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    Clinical Trial Results:
    A phase III, randomized, double-blind, placebo-controlled, multicentre, clinical trial to assess the efficacy and safety of VPM1002 in reducing hospital admissions and/or severe respiratory infectious diseases in elderly in the SARS-CoV-2 pandemic by modulating the immune system

    Summary
    EudraCT number
    		 2020-001675-33
    Trial protocol
    		 DE  
    Global end of trial date
    12 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Sep 2022
    First version publication date
    01 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VPM1002-DE-3.07CoV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vakzine Projekt Management GmbH
    Sponsor organisation address
    Mellendorfer Strasse 9, Hannover, Germany, 30625
    Public contact
    Clinical Trial Information, Vakzine Projekt Management GmbH, +49 5111699080, info@vakzine-manager.de
    Scientific contact
    Clinical Trial Information, Vakzine Projekt Management GmbH, +49 5111699080, info@vakzine-manager.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the reduction of days with severe respiratory infectious diseases at hospital and/or at home in elderly subjects during the pandemic of SARS-CoV-2
    Protection of trial subjects
    VPM1002 had been tested in four clinical trials involving healthy adults and newborn infants prior to the VPM1002-DE-3.07CoV trial and was investigated in parallel in larger phase III trials with infants, children and adults. As VPM1002 was shown to be safe and well tolerated, the assessments conducted during this trial were considered appropriate to monitor subject safety and well-being. After the vaccination with the investigational medicinal product (IMP; VPM1002 or placebo), the subjects were medically monitored at the site under supervision of medical staff for at least 30 minutes. Prior discharge, physical examination and vital signs were repeated when indicated. The subjects were followed up remotely via a web application for 240 days after IMP administration and contacted monthly by clinical trial staff to assess their health status (i.e., they were asked about adverse events [AEs], presence of fever, and concomitant medications). Subjects with confirmed SARS-CoV-2 infection were followed up for at least 6 weeks from the day of the test result. The subjects were encouraged to contact the site in case of AEs and to designate a caregiver who was to provide follow-up data in case of a hospitalization or severe illness of the subject. An independent data and safety monitoring board (DSMB) was established to monitor the conduct of the trial. Monthly, the DSMB reviewed and discussed unblinded safety data and provided recommendations to the sponsor as to whether there were any safety concerns and whether the trial was to continue without change, be modified, or terminated. The DSMB consisted of 3 voting members who were experts in vaccine and/or infectious diseases and a non-voting statistician.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 2064
    Worldwide total number of subjects
    2064
    EEA total number of subjects
    2064
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    747
    From 65 to 84 years
    1309
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    		 Male and female subjects aged 60 years or older were enrolled at 12 centers in Germany. The first subject signed the informed consent form on 18-Jun-2020 and the last on 26-Jan-2021.

    Pre-assignment
    Screening details
    		 2064 subjects were screened and enrolled in the trial. 2037 subjects were randomized in a 1:1 ratio to receive a single dose of either VPM1002 or placebo. Twelve of the randomized subjects were not treated, 1013 subjects were vaccinated with VPM1002, and 1012 subjects were vaccinated with placebo.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Subject
    Blinding implementation details
    The vaccine preparation was done by designated unblinded personnel who did not participate in any of the clinical study evaluations. The administration was done by blinded trial staff. Because the vaccine and the placebo could have distinct appearances, even when drawn into syringes, the syringes were masked with an translucent wrapping before administration.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received a single dose of placebo injected into the arm.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received a single dose of placebo (physiological saline) as an intradermal injection of 0.1 mL in the arm over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm) or lateral to the posterior aspect of the forearm.

    Arm title
    		 VPM1002
    Arm description
    		 Subjects received a single dose of VPM1002 injected into the arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VPM1002
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received a single dose of VPM1002 reconstituted with 1 mL water for injection as an intradermal injection of 0.1 mL, containing 2-8 x 10E5 colony forming units, in the arm over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm) or lateral to the posterior aspect of the forearm.

    Number of subjects in period 1 [1]
    		Placebo VPM1002
    Started
    1012
    1013
    Completed
    997
    989
    Not completed
    15
    24
         Adverse event, serious fatal
    3
    6
         Consent withdrawn by subject
    10
    10
         Lost to follow-up
    2
    7
         non-compliance
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 27 of the enrolled subjects were not randomized to IMP treatment and 12 of the randomized subjects (Placebo: N=5, VPM1002: N=7) were not treated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single dose of placebo injected into the arm.

    Reporting group title
    VPM1002
    Reporting group description
    		 Subjects received a single dose of VPM1002 injected into the arm.

    Reporting group values
    		 Placebo VPM1002 Total
    Number of subjects
    		 1012 1013 2025
    Age categorical
    Units: Subjects
        Adults (>60 years)
    		 1012 1013 2025
    Age continuous
    Units: years
        median (full range (min-max))
    		 67 (60 to 88) 66 (60 to 91) -
    Gender categorical
    Units: Subjects
        Female
    		 478 475 953
        Male
    		 534 538 1072
    Body weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 83.97 ± 18.26 83.74 ± 18.04 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single dose of placebo injected into the arm.

    Reporting group title
    VPM1002
    Reporting group description
    		 Subjects received a single dose of VPM1002 injected into the arm.

    Primary: Number of days with severe respiratory disease at hospital and/or home

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    End point title
    		 Number of days with severe respiratory disease at hospital and/or home
    End point description
    Daily in the 1st week and weekly thereafter, subjects had to answer a health status questionnaire (HSQ) with several questions regarding hospitalization, AEs, intensive care unit (ICU) admissions and other secondary endpoints in a web application. They could also document in a paper diary their body temperature, if considered necessary (e.g., if they felt unwell), as well as any AEs or concomitant medications. Entries in HSQ and patient diary as well as data from monthly phone calls were used to calculate the number of days with severe respiratory disease at hospital and/or home.
    End point type
    Primary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009 [1]
    1008 [2]
    Units: day
    arithmetic mean (standard deviation)
        All subjects
    0.54 ± 4.13
    0.29 ± 2.28
        Subjects with number of days >0
    14.29 ± 16.25
    9.39 ± 9.28
    Notes
    [1] - Subjects with number of days >0: N=38
    [2] - Subjects with number of days >0: N=31
    Statistical analysis title
    		 Comparison VPM1002 vs placebo - primary model
    Statistical analysis description
    The ratio between VPM1002 and placebo in the mean weekly number of days with a severe respiratory disease at the hospital and/or at home (rate ratio) was analyzed using a negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, site, and observation week.
    Comparison groups
    Placebo v VPM1002
    Number of subjects included in analysis
    2017
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.3496 [4]
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.5993
    Confidence interval
         level
    		 95.2%
         sides
    2-sided
         lower limit
    		 0.203
         upper limit
    		 1.769
    Notes
    [3] - Negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, site, and observation week. An unstructured covariance matrix was used.
    [4] - Significance can be assumed if p-value <0.048 (2-sided).
    Statistical analysis title
    		 Comparison VPM1002 vs placebo - secondary model
    Statistical analysis description
    The ratio between VPM1002 and placebo in the mean weekly number of days with a severe respiratory disease at the hospital and/or at home (rate ratio) was analyzed using a negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, treatment*sex, site, and observation week.
    Comparison groups
    Placebo v VPM1002
    Number of subjects included in analysis
    2017
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.3546 [6]
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.6023
    Confidence interval
         level
    		 95.2%
         sides
    2-sided
         lower limit
    		 0.2039
         upper limit
    		 1.779
    Notes
    [5] - Negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, treatment*sex, site, and observation week. An unstructured covariance matrix was used.
    [6] - Significance can be assumed if p-value <0.048 (2-sided).

    Secondary: Cumulative incidence of severe respiratory disease at hospital and/or home

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    End point title
    		 Cumulative incidence of severe respiratory disease at hospital and/or home
    End point description
    The cumulative incidence of severe respiratory disease at hospital and/or home was calculated using the life table method. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.0385
    0.0315
        All subjects (events at home)
    0.0304
    0.0264
        All subjects (events at hospital)
    0.0152
    0.0143
    No statistical analyses for this end point

    Secondary: Cumulative incidence of documented SARS-CoV-2 infection

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    End point title
    		 Cumulative incidence of documented SARS-CoV-2 infection
    End point description
    The cumulative incidence of documented SARS-CoV-2 infection was calculated using the life table method based on HSQ and AE entries. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.0202
    0.0226
    No statistical analyses for this end point

    Secondary: Number of days with self-reported fever

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    End point title
    		 Number of days with self-reported fever
    End point description
    Data entered in the web based HSQ and paper diary were used to calculate the number of days with self-reported fever (≥38 °C).
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009 [7]
    1008 [8]
    Units: day
    arithmetic mean (standard deviation)
        All subjects
    0.14 ± 0.95
    0.05 ± 0.33
        Subjects with number of days >0
    2.75 ± 3.18
    1.88 ± 0.97
    Notes
    [7] - Subjects with number of days >0: N=53
    [8] - Subjects with number of days >0: N=25
    Statistical analysis title
    		 Comparison VPM1002 vs placebo - primary model
    Statistical analysis description
    The ratio between VPM1002 and placebo in the mean weekly number of days with self-reported fever (rate ratio) was analyzed using a negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, site, and observation week.
    Comparison groups
    Placebo v VPM1002
    Number of subjects included in analysis
    2017
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.001 [10]
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.312
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1554
         upper limit
    		 0.6262
    Notes
    [9] - Negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, site, and observation week. An unstructured covariance matrix was used.
    [10] - Significance can be assumed if p-value <0.05 (2-sided).
    Statistical analysis title
    		 Comparison VPM1002 vs placebo - secondary model
    Statistical analysis description
    The ratio between VPM1002 and placebo in the mean weekly number of days with self-reported fever (rate ratio) was analyzed using a negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, treatment*sex, site, and observation week.
    Comparison groups
    VPM1002 v Placebo
    Number of subjects included in analysis
    2017
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.0007 [12]
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.2964
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1467
         upper limit
    		 0.5989
    Notes
    [11] - Negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, treatment*sex, site, and observation week. An unstructured covariance matrix was used.
    [12] - Significance can be assumed if p-value <0.05 (2-sided).

    Secondary: Number of days with self-reported acute respiratory symptoms

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    End point title
    		 Number of days with self-reported acute respiratory symptoms
    End point description
    Data entered in the web based HSQ and paper diary were used to calculate the number of days with self-reported acute respiratory symptoms.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009 [13]
    1008 [14]
    Units: day
    arithmetic mean (standard deviation)
        All subjects
    0.52 ± 3.18
    0.72 ± 5.03
        Subjects with number of days >0
    9.70 ± 10.09
    12.75 ± 17.27
    Notes
    [13] - Subjects with number of days >0: N=54
    [14] - Subjects with number of days >0: N=57
    Statistical analysis title
    		 Comparison VPM1002 vs placebo - primary model
    Statistical analysis description
    The ratio between VPM1002 and placebo in the mean weekly number of days with self-reported acute respiratory symptoms (rate ratio) was analyzed using a negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, site, and observation week.
    Comparison groups
    Placebo v VPM1002
    Number of subjects included in analysis
    2017
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 = 0.0064 [16]
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.2452
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08923
         upper limit
    		 0.6739
    Notes
    [15] - Negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, site, and observation week. An unstructured covariance matrix was used.
    [16] - Significance can be assumed if p-value <0.05 (2-sided).
    Statistical analysis title
    		 Comparison VPM1002 vs placebo - secondary model
    Statistical analysis description
    The ratio between VPM1002 and placebo in the mean weekly number of days with self-reported acute respiratory symptoms (rate ratio) was analyzed using a negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, treatment*sex, site, and observation week.
    Comparison groups
    Placebo v VPM1002
    Number of subjects included in analysis
    2017
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.8334 [18]
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    1.1088
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4236
         upper limit
    		 2.9025
    Notes
    [17] - Negative binomial regression model with a random intercept per subject and fixed effects for treatment, sex, treatment*sex, site, and observation week. An unstructured covariance matrix was used.
    [18] - Significance can be assumed if p-value <0.05 (2-sided).

    Secondary: Cumulative incidence of self-reported acute respiratory symptoms

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    End point title
    		 Cumulative incidence of self-reported acute respiratory symptoms
    End point description
    The cumulative incidence of self-reported acute respiratory symptoms was calculated using the life table method. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.0544
    0.0581
    No statistical analyses for this end point

    Secondary: Cumulative incidence of death for any reason

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    End point title
    		 Cumulative incidence of death for any reason
    End point description
    The cumulative incidence of death for any reason was calculated using the life table method. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.0030
    0.0061
    No statistical analyses for this end point

    Secondary: Cumulative incidence of death due to documented SARS-CoV-2 infection

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    End point title
    		 Cumulative incidence of death due to documented SARS-CoV-2 infection
    End point description
    The cumulative incidence of death due to documented SARS-CoV-2 infection was calculated using the life table method. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.0010
    0.0010
    No statistical analyses for this end point

    Secondary: Cumulative incidence of ICU admission for any reason

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    End point title
    		 Cumulative incidence of ICU admission for any reason
    End point description
    The cumulative incidence of ICU admission for any reason was calculated using the life table method. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.0142
    0.0102
    No statistical analyses for this end point

    Secondary: Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection

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    End point title
    		 Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection
    End point description
    The cumulative incidence of ICU admission due to documented SARS-CoV-2 infection was calculated using the life table method. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.0051
    0.0010
    No statistical analyses for this end point

    Secondary: Cumulative incidence of hospital admissions

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    End point title
    		 Cumulative incidence of hospital admissions
    End point description
    The cumulative incidence of hospital admissions for any reason using the life table method. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.1173
    0.1075
    No statistical analyses for this end point

    Secondary: Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection

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    End point title
    		 Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection
    End point description
    The cumulative incidence of hospital admission due to documented SARS-CoV-2 infection was calculated using the life table method. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.0081
    0.0020
    No statistical analyses for this end point

    Secondary: Cumulative incidence of self-reported fever

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    End point title
    		 Cumulative incidence of self-reported fever
    End point description
    The cumulative incidence of self-reported fever was calculated using the life table method. Only subjects with data were included in analysis.
    End point type
    Secondary
    End point timeframe
    From day of vaccination with the IMP (Day 0) until the end of the 240-day follow-up.
    End point values
    		 Placebo VPM1002
    Number of subjects analysed
    1009
    1008
    Units: cumulative incidence over 240 days
    number (not applicable)
        All subjects
    0.0539
    0.0257
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were recorded from the informed consent signature until the end of the 240-day follow-up. Treatment-emergent AEs (TEAEs) started after vaccination with the IMP (Day 0).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single dose of placebo injected into the arm.

    Reporting group title
    VPM1002
    Reporting group description
    		 Subjects received a single dose of VPM1002 injected into the arm.

    Serious adverse events
    		 Placebo VPM1002
    Total subjects affected by serious adverse events
         subjects affected / exposed
    94 / 1012 (9.29%)
    79 / 1013 (7.80%)
         number of deaths (all causes)
    3
    6
         number of deaths resulting from adverse events
    3
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioimmunoblastic T-cell lymphoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign pancreatic neoplasm
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Central nervous system lymphoma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary renal cell carcinoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Arteriovenous fistula operation
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary arterial stent insertion
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia diaphragmatic repair
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal shunt procedure
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensation of foreign body
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular stent stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1013 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pickwickian syndrome
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 1012 (0.10%)
    3 / 1013 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid lung
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device leakage
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular pressure increased
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Biliary anastomosis complication
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1013 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1013 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1013 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1013 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    7 / 1012 (0.69%)
    3 / 1013 (0.30%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 1012 (0.20%)
    4 / 1013 (0.39%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiorenal syndrome
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    3 / 1012 (0.30%)
    2 / 1013 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain stem stroke
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nystagmus
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness neurosensory
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Dermatochalasis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lagophthalmos
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal food impaction
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngo-oesophageal diverticulum
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder tamponade
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1013 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    5 / 1012 (0.49%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 1012 (0.00%)
    3 / 1013 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1013 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    6 / 1012 (0.59%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter bacteraemia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Sinusitis aspergillus
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1013 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1013 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock hypoglycaemic
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1013 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo VPM1002
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    520 / 1012 (51.38%)
    727 / 1013 (71.77%)
    Injury, poisoning and procedural complications
    Vaccination complication
         subjects affected / exposed
    143 / 1012 (14.13%)
    134 / 1013 (13.23%)
         occurrences all number
    277
    260
    Nervous system disorders
    Headache
         subjects affected / exposed
    97 / 1012 (9.58%)
    95 / 1013 (9.38%)
         occurrences all number
    141
    129
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    8 / 1012 (0.79%)
    367 / 1013 (36.23%)
         occurrences all number
    8
    382
    Injection site induration
         subjects affected / exposed
    3 / 1012 (0.30%)
    71 / 1013 (7.01%)
         occurrences all number
    3
    71
    Injection site inflammation
         subjects affected / exposed
    0 / 1012 (0.00%)
    61 / 1013 (6.02%)
         occurrences all number
    0
    62
    Injection site pain
         subjects affected / exposed
    17 / 1012 (1.68%)
    83 / 1013 (8.19%)
         occurrences all number
    19
    85
    Injection site pruritus
         subjects affected / exposed
    5 / 1012 (0.49%)
    92 / 1013 (9.08%)
         occurrences all number
    5
    94
    Injection site swelling
         subjects affected / exposed
    4 / 1012 (0.40%)
    209 / 1013 (20.63%)
         occurrences all number
    4
    214
    Vaccination site pain
         subjects affected / exposed
    53 / 1012 (5.24%)
    49 / 1013 (4.84%)
         occurrences all number
    64
    60
    Injection site scab
         subjects affected / exposed
    0 / 1012 (0.00%)
    34 / 1013 (3.36%)
         occurrences all number
    0
    34
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    46 / 1012 (4.55%)
    32 / 1013 (3.16%)
         occurrences all number
    53
    49
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    29 / 1012 (2.87%)
    34 / 1013 (3.36%)
         occurrences all number
    37
    45
    Oropharyngeal pain
         subjects affected / exposed
    33 / 1012 (3.26%)
    30 / 1013 (2.96%)
         occurrences all number
    40
    35
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    28 / 1012 (2.77%)
    32 / 1013 (3.16%)
         occurrences all number
    36
    34
    Infections and infestations
    Injection site abscess
         subjects affected / exposed
    0 / 1012 (0.00%)
    72 / 1013 (7.11%)
         occurrences all number
    0
    72
    Injection site pustule
         subjects affected / exposed
    2 / 1012 (0.20%)
    69 / 1013 (6.81%)
         occurrences all number
    2
    73
    Nasopharyngitis
         subjects affected / exposed
    80 / 1012 (7.91%)
    76 / 1013 (7.50%)
         occurrences all number
    92
    97

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2020
    Protocol Version 4.0 with following main changes to Version 3.0 (first protocol version under which subjects were included and treated): - Exclusion criterion 4 was changed from “Expected vaccination during the study period; vaccinations against influenza and pneumococcal disease are allowed” to “Expected vaccination during the study period; vaccinations against influenza and pneumococcal disease are allowed with ≥4 weeks between these vaccinations and the trial vaccination”. - Exclusion criterion 5 was changed from “Participation in another study within 30 days before screening and during this study” to “Participation in another interventional study within 30 days before screening and during this study”. - Exclusion criterion 8 was changed from “Active solid or non-solid malignancy or lymphoma in the past 5 years” to “History of malignancies, unless the subject has been free of the disease for ≥2 years; exception: subjects with adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer and adequately treated carcinoma in situ of the cervix may participate in the trial”. - It was clarified that the subjects were “encouraged” to name a caregiver, but they did not need to. - It was added that subjects who dropped out before application of the trial intervention were to be replaced and subjects who dropped out after application of the trial intervention were not to be replaced. - The completion of a paper diary became optional. - The per-protocol set was introduced for the sensitivity analysis of the primary endpoint.

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

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

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