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    Clinical Trial Results:
    Study of T- and B-cell immunity after vaccination with a virosomebased influenza vaccine (Inflexal V) in patients who have undergone hematopoietic allogeneic stem cell transplantation.

    Summary
    EudraCT number
    2013-003403-19
    Trial protocol
    SE  
    Global end of trial date
    28 Jul 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Nov 2021
    First version publication date
    27 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HCK1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Karolinska University Hospital
    Sponsor organisation address
    Halsovagen 17, Stockholm, Sweden, SE-14186
    Public contact
    Dept. of Hematology, Karolinska University Hospital, 46 858582507, per.ljungman@ki.se
    Scientific contact
    Dept. of Hematology, Karolinska University Hospital, 46 858582507, per.ljungman@ki.se
    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
    31 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Analyze T-cell and B-cell immune response after influenzavaccination with Inflexal V.
    Protection of trial subjects
    Nothing in addition to routine monitoring of AE, SAE, and SUSAR.
    Background therapy
    Patients had undergone allogeneic stem cell transplantation as an inclusion criterion into the trial.
    Evidence for comparator
    The study product was a licensed virosomal influenza vaccine (Inflexal V). There was no comparator since it was an open exploratory study
    Actual start date of recruitment
    23 Oct 2013
    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
    Sweden: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    22
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The recruitment occurred from Oct 23, 2013 to Jan 03, 2014.

    Pre-assignment
    Screening details
    During this time 25 patients were included of whom 24 patients received the study vaccine. One patient was not vaccinated due to development of thrombocytopenia. The planned recruitment was 30 patients. The main reason that we did not reach the target recruitment was that patients received routine influenza vaccine by their local physicians.

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

    Arms
    Arm title
    Experimental arm
    Arm description
    This was a single arm open trial so this was the only arm in the study
    Arm type
    Experimental

    Investigational medicinal product name
    Inflexal V virosomal influenza vaccine
    Investigational medicinal product code
    Market Authorization number 20335
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One single dose given intramuscularly

    Number of subjects in period 1
    Experimental arm
    Started
    24
    Completed
    24

    Baseline characteristics

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

    Reporting group values
    Overall trial Total
    Number of subjects
    24 24
    Age categorical
    All vaccinated subjects
    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)
    22 22
        From 65-84 years
    2 2
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    12 12
        Male
    12 12
    Type of transplant conditioning
    Myeloablative vs. reduced intensity
    Units: Subjects
        Myeloablative
    9 9
        Reduced intensity
    15 15
    Time from transplantation to vaccination
    Units: Subjects
        < 6 months
    12 12
        > 6 months
    12 12
    Subject analysis sets

    Subject analysis set title
    Vaccinated patients
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All vaccinated patients

    Subject analysis sets values
    Vaccinated patients
    Number of subjects
    24
    Age categorical
    All vaccinated subjects
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    22
        From 65-84 years
    2
        85 years and over
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    12
        Male
    12
    Type of transplant conditioning
    Myeloablative vs. reduced intensity
    Units: Subjects
        Myeloablative
    9
        Reduced intensity
    15
    Time from transplantation to vaccination
    Units: Subjects
        < 6 months
    12
        > 6 months
    12

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    This was a single arm open trial so this was the only arm in the study

    Subject analysis set title
    Vaccinated patients
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All vaccinated patients

    Primary: Serologic titer increase

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    End point title
    Serologic titer increase [1]
    End point description
    No. of subjects achieving a four-fold rise in HI titers after vaccination.
    End point type
    Primary
    End point timeframe
    Four weeks after vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a one arm study looking at the response. There was no statistical analysis planned
    End point values
    Vaccinated patients
    Number of subjects analysed
    21 [2]
    Units: No. of subjects
    5
    Notes
    [2] - Three patients had no sample at 4 weeks after vaccination
    No statistical analyses for this end point

    Primary: Increase in influenza-specific T cells

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    End point title
    Increase in influenza-specific T cells [3]
    End point description
    No. of patients doubling the number of influenza-specific T cells producing gamma-interferon after vaccination.
    End point type
    Primary
    End point timeframe
    Four weeks after vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a one arm study looking at the response. There was no statistical analysis planned
    End point values
    Vaccinated patients
    Number of subjects analysed
    24
    Units: Number of subjects
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Four weeks after vaccination
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    This was a single arm open trial so this was the only arm in the study

    Serious adverse events
    Experimental arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 24 (25.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Cardiac failure congestive
    Additional description: Assessed as due to previous chemotherapy. Contributed to death.
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Two patients developed diarrhoea due to pre-existing graft-vs-host disease
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
    Additional description: Hospitalization
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
    Additional description: Hospitalization necessary. One influenza B. One of unknown cause
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Herpes zoster
    Additional description: Hospitalized
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocarditis bacterial
    Additional description: Contributed to death. Detected at autopsy. Same patient as the patient having cardiac failure
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Experimental arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 24 (20.83%)
    General disorders and administration site conditions
    Local reactions
    Additional description: At the vaccination site
         subjects affected / exposed
    5 / 24 (20.83%)
         occurrences all number
    5
    Gastrointestinal disorders
    Nausea and vomiting
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2

    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.
    Small number of patients

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/25817044
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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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