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    Clinical Trial Results:
    Toward an optimal accelerated Tick-Borne Encephalitis (TBE) vaccination schedule for the last-minute traveler

    Summary
    EudraCT number
    		 2019-000801-61
    Trial protocol
    		 BE  
    Global end of trial date
    11 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Nov 2023
    First version publication date
    23 Nov 2023
    Other versions
    Summary report(s)
    		 Poster
    Statistical Analysis Report
    Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    ITM201901
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Insitute of Tropical Medicine
    Sponsor organisation address
    Nationalestraat 155, Antwerpen, Belgium, 2000
    Public contact
    Yven Van Herrewege, ITM Clinical Trial Unit, +32 33455557, yvanherrewege@itg.be
    Scientific contact
    Yven Van Herrewege, ITM Clinical Trial Unit, +32 33455557, yvanherrewege@itg.be
    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
    10 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the time to seroconversion of the different schedules of accelerated TBE vaccination based on reactogenicity data up to 28 days after the first dose.
    Protection of trial subjects
    Since this can be considered a low-risk clinical trial; testing only a registered vaccine, a Data and Safety Monitoring Board will not be installed for this study. However, an Independent Expert Group will be set-up to review and advise on any SAE reported in the study. This Independent Expert Group will consist of at least 2 medical doctors with relevant experience who are not part of the study team.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2019
    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
    Belgium: 77
    Worldwide total number of subjects
    77
    EEA total number of subjects
    77
    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)
    77
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Ninety-six (96) patients were screened, and 77 patients were enrolled. Nineteen (19) patients were excluded at enrolment. All 77 patients completed the primary vaccination. Sixty-seven (67) patients completed the booster vaccination, 4 were lost to follow-up and 6 withdrew consent.

    Pre-assignment
    Screening details
    		 Ninety-six (96) patients were screened, and 77 patients were enrolled. Nineteen (19) patients were excluded at enrolment.

    Period 1
    Period 1 title
    Primary vaccination period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA. Open-label study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Classic accelerated schedule Day 0: 1 dose 0.5ml IM Day 14: 1 dose 0,5 ml IM
    Arm type
    		 Active comparator

    Investigational medicinal product name
    FSME Immun ® vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Day 0: 1 dose 0.5ml intra-muscular Day 14: 1 dose 0,5 ml intra-muscular

    Arm title
    		 Group 2
    Arm description
    		 Day 0: 2 doses 0.5ml IM
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSME Immun ® vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Day 0: 2 doses 0.5ml IM

    Arm title
    		 Group 3
    Arm description
    		 Day 0: 2 doses 0.1ml ID
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSME Immun ® vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Day 0: 2 doses 0.1ml intra-dermal

    Arm title
    		 Group 4
    Arm description
    		 Day 0: 2 doses 0.1ml ID Day 7: 2 doses 0,1 ml ID
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSME Immun ® vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Day 0: 2 doses 0.1ml ID Day 7: 2 doses 0,1 ml ID

    Arm title
    		 Group 5
    Arm description
    		 Day 0: 2 doses 0.1ml ID Day 14: 2 doses 0,1 ml ID
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSME Immun ® vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Day 0: 2 doses 0.1ml ID Day 14: 2 doses 0,1 ml ID

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4 Group 5
    Started
    15
    16
    15
    15
    16
    Completed
    15
    15
    13
    11
    13
    Not completed
    0
    1
    2
    4
    3
         Consent withdrawn by subject
    -
    -
    1
    3
    2
         Lost to follow-up
    -
    1
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Classic accelerated schedule Day 0: 1 dose 0.5ml IM Day 14: 1 dose 0,5 ml IM

    Reporting group title
    Group 2
    Reporting group description
    		 Day 0: 2 doses 0.5ml IM

    Reporting group title
    Group 3
    Reporting group description
    		 Day 0: 2 doses 0.1ml ID

    Reporting group title
    Group 4
    Reporting group description
    		 Day 0: 2 doses 0.1ml ID Day 7: 2 doses 0,1 ml ID

    Reporting group title
    Group 5
    Reporting group description
    		 Day 0: 2 doses 0.1ml ID Day 14: 2 doses 0,1 ml ID

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Total
    Number of subjects
    		 15 16 15 15 16 77
    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
    Age (in year): median
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 19 (18 to 20) 19 (18 to 19.5) 19 (18 to 20) 19 (18 to 21) 19.5 (18 to 21.5) -
    Gender categorical
    Units: Subjects
        Female
    		 2 4 2 3 2 13
        Male
    		 13 12 13 12 14 64

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Classic accelerated schedule Day 0: 1 dose 0.5ml IM Day 14: 1 dose 0,5 ml IM

    Reporting group title
    Group 2
    Reporting group description
    		 Day 0: 2 doses 0.5ml IM

    Reporting group title
    Group 3
    Reporting group description
    		 Day 0: 2 doses 0.1ml ID

    Reporting group title
    Group 4
    Reporting group description
    		 Day 0: 2 doses 0.1ml ID Day 7: 2 doses 0,1 ml ID

    Reporting group title
    Group 5
    Reporting group description
    		 Day 0: 2 doses 0.1ml ID Day 14: 2 doses 0,1 ml ID

    Primary: Time to seropositivity

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    End point title
    		 Time to seropositivity [1]
    End point description
    ITT analysis
    End point type
    Primary
    End point timeframe
    Up to day 28 after the first injection
    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: Due to the nature of this pilot study, and the relatively small sample size, no formal statistical comparisons were planned.
    End point values
    		 Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    15
    16
    15
    15
    16
    Units: Days
    number (not applicable)
        Quartile 25
    21
    28
    14
    14
    18
        Quartile 50
    28
    0.0
    28
    14
    21
        Quartile 75
    0.0
    0.0
    0.0
    17
    0.0
    Attachments
    		 1
    No statistical analyses for this end point

    Secondary: Proportion of subjects with neutralizing antibodies

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    End point title
    		 Proportion of subjects with neutralizing antibodies
    End point description
    Secondary objectives: To estimate the proportion of subjects with neutralizing antibodies (≥ 10) at day 7, day 14, day 21, day 28, month 3, month 6, 1 year and 1 year + 21 days after the start of the primary vaccination with 95% Wilson confidence interval for the five vaccination regimens (ITT analysis).
    End point type
    Secondary
    End point timeframe
    at day 7, day 14, day 21, day 28, month 3, month 6, 1 year and 1 year + 21 days after the start of the primary vaccination
    End point values
    		 Group 1 Group 2 Group 3 Group 4 Group 5
    Number of subjects analysed
    15
    16
    14
    15
    16
    Units: Percentage
    number (confidence interval 95%)
        Day 7
    0.0 (0.0 to 20.4)
    0.0 (0.0 to 19.4)
    7.1 (1.3 to 31.5)
    6.7 (1.2 to 29.8)
    0.0 (0.0 to 19.4)
        Day 14
    0.0 (0.0 to 20.4)
    6.7 (1.2 to 29.8)
    40.0 (19.8 to 64.3)
    78.6 (52.4 to 92.4)
    26.7 (10.9 to 52.0)
        Day 21
    40.0 (19.8 to 64.3)
    18.8 (6.6 to 43.0)
    26.7 (10.9 to 52.0)
    71.4 (45.4 to 88.3)
    56.3 (33.2 to 76.9)
        Day 28
    53.3 (30.1 to 75.2)
    25.0 (10.2 to 49.5)
    46.7 (24.8 to 69.9)
    69.2 (42.4 to 87.3)
    56.3 (33.2 to 76.9)
        Month 3
    0.0 (0.0 to 20.4)
    6.3 (1.1 to 28.3)
    6.7 (1.2 to 29.8)
    6.7 (1.2 to 29.8)
    0.0 (0.0 to 19.4)
        Month 6
    0.0 (0.0 to 20.4)
    6.3 (1.1 to 28.3)
    13.3 (3.7 to 37.9)
    13.3 (3.7 to 37.9)
    6.7 (1.2 to 29.8)
        Month 12
    0.0 (0.0 to 20.4)
    6.7 (1.2 to 29.8)
    7.7 (1.4 to 33.3)
    45.5 (21.3 to 72.0)
    30.8 (12.7 to 57.6)
        Month 12 + 21 days
    100.0 (79.6 to 100.0)
    93.3 (70.2 to 98.8)
    100.0 (77.2 to 100.0)
    90.9 (62.3 to 98.4)
    100 (77.2 to 100.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    • Occurrence of solicited local and general symptoms within 7 days after each vaccination. • Occurrence of (vaccine-related) AEs for 7 days after each vaccination. • Occurrence of (vaccine-related) SAEs for 14 days after each vaccination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Classic accelerated schedule Day 0: 1 dose 0.5ml IM Day 14: 1 dose 0,5 ml IM

    Reporting group title
    Group 2
    Reporting group description
    		 Day 0: 2 doses 0.5ml IM

    Reporting group title
    Group 3
    Reporting group description
    		 Day 0: 2 doses 0.1ml ID

    Reporting group title
    Group 4
    Reporting group description
    		 Day 0: 2 doses 0.1ml ID Day 7: 2 doses 0,1 ml ID

    Reporting group title
    Group 5
    Reporting group description
    		 Day 0: 2 doses 0.1ml ID Day 14: 2 doses 0,1 ml ID

    Serious adverse events
    		 Group 1 Group 2 Group 3 Group 4 Group 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1 Group 2 Group 3 Group 4 Group 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 15 (26.67%)
    2 / 16 (12.50%)
    3 / 15 (20.00%)
    2 / 15 (13.33%)
    4 / 16 (25.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Axillary pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    0
    1
    Chills
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Axillary mass
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Back pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Muscle rigidity
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Torticollis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infections and infestations
    Mumps
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2019
    The protocol was amended in response to a comment from the FAGG on the initial submission. Changes: - Addition of the inclusion criterium “willing to take contraception until the last vaccination (for women of childbearing potential)” - Addition of pregnancy testing (urine) at every vaccination visit
    28 Oct 2019
    According to version 1.2 of the protocol, the intradermal injections would be prepared by the study nurses, just before administration to the patient. However, to provide a more controlled setting the intradermal syringes will be created by the hospital pharmacist or a delegated person at the Hospital pharmacy. It will be possible to trace the created intradermal syringes back to the batch number of the original vials.
    14 Jul 2020
    Changes: - Extra follow-up assessment on local reactions during month 3 and month 6 visit. - Including interim safety analysis after month 6 visit.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37074147
    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
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