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    Clinical Trial Results:
    A single blind, randomized comparative and multicentre clinical trial of the immunogenicity and safety of booster immunisation with bivalent vaccine against tetanus and diphtheria VACDITE (BIODRUG) and IMOVAX D.T. ADULT (Sanofi Pasteur SA) in healthy adults.

    Summary
    EudraCT number
    		 2018-001604-10
    Trial protocol
    		 SK  
    Global end of trial date
    29 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2019
    First version publication date
    19 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TriDiTe2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BIODRUG s.r.o.
    Sponsor organisation address
    Boženy Němcovej 8, Bratislava, Slovakia, 811 04
    Public contact
    Clinical Trial Information Desk, BIODRUG s.r.o., biodrugpost@gmail.com
    Scientific contact
    Clinical Trial Information Desk, BIODRUG s.r.o., biodrugpost@gmail.com
    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
    19 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective of this trial is to demonstrate non-inferior immunogenicity (represented by seroconversion rate for tetanus and/or diphtheriae) of booster vaccination with the VACDITE vaccine compared to that of the reference vaccine (IMOVAX D.T. ADULT) in healthy adults.
    Protection of trial subjects
    The risk to subjects enrolled in this study was not higher than the general risks of adverse reactions after tetanus and diphtheriae vaccination because both commercial vaccines are registered in the Slovakia. Subjects were not exposed to more stress or pain than they are from the vaccination or blood sampling.
    Background therapy
    		 Healthy adults
    Evidence for comparator
    		 The comparator, further called as reference vaccine, was chosen as it was the only one bivalent vaccine against tetanus and dphtheriae available and authorised in the Slovakia. There was no other reason of this selection.
    Actual start date of recruitment
    12 Sep 2018
    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
    Slovakia: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    200
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In the study was planned to enrol a total of 200 subjects recruited from healthy adults. All patients were selected from outpatient’s clinic (clinical sites) according to inclusion and exclusion criteria. In one clinical site, there were planned to enrol a total of 50 subjects.

    Pre-assignment
    Screening details
    		 Subjects had have written confirmation on previous immunisation against tetanus and/or diphtheriae not later than 15.9 years and not early than 9.9 years.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    The single blinding was achieved by simple overlapping of subject eyes with a mask before the administration of vaccine. So a subject did not know which vaccine had been administered to him. The single blinding helped especially to objectively assess any adverse events.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test medication
    Arm description
    		 Subjects received one dose of the test vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VACDITE
    Investigational medicinal product code
    SUB25254
    Other name
    DIPHTHERIA AND TETANUS VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly to minimize the occurrence of local adverse reactions as it is recommended by the manufacture. The recommended site of the application was deltoid region in adults. The vaccine dose was the same for both vaccines, i.e. volume of 0.5 ml. The volume of dose, including the way of administration was in accordance of SmPC of both study vaccines.

    Arm title
    		 Reference medication
    Arm description
    		 Subjects received one dose of the reference vaccine.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    IMOVAX D.T. ADULT
    Investigational medicinal product code
    SUB25254
    Other name
    DIPHTHERIA AND TETANUS VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly to minimize the occurrence of local adverse reactions as it is recommended by the manufacture. The recommended site of the application was deltoid region in adults. The vaccine dose was the same for both vaccines, i.e. volume of 0.5 ml. The volume of dose, including the way of administration was in accordance of SmPC of both study vaccines.

    Number of subjects in period 1
    		Test medication Reference medication
    Started
    100
    100
    Completed
    100
    100

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test medication
    Reporting group description
    		 Subjects received one dose of the test vaccine.

    Reporting group title
    Reference medication
    Reporting group description
    		 Subjects received one dose of the reference vaccine.

    Reporting group values
    		 Test medication Reference medication Total
    Number of subjects
    		 100 100 200
    Age categorical
    The study stratification was performed on the base of sex and age as follows: 24.1-29.9 years, 30- 49.9 years, 50-64.9 years for both males and females.
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Adults 24.1-29.9
    		 24 24 48
        Adults 30-49.9
    		 44 44 88
        Adults 50-64.9
    		 32 32 64
    Gender categorical
    Units: Subjects
        Female
    		 50 50 100
        Male
    		 50 50 100
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The primary objective of proving non-inferiority based on primary analysis of variables was performed on the ITT set (intention-to-treat). It was conservative in approach. This set included all subjects since each subject had the primary endpoint, i.e. the concentration of tetanus-specific and diphtheriae-specific antibodies at the started and completed milestone.

    Subject analysis sets values
    		 ITT
    Number of subjects
    200
    Age categorical
    The study stratification was performed on the base of sex and age as follows: 24.1-29.9 years, 30- 49.9 years, 50-64.9 years for both males and females.
    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
        Adults 24.1-29.9
    48
        Adults 30-49.9
    88
        Adults 50-64.9
    64
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    100
        Male
    100

    End points

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    End points reporting groups
    Reporting group title
    Test medication
    Reporting group description
    		 Subjects received one dose of the test vaccine.

    Reporting group title
    Reference medication
    Reporting group description
    		 Subjects received one dose of the reference vaccine.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The primary objective of proving non-inferiority based on primary analysis of variables was performed on the ITT set (intention-to-treat). It was conservative in approach. This set included all subjects since each subject had the primary endpoint, i.e. the concentration of tetanus-specific and diphtheriae-specific antibodies at the started and completed milestone.

    Primary: Seroconversion rate SCR4

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    End point title
    		 Seroconversion rate SCR4
    End point description
    The seroconversion rate was evaluated positive if the increase in antibody levels is at least 4-fold and the concentration of antibodies was at least 0.4 IU/mL.
    End point type
    Primary
    End point timeframe
    Between started and completed milestone (i.e. 28 days)
    End point values
    		 Test medication Reference medication ITT
    Number of subjects analysed
    100
    100
    200
    Units: 100
        tetanus
    75
    67
    142
        diphtheriae
    39
    30
    69
    Statistical analysis title
    		 seroconversion rate's difference for tetanus
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Reference medication v Test medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.53
         upper limit
    		 20.53
    Notes
    [1] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).
    Statistical analysis title
    		 seroconversion rate's difference for diphtheriae
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Test medication v Reference medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.12
         upper limit
    		 22.12
    Notes
    [2] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).

    Secondary: Seroconversion rate SCR2

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    End point title
    		 Seroconversion rate SCR2
    End point description
    The seroconversion rate was evaluated positive if the increase in antibodies was at least 2-fold for pre-vaccination levels ≥1.0 IU/mL or at least 4-fold for pre-vaccination level <1.0 IU/mL and if the concentration of antibodies was at least 0.4 IU/mL.
    End point type
    Secondary
    End point timeframe
    Between started and completed milestone (i.e. 28 days)
    End point values
    		 Test medication Reference medication ITT
    Number of subjects analysed
    100
    100
    200
    Units: 100
        tetanus
    87
    85
    172
        diphtheriae
    39
    30
    69
    Statistical analysis title
    		 seroconversion rate's difference for tetanus
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Reference medication v Test medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.61
         upper limit
    		 11.61
    Notes
    [3] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).
    Statistical analysis title
    		 seroconversion rate's difference for diphtheriae
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Test medication v Reference medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.12
         upper limit
    		 22.12
    Notes
    [4] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).

    Secondary: Seroconversion rate SCR-URL/4

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    End point title
    		 Seroconversion rate SCR-URL/4
    End point description
    The seroconversion rate was evaluated positive if the increase in antibodies was at least 2-fold for pre-vaccination levels > ULR/4 (upper limit of measuring range divided by four) or at least 4-fold for pre-vaccination level < ULR/4 and if the concentration of antibodies was at least 0.4 IU/mL. URL/4 = 1.75 IU/mL for tetanus antibodies URL/4 = 0.75 IU/mL for diphtheriae antibodies
    End point type
    Secondary
    End point timeframe
    Between started and completed milestone (i.e. 28 days)
    End point values
    		 Test medication Reference medication ITT
    Number of subjects analysed
    100
    100
    200
    Units: 100
        tetanus
    82
    81
    163
        diphtheriae
    39
    30
    69
    Statistical analysis title
    		 seroconversion rate's difference for tetanus
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Reference medication v Test medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.76
         upper limit
    		 11.76
    Notes
    [5] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).
    Statistical analysis title
    		 seroconversion rate's difference for diphtheriae
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Reference medication v Test medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.12
         upper limit
    		 22.12
    Notes
    [6] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).

    Secondary: Seroconversion rate SCR1

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    End point title
    		 Seroconversion rate SCR1
    End point description
    The seroconversion rate was evaluated positive if the post-vaccination antibodies' levels were at least 1.0 IU/mL.
    End point type
    Secondary
    End point timeframe
    Between started and completed milestone (i.e. 28 days)
    End point values
    		 Test medication Reference medication ITT
    Number of subjects analysed
    100
    100
    200
    Units: 100
        tetanus
    97
    98
    195
        diphtheriae
    25
    22
    47
    Statistical analysis title
    		 seroconversion rate's difference for tetanus
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Test medication v Reference medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.33
         upper limit
    		 3.33
    Notes
    [7] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).
    Statistical analysis title
    		 seroconversion rate's difference for diphtheriae
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Test medication v Reference medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.75
         upper limit
    		 14.75
    Notes
    [8] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).

    Secondary: Seroconversion rate SCR01

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    End point title
    		 Seroconversion rate SCR01
    End point description
    The seroconversion rate was evaluated positive if the post-vaccination antibodies' levels were at least 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    Between started and completed milestone (i.e. 28 days)
    End point values
    		 Test medication Reference medication ITT
    Number of subjects analysed
    100
    100
    200
    Units: 100
        tetanus
    100
    100
    200
        diphtheriae
    81
    75
    156
    Statistical analysis title
    		 seroconversion rate's difference for tetanus
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Reference medication v Test medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [9] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).
    Statistical analysis title
    		 seroconversion rate's difference for diphtheriae
    Statistical analysis description
    seroconversion rate's difference between test and reference vaccine
    Comparison groups
    Reference medication v Test medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.45
         upper limit
    		 17.45
    Notes
    [10] - Fisher's exact test, simple asymptotic interval of difference. The efficacy objective was met if the seroconversion rate induced with the test vaccine was not worse than 10% compared to reference vaccine-induced seroconversion rate (i.e. seroconversion rates of test minus reference vaccine, including the lower limit of the 95% confidence interval of this difference was not lower than -10%).

    Secondary: Geometric means of antibodies

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    End point title
    		 Geometric means of antibodies
    End point description
    Concentrations of antibodies after booster immunisation were expressed with geometric mean (GMC).The ratio of GMCs (test/reference vaccine) was investigated. If the lower limit of 95% confidence interval of this ratio (i.e. [test] / [reference]) was > 0.67 and the two-sided confidence interval contained 1, then the criterion of non-inferiority was met.
    End point type
    Secondary
    End point timeframe
    Between started and completed milestone (i.e. 28 days)
    End point values
    		 Test medication Reference medication ITT
    Number of subjects analysed
    100
    100
    200
    Units: IU/mL
    geometric mean (confidence interval 95%)
        tetanus
    5.03 (4.40 to 5.75)
    5.18 (4.66 to 5.75)
    5.10 (4.69 to 5.55)
        diphtheriae
    0.33 (0.25 to 0.44)
    0.27 (0.21 to 0.35)
    0.30 (0.25 to 0.36)
    Statistical analysis title
    		 ratio of geometric means for tetanus
    Statistical analysis description
    ratio of geometric means - test/reference
    Comparison groups
    Test medication v Reference medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    P-value
    		 < 0.05
    Method
    		 ratio
    Parameter type
    		 ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.15
    Notes
    [11] - It was computed as a difference of logarithms of both geometric means.
    Statistical analysis title
    		 ratio of geometric means for diphtheriae
    Statistical analysis description
    ratio of geometric means - test/reference
    Comparison groups
    Test medication v Reference medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    P-value
    		 < 0.05
    Method
    		 ratio
    Parameter type
    		 ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.8
    Notes
    [12] - It was computed as a difference of logarithms of both geometric means.

    Secondary: Rise in antibodies (RA) for tetanus

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    End point title
    		 Rise in antibodies (RA) for tetanus
    End point description
    The rise in antibodies (RA) was obtained from ratio of the post- and pre-vaccination antibodies' level. The ratio of RA (test/reference vaccine) was investigated. If the lower limit of 95% confidence interval of this ratio (i.e. [test] / [reference]) was > 0.67 and the two-sided confidence interval contained 1, then the criterion of non-inferiority was met.
    End point type
    Secondary
    End point timeframe
    Between started and completed milestone (i.e. 28 days)
    End point values
    		 Test medication Reference medication ITT
    Number of subjects analysed
    100
    100
    200
    Units: dimensionless
    geometric mean (confidence interval 95%)
        tetanus
    7.57 (6.22 to 9.22)
    8.00 (6.46 to 9.89)
    7.78 (6.74 to 8.98)
        diphtheriae
    5.70 (4.41 to 7.36)
    5.80 (4.55 to 7.39)
    5.75 (4.83 to 6.85)
    Statistical analysis title
    		 ratio of rise in antibodies for tetanus
    Statistical analysis description
    ratio of rise in antibodies - test/reference
    Comparison groups
    Test medication v Reference medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    P-value
    		 < 0.05
    Method
    		 ratio
    Parameter type
    		 ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.26
    Notes
    [13] - It was computed as a difference of logarithms of both geometric means.
    Statistical analysis title
    		 ratio of rise in antibodies for diphtheriae
    Statistical analysis description
    ratio of rise in antibodies - test/reference
    Comparison groups
    Test medication v Reference medication
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [14]
    P-value
    		 < 0.05
    Method
    		 ratio
    Parameter type
    		 ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.39
    Notes
    [14] - It was computed as a difference of logarithms of both geometric means.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Between started and completed milestone
    Adverse event reporting additional description
    The measures of safety used in this study were routine clinical procedures. They were chosen to capture known undesirable effects of tboth vaccnes from the SmPC. Safety measures were conducted by the investigators. They included close vigilance for reporting of reactions on the day of immunisation and 4 weeks after immunisation.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    test vaccine
    Reporting group description
    		 -

    Reporting group title
    reference vaccine
    Reporting group description
    		 -

    Serious adverse events
    		 test vaccine reference vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 test vaccine reference vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 100 (24.00%)
    29 / 100 (29.00%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    2 / 100 (2.00%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    Pain in extremity
    Additional description: Arm/Shoulder pain
         subjects affected / exposed
    2 / 100 (2.00%)
    8 / 100 (8.00%)
         occurrences all number
    2
    8
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    Injection related reaction
    Additional description: Bruise, Elevated temperature, Induration, Itching, Pain, Redness, Swelling at injection site
         subjects affected / exposed
    18 / 100 (18.00%)
    22 / 100 (22.00%)
         occurrences all number
    31
    26
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1

    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.
    None
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