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    Clinical Trial Results:
    A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa

    Summary
    EudraCT number
    2019-000690-22
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    12 Feb 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Aug 2019
    First version publication date
    28 Aug 2019
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CR107249
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02564523
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines & Prevention B.V.
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333 CM
    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)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002307-PIP01-17, EMEA-002308-PIP01-17
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    12 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the safety and tolerability of different vaccination schedules of adenovirus serotype 26 expressing the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) and Modified Vaccinia Ankara Bavarian Nordic vector expressing multiple filovirus proteins (MVA-BN-Filo) administered intramuscularly (IM) as heterologous prime-boost regimens on Days 1 and 29, Days 1 and 57, or Days 1 and 85, in healthy adults, including elderly subjects, and on Days 1 and 29, or Days 1 and 57 in human immunodeficiency virus (HIV) infected subjects and healthy children in 2 age strata.
    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 monitoring of adverse events (AEs), serious adverse events (SAEs), solicited local and systemic adverse events (AEs), clinical laboratory parameters (chemistry, hematology, urinalysis), vital signs, electrocardiograms (ECG), and physical examination.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Nov 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Burkina Faso: 369
    Country: Number of subjects enrolled
    Côte d’Ivoire: 178
    Country: Number of subjects enrolled
    Kenya: 158
    Country: Number of subjects enrolled
    Uganda: 368
    Worldwide total number of subjects
    1073
    EEA total number of subjects
    0
    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)
    133
    Adolescents (12-17 years)
    130
    Adults (18-64 years)
    802
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1073 subjects were enrolled into the study. Of these, 1035 subjects completed the study and 38 subjects discontinued.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Arm description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 viral particles (vp) on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of Ad26.ZEBOV (5*10^10 viral particles) vaccine on Day 1. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of MVA-BN-Filo (1*10^8 infectious units) vaccine on Day 29.

    Arm title
    Cohort 1 (Group 1): Placebo, 28-Day Interval
    Arm description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9 percent [%] saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received first dose of placebo (0.5 mL IM injection of 0.9 percent [%] saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.

    Arm title
    Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Arm description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of Ad26.ZEBOV (5*10^10 vp) vaccine on Day 1. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of MVA-BN-Filo (1*10^8 infectious units) vaccine on Day 57.

    Arm title
    Cohort 1 (Group 2): Placebo, 56-Day Interval
    Arm description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of 0.9% saline on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.

    Arm title
    Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval
    Arm description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 84-day interval that is on Day 85.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of Ad26.ZEBOV (5*10^10 vp) vaccine on Day 1.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of MVA-BN-Filo (1*10^8 infectious units) vaccine on Day 85.

    Arm title
    Cohort 1 (Group 3): Placebo, 84-Day Interval
    Arm description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 84-day interval that is on Day 85.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of 0.9% saline on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 84-day interval that is on Day 85.

    Arm title
    Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Arm description
    Subjects (human immunodeficiency virus [HIV]-infected subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.
    Arm type
    Experimental

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of MVA-BN-Filo (1*10^8 infectious units) vaccine on Day 29.

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of Ad26.ZEBOV (5*10^10 vp) vaccine on Day 1.

    Arm title
    Cohort 2a: Placebo, 28-Day Interval
    Arm description
    Subjects (HIV-infected subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of 0.9% saline on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Arm title
    Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Arm description
    Subjects (HIV-infected subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.
    Arm type
    Experimental

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of MVA-BN-Filo (1*10^8 infectious units) vaccine on Day 57.

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of Ad26.ZEBOV (5*10^10 vp) vaccine on Day 1.

    Arm title
    Cohort 2a: Placebo, 56-Day Interval
    Arm description
    Subjects (HIV-infected subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of 0.9% saline on Day 1 followed by a second vaccination of placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Arm title
    Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Arm description
    Subjects (healthy adolescents) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of Ad26.ZEBOV (5*10^10 vp) vaccine on Day 1.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of MVA-BN-Filo (1*10^8 infectious units) vaccine on Day 29.

    Arm title
    Cohort 2b: Placebo, 28-Day Interval
    Arm description
    Subjects (healthy adolescents) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of 0.9% saline on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Arm title
    Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Arm description
    Subjects (healthy adolescents) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of Ad26.ZEBOV (5*10^10 vp) vaccine on Day 1.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of MVA-BN-Filo (1*10^8 infectious units) vaccine on Day 57.

    Arm title
    Cohort 2b: Placebo, 56-Day Interval
    Arm description
    Subjects (healthy adolescents) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of 0.9% saline on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Arm title
    Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Arm description
    Subjects (healthy children) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of Ad26.ZEBOV (5*10^10 vp) vaccine on Day 1.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of MVA-BN-Filo (1*10^8 infectious units) vaccine on Day 29.

    Arm title
    Cohort 3: Placebo, 28-Day Interval
    Arm description
    Subjects (healthy children) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of 0.9% saline on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Arm title
    Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Arm description
    Subjects (healthy children) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.
    Arm type
    Experimental

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of MVA-BN-Filo (1*10^8 infectious units) vaccine on Day 57.

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of Ad26.ZEBOV (5*10^10 vp) vaccine on Day 1.

    Arm title
    Cohort 3: Placebo, 56-Day Interval
    Arm description
    Subjects (healthy children) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one 0.5 mL IM injection of 0.9% saline on Day 1 followed by a second vaccination of placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Number of subjects in period 1
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval Cohort 1 (Group 3): Placebo, 84-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2a: Placebo, 28-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2a: Placebo, 56-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2b: Placebo, 28-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2b: Placebo, 56-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 3: Placebo, 28-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 3: Placebo, 56-Day Interval
    Started
    225
    43
    224
    44
    110
    22
    59
    12
    59
    12
    55
    11
    55
    10
    54
    12
    54
    12
    Completed
    215
    40
    214
    43
    106
    22
    56
    12
    59
    12
    52
    10
    53
    10
    54
    12
    54
    11
    Not completed
    10
    3
    10
    1
    4
    0
    3
    0
    0
    0
    3
    1
    2
    0
    0
    0
    0
    1
         Protocol deviation
    2
    2
    5
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Physician decision
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
         Unspecified
    3
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    3
    -
    1
    -
    1
    -
    1
    -
    -
    -
    1
    -
    1
    -
    -
    -
    -
    -
         Lost to follow-up
    2
    1
    4
    -
    1
    -
    1
    -
    -
    -
    -
    1
    1
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 viral particles (vp) on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.

    Reporting group title
    Cohort 1 (Group 1): Placebo, 28-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9 percent [%] saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.

    Reporting group title
    Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.

    Reporting group title
    Cohort 1 (Group 2): Placebo, 56-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.

    Reporting group title
    Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 84-day interval that is on Day 85.

    Reporting group title
    Cohort 1 (Group 3): Placebo, 84-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 84-day interval that is on Day 85.

    Reporting group title
    Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (human immunodeficiency virus [HIV]-infected subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2a: Placebo, 28-Day Interval
    Reporting group description
    Subjects (HIV-infected subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (HIV-infected subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 2a: Placebo, 56-Day Interval
    Reporting group description
    Subjects (HIV-infected subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2b: Placebo, 28-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 2b: Placebo, 56-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 3: Placebo, 28-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 3: Placebo, 56-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Reporting group values
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval Cohort 1 (Group 3): Placebo, 84-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2a: Placebo, 28-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2a: Placebo, 56-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2b: Placebo, 28-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2b: Placebo, 56-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 3: Placebo, 28-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 3: Placebo, 56-Day Interval Total
    Number of subjects
    225 43 224 44 110 22 59 12 59 12 55 11 55 10 54 12 54 12 1073
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0 0 0 0 0 0 1 0 0 0 54 12 54 12 133
        Adolescents (12-17 years)
    0 0 0 0 0 0 0 0 0 0 54 11 55 10 0 0 0 0 130
        Adults (18-64 years)
    222 43 223 42 109 21 59 12 59 12 0 0 0 0 0 0 0 0 802
        From 65 to 84 years
    3 0 1 2 1 1 0 0 0 0 0 0 0 0 0 0 0 0 8
        85 years and over
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    33.3 ± 12.41 32 ± 10.43 33.3 ± 11.52 33.3 ± 11.57 31.4 ± 11.53 33.7 ± 12.31 38.8 ± 6.61 34.3 ± 7.66 39 ± 6.69 42.1 ± 4.96 14.4 ± 1.76 14.5 ± 1.86 14.1 ± 1.56 14.2 ± 1.81 7.6 ± 2.06 7.1 ± 2.07 7.8 ± 2.23 7.3 ± 2.09 -
    Title for Gender
    Units: subjects
        Female
    73 15 71 16 27 8 39 8 42 10 25 5 26 4 27 5 28 5 434
        Male
    152 28 153 28 83 14 20 4 17 2 30 6 29 6 27 7 26 7 639

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 viral particles (vp) on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.

    Reporting group title
    Cohort 1 (Group 1): Placebo, 28-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9 percent [%] saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.

    Reporting group title
    Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.

    Reporting group title
    Cohort 1 (Group 2): Placebo, 56-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.

    Reporting group title
    Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 84-day interval that is on Day 85.

    Reporting group title
    Cohort 1 (Group 3): Placebo, 84-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 84-day interval that is on Day 85.

    Reporting group title
    Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (human immunodeficiency virus [HIV]-infected subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2a: Placebo, 28-Day Interval
    Reporting group description
    Subjects (HIV-infected subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (HIV-infected subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 2a: Placebo, 56-Day Interval
    Reporting group description
    Subjects (HIV-infected subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2b: Placebo, 28-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 2b: Placebo, 56-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 3: Placebo, 28-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 3: Placebo, 56-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Primary: Number of Subjects with Unsolicited Adverse Events (Post-dose 1 and Post-dose 2 combined)

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    End point title
    Number of Subjects with Unsolicited Adverse Events (Post-dose 1 and Post-dose 2 combined) [1]
    End point description
    An Adverse Events (AEs) is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited AEs included all AEs for which the subject was specifically not questioned in the subject diary. The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations (PDs).
    End point type
    Primary
    End point timeframe
    Up to Day 113 (28 days post-dose 1 and post-dose 2)
    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.
    End point values
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval Cohort 1 (Group 3): Placebo, 84-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2a: Placebo, 28-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2a: Placebo, 56-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2b: Placebo, 28-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2b: Placebo, 56-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 3: Placebo, 28-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 3: Placebo, 56-Day Interval
    Number of subjects analysed
    225
    43
    224
    44
    110
    22
    59
    12
    59
    12
    55
    11
    55
    10
    54
    12
    54
    12
    Units: Subjects
    126
    24
    100
    25
    56
    13
    35
    9
    33
    5
    35
    5
    42
    6
    34
    9
    30
    9
    No statistical analyses for this end point

    Primary: Number of Subjects with Serious Adverse Events

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    End point title
    Number of Subjects with Serious Adverse Events [2]
    End point description
    An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize subjects and/or may require medical or surgical intervention to prevent one of the outcomes listed above. The FAS included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of PDs.
    End point type
    Primary
    End point timeframe
    Up to Day 720 (from signing of informed consent form up to end of study)
    Notes
    [2] - 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.
    End point values
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval Cohort 1 (Group 3): Placebo, 84-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2a: Placebo, 28-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2a: Placebo, 56-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2b: Placebo, 28-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2b: Placebo, 56-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 3: Placebo, 28-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 3: Placebo, 56-Day Interval
    Number of subjects analysed
    225
    43
    224
    44
    110
    22
    59
    12
    59
    12
    55
    11
    55
    10
    54
    12
    54
    12
    Units: Subjects
    7
    1
    7
    0
    6
    0
    1
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    1
    No statistical analyses for this end point

    Primary: Number of Subjects with Immediate Reportable Event (IRE)

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    End point title
    Number of Subjects with Immediate Reportable Event (IRE) [3]
    End point description
    Number of subjects with IREs were reported. IRE: Any event of neuroimmunologic significance. FAS included all subjects who were randomized and received at least 1 dose of study vaccine, regardless of occurrence of PDs.
    End point type
    Primary
    End point timeframe
    Up to Day 720 (from signing of Informed Consent Form up to end of study)
    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.
    End point values
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval Cohort 1 (Group 3): Placebo, 84-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2a: Placebo, 28-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2a: Placebo, 56-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2b: Placebo, 28-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2b: Placebo, 56-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 3: Placebo, 28-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 3: Placebo, 56-Day Interval
    Number of subjects analysed
    225
    43
    224
    44
    110
    22
    59
    12
    59
    12
    55
    11
    55
    10
    54
    12
    54
    12
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Solicited Local and Systemic Adverse Events (Post-dose 1 and Post-dose 2 Combined)

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    End point title
    Number of Subjects with Solicited Local and Systemic Adverse Events (Post-dose 1 and Post-dose 2 Combined) [4]
    End point description
    Number of subjects with solicited injection site (local and systemic) AEs were reported. Solicited local AEs (pain, erythema, and induration at the study vaccine injection site) and systemic AEs (fever, chills, headache, fatigue, nausea, myalgia, and arthralgia) were noted in the subject diary until 7 days after each administration of study vaccine. The FAS included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of PDs.
    End point type
    Primary
    End point timeframe
    Up to Day 92 (7 days post-dose 1 and post-dose 2)
    Notes
    [4] - 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.
    End point values
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval Cohort 1 (Group 3): Placebo, 84-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2a: Placebo, 28-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2a: Placebo, 56-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2b: Placebo, 28-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2b: Placebo, 56-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 3: Placebo, 28-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 3: Placebo, 56-Day Interval
    Number of subjects analysed
    225
    43
    224
    44
    110
    22
    59
    12
    59
    12
    55
    11
    55
    10
    54
    12
    54
    12
    Units: Subjects
        Solicited Local AE
    154
    19
    155
    23
    81
    12
    40
    5
    40
    2
    35
    5
    33
    5
    34
    6
    33
    5
        Solicited Systemic AE
    165
    29
    171
    28
    90
    17
    49
    7
    40
    7
    34
    4
    34
    6
    26
    3
    24
    5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Anti-Ebola virus (EBOV) Glycoprotein (GP) Binding Antibodies Level

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    End point title
    Percentage of Subjects with Anti-Ebola virus (EBOV) Glycoprotein (GP) Binding Antibodies Level
    End point description
    Percentage of subjects with anti-EBOV GP binding antibodies levels elicited by vaccination by enzyme-linked immunosorbent assay (ELISA) were reported. The 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. 99999 indicates that data was not assessable as no subject was analysed for this endpoint at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 50, Day 78, and Day 106
    End point values
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval Cohort 1 (Group 3):Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval Cohort 1 (Group 3): Placebo, 84-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2a: Placebo, 28-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2a: Placebo, 56-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2b: Placebo, 28-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2b: Placebo, 56-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 3: Placebo, 28-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 3: Placebo, 56-Day Interval
    Number of subjects analysed
    169
    32
    134
    24
    26
    7
    58
    10
    58
    12
    54
    10
    53
    10
    53
    12
    52
    11
    Units: Percentage of Subjects
    number (not applicable)
        Day 50
    100
    13.3
    99999
    99999
    99999
    99999
    100
    36.4
    99999
    99999
    100
    30.0
    99999
    99999
    100
    25.0
    99999
    99999
        Day 78
    99999
    99999
    100
    33.3
    99999
    99999
    99999
    99999
    100
    8.3
    99999
    99999
    100
    30.0
    99999
    99999
    100
    9.1
        Day 106
    99999
    99999
    99999
    99999
    100
    0.0
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Cohort 1 Substudy: Number of Subjects with Unsolicited Adverse Events (Post booster dose)

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    End point title
    Cohort 1 Substudy: Number of Subjects with Unsolicited Adverse Events (Post booster dose) [5]
    End point description
    An AE is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited AEs included all AEs for which the subject was specifically not questioned in the subject diary. The FAS included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of PDs. Here 'N' (number of subjects analysed) signifies those subjects who were evaluable for this endpoint. This endpoint was planned to be analysed and reported for specified cohorts only.
    End point type
    Secondary
    End point timeframe
    Up to Day 393 (28 days post booster dose [dose 3])
    Notes
    [5] - 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 analysed for specified arms only.
    End point values
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval
    Number of subjects analysed
    34
    8
    39
    9
    Units: Subjects
    9
    3
    14
    0
    No statistical analyses for this end point

    Secondary: Cohort 1 Substudy: Number of Subjects with Solicited Local and Systemic Adverse Events (Post booster dose)

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    End point title
    Cohort 1 Substudy: Number of Subjects with Solicited Local and Systemic Adverse Events (Post booster dose) [6]
    End point description
    Number of subjects with solicited injection site (local and systemic) AEs were reported. Solicited local AEs (pain, erythema, and induration at the study vaccine injection site) and systemic AEs (fever, chills, headache, fatigue, nausea, myalgia, and arthralgia) were noted in the subject diary until 7 days after each administration of study vaccine. Here 'N' (number of subjects analysed) signifies those subjects who were evaluable for this endpoint. Here 'N' (number of subjects analysed) signifies those subjects who were evaluable for this endpoint. This endpoint was planned to be analysed and reported for specified cohorts only.
    End point type
    Secondary
    End point timeframe
    Up to Day 372 (7 days post booster dose [dose 3])
    Notes
    [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 analysed for specified arms only.
    End point values
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1(Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval
    Number of subjects analysed
    34
    8
    34
    9
    Units: Subjects
        Solicited Local AE
    18
    1
    16
    3
        Solicited Systemic AE
    17
    2
    18
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 720
    Adverse event reporting additional description
    The 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.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo,28-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 viral particles (vp) on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.

    Reporting group title
    Cohort 1 (Group 1): Placebo, 28-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9 percent [%] saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.

    Reporting group title
    Cohort 1 (Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57. Only subjects who reconsented for sub-study received a booster dose of Ad26.ZEBOV (5*10^10 vp) on Day 365.

    Reporting group title
    Cohort 1 (Group 2): Placebo, 56-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57. Only subjects who reconsented for sub-study received a booster dose of placebo on Day 365.

    Reporting group title
    Cohort 1(Group 3): Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 84-day interval that is on Day 85.

    Reporting group title
    Cohort 1 (Group 3): Placebo, 84-Day Interval
    Reporting group description
    Subjects (healthy adult and elderly subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 84-day interval that is on Day 85.

    Reporting group title
    Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (human immunodeficiency virus [HIV]-infected subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2a: Placebo, 28-Day Interval
    Reporting group description
    Subjects (HIV-infected subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (HIV-infected subjects) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 2a: Placebo, 56-Day Interval
    Reporting group description
    Subjects (HIV-infected subjects) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2b: Placebo, 28-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 2b: Placebo, 56-Day Interval
    Reporting group description
    Subjects (healthy adolescents) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 3: Placebo, 28-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 28-day interval that is on Day 29.

    Reporting group title
    Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of Ad26.ZEBOV vaccine at a dose of 5*10^10 vp on Day 1, followed by a second vaccination using MVA-BN-Filo at a dose of 1*10^8 infectious units at a 56-day interval that is on Day 57.

    Reporting group title
    Cohort 3: Placebo, 56-Day Interval
    Reporting group description
    Subjects (healthy children) received first dose of placebo (0.9% saline) on Day 1 followed by a second vaccination using placebo (0.9% saline) at a 56-day interval that is on Day 57.

    Serious adverse events
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo,28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1 (Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval Cohort 1(Group 3): Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval Cohort 1 (Group 3): Placebo, 84-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2a: Placebo, 28-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2a: Placebo, 56-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2b: Placebo, 28-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2b: Placebo, 56-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 3: Placebo, 28-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 3: Placebo, 56-Day Interval
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 225 (3.11%)
    1 / 43 (2.33%)
    7 / 224 (3.13%)
    0 / 44 (0.00%)
    6 / 110 (5.45%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Alcohol Poisoning
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (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
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns Second Degree
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
         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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament Sprain
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Dolichocolon
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anembryonic Gestation
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Meniere's Disease
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 43 (2.33%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal Hernia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstruction Gastric
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Electrolyte Imbalance
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 43 (2.33%)
    3 / 224 (1.34%)
    0 / 44 (0.00%)
    3 / 110 (2.73%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Typhoid Fever
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (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 / 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 / 1
    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
    Cohort 1(Group 1):Ad26.ZEBOV and MVA-BN-Filo,28-Day Interval Cohort 1 (Group 1): Placebo, 28-Day Interval Cohort 1 (Group 2):Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 1 (Group 2): Placebo, 56-Day Interval Cohort 1(Group 3): Ad26.ZEBOV and MVA-BN-Filo, 84-Day Interval Cohort 1 (Group 3): Placebo, 84-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2a: Placebo, 28-Day Interval Cohort 2a: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2a: Placebo, 56-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 2b: Placebo, 28-Day Interval Cohort 2b: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 2b: Placebo, 56-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 28-Day Interval Cohort 3: Placebo, 28-Day Interval Cohort 3: Ad26.ZEBOV and MVA-BN-Filo, 56-Day Interval Cohort 3: Placebo, 56-Day Interval
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 225 (41.78%)
    17 / 43 (39.53%)
    80 / 224 (35.71%)
    21 / 44 (47.73%)
    43 / 110 (39.09%)
    12 / 22 (54.55%)
    24 / 59 (40.68%)
    9 / 12 (75.00%)
    28 / 59 (47.46%)
    5 / 12 (41.67%)
    29 / 55 (52.73%)
    5 / 11 (45.45%)
    33 / 55 (60.00%)
    6 / 10 (60.00%)
    27 / 54 (50.00%)
    9 / 12 (75.00%)
    22 / 54 (40.74%)
    9 / 12 (75.00%)
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    2 / 224 (0.89%)
    1 / 44 (2.27%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    1 / 55 (1.82%)
    1 / 10 (10.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    0
    0
    0
    0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    3 / 225 (1.33%)
    1 / 43 (2.33%)
    1 / 224 (0.45%)
    3 / 44 (6.82%)
    2 / 110 (1.82%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    1
    2
    3
    2
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Foot Fracture
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ligament Sprain
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 43 (2.33%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    4 / 59 (6.78%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    1
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    2 / 225 (0.89%)
    2 / 43 (4.65%)
    2 / 224 (0.89%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    1 / 11 (9.09%)
    1 / 55 (1.82%)
    0 / 10 (0.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
         occurrences all number
    2
    2
    2
    0
    1
    0
    0
    0
    2
    0
    1
    1
    1
    0
    1
    0
    1
    0
    Blood Potassium Decreased
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 43 (0.00%)
    3 / 224 (1.34%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    3
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood Pressure Increased
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    1 / 11 (9.09%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Blood Sodium Decreased
         subjects affected / exposed
    9 / 225 (4.00%)
    0 / 43 (0.00%)
    4 / 224 (1.79%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    3 / 55 (5.45%)
    1 / 10 (10.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    9
    0
    4
    0
    0
    0
    0
    0
    1
    0
    1
    0
    3
    1
    0
    0
    0
    0
    Blood Urea Decreased
         subjects affected / exposed
    3 / 225 (1.33%)
    0 / 43 (0.00%)
    2 / 224 (0.89%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    5 / 55 (9.09%)
    0 / 11 (0.00%)
    1 / 55 (1.82%)
    1 / 10 (10.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    2
    0
    1
    0
    1
    0
    1
    0
    5
    0
    1
    1
    0
    0
    1
    0
    Monocyte Count Decreased
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Neutrophil Count Decreased
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    1 / 44 (2.27%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    2 / 55 (3.64%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    1
    Transaminases Increased
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    1 / 10 (10.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 225 (0.44%)
    2 / 43 (4.65%)
    4 / 224 (1.79%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    1 / 11 (9.09%)
    0 / 55 (0.00%)
    1 / 10 (10.00%)
    2 / 54 (3.70%)
    3 / 12 (25.00%)
    2 / 54 (3.70%)
    1 / 12 (8.33%)
         occurrences all number
    1
    2
    4
    0
    1
    0
    0
    0
    2
    0
    1
    1
    0
    1
    2
    3
    2
    1
    Productive Cough
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    1 / 55 (1.82%)
    0 / 10 (0.00%)
    3 / 54 (5.56%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    1 / 55 (1.82%)
    0 / 10 (0.00%)
    3 / 54 (5.56%)
    1 / 12 (8.33%)
    1 / 54 (1.85%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    1
    1
    0
    1
    0
    1
    0
    3
    1
    1
    1
    Leukopenia
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 43 (2.33%)
    4 / 224 (1.79%)
    1 / 44 (2.27%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    1 / 12 (8.33%)
    3 / 59 (5.08%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    2 / 11 (18.18%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    2 / 54 (3.70%)
    0 / 12 (0.00%)
    1 / 54 (1.85%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    4
    1
    0
    0
    1
    1
    3
    0
    0
    2
    0
    0
    2
    0
    1
    1
    Microcytic Anaemia
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    1 / 10 (10.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    14 / 225 (6.22%)
    1 / 43 (2.33%)
    8 / 224 (3.57%)
    4 / 44 (9.09%)
    2 / 110 (1.82%)
    2 / 22 (9.09%)
    2 / 59 (3.39%)
    2 / 12 (16.67%)
    6 / 59 (10.17%)
    1 / 12 (8.33%)
    2 / 55 (3.64%)
    0 / 11 (0.00%)
    3 / 55 (5.45%)
    1 / 10 (10.00%)
    1 / 54 (1.85%)
    1 / 12 (8.33%)
    1 / 54 (1.85%)
    1 / 12 (8.33%)
         occurrences all number
    14
    1
    9
    5
    2
    2
    2
    2
    6
    1
    2
    0
    3
    1
    1
    1
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 225 (6.67%)
    4 / 43 (9.30%)
    8 / 224 (3.57%)
    3 / 44 (6.82%)
    7 / 110 (6.36%)
    2 / 22 (9.09%)
    3 / 59 (5.08%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    1 / 12 (8.33%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    4 / 55 (7.27%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    1 / 54 (1.85%)
    1 / 12 (8.33%)
         occurrences all number
    15
    4
    8
    3
    7
    3
    4
    0
    2
    1
    1
    0
    4
    0
    0
    0
    1
    1
    Paraesthesia
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    1 / 11 (9.09%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Conjunctivitis Allergic
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    1 / 11 (9.09%)
    0 / 55 (0.00%)
    1 / 10 (10.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    Eye Pruritus
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Dental Caries
         subjects affected / exposed
    2 / 225 (0.89%)
    1 / 43 (2.33%)
    2 / 224 (0.89%)
    1 / 44 (2.27%)
    0 / 110 (0.00%)
    1 / 22 (4.55%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    1 / 55 (1.82%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    1
    2
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    3 / 225 (1.33%)
    0 / 43 (0.00%)
    3 / 224 (1.34%)
    1 / 44 (2.27%)
    3 / 110 (2.73%)
    1 / 22 (4.55%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    1 / 10 (10.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    3
    1
    3
    1
    0
    0
    1
    0
    1
    0
    0
    1
    1
    0
    1
    0
    Food Poisoning
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dry Skin
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    3 / 225 (1.33%)
    1 / 43 (2.33%)
    5 / 224 (2.23%)
    3 / 44 (6.82%)
    3 / 110 (2.73%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    5 / 59 (8.47%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    1
    5
    3
    4
    0
    1
    0
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    5 / 225 (2.22%)
    0 / 43 (0.00%)
    5 / 224 (2.23%)
    0 / 44 (0.00%)
    2 / 110 (1.82%)
    0 / 22 (0.00%)
    3 / 59 (5.08%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    5
    0
    5
    0
    2
    0
    3
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hypercreatininaemia
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    2 / 55 (3.64%)
    1 / 11 (9.09%)
    5 / 55 (9.09%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    1
    5
    0
    0
    0
    0
    0
    Hypernatraemia
         subjects affected / exposed
    2 / 225 (0.89%)
    2 / 43 (4.65%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    2 / 110 (1.82%)
    1 / 22 (4.55%)
    3 / 59 (5.08%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    6 / 55 (10.91%)
    1 / 11 (9.09%)
    7 / 55 (12.73%)
    0 / 10 (0.00%)
    4 / 54 (7.41%)
    1 / 12 (8.33%)
    3 / 54 (5.56%)
    1 / 12 (8.33%)
         occurrences all number
    2
    2
    0
    0
    2
    1
    3
    0
    0
    0
    6
    2
    13
    0
    4
    1
    3
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    2 / 59 (3.39%)
    0 / 12 (0.00%)
    3 / 59 (5.08%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    1 / 55 (1.82%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    0
    3
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 225 (1.33%)
    2 / 43 (4.65%)
    4 / 224 (1.79%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    4 / 54 (7.41%)
    1 / 12 (8.33%)
    2 / 54 (3.70%)
    2 / 12 (16.67%)
         occurrences all number
    3
    2
    4
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    4
    1
    2
    2
    Conjunctivitis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    2 / 224 (0.89%)
    0 / 44 (0.00%)
    3 / 110 (2.73%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    3 / 55 (5.45%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    2
    0
    3
    0
    1
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    Infection Parasitic
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    2 / 225 (0.89%)
    1 / 43 (2.33%)
    4 / 224 (1.79%)
    1 / 44 (2.27%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    1 / 55 (1.82%)
    0 / 10 (0.00%)
    2 / 54 (3.70%)
    1 / 12 (8.33%)
    3 / 54 (5.56%)
    0 / 12 (0.00%)
         occurrences all number
    2
    1
    5
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    2
    1
    3
    0
    Malaria
         subjects affected / exposed
    16 / 225 (7.11%)
    2 / 43 (4.65%)
    12 / 224 (5.36%)
    5 / 44 (11.36%)
    6 / 110 (5.45%)
    2 / 22 (9.09%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    3 / 59 (5.08%)
    0 / 12 (0.00%)
    3 / 55 (5.45%)
    1 / 11 (9.09%)
    8 / 55 (14.55%)
    1 / 10 (10.00%)
    7 / 54 (12.96%)
    2 / 12 (16.67%)
    4 / 54 (7.41%)
    0 / 12 (0.00%)
         occurrences all number
    16
    2
    14
    6
    6
    2
    1
    0
    3
    0
    4
    1
    8
    1
    10
    2
    4
    0
    Nasopharyngitis
         subjects affected / exposed
    8 / 225 (3.56%)
    4 / 43 (9.30%)
    11 / 224 (4.91%)
    1 / 44 (2.27%)
    2 / 110 (1.82%)
    1 / 22 (4.55%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    3 / 55 (5.45%)
    0 / 11 (0.00%)
    4 / 55 (7.27%)
    2 / 10 (20.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
    2 / 54 (3.70%)
    0 / 12 (0.00%)
         occurrences all number
    8
    4
    11
    1
    3
    1
    1
    0
    0
    0
    3
    0
    5
    3
    1
    0
    2
    0
    Pharyngitis
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 43 (2.33%)
    1 / 224 (0.45%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    7 / 225 (3.11%)
    0 / 43 (0.00%)
    2 / 224 (0.89%)
    1 / 44 (2.27%)
    4 / 110 (3.64%)
    2 / 22 (9.09%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    4 / 54 (7.41%)
    0 / 12 (0.00%)
    6 / 54 (11.11%)
    1 / 12 (8.33%)
         occurrences all number
    7
    0
    2
    1
    4
    2
    0
    0
    2
    0
    0
    0
    0
    0
    4
    0
    6
    1
    Sepsis
         subjects affected / exposed
    0 / 225 (0.00%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Tonsillitis
         subjects affected / exposed
    3 / 225 (1.33%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    1 / 44 (2.27%)
    0 / 110 (0.00%)
    0 / 22 (0.00%)
    1 / 59 (1.69%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    1 / 55 (1.82%)
    0 / 11 (0.00%)
    1 / 55 (1.82%)
    0 / 10 (0.00%)
    1 / 54 (1.85%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    0
    1
    0
    0
    2
    1
    0
    1
    0
    1
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    17 / 225 (7.56%)
    1 / 43 (2.33%)
    18 / 224 (8.04%)
    3 / 44 (6.82%)
    9 / 110 (8.18%)
    3 / 22 (13.64%)
    7 / 59 (11.86%)
    1 / 12 (8.33%)
    3 / 59 (5.08%)
    1 / 12 (8.33%)
    6 / 55 (10.91%)
    0 / 11 (0.00%)
    3 / 55 (5.45%)
    2 / 10 (20.00%)
    0 / 54 (0.00%)
    1 / 12 (8.33%)
    4 / 54 (7.41%)
    0 / 12 (0.00%)
         occurrences all number
    20
    1
    18
    3
    9
    3
    7
    1
    5
    1
    7
    0
    3
    2
    0
    1
    4
    0
    Vulvovaginal Candidiasis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 43 (0.00%)
    0 / 224 (0.00%)
    0 / 44 (0.00%)
    1 / 110 (0.91%)
    0 / 22 (0.00%)
    0 / 59 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 12 (0.00%)
    0 / 55 (0.00%)
    0 / 11 (0.00%)
    0 / 55 (0.00%)
    0 / 10 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
    0 / 54 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    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
    09 Sep 2016
    The overall reason for the amendment #2 was to include the request of the Center for Biologics Evaluation and Research (CBER, a division of United States [US] Food and Drug Administration [FDA]) to change the age ranges of Cohorts 3 and 4 and to extend the safety follow-up to 6 months post-boost.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Apr 2016
    On 28 April 2016, sites were notified to halt all vaccinations due to occurrence of a serious adverse event (SAE) in VAC52150EBL2001 that met study pause rule. On 19 May 2016, when the study pause was still in a effect, a second SAE report was received for VAC52150EBL2001 and a clinical hold was issued by the FDA on 26 May 2016 on all screening and vaccinations. After receipt of follow up information, the clinical hold was lifted on 16 June 2016.
    12 Aug 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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