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    Clinical Trial Results:
    Immunization of immunosuppressed patients – Knowledge, practices and serological response

    Summary
    EudraCT number
    		 2016-004123-23
    Trial protocol
    		 DK  
    Global end of trial date
    19 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2022
    First version publication date
    24 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Immunovax_Renal
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Infectious Diseases, Odense University Hospital, Odense, Denmark
    Sponsor organisation address
    J. B. Winsløws Vej 4, Odense C, Denmark, 5000
    Public contact
    Lykke Larsen, Department of Infectious Diseases, Odense University Hospital, 45 65412651, llarsen@dadlnet.dk
    Scientific contact
    Lykke Larsen, Department of Infectious Diseases, Odense University Hospital, 26672029 65412651, llarsen@dadlnet.dk
    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
    13 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    A direct head to head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, for Prenevar 13 and Pneumovax, independently of the immunomodulatory therapy.
    Protection of trial subjects
    No measures were done or needed
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2017
    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
    Denmark: 139
    Worldwide total number of subjects
    139
    EEA total number of subjects
    139
    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)
    119
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Mulige deltagere udfyldte frivilligt spørgeskema og hvis de ønskede deltagelse i lægemiddelstudie blev de inviteret til samtale

    Pre-assignment
    Screening details
    		 lægelig vurdering og spørgeskema

    Pre-assignment period milestones
    Number of subjects started
    		 139
    Intermediate milestone: Number of subjects
    vaccinated PCV13: 139
    Number of subjects completed
    		 139

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Recipient- Double dosage
    Arm description
    		 recieved 1 ml PCV13 and 1 ml PPV23
    Arm type
    		 Experimental

    Investigational medicinal product name
    13-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 ml im

    Investigational medicinal product name
    23-valent pneumococcal vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 ml im

    Arm title
    		 Recipient- Single dosage
    Arm description
    		 recieved 0.5 ml PCV13 + 0.5 ml PPV23
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 ml im

    Investigational medicinal product name
    23-valent pneumococcal vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 ml im

    Arm title
    		 candidate-double dosage
    Arm description
    		 recieved 1 ml PCV13 and 1 ml PPV23
    Arm type
    		 Experimental

    Investigational medicinal product name
    13-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 ml im

    Investigational medicinal product name
    23-valent pneumococcal vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 ml im

    Arm title
    		 candidate- single dosage
    Arm description
    		 recieved 0,5 ml PCV13 and 0,5 ml PPV23
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 ml im

    Investigational medicinal product name
    23-valent pneumococcal vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 ml im

    Number of subjects in period 1
    		Recipient- Double dosage Recipient- Single dosage candidate-double dosage candidate- single dosage
    Started
    35
    39
    33
    32
    Completed
    35
    37
    32
    31
    Not completed
    0
    2
    1
    1
         Adverse event, serious fatal
    -
    1
    1
    -
         Consent withdrawn by subject
    -
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 139 139
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 119 119
        From 65-84 years
    		 20 20
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 52 (41 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 43 43
        Male
    		 96 96

    End points

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    End points reporting groups
    Reporting group title
    Recipient- Double dosage
    Reporting group description
    		 recieved 1 ml PCV13 and 1 ml PPV23

    Reporting group title
    Recipient- Single dosage
    Reporting group description
    		 recieved 0.5 ml PCV13 + 0.5 ml PPV23

    Reporting group title
    candidate-double dosage
    Reporting group description
    		 recieved 1 ml PCV13 and 1 ml PPV23

    Reporting group title
    candidate- single dosage
    Reporting group description
    		 recieved 0,5 ml PCV13 and 0,5 ml PPV23

    Primary: protective response

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    End point title
    		 protective response
    End point description
    End point type
    Primary
    End point timeframe
    5 weeks after PPV23
    End point values
    		 Recipient- Double dosage Recipient- Single dosage candidate-double dosage candidate- single dosage
    Number of subjects analysed
    35
    39
    33
    32
    Units: 0,1
    9
    13
    20
    11
    Statistical analysis title
    		 protective response
    Statistical analysis description
    hvor mange har en average pneumococcal AB GMC over 1 mg/L
    Comparison groups
    Recipient- Double dosage v Recipient- Single dosage
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 protective response
    Statistical analysis description
    forskel i antal peroner med average pneumococcal AB GMC > 1 mg /L
    Comparison groups
    candidate-double dosage v candidate- single dosage
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    5 weeks after PPV23
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    1
    Reporting groups
    Reporting group title
    overall
    Reporting group description
    		 -

    Serious adverse events
    		 overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    43 / 139 (30.94%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adverse event
         subjects affected / exposed
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Adverse event
         subjects affected / exposed
    10 / 139 (7.19%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Adverse event
         subjects affected / exposed
    2 / 139 (1.44%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 139 (3.60%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Adverse event
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 139 (2.88%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Adverse event
         subjects affected / exposed
    5 / 139 (3.60%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Adverse event
         subjects affected / exposed
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Adverse event
         subjects affected / exposed
    16 / 139 (11.51%)
         occurrences causally related to treatment / all
    0 / 24
         deaths causally related to treatment / all
    0 / 2
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 139 (44.60%)
    General disorders and administration site conditions
    Adverse event following immunisation
         subjects affected / exposed
    62 / 139 (44.60%)
         occurrences all number
    131

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    We were not able to enroll 200 as planned
    For support, Contact us.
    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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