    		 Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval
    Arm description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85 in an open-label fashion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85.

    Arm title
    		 Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval
    Arm description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 29 in a blinded fashion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 29.

    Arm title
    		 Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval
    Arm description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 29 in a blinded fashion.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 29.

    Arm title
    		 Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval
    Arm description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57 in a blinded fashion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57.

    Arm title
    		 Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval
    Arm description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 57 in a blinded fashion.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 57.

    Arm title
    		 Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval
    Arm description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by of MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85 in a blinded fashion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85.

    Arm title
    		 Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Arm description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 85 in a blinded fashion.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 85.

    Arm title
    		 Group 4: Ad26.ZEBOV
    Arm description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1 in a blinded fashion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1.

    Arm title
    		 Group 4: Placebo
    Arm description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1 in a blinded fashion.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Placebo (0.9% saline) as Dose 1 on Day 1.

    Number of subjects in period 1
    		Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval Group 4: Ad26.ZEBOV Group 4: Placebo
    Started
    10
    10
    10
    112
    13
    114
    13
    106
    18
    13
    2
    Completed
    7
    7
    9
    97
    12
    98
    11
    94
    13
    13
    2
    Not completed
    3
    3
    1
    15
    1
    16
    2
    12
    5
    0
    0
         Consent withdrawn by subject
    2
    -
    -
    5
    1
    8
    -
    8
    4
    -
    -
         Physician decision
    -
    -
    -
    -
    -
    1
    1
    1
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    2
    -
    1
    -
    -
    -
    -
    -
         Other
    -
    -
    1
    -
    -
    1
    -
    -
    -
    -
    -
         Lost to follow-up
    1
    3
    -
    8
    -
    5
    1
    3
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval
    Reporting group description
    		 Subjects received intramuscular (IM) injection of Ad26 vector expressing the glycoprotein of the Ebola virus Mayinga variant (Ad26.ZEBOV) at a dose of 5*10^10 viral particles (vp) as Dose 1 on Day 1, followed by Modified Vaccinia Ankara - Bavarian Nordic vector expressing the glycoproteins of Ebola virus, Sudan virus and Marburg virus and the nucleoprotein of Tai Forest virus (MVA-BN-Filo) at a dose of 1*10^8 infectious units (Inf.U) (nominal titer) as Dose 2 on Day 29 in an open-label fashion.

    Reporting group title
    Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57 in an open-label fashion.

    Reporting group title
    Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85 in an open-label fashion.

    Reporting group title
    Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 29 in a blinded fashion.

    Reporting group title
    Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 29 in a blinded fashion.

    Reporting group title
    Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57 in a blinded fashion.

    Reporting group title
    Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 57 in a blinded fashion.

    Reporting group title
    Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by of MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85 in a blinded fashion.

    Reporting group title
    Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 85 in a blinded fashion.

    Reporting group title
    Group 4: Ad26.ZEBOV
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1 in a blinded fashion.

    Reporting group title
    Group 4: Placebo
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1 in a blinded fashion.

    Reporting group values
    		 Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval Group 4: Ad26.ZEBOV Group 4: Placebo Total
    Number of subjects
    		 10 10 10 112 13 114 13 106 18 13 2 421
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 10 10 10 111 13 114 13 104 18 13 2 418
        From 65 to 84 years
    		 0 0 0 1 0 0 0 2 0 0 0 3
        85 years and over
    		 0 0 0 0 0 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.2 ( 12.95 ) 47.4 ( 16.53 ) 38.7 ( 13.99 ) 41 ( 15 ) 39.1 ( 13.9 ) 41 ( 14.02 ) 38.2 ( 13.66 ) 38.3 ( 14.34 ) 41.1 ( 15.11 ) 37.9 ( 11.37 ) 47 ( 4.24 ) -
    Title for Gender
    Units: subjects
        Female
    		 4 6 7 57 6 62 8 53 10 3 1 217
        Male
    		 6 4 3 55 7 52 5 53 8 10 1 204

    End points

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    End points reporting groups
    Reporting group title
    Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval
    Reporting group description
    		 Subjects received intramuscular (IM) injection of Ad26 vector expressing the glycoprotein of the Ebola virus Mayinga variant (Ad26.ZEBOV) at a dose of 5*10^10 viral particles (vp) as Dose 1 on Day 1, followed by Modified Vaccinia Ankara - Bavarian Nordic vector expressing the glycoproteins of Ebola virus, Sudan virus and Marburg virus and the nucleoprotein of Tai Forest virus (MVA-BN-Filo) at a dose of 1*10^8 infectious units (Inf.U) (nominal titer) as Dose 2 on Day 29 in an open-label fashion.

    Reporting group title
    Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57 in an open-label fashion.

    Reporting group title
    Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85 in an open-label fashion.

    Reporting group title
    Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 29 in a blinded fashion.

    Reporting group title
    Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 29 in a blinded fashion.

    Reporting group title
    Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57 in a blinded fashion.

    Reporting group title
    Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 57 in a blinded fashion.

    Reporting group title
    Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by of MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85 in a blinded fashion.

    Reporting group title
    Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 85 in a blinded fashion.

    Reporting group title
    Group 4: Ad26.ZEBOV
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1 in a blinded fashion.

    Reporting group title
    Group 4: Placebo
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1 in a blinded fashion.

    Primary: Group 1, 2 and 3: Percentage of Subjects with Adverse Events (Unsolicited Adverse Events)

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    End point title
    		 Group 1, 2 and 3: Percentage of Subjects with Adverse Events (Unsolicited Adverse Events) [1] [2]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Full Analysis set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    From signing of ICF (Inform Consent Form) Up to 42-day post-boost visit (Day 71 for Group 1; Day 99 for Group 2; and Day 127 for Group 3)
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Number of subjects analysed
    10
    10
    10
    112
    13
    114
    13
    106
    18
    Units: Percentage of subjects
        number (not applicable)
    40.0
    60.0
    60.0
    55.4
    46.2
    45.6
    53.8
    43.4
    44.4
    No statistical analyses for this end point

    Primary: Group 1, 2 and 3: Percentage of Subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Group 1, 2 and 3: Percentage of Subjects with Serious Adverse Events (SAEs) [3] [4]
    End point description
    SAEs are any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Full Analysis set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    From signing of ICF up to end of the study (Day 365)
    Notes
    [3] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Number of subjects analysed
    10
    10
    10
    112
    13
    114
    13
    106
    18
    Units: Percentage of subjects
        number (not applicable)
    0
    10.0
    0
    1.8
    0
    3.5
    7.7
    4.7
    5.6
    No statistical analyses for this end point

    Primary: Group 1, 2 and 3: Percentage of Subjects with Immediate Reportable Events (IREs)

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    End point title
    		 Group 1, 2 and 3: Percentage of Subjects with Immediate Reportable Events (IREs) [5] [6]
    End point description
    Any event of neuroimmunologic significance categorized as IREs which includes Cranial nerve disorders, including Paralyses/paresis, Optic neuritis, Multiple sclerosis, Transverse myelitis, Guillain-Barre syndrome, Miller Fisher syndrome, Bickerstaff’s encephalitis, Acute disseminated encephalomyelitis (including site specific variants: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), Myasthenia gravis, Lambert-Eaton myasthenic syndrome, Immune-mediated peripheral neuropathies, plexopathies (including chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and polyneuropathies associated with monoclonal gammopathy), Narcolepsy, Isolated paresthesia of greater than (>) 7 days duration. Full Analysis set included all subjects who were randomized, received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here, '99999' defines that no immediate reportable events indicated for cohort 1.
    End point type
    Primary
    End point timeframe
    From signing of ICF Up to end of the study (Day 365)
    Notes
    [5] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Number of subjects analysed
    10
    10
    10
    112
    13
    114
    13
    106
    18
    Units: Percentage of subjects
        number (not applicable)
    99999
    99999
    99999
    0
    0
    1.8
    0
    1.9
    0
    No statistical analyses for this end point

    Primary: Group 1, 2 and 3: Percentage of Subjects with Solicited Local Adverse Events

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    End point title
    		 Group 1, 2 and 3: Percentage of Subjects with Solicited Local Adverse Events [7] [8]
    End point description
    Subjects with solicited local (injection site) adverse events were instructed on how to note occurrences of erythema, induration/swelling (measured using the ruler supplied), pain/tenderness and itching at the injection site in the evening after each study vaccine administration and then daily for the next 7 days in the diary. Full Analysis set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' indicates the number of subjects who were analyzed at specified timepoint for each arm.
    End point type
    Primary
    End point timeframe
    Up to 7 days Post Dose 1 (Day 8 for Group 1, 2 and 3) and Post Dose 2 (Day 35, 63 and 91 for Group 1, 2 and 3 respectively)
    Notes
    [7] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Number of subjects analysed
    10
    10
    10
    112
    13
    114
    13
    106
    18
    Units: Percentage of subjects
    number (not applicable)
        Post-dose 1 (n=10,10,10,112,13, 114,13,106,18)
    80.0
    60.0
    80.0
    56.3
    23.1
    57.0
    15.4
    73.6
    22.2
        Post-dose 2(n=8,9,9, 91,10,83,7,62,11)
    50.0
    55.6
    88.9
    50.5
    20.0
    59.0
    0
    66.1
    0
    No statistical analyses for this end point

    Primary: Group 1, 2 and 3: Percentage of Subjects with Solicited Systemic Adverse Events

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    End point title
    		 Group 1, 2 and 3: Percentage of Subjects with Solicited Systemic Adverse Events [9] [10]
    End point description
    An AE is defined as any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Solicited systemic AEs included fever (defined as body temperature of 38 degree Celsius or higher), Headache, fatigue/Malaise, myalgia, nausea/vomiting, arthralgia, chills. Full Analysis set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' signifies number of subjects who were analyzed at specified timepoint for each arm.
    End point type
    Primary
    End point timeframe
    Up to 7 days Post Dose 1 (Day 8 for Group 1, 2 and 3) and Post Dose 2 (Day 35, 63 and 91 for Group 1, 2 and 3 respectively)
    Notes
    [9] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group1: Cohort I: Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Number of subjects analysed
    10
    10
    10
    112
    13
    114
    13
    106
    18
    Units: Percentage of subjects
    number (not applicable)
        Post-dose 1 (n=10,10,10,112,13,114,13,106,18)
    80.0
    100.0
    100.0
    79.5
    53.8
    73.7
    61.5
    77.4
    38.9
        Post-dose 2 (n=8,9,9,91,10,83,7,62,11)
    75.0
    55.6
    55.6
    46.2
    50.0
    43.4
    28.6
    61.3
    36.4
    No statistical analyses for this end point

    Secondary: Group 4: Percentage of Subjects with Adverse Events (Unsolicited Adverse Events)

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    End point title
    		 Group 4: Percentage of Subjects with Adverse Events (Unsolicited Adverse Events) [11]
    End point description
    An AE is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Full Analysis set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Secondary
    End point timeframe
    Up to 28-day post vaccination visit (Day 29 for Group 4)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group 4: Ad26.ZEBOV Group 4: Placebo
    Number of subjects analysed
    13
    2
    Units: Percentage of subjects
        number (not applicable)
    46.2
    50.0
    No statistical analyses for this end point

    Secondary: Group 4: Percentage of Subjects with Serious Adverse Events

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    End point title
    		 Group 4: Percentage of Subjects with Serious Adverse Events [12]
    End point description
    SAEs are any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Full Analysis set includes all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Secondary
    End point timeframe
    From signing of ICF up to end of the study (Day 365)
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group 4: Ad26.ZEBOV Group 4: Placebo
    Number of subjects analysed
    13
    2
    Units: Percentage of subjects
        number (not applicable)
    15.4
    0
    No statistical analyses for this end point

    Secondary: Group 4: Percentage of Subjects with Immediate Reportable Events (IREs)

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    End point title
    		 Group 4: Percentage of Subjects with Immediate Reportable Events (IREs) [13]
    End point description
    Any event of neuroimmunologic significance categorized as IREs which includes Cranial nerve disorders, including Paralyses/paresis, Optic neuritis, Multiple sclerosis, Transverse myelitis, Guillain-Barre syndrome, including Miller Fisher syndrome, Bickerstaff’s encephalitis, Acute disseminated encephalomyelitis (including site specific variants: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), Myasthenia gravis and Lambert-Eaton myasthenic syndrome, Immune-mediated peripheral neuropathies and plexopathies (including chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and polyneuropathies associated with monoclonal gammopathy), Narcolepsy, Isolated paresthesia of >7 days duration. Full Analysis set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here, '99999' defines that no immediate reportable events indicated for Group 4.
    End point type
    Secondary
    End point timeframe
    From signing of ICF up to end of the study (Day 365)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group 4: Ad26.ZEBOV Group 4: Placebo
    Number of subjects analysed
    13
    2
    Units: Percentage of subjects
        number (not applicable)
    99999
    99999
    No statistical analyses for this end point

    Secondary: Group 4: Percentage of Subjects with Solicited Local Adverse Events

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    End point title
    		 Group 4: Percentage of Subjects with Solicited Local Adverse Events [14]
    End point description
    Solicited adverse events are precisely defined events that subjects are specifically asked about and which are noted by subjects in the diary. Subjects with Solicited Local (Injection Site) Adverse Events were instructed on how to note occurrences of erythema, induration/swelling (measured using the ruler supplied), pain/tenderness and itching at the injection site in the evening after each study vaccine administration and then daily for the next 7 days in the diary. Full Analysis set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Secondary
    End point timeframe
    Up to 7 days Post-dose 1 (Day 8)
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group 4: Ad26.ZEBOV Group 4: Placebo
    Number of subjects analysed
    13
    2
    Units: Percentage of subjects
        number (not applicable)
    61.5
    0
    No statistical analyses for this end point

    Secondary: Group 4: Percentage of Subjects with Solicited Systemic Adverse Events

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    End point title
    		 Group 4: Percentage of Subjects with Solicited Systemic Adverse Events [15]
    End point description
    An AE is defined as any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Solicited systemic AEs included fever (defined as body temperature of 38°C or higher), Headache, fatigue/Malaise, myalgia, nausea/vomiting, arthralgia, chills. Full Analysis set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Secondary
    End point timeframe
    Up to 7 days Post-dose 1 (Day 8)
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group 4: Ad26.ZEBOV Group 4: Placebo
    Number of subjects analysed
    13
    2
    Units: Percentage of subjects
        number (not applicable)
    84.6
    50.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Anti-Ebola Virus (EBOV) Glycoprotein (GP) Binding Antibody Responses

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    End point title
    		 Percentage of Subjects with Anti-Ebola Virus (EBOV) Glycoprotein (GP) Binding Antibody Responses [16]
    End point description
    Humoral immune responses were measured by binding antibody responses using Filovirus Animal Nonclinical Group (FANG). ELISA Per Protocol analysis set included all randomized and vaccinated subjects, who received both the prime and boost (administered not more than 10 days outside the visit window) vaccinations, had immunogenicity data from baseline and at least one post-vaccination evaluable immunogenicity sample, and had no major protocol violations influencing the immune response. Here, 99999 indicates that data was not reported as no subjects analyzed in the respective group at specified timepoint. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint and 'n' indicates the number of subjects who were analyzed at specified timepoint for each arm.
    End point type
    Secondary
    End point timeframe
    At 21 days post boost (Day 50 for Group 1; Day 78 for Group 2; and Day 106 for Group 3)
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be reported for the specified arms only.
    End point values
    		 Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Number of subjects analysed
    80
    8
    70
    7
    51
    6
    Units: Percentage of subjects
    number (not applicable)
        Day 50 (n=77, 7, 0, 0, 0, 0)
    98.7
    0
    99999
    99999
    99999
    99999
        Day 78 (n=0, 0, 69, 7, 0, 0)
    99999
    99999
    100
    0
    99999
    99999
        Day 106 (n=0, 0, 0, 0, 48, 6)
    99999
    99999
    99999
    99999
    100
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to Day 365
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Group1:Cohort I:Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval
    Reporting group description
    		 Subjects received intramuscular (IM) injection of Ad26 vector expressing the glycoprotein of the Ebola virus Mayinga variant (Ad26.ZEBOV) at a dose of 5*10^10 viral particles (vp) as Dose 1 on Day 1, followed by Modified Vaccinia Ankara – Bavarian Nordic vector expressing the glycoproteins of Ebola virus, Sudan virus and Marburg virus and the nucleoprotein of Tai Forest virus (MVA-BN-Filo) at a dose of 1*10^8 infectious units (Inf.U) (nominal titer) as Dose 2 on Day 29 in an open-label fashion.

    Reporting group title
    Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57 in an open-label fashion.

    Reporting group title
    Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85 in an open-label fashion.

    Reporting group title
    Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 29 in a blinded fashion.

    Reporting group title
    Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 29 in a blinded fashion.

    Reporting group title
    Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 57 in a blinded fashion.

    Reporting group title
    Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 56 in a blinded fashion.

    Reporting group title
    Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1, followed by MVA-BN-Filo at a dose of 1*10^8 Inf.U (nominal titer) as Dose 2 on Day 85 in a blinded fashion.

    Reporting group title
    Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1, followed by placebo (0.9% saline) as Dose 2 on Day 85 in a blinded fashion.

    Reporting group title
    Group 4: Ad26
    Reporting group description
    		 Subjects received IM injection of Ad26.ZEBOV at a dose of 5*10^10 vp as Dose 1 on Day 1 in a blinded fashion.

    Reporting group title
    Group 4: Placebo
    Reporting group description
    		 Subjects received Placebo (0.9% saline) as Dose 1 on Day 1 in a blinded fashion.

    Serious adverse events
    		 Group1:Cohort I:Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval Group 4: Ad26 Group 4: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    2 / 112 (1.79%)
    0 / 13 (0.00%)
    4 / 114 (3.51%)
    1 / 13 (7.69%)
    5 / 106 (4.72%)
    1 / 18 (5.56%)
    2 / 13 (15.38%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Osteosarcoma
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 112 (0.89%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Human Papilloma Virus Test Positive
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    1 / 13 (7.69%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Appendicectomy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Miller Fisher Syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Fibre Neuropathy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral Venous Thrombosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    1 / 106 (0.94%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    1 / 106 (0.94%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Food Allergy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    1 / 106 (0.94%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal Hernia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    1 / 106 (0.94%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Acute
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    1 / 106 (0.94%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic Sinusitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 112 (0.89%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group1:Cohort I:Ad26.ZEBOV then MVA-BN-Filo,28-Day Interval Group 2:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 56-Day Interval Group 3:Cohort I: Ad26.ZEBOV then MVA-BN-Filo, 84-Day Interval Group1:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,28-Day Interval Group 1: Cohorts II & III: Placebo, Placebo, 28-Day Interval Group2:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,56-Day Interval Group 2: Cohorts II & III: Placebo, Placebo, 56-Day Interval Group3:Cohorts II & III:Ad26.ZEBOV/MVA-BN-Filo,84-Day Interval Group 3: Cohorts II & III: Placebo, Placebo, 84-Day Interval Group 4: Ad26 Group 4: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 10 (40.00%)
    5 / 10 (50.00%)
    6 / 10 (60.00%)
    41 / 112 (36.61%)
    6 / 13 (46.15%)
    30 / 114 (26.32%)
    7 / 13 (53.85%)
    26 / 106 (24.53%)
    8 / 18 (44.44%)
    6 / 13 (46.15%)
    1 / 2 (50.00%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    3 / 106 (2.83%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    3
    0
    0
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    3 / 114 (2.63%)
    0 / 13 (0.00%)
    3 / 106 (2.83%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    3
    0
    3
    0
    0
    0
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 112 (0.89%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Neutrophil Count Decreased
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
    3 / 112 (2.68%)
    0 / 13 (0.00%)
    2 / 114 (1.75%)
    0 / 13 (0.00%)
    2 / 106 (1.89%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    3
    3
    0
    2
    0
    2
    1
    0
    0
    Prothrombin Time Prolonged
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 112 (0.89%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    1 / 13 (7.69%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Ligament Sprain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 112 (0.89%)
    1 / 13 (7.69%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Dizziness Postural
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 112 (0.89%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    1 / 106 (0.94%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    1 / 106 (0.94%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Headache
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    3 / 112 (2.68%)
    1 / 13 (7.69%)
    3 / 114 (2.63%)
    1 / 13 (7.69%)
    5 / 106 (4.72%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    3
    1
    3
    1
    12
    0
    0
    0
    General disorders and administration site conditions
    Application Site Bruise
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Asthenia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Influenza Like Illness
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 112 (1.79%)
    0 / 13 (0.00%)
    2 / 114 (1.75%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    0
    0
    0
    1
    0
    Injection Site Erythema
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 112 (0.89%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Injection Site Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    1 / 13 (7.69%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Dental Discomfort
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    1 / 13 (7.69%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    1 / 106 (0.94%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    2 / 114 (1.75%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    0
    0
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    1 / 13 (7.69%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Oral Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    1 / 106 (0.94%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 112 (1.79%)
    0 / 13 (0.00%)
    2 / 114 (1.75%)
    1 / 13 (7.69%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    1
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    4 / 112 (3.57%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    2 / 13 (15.38%)
    3 / 106 (2.83%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    1
    2
    3
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 112 (0.89%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 112 (0.89%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    1 / 13 (7.69%)
    0 / 106 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    0
    1
    0
    0
    Back Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    3 / 112 (2.68%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    1 / 13 (7.69%)
    3 / 106 (2.83%)
    0 / 18 (0.00%)
    2 / 13 (15.38%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    4
    0
    2
    1
    3
    0
    2
    0
    Chondropathy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 112 (1.79%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Pain in Extremity
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 112 (0.89%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    1 / 13 (7.69%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    3 / 112 (2.68%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    1 / 13 (7.69%)
    1 / 106 (0.94%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    1
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 112 (1.79%)
    0 / 13 (0.00%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    0
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    7 / 112 (6.25%)
    0 / 13 (0.00%)
    6 / 114 (5.26%)
    0 / 13 (0.00%)
    3 / 106 (2.83%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    1
    8
    0
    6
    0
    3
    0
    0
    0
    Tooth Abscess
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 112 (0.00%)
    0 / 13 (0.00%)
    1 / 114 (0.88%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    6 / 112 (5.36%)
    1 / 13 (7.69%)
    6 / 114 (5.26%)
    1 / 13 (7.69%)
    3 / 106 (2.83%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    7
    1
    6
    1
    3
    1
    0
    0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 112 (0.89%)
    1 / 13 (7.69%)
    0 / 114 (0.00%)
    0 / 13 (0.00%)
    0 / 106 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2015
    This amendment was created upon request of the Medicines and Healthcare Products Regulatory Agency (MHRA). Further modifications were made to implement a site-specific request, to update the list of references and to correct minor inconsistencies.
    18 Aug 2015
    This amendment was created to implement site-specific requests and only subjects who received active vaccine will enter a long-term follow-up phase.
    26 Jan 2016
    This amendment includes the request of the Center for Biologics Evaluation and Research (CBER, a division of US Food and Drug Administration [FDA]) to extend the safety follow-up to 6 months post-boost.
    01 Sep 2016
    The sponsor halted vaccinations following a case of Miller Fisher syndrome after receipt of MVA-BN-Filo or placebo in this clinical study, until a revised inform consent form (ICF) containing updated safety language for the current study VAC52150EBL2001 was prepared and approval to restart the study was granted by the relevant competent authority. As a result of the pause, some subjects were outside the protocol-defined boost vaccination window. Information was added to clarify the procedures that need to be followed for these subjects. As requested by the Agence Nationale de Securite du Medicament et des produits de sante (ANSM), wording on the collection of Immediate Reportable Events was added after observation of the case of Miller Fisher syndrome. Randomization to Group 3 will be stopped to focus on the schedules for which an indication will be sought.
    20 Apr 2017
    This amendment was created due to significant delays in scheduled boost vaccinations caused by study pauses required for safety evaluations. Since many subjects in France have had no boost vaccination and many subjects in the United Kingdom (UK) have had a late boost vaccination, it will be very difficult to evaluate the planned dosing regimens. Therefore, no further subjects will be recruited in the entire study (ie, UK and France). Vaccinated subjects in both countries will still be followed per protocol for safety.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Apr 2016
    Study vaccinations were halted due to the occurrence of a serious adverse event (Miller Fisher syndrome). The event was considered to be possibly related to study vaccination by the investigator and therefore met the pre-specified pausing rules installed for this study. Per IDMC recommendation, further investigations and analyses were performed, and all study vaccinations were halted until the safety language of the ICF was updated.
    27 May 2016
    20 May 2016
    A second serious adverse event was reported (initially reported as ‘possible cervical myelitis’, ultimately diagnosed as small fiber neuropathy), which also was assessed as possibly related to study vaccination by the investigator and investigated and analyzed further. This event resulted in halt of screening and all study vaccinations.
    27 Sep 2016

    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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