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    Clinical Trial Results:
    Immunological responses after concomitant vaccination with the yellow fever-vaccine Stamaril and the TBE-vaccine FSME Immun, or JE-vaccine Ixiaro

    Summary
    EudraCT number
    		 2017-002137-32
    Trial protocol
    		 SE  
    Global end of trial date
    16 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Apr 2022
    First version publication date
    08 Apr 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FV001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet, Department of Medicine, Center for Infectious Medicine
    Sponsor organisation address
    Alfred Nobels Allé 8, Huddinge, Sweden, 14152
    Public contact
    Hans-Gustaf Ljunggren, Karolinska Institutet, Department of Medicine, Center for Infectious Medicine, hans-gustaf.ljunggren@ki.se
    Scientific contact
    Hans-Gustaf Ljunggren, Karolinska Institutet, Department of Medicine, Center for Infectious Medicine, hans-gustaf.ljunggren@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
    16 Apr 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study if individuals that have received concomittant vaccinations with FSME Immun and Stamaril generate a better immune response against TBE compared to individuals that only received FSME Immun and to study if individuals that have received concomittant vaccinations with Ixiaro and Stamaril generate a better immune response against JE compared to individuals that only received Ixiaro.
    Protection of trial subjects
    The study was conducted in compliance with the protocol, regulatory requirements, good clinical practice (GCP) and the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association.
    Background therapy
    		 Concomitant medications not mentioned in the exclusion criteria were permitted. Medications that were not permitted were those that have a lasting effect on the individual's immune response and those that may endanger the individual during vaccination. Examples of the above are long-term antiviral treatment, such as treatment for HIV and HCV infection, chronic immunosuppressive treatment or anticoagulants. Concomitant medications were recorded in the CRF.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 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
    Sweden: 145
    Worldwide total number of subjects
    145
    EEA total number of subjects
    145
    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)
    145
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 161 subjects who wanted vaccination against TBE, JE and/or Yellow fever were screened in order to reach the planned number of subjects for the trial. 16 of the 161 screened subjects dit not meet the inclusion criteria.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A1 TBE and Yellow fever
    Arm description
    		 Individuals that were vaccinated against TBE and Yellow fever. The vaccinations were administered in different arms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSME-IMMUN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL administered day 0, day 30 and day 180

    Investigational medicinal product name
    Stamaril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0,5 mL administered day 0 (single dose)

    Arm title
    		 Cohort A2 TBE and Yellow fever
    Arm description
    		 Individuals that were vaccinated against TBE and Yellow fever. The vaccinations were administered in the same arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSME-IMMUN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL administered day 0, day 30 and day 180

    Investigational medicinal product name
    Stamaril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0,5 mL administered day 0 (single dose)

    Arm title
    		 Cohort B1 JE and Yellow fever
    Arm description
    		 Individuals that were vaccinated against JE and Yellow fever. The vaccinations were administered in different arms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IXIARO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL administered day 0 and day 30

    Investigational medicinal product name
    Stamaril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0,5 mL administered day 0 (single dose)

    Arm title
    		 Cohort B2 JE and Yellow fever
    Arm description
    		 Individuals that were vaccinated against JE and Yellow fever. The vaccinations were administered in the same arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IXIARO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL administered day 0 and day 30

    Investigational medicinal product name
    Stamaril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0,5 mL administered day 0 (single dose)

    Arm title
    		 Cohort C TBE
    Arm description
    		 Individuals that were vaccinated against TBE.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    FSME-IMMUN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL administered day 0, day 30 and day 180

    Arm title
    		 Cohort D JE
    Arm description
    		 Individuals that were vaccinated against JE.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    IXIARO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL administered day 0 and day 30

    Arm title
    		 Cohort E Yellow fever
    Arm description
    		 Individuals that were vaccinated against Yellow fever.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Stamaril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0,5 mL administered day 0 (single dose)

    Number of subjects in period 1
    		Cohort A1 TBE and Yellow fever Cohort A2 TBE and Yellow fever Cohort B1 JE and Yellow fever Cohort B2 JE and Yellow fever Cohort C TBE Cohort D JE Cohort E Yellow fever
    Started
    23
    20
    21
    21
    20
    20
    20
    Completed
    20
    20
    20
    20
    19
    20
    20
    Not completed
    3
    0
    1
    1
    1
    0
    0
         Adverse event, non-fatal
    1
    -
    -
    1
    -
    -
    -
         Poor compliance
    2
    -
    1
    -
    -
    -
    -
         Subject moved to another location
    -
    -
    -
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A1 TBE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against TBE and Yellow fever. The vaccinations were administered in different arms.

    Reporting group title
    Cohort A2 TBE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against TBE and Yellow fever. The vaccinations were administered in the same arm.

    Reporting group title
    Cohort B1 JE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against JE and Yellow fever. The vaccinations were administered in different arms.

    Reporting group title
    Cohort B2 JE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against JE and Yellow fever. The vaccinations were administered in the same arm.

    Reporting group title
    Cohort C TBE
    Reporting group description
    		 Individuals that were vaccinated against TBE.

    Reporting group title
    Cohort D JE
    Reporting group description
    		 Individuals that were vaccinated against JE.

    Reporting group title
    Cohort E Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against Yellow fever.

    Reporting group values
    		 Cohort A1 TBE and Yellow fever Cohort A2 TBE and Yellow fever Cohort B1 JE and Yellow fever Cohort B2 JE and Yellow fever Cohort C TBE Cohort D JE Cohort E Yellow fever Total
    Number of subjects
    		 23 20 21 21 20 20 20 145
    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 is reported for the subjects that completed the study.
    Units: years
        arithmetic mean (standard deviation)
    		 31.3 ± 9.0 28.9 ± 7.1 28.3 ± 10.2 27.8 ± 4.6 24.4 ± 5.9 26.0 ± 6.3 29.7 ± 9.5 -
    Gender categorical
    Gender is reported for the subjects that completed the study.
    Units: Subjects
        Female
    		 13 14 11 10 13 13 12 86
        Male
    		 7 6 9 10 6 7 8 53
        Not recorded
    		 3 0 1 1 1 0 0 6

    End points

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    End points reporting groups
    Reporting group title
    Cohort A1 TBE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against TBE and Yellow fever. The vaccinations were administered in different arms.

    Reporting group title
    Cohort A2 TBE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against TBE and Yellow fever. The vaccinations were administered in the same arm.

    Reporting group title
    Cohort B1 JE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against JE and Yellow fever. The vaccinations were administered in different arms.

    Reporting group title
    Cohort B2 JE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against JE and Yellow fever. The vaccinations were administered in the same arm.

    Reporting group title
    Cohort C TBE
    Reporting group description
    		 Individuals that were vaccinated against TBE.

    Reporting group title
    Cohort D JE
    Reporting group description
    		 Individuals that were vaccinated against JE.

    Reporting group title
    Cohort E Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against Yellow fever.

    Primary: Neutralizing antibodies against TBEV

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    End point title
    		 Neutralizing antibodies against TBEV [1]
    End point description
    Number of subjects with neutralizing antibodies (nAbs) against TBE virus
    End point type
    Primary
    End point timeframe
    Final time point, 30 (+14) days after last dose of vaccine
    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: This endpoint is only applicable for subjects receiving vaccine against TBE, hence only applicable for cohorts A1, A2 and C.
    End point values
    		 Cohort A1 TBE and Yellow fever Cohort A2 TBE and Yellow fever Cohort C TBE
    Number of subjects analysed
    20
    20
    19
    Units: subjects
    17
    19
    16
    Statistical analysis title
    		 Comparison of nAbs (TBEV) titers between cohorts
    Comparison groups
    Cohort A1 TBE and Yellow fever v Cohort A2 TBE and Yellow fever v Cohort C TBE
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Neutralizing antibodies against JEV

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    End point title
    		 Neutralizing antibodies against JEV [2]
    End point description
    Number of subjects with neutralizing antibodies (nAbs) against JE virus
    End point type
    Primary
    End point timeframe
    Final time point, 30 (+14) days after last dose of vaccine
    Notes
    [2] - 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: This endpoint is only applicable for subjects receiving vaccine against JE, hence only applicable for cohorts B1, B2 and D.
    End point values
    		 Cohort B1 JE and Yellow fever Cohort B2 JE and Yellow fever Cohort D JE
    Number of subjects analysed
    20
    20
    20
    Units: subjects
    17
    11
    12
    Statistical analysis title
    		 Comparison of nAbs (JEV) titers between cohorts
    Comparison groups
    Cohort B1 JE and Yellow fever v Cohort B2 JE and Yellow fever v Cohort D JE
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Neutralizing antibodies against YFV

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    End point title
    		 Neutralizing antibodies against YFV [3]
    End point description
    Number of subjects with neutralizing antibodies (nAbs) against YF virus
    End point type
    Primary
    End point timeframe
    Final time point: for cohort A1, A2, B1 and B2 30 (+14) days after last dose of vaccine, for cohort E 60 (+14) days after vaccination
    Notes
    [3] - 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: This endpoint is only applicable for subjects receiving vaccine against YF, hence only applicable for cohorts A1, A2, B1, B2 and E.
    End point values
    		 Cohort A1 TBE and Yellow fever Cohort A2 TBE and Yellow fever Cohort B1 JE and Yellow fever Cohort B2 JE and Yellow fever Cohort E Yellow fever
    Number of subjects analysed
    20
    20
    20
    20
    20
    Units: subjects
    20
    20
    20
    20
    20
    Statistical analysis title
    		 Comparison of nAbs (YFV) titers between cohorts
    Comparison groups
    Cohort A1 TBE and Yellow fever v Cohort A2 TBE and Yellow fever v Cohort B1 JE and Yellow fever v Cohort B2 JE and Yellow fever v Cohort E Yellow fever
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the time point of the first vaccination until end of study for each subject.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Cohort A1 TBE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against TBE and Yellow fever. The vaccinations were administered in different arms.

    Reporting group title
    Cohort A2 TBE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against TBE and Yellow fever. The vaccinations were administered in the same arm.

    Reporting group title
    Cohort B1 JE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against JE and Yellow fever. The vaccinations were administered in different arms.

    Reporting group title
    Cohort B2 JE and Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against JE and Yellow fever. The vaccinations were administered in the same arm.

    Reporting group title
    Cohort C TBE
    Reporting group description
    		 Individuals that were vaccinated against TBE.

    Reporting group title
    Cohort D JE
    Reporting group description
    		 Individuals that were vaccinated against JE.

    Reporting group title
    Cohort E Yellow fever
    Reporting group description
    		 Individuals that were vaccinated against Yellow fever.

    Serious adverse events
    		 Cohort A1 TBE and Yellow fever Cohort A2 TBE and Yellow fever Cohort B1 JE and Yellow fever Cohort B2 JE and Yellow fever Cohort C TBE Cohort D JE Cohort E Yellow fever
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    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
    Reproductive system and breast disorders
    Dislocation of hip, baby
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort A1 TBE and Yellow fever Cohort A2 TBE and Yellow fever Cohort B1 JE and Yellow fever Cohort B2 JE and Yellow fever Cohort C TBE Cohort D JE Cohort E Yellow fever
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 23 (82.61%)
    16 / 20 (80.00%)
    12 / 21 (57.14%)
    10 / 21 (47.62%)
    16 / 20 (80.00%)
    16 / 20 (80.00%)
    11 / 20 (55.00%)
    General disorders and administration site conditions
    Flu like symtoms
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 20 (15.00%)
    3 / 21 (14.29%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    3
    3
    2
    0
    1
    0
    Injection site abscess
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Pain/redness at site
         subjects affected / exposed
    7 / 23 (30.43%)
    7 / 20 (35.00%)
    1 / 21 (4.76%)
    2 / 21 (9.52%)
    3 / 20 (15.00%)
    3 / 20 (15.00%)
    2 / 20 (10.00%)
         occurrences all number
    7
    7
    1
    2
    4
    3
    2
    Fatigue
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    2
    0
    0
    1
    0
    0
    Fever
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 20 (15.00%)
    3 / 21 (14.29%)
    2 / 21 (9.52%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    4
    3
    2
    2
    0
    0
    Reproductive system and breast disorders
    Scrotal pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pregnancy
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    4
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Sore throat
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    0
    2
    0
    0
    0
    1
    Asthma
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    allergic rhinitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Bruising
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Cut
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    Fall
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 23 (13.04%)
    4 / 20 (20.00%)
    2 / 21 (9.52%)
    2 / 21 (9.52%)
    3 / 20 (15.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    4
    6
    2
    2
    3
    5
    0
    Dizziness
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Lymph node pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Middle ear inflammation
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    1
    Nausea/vomiting
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    1
    2
    0
    1
    Stomac flu
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    0
    1
    2
    1
    Gastric ulcer
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Localised infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Joint pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    1
    Muscle (body) pain
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    1
    2
    1
    2
    1
    Heel spur
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Upper respiratory infection
         subjects affected / exposed
    8 / 23 (34.78%)
    7 / 20 (35.00%)
    3 / 21 (14.29%)
    5 / 21 (23.81%)
    10 / 20 (50.00%)
    11 / 20 (55.00%)
    7 / 20 (35.00%)
         occurrences all number
    12
    12
    4
    6
    12
    13
    9
    Urinary tract infection
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Vaginal infection
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 20 (15.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Diabetes type 2
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Apr 2018
    Changes in protocol version 3 compared to version 2: - Introduced the possibility of recruiting subjects to more than one cohort at a time. - Subjects receiving dose 2 and 3 should stay 30 minutes instead of 60 minutes. The risk of an allergic reaction is very small after receiving the second and third dose of the same vaccine. - Extended the time window for the third dose TBE vaccine from 5 months (+/- 14 days) after the second dose to 5-12 months after the second dose (according to SmPC). - The use of corticosteroids may be permitted, but not orally or if it is used so frequently or in such doses that it can be considered to significantly affect the effect of the vaccine. - Introduced the possibility for a subject to continue in the study with blood sampling only, if vaccination has been stopped due to safety reasons. - Discontinued subjects will be offered a final follow-up visit. - Introduced the possibility to replace a subject that has dropped out before visit 4.

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

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

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