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    Clinical Trial Results:
    Immunogenicity of COVID-19 vaccines in medical staff and special risk populations

    Summary
    EudraCT number
    		 2021-001512-28
    Trial protocol
    		 DE  
    Global end of trial date
    30 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Aug 2023
    First version publication date
    03 Aug 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    COVIM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Med. Klinik m. S. Infektiologie, Charité - Universitätsmedizin Berlin, 49 30450653034, leif-erik.sander@charite.de
    Scientific contact
    Med. Klinik m. S. Infektiologie, Charité - Universitätsmedizin Berlin, 49 30450653034, leif-erik.sander@charite.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
    Interim
    Date of interim/final analysis
    01 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determination of immunogenicity of SARS-CoV-2 vaccines in healthy individuals compared to special risk populations
    Protection of trial subjects
    The study was conducted according the declaration of Helsiniki.
    Background therapy
    		 Despite the available immunogenicity, safety and efficacy data from randomized controlled trials, key questions regarding the newly approved SARS-CoV-2 vaccines remain unanswered. Immunogenicity and safety of SARS-CoV-2 vaccines in individuals with varying degrees of immunodeficiency is unknown. These risk populations include patients with chronic kidney failure and hemodialysis, kidney transplant recipients, patients with neuroimmunological diseases such as MS and NMOSD with and without B cell depleting therapies, patients with hemato-oncological malignancies including B cell malignancies, patients with rheumatic and autoimmune diseases and patients with primary immunodeficiencies. The identification of immunological correlates of protection for COVID-19 vaccines is of critical importance to determine vaccine success in such risk populations and for the design and evaluation of new vaccines.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 1889
    Worldwide total number of subjects
    1889
    EEA total number of subjects
    1889
    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)
    1396
    From 65 to 84 years
    408
    85 years and over
    85

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 26 sites in Germany. First Patient, first Visit: 26-MAY-2021, Last Patient, last Visit: 30-DEC-2021

    Pre-assignment
    Screening details
    		 Planned recruitment: approximately 3050 participants in a total of eight cohorts vaccinated with different SARS-CoV-2 vaccines in specific at-risk populations. -> Total number of recruited participants: 1889 There are no specific sex distribution as no sex specific differences. Participants were not randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BNPL
    Arm description
    		 Haemato-oncological participants and participants with B-cell neoplasia (BNPL)
    Arm type
    		 vaccination

    Investigational medicinal product name
    Tozinameran
    Investigational medicinal product code
    Other name
    Comirnaty; COVID-19 mRNA vaccine (nucleoside-modified)
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    CO­VID-19 Vac­ci­ne Jans­sen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    1 dose

    Investigational medicinal product name
    COVID-19 mRNA vaccine Moderna (CX-024414)
    Investigational medicinal product code
    SUB207171
    Other name
    COVID-19 Vaccine Moderna
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    Investigational medicinal product code
    SUB207764
    Other name
    Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Arm title
    		 Participants with haemodialysis (HD)
    Arm description
    		 Participants with chronic kidney failure undergoing a haemodialysis (HD)
    Arm type
    		 Vaccination cohort

    Investigational medicinal product name
    Tozinameran
    Investigational medicinal product code
    Other name
    Comirnaty; COVID-19 mRNA vaccine (nucleoside-modified)
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    CO­VID-19 Vac­ci­ne Jans­sen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    1 dose

    Investigational medicinal product name
    COVID-19 mRNA vaccine Moderna (CX-024414)
    Investigational medicinal product code
    SUB207171
    Other name
    COVID-19 Vaccine Moderna
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    Investigational medicinal product code
    SUB207764
    Other name
    Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Arm title
    		 health care workers (HCW)
    Arm description
    		 Healthy health care workers at one of the participating trial centers (HCW)
    Arm type
    		 Vaccination cohort

    Investigational medicinal product name
    Tozinameran
    Investigational medicinal product code
    Other name
    Comirnaty; COVID-19 mRNA vaccine (nucleoside-modified)
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    CO­VID-19 Vac­ci­ne Jans­sen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    1 dose

    Investigational medicinal product name
    COVID-19 mRNA vaccine Moderna (CX-024414)
    Investigational medicinal product code
    SUB207171
    Other name
    COVID-19 Vaccine Moderna
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    Investigational medicinal product code
    SUB207764
    Other name
    Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Arm title
    		 Patients with IBD
    Arm description
    		 Patients with inflammatory bowel disease (IBD)
    Arm type
    		 vaccination cohort

    Investigational medicinal product name
    Tozinameran
    Investigational medicinal product code
    Other name
    Comirnaty; COVID-19 mRNA vaccine (nucleoside-modified)
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    CO­VID-19 Vac­ci­ne Jans­sen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    1 dose

    Investigational medicinal product name
    COVID-19 mRNA vaccine Moderna (CX-024414)
    Investigational medicinal product code
    SUB207171
    Other name
    COVID-19 Vaccine Moderna
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    Investigational medicinal product code
    SUB207764
    Other name
    Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Arm title
    		 NEUR
    Arm description
    		 Participants with neuroimmunological diseases such as MS and NMOSD (NEUR)
    Arm type
    		 Vaccination cohort

    Investigational medicinal product name
    Tozinameran
    Investigational medicinal product code
    Other name
    Comirnaty; COVID-19 mRNA vaccine (nucleoside-modified)
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    CO­VID-19 Vac­ci­ne Jans­sen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    1 dose

    Investigational medicinal product name
    COVID-19 mRNA vaccine Moderna (CX-024414)
    Investigational medicinal product code
    SUB207171
    Other name
    COVID-19 Vaccine Moderna
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    Investigational medicinal product code
    SUB207764
    Other name
    Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Arm title
    		 Participants with NTX
    Arm description
    		 Participants with history of kidney transplantation (NTX)
    Arm type
    		 vaccination cohort

    Investigational medicinal product name
    Tozinameran
    Investigational medicinal product code
    Other name
    Comirnaty; COVID-19 mRNA vaccine (nucleoside-modified)
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    CO­VID-19 Vac­ci­ne Jans­sen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    1 dose

    Investigational medicinal product name
    COVID-19 mRNA vaccine Moderna (CX-024414)
    Investigational medicinal product code
    SUB207171
    Other name
    COVID-19 Vaccine Moderna
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    Investigational medicinal product code
    SUB207764
    Other name
    Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Arm title
    		 Participants with PID
    Arm description
    		 Participants with primary immunodeficiency (PID)
    Arm type
    		 vaccination cohort

    Investigational medicinal product name
    Tozinameran
    Investigational medicinal product code
    Other name
    Comirnaty; COVID-19 mRNA vaccine (nucleoside-modified)
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    CO­VID-19 Vac­ci­ne Jans­sen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    1 dose

    Investigational medicinal product name
    COVID-19 mRNA vaccine Moderna (CX-024414)
    Investigational medicinal product code
    SUB207171
    Other name
    COVID-19 Vaccine Moderna
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    Investigational medicinal product code
    SUB207764
    Other name
    Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Arm title
    		 RHEU
    Arm description
    		 Participants with rheumatic and autoimmune diseases under immunosuppression (RHEU)
    Arm type
    		 vaccination cohort

    Investigational medicinal product name
    Tozinameran
    Investigational medicinal product code
    Other name
    Comirnaty; COVID-19 mRNA vaccine (nucleoside-modified)
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    CO­VID-19 Vac­ci­ne Jans­sen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    1 dose

    Investigational medicinal product name
    COVID-19 mRNA vaccine Moderna (CX-024414)
    Investigational medicinal product code
    SUB207171
    Other name
    COVID-19 Vaccine Moderna
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    Investigational medicinal product code
    SUB207764
    Other name
    Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Arm title
    		 Participants older than 70 years SEN
    Arm description
    		 Participants ≥70 years-of age, with none of the medical conditions specified above (SEN)
    Arm type
    		 vaccination cohort

    Investigational medicinal product name
    Tozinameran
    Investigational medicinal product code
    Other name
    Comirnaty; COVID-19 mRNA vaccine (nucleoside-modified)
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    CO­VID-19 Vac­ci­ne Jans­sen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    1 dose

    Investigational medicinal product name
    COVID-19 mRNA vaccine Moderna (CX-024414)
    Investigational medicinal product code
    SUB207171
    Other name
    COVID-19 Vaccine Moderna
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Investigational medicinal product name
    COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    Investigational medicinal product code
    SUB207764
    Other name
    Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 doses

    Number of subjects in period 1
    		BNPL Participants with haemodialysis (HD) health care workers (HCW) Patients with IBD NEUR Participants with NTX Participants with PID RHEU Participants older than 70 years SEN
    Started
    81
    87
    669
    93
    252
    147
    139
    114
    307
    Completed
    65
    79
    595
    69
    203
    124
    103
    98
    299
    Not completed
    16
    8
    74
    24
    49
    23
    36
    16
    8
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    1
    -
    -
    1
         Consent withdrawn by subject
    2
    4
    2
    1
    5
    2
    2
    -
    -
         Exclusion criteria occur after recruitment
    -
    -
    1
    -
    -
    -
    -
    2
    -
         personal reason/ discontinuation recommendation d.
    -
    4
    64
    19
    39
    14
    33
    3
    7
         discontinuation recommendation by investigator
    14
    -
    -
    -
    -
    -
    -
    -
    -
         missing data
    -
    -
    3
    3
    -
    -
    1
    8
    -
         lost contact
    -
    -
    4
    1
    2
    5
    -
    3
    -
         Protocol deviation
    -
    -
    -
    -
    3
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BNPL
    Reporting group description
    		 Haemato-oncological participants and participants with B-cell neoplasia (BNPL)

    Reporting group title
    Participants with haemodialysis (HD)
    Reporting group description
    		 Participants with chronic kidney failure undergoing a haemodialysis (HD)

    Reporting group title
    health care workers (HCW)
    Reporting group description
    		 Healthy health care workers at one of the participating trial centers (HCW)

    Reporting group title
    Patients with IBD
    Reporting group description
    		 Patients with inflammatory bowel disease (IBD)

    Reporting group title
    NEUR
    Reporting group description
    		 Participants with neuroimmunological diseases such as MS and NMOSD (NEUR)

    Reporting group title
    Participants with NTX
    Reporting group description
    		 Participants with history of kidney transplantation (NTX)

    Reporting group title
    Participants with PID
    Reporting group description
    		 Participants with primary immunodeficiency (PID)

    Reporting group title
    RHEU
    Reporting group description
    		 Participants with rheumatic and autoimmune diseases under immunosuppression (RHEU)

    Reporting group title
    Participants older than 70 years SEN
    Reporting group description
    		 Participants ≥70 years-of age, with none of the medical conditions specified above (SEN)

    Reporting group values
    		 BNPL Participants with haemodialysis (HD) health care workers (HCW) Patients with IBD NEUR Participants with NTX Participants with PID RHEU Participants older than 70 years SEN Total
    Number of subjects
    		 81 87 669 93 252 147 139 114 307 1889
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.33 ( 12.02 ) 60.01 ( 14.44 ) 40.27 ( 12.74 ) 39.73 ( 11.97 ) 44.93 ( 12.64 ) 51.83 ( 15.70 ) 45.67 ( 14.6 ) 57.34 ( 13.9 ) 81.03 ( 6.65 ) -
    Gender categorical
    Units: Subjects
        Female
    		 34 27 465 40 182 60 78 62 214 1162
        Male
    		 47 60 204 53 70 87 61 52 93 727
    no. of vaccine doses
    Units: Subjects
        0 does
    		 1 1 0 1 2 0 0 0 0 5
        1 dose
    		 1 0 8 1 10 5 3 1 0 29
        2 doses
    		 39 66 360 87 188 69 107 50 40 1006
        3 doses
    		 38 18 301 3 51 65 28 58 267 829
        4 doses
    		 2 0 0 0 1 7 0 5 0 15
        Not recorded
    		 0 2 0 1 0 1 1 0 0 5
    BMI
    body mass idex
    Units: kg/ m2
        arithmetic mean (standard deviation)
    		 25.66 ( 4.14 ) 26.15 ( 6.8 ) 24.11 ( 4.28 ) 25.12 ( 5.55 ) 24.44 ( 4.64 ) 24.82 ( 4.71 ) 24.7 ( 5.16 ) 25.99 ( 5.42 ) 24.82 ( 4.04 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    BNPL
    Reporting group description
    		 Haemato-oncological participants and participants with B-cell neoplasia (BNPL)

    Reporting group title
    Participants with haemodialysis (HD)
    Reporting group description
    		 Participants with chronic kidney failure undergoing a haemodialysis (HD)

    Reporting group title
    health care workers (HCW)
    Reporting group description
    		 Healthy health care workers at one of the participating trial centers (HCW)

    Reporting group title
    Patients with IBD
    Reporting group description
    		 Patients with inflammatory bowel disease (IBD)

    Reporting group title
    NEUR
    Reporting group description
    		 Participants with neuroimmunological diseases such as MS and NMOSD (NEUR)

    Reporting group title
    Participants with NTX
    Reporting group description
    		 Participants with history of kidney transplantation (NTX)

    Reporting group title
    Participants with PID
    Reporting group description
    		 Participants with primary immunodeficiency (PID)

    Reporting group title
    RHEU
    Reporting group description
    		 Participants with rheumatic and autoimmune diseases under immunosuppression (RHEU)

    Reporting group title
    Participants older than 70 years SEN
    Reporting group description
    		 Participants ≥70 years-of age, with none of the medical conditions specified above (SEN)

    Primary: change of immunogenicity of Covid 19 vaccination

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    End point title
    		 change of immunogenicity of Covid 19 vaccination [1]
    End point description
    presence of anti SARS-CoV-2 specific antibodies after first vaccination
    End point type
    Primary
    End point timeframe
    six months up to max. 9 months after first vaccination
    Notes
    [1] - 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: HCW vs RAID OR = 0.014 , OR lower CI = 0.000755, OR upper CI = 0.0733 (RAID is defined as participants with rheumatic and autoimmune diseases under immunosuppression including participants with inflammatory bowel diseases (IBD) or rheumatological disorders (RHEU). These two cohorts are separately characterized in baseline characteristics, but analysed as one new cohort RAID
    End point values
    		 BNPL Participants with haemodialysis (HD) health care workers (HCW) NEUR Participants with NTX Participants with PID Participants older than 70 years SEN
    Number of subjects analysed
    63
    65
    526
    171
    99
    86
    275
    Units: subjects
        number of subjects
    36
    56
    525
    110
    55
    62
    260
    Statistical analysis title
    		 HCW vs. NTX
    Comparison groups
    health care workers (HCW) v Participants with NTX
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.00319
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.000175
         upper limit
    		 0.016
    Statistical analysis title
    		 HCW vs HD
    Comparison groups
    health care workers (HCW) v Participants with haemodialysis (HD)
    Number of subjects included in analysis
    591
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.00782
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.00782
         upper limit
    		 0.0622
    Statistical analysis title
    		 HCW vs PID
    Comparison groups
    Participants with PID v health care workers (HCW)
    Number of subjects included in analysis
    612
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.00457
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.000197
         upper limit
    		 0.027
    Statistical analysis title
    		 HCW vs BNPL
    Comparison groups
    BNPL v health care workers (HCW)
    Number of subjects included in analysis
    589
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.00442
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.000217
         upper limit
    		 0.0285
    Statistical analysis title
    		 HCW vs. NEUR
    Comparison groups
    NEUR v health care workers (HCW)
    Number of subjects included in analysis
    697
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.00414
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.000229
         upper limit
    		 0.0201
    Statistical analysis title
    		 HCW vs Eldery
    Comparison groups
    health care workers (HCW) v Participants older than 70 years SEN
    Number of subjects included in analysis
    801
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.0511
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.00282
         upper limit
    		 0.255

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    NEUR
    Reporting group description
    		 -

    Reporting group title
    BNPL
    Reporting group description
    		 -

    Reporting group title
    HCW Healthy1 health care workers
    Reporting group description
    		 -

    Reporting group title
    kidney failure under haemodialysis (HD)
    Reporting group description
    		 -

    Reporting group title
    NTX kidney transplantation
    Reporting group description
    		 Participants with history of kidney transplantation (NTX)

    Reporting group title
    SEN ≥70 years-of age
    Reporting group description
    		 Participants ≥70 years-of age, with none of the medical conditions specified above (SEN)

    Reporting group title
    inflammatory bowel diseases IBD
    Reporting group description
    		 -

    Reporting group title
    primary immunodeficiency PID
    Reporting group description
    		 -

    Reporting group title
    RHEU
    Reporting group description
    		 -

    Serious adverse events
    		 NEUR BNPL HCW Healthy1 health care workers kidney failure under haemodialysis (HD) NTX kidney transplantation SEN ≥70 years-of age inflammatory bowel diseases IBD primary immunodeficiency PID RHEU
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 252 (0.79%)
    1 / 81 (1.23%)
    1 / 669 (0.15%)
    1 / 87 (1.15%)
    0 / 147 (0.00%)
    6 / 307 (1.95%)
    1 / 93 (1.08%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    5
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    other, Hodgkin's disease unclassifiable
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    1 / 307 (0.33%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    other. V.a. malignoma of lung
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    1 / 307 (0.33%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Retinal vascular disorder
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    1 / 307 (0.33%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    heart failure, Death
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    1 / 307 (0.33%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemia
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    1 / 87 (1.15%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death NOS
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    1 / 307 (0.33%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pregnancy loss
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    1 / 669 (0.15%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 81 (1.23%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    Infections and infestations
    shingles
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    1 / 93 (1.08%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    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
    Urinary tract infection
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    1 / 307 (0.33%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 NEUR BNPL HCW Healthy1 health care workers kidney failure under haemodialysis (HD) NTX kidney transplantation SEN ≥70 years-of age inflammatory bowel diseases IBD primary immunodeficiency PID RHEU
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 252 (32.54%)
    5 / 81 (6.17%)
    6 / 669 (0.90%)
    3 / 87 (3.45%)
    3 / 147 (2.04%)
    6 / 307 (1.95%)
    4 / 93 (4.30%)
    1 / 139 (0.72%)
    17 / 114 (14.91%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    carcinoma, colon (chemotherapy)
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    1 / 307 (0.33%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Vascular disorders
    shunt insufficiency
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    1 / 87 (1.15%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    peripheral artery disease
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    1 / 87 (1.15%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Elective surgery
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    1 / 669 (0.15%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    2 / 307 (0.65%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 252 (2.38%)
    0 / 81 (0.00%)
    1 / 669 (0.15%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    3 / 114 (2.63%)
         occurrences all number
    9
    0
    1
    0
    0
    0
    0
    0
    3
    flu like symptoms
         subjects affected / exposed
    11 / 252 (4.37%)
    0 / 81 (0.00%)
    1 / 669 (0.15%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    11
    0
    1
    0
    0
    0
    0
    0
    2
    fever
         subjects affected / exposed
    5 / 252 (1.98%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    5
    0
    0
    0
    0
    0
    0
    0
    2
    Injection site reaction
         subjects affected / exposed
    14 / 252 (5.56%)
    0 / 81 (0.00%)
    1 / 669 (0.15%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    1 / 93 (1.08%)
    0 / 139 (0.00%)
    9 / 114 (7.89%)
         occurrences all number
    15
    0
    1
    0
    0
    0
    1
    0
    12
    Chills
         subjects affected / exposed
    3 / 252 (1.19%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    1
    Intestinal diverticulitis
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    1 / 307 (0.33%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Reproductive system and breast disorders
    Irregular menstruation
         subjects affected / exposed
    2 / 252 (0.79%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    1 / 87 (1.15%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    2
    Epistaxis
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    1 / 87 (1.15%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Investigations
    GGT increased
         subjects affected / exposed
    0 / 252 (0.00%)
    2 / 81 (2.47%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 252 (4.37%)
    0 / 81 (0.00%)
    2 / 669 (0.30%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    1 / 93 (1.08%)
    0 / 139 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    12
    0
    2
    0
    0
    0
    1
    0
    2
    Vertigo
         subjects affected / exposed
    3 / 252 (1.19%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    worsening existing symptoms (MS, spasm)
         subjects affected / exposed
    5 / 252 (1.98%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    5
    0
    0
    0
    0
    0
    0
    0
    0
    Tingling (leg, finger)
         subjects affected / exposed
    3 / 252 (1.19%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 252 (0.79%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Gastrointestinal pain
         subjects affected / exposed
    4 / 252 (1.59%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    0
    0
    0
    0
    Diarrhea
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 81 (0.00%)
    1 / 669 (0.15%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    1 / 93 (1.08%)
    0 / 139 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    0
    1
    Nausea and Vomiting
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Muscle and joint pain
         subjects affected / exposed
    6 / 252 (2.38%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    3 / 114 (2.63%)
         occurrences all number
    6
    0
    0
    0
    0
    0
    0
    0
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 252 (3.17%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    1 / 139 (0.72%)
    1 / 114 (0.88%)
         occurrences all number
    9
    0
    0
    0
    0
    0
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    6 / 252 (2.38%)
    0 / 81 (0.00%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    3 / 147 (2.04%)
    2 / 307 (0.65%)
    1 / 93 (1.08%)
    0 / 139 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    6
    0
    0
    0
    3
    2
    1
    0
    1
    SARS-COV 19 test positive
         subjects affected / exposed
    3 / 252 (1.19%)
    1 / 81 (1.23%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    0
    reactivation Herpes (simplex vs. labialis)
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 81 (1.23%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    2
    Metabolism and nutrition disorders
    Hyperglycemia
         subjects affected / exposed
    0 / 252 (0.00%)
    2 / 81 (2.47%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    1
    Hypothyroidism
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 81 (1.23%)
    0 / 669 (0.00%)
    0 / 87 (0.00%)
    0 / 147 (0.00%)
    0 / 307 (0.00%)
    0 / 93 (0.00%)
    0 / 139 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2021
    new Protocol Version 1.3: - Increase in the number of patients (from 2250 to 2900), - additional samples and investigations in the MS/NMOSD cohort and adding another secondary endpoint for the RAID and the MS/NMOSD cohort (Effects of vaccination on underlying chronic disease measured by disease activity scores) - Performance of SARS-CoV-2 antigen test instead of PCR test possible - Harmonization of the information on the questionnaires - Completion of the responsible laboratories for assessments -Adding an unscheduled visit after any booster vaccination following second vaccination and modification in the schedule of assessments to make it more flexible due to different vaccination schedules -Exceptions in AE- and SAE-reporting
    16 Aug 2021
    new Protocol Version 1.4: - Adjustment of the primary endpoint (immunogenicity of COVID-19 vaccination) to make the timing of measurement of it more flexible. It is measured between six and up to max. nine months after primary vaccination. - Correction of the time of Visit 4 (6 months ± 2 weeks instead of 24 ± 2 weeks after first vaccination). - Increase in number of patients in elderly cohort (from 150 to 300, total number of patients from 2900 to 3050) - Adding further secondary endpoints related to unscheduled visit after any booster vaccination. - Accordingly, secondary endpoints were added for the monthly data locks - Adding an optional visit 9 months ± 2 weeks after first vaccination - Secondary endpoints were added accordingly
    22 Aug 2021
    new Protocol Version 1.5: -Possibility of including individuals incapable of giving consent in cohort 8 (Elderly). - Correction of the duration of individual study participation (8 months ± 2 weeks instead of 9 months ± 2 weeks
    09 Dec 2021
    new Protocol Version 1.6: - Termination of the COVIM-Boost sub-study by 31.12.2021 Due to the dynamic pandemic development and changing COVID-19 vaccination recommendations, adjustments are always necessary, which influence the study implementation. These changes have to be implemented quickly; therefore it was decided to conduct COVIM-Boost as an independent study under the conditions of § 4 para. 7a MedBVSV in the form of an observational study. - Correction of an inclusion criterion related to the adjustment of the primary endpoint (inclusion up to months instead of six months after primary vaccination possible, see Protocol Amendment Version 1.4/16th August 2021) - Removal of the interim analysis 4 months after study, as this was not reasonably possible due to the recruitment status at the time indicated. - It was clarified for the MS/NMOSD cohort in the schedule of assessments when the expanded disability status scale (EDSS) survey is to be conducted. - Correction of the number of aliquots to be sent to the Central Laboratory of the University of Cologne

    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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