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    Clinical Trial Results:
    Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults

    Summary
    EudraCT number
    2018-003838-32
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    21 Feb 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    30 May 2019
    First version publication date
    30 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ADC01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02587520
    WHO universal trial number (UTN)
    U1111-1161-3027
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety profile of each SP0173 investigational formulations. To describe the immunogenicity of each SP0173 investigational formulations.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate adverse reactions.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Oct 2015
    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
    United States: 1363
    Worldwide total number of subjects
    1363
    EEA total number of subjects
    0
    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)
    383
    Adolescents (12-17 years)
    70
    Adults (18-64 years)
    455
    From 65 to 84 years
    449
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled in 20 centers in the Unites States (US) from 22 October 2015 to 15 August 2016.

    Pre-assignment
    Screening details
    A total of 1363 subjects were randomized in a 1:1:1 ratio to 1 of the 6 formulation study groups. Randomization was stratified by age (adolescents: age 10–18 years, adults: age 19–64 years, older adults: age >= 65 years).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Adolescents: SP0173 Formulation 1
    Arm description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 milliliter (mL), intramuscular, single dose on Day 0.

    Arm title
    Adolescents: SP0173 Formulation 2
    Arm description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adolescents: SP0173 Formulation 3
    Arm description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adolescents: SP0173 Formulation 4
    Arm description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adolescents: Adacel®
    Arm description
    Healthy subjects aged 10–18 years received Adacel®.
    Arm type
    Active comparator

    Investigational medicinal product name
    Adacel®
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adolescents: Boostrix®
    Arm description
    Healthy subjects aged 10–18 years received Boostrix®.
    Arm type
    Active comparator

    Investigational medicinal product name
    Boostrix®
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adults: SP0173 Formulation 1
    Arm description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adults: SP0173 Formulation 2
    Arm description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adults: SP0173 Formulation 3
    Arm description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adults: SP0173 Formulation 4
    Arm description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adults: Adacel®
    Arm description
    Healthy subjects aged 19–64 years received Adacel®.
    Arm type
    Active comparator

    Investigational medicinal product name
    Adacel®
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Adults: Boostrix®
    Arm description
    Healthy subjects aged 19–64 years received Boostrix®.
    Arm type
    Active comparator

    Investigational medicinal product name
    Boostrix®
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Older Adults: SP0173 Formulation 1
    Arm description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Older Adults: SP0173 Formulation 2
    Arm description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Older Adults: SP0173 Formulation 3
    Arm description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Older Adults: SP0173 Formulation 4
    Arm description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    SP0173
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Older Adults: Adacel®
    Arm description
    Healthy subjects aged >= 65 years received Adacel®.
    Arm type
    Active comparator

    Investigational medicinal product name
    Adacel®
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    Older Adults: Boostrix®
    Arm description
    Healthy subjects aged >= 65 years received Boostrix®.
    Arm type
    Active comparator

    Investigational medicinal product name
    Boostrix®
    Investigational medicinal product code
    Other name
    Tdap
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Number of subjects in period 1
    Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Started
    80
    71
    78
    79
    75
    75
    76
    73
    76
    76
    76
    73
    77
    74
    78
    72
    76
    78
    Completed
    78
    69
    77
    74
    75
    72
    73
    71
    73
    71
    73
    69
    77
    73
    78
    72
    76
    78
    Not completed
    2
    2
    1
    5
    0
    3
    3
    2
    3
    5
    3
    4
    0
    1
    0
    0
    0
    0
         Protocol deviation
             2
             -
             -
             2
             -
             1
             1
             1
             3
             3
             1
             2
             -
             -
             -
             -
             -
             -
         Adverse event
             -
             -
             -
             -
             -
             -
             -
             -
             -
             -
             -
             1
             -
             -
             -
             -
             -
             -
         Consent withdrawn by subject
             -
             -
             1
             1
             -
             1
             1
             -
             -
             -
             -
             -
             -
             1
             -
             -
             -
             -
         Lost to follow-up
             -
             2
             -
             2
             -
             1
             1
             1
             -
             2
             2
             1
             -
             -
             -
             -
             -
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adolescents: SP0173 Formulation 1
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.

    Reporting group title
    Adolescents: SP0173 Formulation 2
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adolescents: SP0173 Formulation 3
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adolescents: SP0173 Formulation 4
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adolescents: Adacel®
    Reporting group description
    Healthy subjects aged 10–18 years received Adacel®.

    Reporting group title
    Adolescents: Boostrix®
    Reporting group description
    Healthy subjects aged 10–18 years received Boostrix®.

    Reporting group title
    Adults: SP0173 Formulation 1
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: SP0173 Formulation 2
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: SP0173 Formulation 3
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: SP0173 Formulation 4
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: Adacel®
    Reporting group description
    Healthy subjects aged 19–64 years received Adacel®.

    Reporting group title
    Adults: Boostrix®
    Reporting group description
    Healthy subjects aged 19–64 years received Boostrix®.

    Reporting group title
    Older Adults: SP0173 Formulation 1
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: SP0173 Formulation 2
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: SP0173 Formulation 3
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: SP0173 Formulation 4
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: Adacel®
    Reporting group description
    Healthy subjects aged >= 65 years received Adacel®.

    Reporting group title
    Older Adults: Boostrix®
    Reporting group description
    Healthy subjects aged >= 65 years received Boostrix®.

    Reporting group values
    Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix® Total
    Number of subjects
    80 71 78 79 75 75 76 73 76 76 76 73 77 74 78 72 76 78 1363
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    10.8 ± 1.3 11.0 ± 1.3 11.1 ± 1.6 10.8 ± 1.4 10.8 ± 1.5 11.1 ± 1.6 42.5 ± 12.5 41.2 ± 12.1 40.1 ± 12.8 42.1 ± 13.0 41.3 ± 12.7 42.5 ± 13.2 71.3 ± 5.4 71.8 ± 5.4 70.9 ± 4.8 70.8 ± 5.1 70.9 ± 5.0 71.3 ± 4.8 -
    Gender categorical
    Units: Subjects
        Female
    41 33 35 37 39 40 43 46 38 39 44 36 37 38 51 38 46 45 726
        Male
    39 38 43 42 36 35 33 27 38 37 32 37 40 36 27 34 30 33 637
    Race
    Units: Subjects
        White
    71 60 71 72 63 65 48 51 46 53 52 51 69 64 70 66 69 68 1109
        Asian
    0 0 1 0 2 2 2 1 4 1 0 1 0 0 0 1 1 0 16
        Black or African American
    7 9 2 4 8 4 23 18 24 18 23 19 7 8 8 5 6 10 203
        American Indian or Alaska Native
    0 1 0 0 0 0 1 1 0 3 0 1 0 1 0 0 0 0 8
        Native Hawaiian or other Pacific Islander
    0 0 1 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 3
        Mixed origin
    2 1 3 2 2 4 2 1 2 1 1 1 1 1 0 0 0 0 24
        Missing
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    4 2 3 4 4 6 17 19 8 11 15 10 11 12 13 15 12 13 179
        Not Hispanic or Latino
    76 69 75 75 71 69 59 54 68 65 61 63 64 59 64 55 63 61 1171
        Missing
    0 0 0 0 0 0 0 0 0 0 0 0 2 3 1 2 1 4 13

    End points

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    End points reporting groups
    Reporting group title
    Adolescents: SP0173 Formulation 1
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.

    Reporting group title
    Adolescents: SP0173 Formulation 2
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adolescents: SP0173 Formulation 3
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adolescents: SP0173 Formulation 4
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adolescents: Adacel®
    Reporting group description
    Healthy subjects aged 10–18 years received Adacel®.

    Reporting group title
    Adolescents: Boostrix®
    Reporting group description
    Healthy subjects aged 10–18 years received Boostrix®.

    Reporting group title
    Adults: SP0173 Formulation 1
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: SP0173 Formulation 2
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: SP0173 Formulation 3
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: SP0173 Formulation 4
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: Adacel®
    Reporting group description
    Healthy subjects aged 19–64 years received Adacel®.

    Reporting group title
    Adults: Boostrix®
    Reporting group description
    Healthy subjects aged 19–64 years received Boostrix®.

    Reporting group title
    Older Adults: SP0173 Formulation 1
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: SP0173 Formulation 2
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: SP0173 Formulation 3
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: SP0173 Formulation 4
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: Adacel®
    Reporting group description
    Healthy subjects aged >= 65 years received Adacel®.

    Reporting group title
    Older Adults: Boostrix®
    Reporting group description
    Healthy subjects aged >= 65 years received Boostrix®.

    Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10–18 Years

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    End point title
    Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10–18 Years [1] [2]
    End point description
    A solicited reaction is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) & considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed & reported under the conditions (nature & onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling & solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Percentages of subjects with at least one solicited injection site reactions & systemic reactions were reported. Safety analysis set that was defined as those subjects who had received study vaccine. All subjects had their safety analyzed according to the vaccine they actually received. Here, "n"= number of subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days 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: As the endpoint is descriptive in nature, no statistical hypothesis was tested.
    [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: Arms applicable for this endpoint are reported.
    End point values
    Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix®
    Number of subjects analysed
    79
    71
    77
    77
    75
    75
    Units: percentage of subjects
    number (not applicable)
        Pain (n= 78, 69, 77, 74, 75, 73)
    75.6
    73.9
    64.9
    66.2
    78.7
    65.8
        Erythema (n= 78, 69, 77, 74, 75, 73)
    11.5
    5.8
    13.0
    1.4
    5.3
    2.7
        Swelling (n= 78, 69, 77, 74, 75, 73)
    9.0
    5.8
    10.4
    0.0
    1.3
    5.5
        Upper limb edema (n= 77, 69, 77, 74, 74, 73)
    58.4
    59.4
    63.6
    62.2
    64.9
    45.2
        Extensive limb swelling (n= 79, 71, 77, 75, 75)
    0.0
    0.0
    0.0
    0.0
    0.0
    0.0
        Fever (n= 77, 69, 77, 74, 75, 73)
    1.3
    0.0
    1.3
    0.0
    0.0
    1.4
        Headache (n= 78, 69, 77, 74, 75, 73)
    26.9
    20.3
    24.7
    33.8
    26.7
    37.0
        Malaise (n= 78, 69, 77, 74, 75, 73)
    17.9
    24.6
    18.2
    24.3
    16.0
    23.3
        Myalgia (n= 78, 69, 77, 74, 75, 73)
    53.8
    50.7
    49.4
    56.8
    69.3
    52.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19–64 Years

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    End point title
    Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19–64 Years [3] [4]
    End point description
    A solicited reaction is an AE that is prelisted in the eCRF and considered to be related to vaccination. A solicited reaction is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Percentages of subjects with at least one solicited injection site reactions and systemic reactions were reported. Analysis was performed on safety analysis set. Here, "n"= number of subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days 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: As the endpoint is descriptive in nature, no statistical hypothesis was tested.
    [4] - 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: Arms applicable for this endpoint are reported.
    End point values
    Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix®
    Number of subjects analysed
    76
    73
    76
    76
    76
    72
    Units: percentage of subjects
    number (not applicable)
        Pain (n= 73, 70, 73, 71, 72, 68)
    52.1
    48.6
    67.1
    59.2
    68.1
    51.5
        Erythema (n= 73, 70, 73, 71, 72, 68)
    2.7
    1.4
    2.7
    0.0
    6.9
    2.9
        Swelling (n= 73, 70, 73, 71, 72, 68)
    1.4
    4.3
    5.5
    1.4
    4.2
    1.5
        Upper limb edema (n= 71, 67, 72, 69, 71, 67)
    39.4
    55.2
    56.9
    53.6
    49.3
    46.3
        Extensive limb swelling (n= 76, 73, 76, 76, 76, 72
    0.0
    0.0
    0.0
    0.0
    1.3
    0.0
        Fever (n= 71, 68, 72, 70, 71, 68)
    0.0
    0.0
    0.0
    0.0
    2.8
    1.5
        Headache (n= 73, 71, 73, 71, 72, 68)
    21.9
    15.5
    26.0
    26.8
    26.4
    27.9
        Malaise (n= 73, 71, 73, 71, 72, 68)
    24.7
    12.7
    21.9
    26.8
    31.9
    22.1
        Myalgia (n= 73, 71, 73, 71, 72, 68)
    43.8
    40.8
    47.9
    50.7
    54.2
    41.2
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >= 65 Years

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    End point title
    Percentage of Subjects With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >= 65 Years [5] [6]
    End point description
    A solicited reaction is an AE that is prelisted in the eCRF and considered to be related to vaccination. A solicited reaction is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Percentages of subjects with at least one solicited injection site reactions and systemic reactions were reported. Analysis was performed on safety analysis set. Here, "n"= number of subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    Within 7 days after vaccination
    Notes
    [5] - 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: As the endpoint is descriptive in nature, no statistical hypothesis was tested.
    [6] - 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: Arms applicable for this endpoint are reported.
    End point values
    Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Number of subjects analysed
    77
    73
    78
    72
    76
    78
    Units: percentage of subjects
    number (not applicable)
        Pain (77, 73, 78, 72, 75, 78)
    27.3
    46.6
    43.6
    47.2
    37.3
    32.1
        Erythema (77, 73, 78, 72, 75, 78)
    0.0
    1.4
    2.6
    2.8
    4.0
    1.3
        Swelling (77, 73, 78, 72, 75, 78)
    1.3
    8.2
    7.7
    2.8
    1.3
    2.6
        Upper limb edema (75, 70, 75, 71, 72, 74)
    50.7
    61.4
    48.0
    53.5
    44.4
    54.1
        Extensive limb swelling (77, 73, 78, 72, 76, 78)
    0.0
    0.0
    0.0
    0.0
    0.0
    0.0
        Fever (76, 72, 77, 71, 72, 74)
    0.0
    1.4
    0.0
    0.0
    0.0
    0.0
        Headache (77, 73, 78, 72, 74, 77)
    7.8
    13.7
    25.6
    16.7
    14.9
    18.2
        Malaise (77, 73, 77, 72, 74, 77)
    7.8
    16.4
    18.2
    12.5
    10.8
    7.8
        Myalgia (77, 73, 77, 72, 74, 77)
    15.6
    28.8
    39.0
    31.9
    31.1
    22.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events (AEs) were collected from Day 0 to Day 7 (solicited reactions) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
    Adverse event reporting additional description
    A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e.,solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the Safety Analysis Set.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Adolescents: SP0173 Formulation 1
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.

    Reporting group title
    Adolescents: SP0173 Formulation 2
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adolescents: SP0173 Formulation 3
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adolescents: SP0173 Formulation 4
    Reporting group description
    Healthy subjects aged 10–18 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adolescents: Adacel®
    Reporting group description
    Healthy subjects aged 10–18 years received Adacel®.

    Reporting group title
    Adolescents: Boostrix®
    Reporting group description
    Healthy subjects aged 10–18 years received Boostrix®.

    Reporting group title
    Adults: SP0173 Formulation 1
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: SP0173 Formulation 2
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: SP0173 Formulation 3
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: SP0173 Formulation 4
    Reporting group description
    Healthy subjects aged 19–64 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Adults: Adacel®
    Reporting group description
    Healthy subjects aged 19–64 years received Adacel®.

    Reporting group title
    Adults: Boostrix®
    Reporting group description
    Healthy subjects aged 19–64 years received Boostrix®.

    Reporting group title
    Older Adults: SP0173 Formulation 1
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: SP0173 Formulation 2
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: SP0173 Formulation 3
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: SP0173 Formulation 4
    Reporting group description
    Healthy subjects aged >= 65 years received a single dose of the SP0173 Tdap vaccine.

    Reporting group title
    Older Adults: Adacel®
    Reporting group description
    Healthy subjects aged >= 65 years received Adacel®.

    Reporting group title
    Older Adults: Boostrix®
    Reporting group description
    Healthy subjects aged >= 65 years received Boostrix®.

    Serious adverse events
    Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    1 / 73 (1.37%)
    1 / 76 (1.32%)
    1 / 76 (1.32%)
    0 / 76 (0.00%)
    2 / 72 (2.78%)
    0 / 77 (0.00%)
    3 / 73 (4.11%)
    4 / 78 (5.13%)
    1 / 72 (1.39%)
    2 / 76 (2.63%)
    2 / 78 (2.56%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Aortic Stenosis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus Fracture
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer Recurrent
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    1 / 76 (1.32%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    1 / 72 (1.39%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    1 / 73 (1.37%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    1 / 78 (1.28%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Embolic Cerebral Infarction
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    1 / 76 (1.32%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    1 / 72 (1.39%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device Dislocation
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    1 / 78 (1.28%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug Withdrawal Syndrome
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    1 / 78 (1.28%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Post-Traumatic Stress Disorder
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    1 / 72 (1.39%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    1 / 78 (1.28%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis Perforated
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    1 / 76 (1.32%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 71 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    1 / 76 (1.32%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Adolescents: SP0173 Formulation 1 Adolescents: SP0173 Formulation 2 Adolescents: SP0173 Formulation 3 Adolescents: SP0173 Formulation 4 Adolescents: Adacel® Adolescents: Boostrix® Adults: SP0173 Formulation 1 Adults: SP0173 Formulation 2 Adults: SP0173 Formulation 3 Adults: SP0173 Formulation 4 Adults: Adacel® Adults: Boostrix® Older Adults: SP0173 Formulation 1 Older Adults: SP0173 Formulation 2 Older Adults: SP0173 Formulation 3 Older Adults: SP0173 Formulation 4 Older Adults: Adacel® Older Adults: Boostrix®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 79 (89.87%)
    64 / 71 (90.14%)
    67 / 77 (87.01%)
    68 / 77 (88.31%)
    71 / 75 (94.67%)
    66 / 75 (88.00%)
    52 / 76 (68.42%)
    53 / 73 (72.60%)
    67 / 76 (88.16%)
    54 / 76 (71.05%)
    62 / 76 (81.58%)
    50 / 72 (69.44%)
    53 / 77 (68.83%)
    60 / 73 (82.19%)
    58 / 78 (74.36%)
    53 / 72 (73.61%)
    49 / 76 (64.47%)
    56 / 78 (71.79%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 79 (1.27%)
    4 / 71 (5.63%)
    4 / 77 (5.19%)
    3 / 77 (3.90%)
    2 / 75 (2.67%)
    0 / 75 (0.00%)
    0 / 76 (0.00%)
    1 / 73 (1.37%)
    2 / 76 (2.63%)
    1 / 76 (1.32%)
    2 / 76 (2.63%)
    1 / 72 (1.39%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    2 / 78 (2.56%)
    1 / 72 (1.39%)
    0 / 76 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    1
    4
    4
    3
    3
    0
    0
    1
    2
    1
    2
    1
    0
    0
    2
    1
    0
    2
    Oropharyngeal Pain
         subjects affected / exposed
    2 / 79 (2.53%)
    5 / 71 (7.04%)
    2 / 77 (2.60%)
    2 / 77 (2.60%)
    4 / 75 (5.33%)
    0 / 75 (0.00%)
    1 / 76 (1.32%)
    2 / 73 (2.74%)
    4 / 76 (5.26%)
    1 / 76 (1.32%)
    0 / 76 (0.00%)
    2 / 72 (2.78%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    1 / 78 (1.28%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    2
    5
    2
    2
    5
    0
    1
    2
    5
    1
    0
    2
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    23 / 79 (29.11%)
    15 / 71 (21.13%)
    19 / 77 (24.68%)
    25 / 77 (32.47%)
    22 / 75 (29.33%)
    29 / 75 (38.67%)
    16 / 76 (21.05%)
    11 / 73 (15.07%)
    19 / 76 (25.00%)
    19 / 76 (25.00%)
    19 / 76 (25.00%)
    19 / 72 (26.39%)
    6 / 77 (7.79%)
    10 / 73 (13.70%)
    20 / 78 (25.64%)
    12 / 72 (16.67%)
    11 / 76 (14.47%)
    14 / 78 (17.95%)
         occurrences all number
    25
    15
    21
    26
    22
    30
    16
    11
    19
    19
    19
    21
    6
    10
    20
    12
    11
    15
    General disorders and administration site conditions
    Change In Limb Circumference
         subjects affected / exposed
    45 / 79 (56.96%)
    41 / 71 (57.75%)
    49 / 77 (63.64%)
    46 / 77 (59.74%)
    48 / 75 (64.00%)
    33 / 75 (44.00%)
    28 / 76 (36.84%)
    37 / 73 (50.68%)
    41 / 76 (53.95%)
    37 / 76 (48.68%)
    35 / 76 (46.05%)
    31 / 72 (43.06%)
    38 / 77 (49.35%)
    43 / 73 (58.90%)
    36 / 78 (46.15%)
    38 / 72 (52.78%)
    32 / 76 (42.11%)
    40 / 78 (51.28%)
         occurrences all number
    45
    41
    49
    46
    48
    33
    28
    37
    41
    37
    35
    31
    38
    43
    36
    38
    32
    40
    Injection Site Erythema
         subjects affected / exposed
    9 / 79 (11.39%)
    4 / 71 (5.63%)
    10 / 77 (12.99%)
    1 / 77 (1.30%)
    4 / 75 (5.33%)
    2 / 75 (2.67%)
    2 / 76 (2.63%)
    1 / 73 (1.37%)
    2 / 76 (2.63%)
    0 / 76 (0.00%)
    5 / 76 (6.58%)
    2 / 72 (2.78%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
    2 / 78 (2.56%)
    2 / 72 (2.78%)
    3 / 76 (3.95%)
    1 / 78 (1.28%)
         occurrences all number
    9
    4
    10
    1
    4
    2
    2
    1
    2
    0
    5
    2
    0
    1
    2
    2
    3
    1
    Injection Site Pain
         subjects affected / exposed
    59 / 79 (74.68%)
    51 / 71 (71.83%)
    50 / 77 (64.94%)
    49 / 77 (63.64%)
    59 / 75 (78.67%)
    48 / 75 (64.00%)
    38 / 76 (50.00%)
    34 / 73 (46.58%)
    49 / 76 (64.47%)
    42 / 76 (55.26%)
    49 / 76 (64.47%)
    35 / 72 (48.61%)
    22 / 77 (28.57%)
    34 / 73 (46.58%)
    34 / 78 (43.59%)
    34 / 72 (47.22%)
    28 / 76 (36.84%)
    25 / 78 (32.05%)
         occurrences all number
    59
    51
    50
    49
    59
    48
    38
    34
    49
    42
    49
    35
    22
    34
    34
    34
    28
    25
    Injection Site Swelling
         subjects affected / exposed
    7 / 79 (8.86%)
    4 / 71 (5.63%)
    8 / 77 (10.39%)
    0 / 77 (0.00%)
    1 / 75 (1.33%)
    4 / 75 (5.33%)
    1 / 76 (1.32%)
    3 / 73 (4.11%)
    4 / 76 (5.26%)
    1 / 76 (1.32%)
    3 / 76 (3.95%)
    1 / 72 (1.39%)
    1 / 77 (1.30%)
    6 / 73 (8.22%)
    6 / 78 (7.69%)
    2 / 72 (2.78%)
    1 / 76 (1.32%)
    2 / 78 (2.56%)
         occurrences all number
    7
    4
    8
    0
    1
    4
    1
    3
    4
    1
    3
    1
    1
    6
    6
    2
    1
    2
    Malaise
         subjects affected / exposed
    14 / 79 (17.72%)
    17 / 71 (23.94%)
    14 / 77 (18.18%)
    18 / 77 (23.38%)
    12 / 75 (16.00%)
    17 / 75 (22.67%)
    18 / 76 (23.68%)
    9 / 73 (12.33%)
    16 / 76 (21.05%)
    19 / 76 (25.00%)
    23 / 76 (30.26%)
    15 / 72 (20.83%)
    6 / 77 (7.79%)
    12 / 73 (16.44%)
    14 / 78 (17.95%)
    9 / 72 (12.50%)
    8 / 76 (10.53%)
    6 / 78 (7.69%)
         occurrences all number
    14
    17
    14
    18
    12
    17
    18
    9
    16
    19
    23
    15
    6
    12
    14
    9
    8
    6
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    3 / 79 (3.80%)
    3 / 71 (4.23%)
    4 / 77 (5.19%)
    1 / 77 (1.30%)
    3 / 75 (4.00%)
    1 / 75 (1.33%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    3
    3
    4
    1
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    42 / 79 (53.16%)
    35 / 71 (49.30%)
    38 / 77 (49.35%)
    42 / 77 (54.55%)
    52 / 75 (69.33%)
    38 / 75 (50.67%)
    32 / 76 (42.11%)
    29 / 73 (39.73%)
    35 / 76 (46.05%)
    36 / 76 (47.37%)
    39 / 76 (51.32%)
    28 / 72 (38.89%)
    12 / 77 (15.58%)
    21 / 73 (28.77%)
    31 / 78 (39.74%)
    23 / 72 (31.94%)
    23 / 76 (30.26%)
    18 / 78 (23.08%)
         occurrences all number
    42
    35
    38
    42
    52
    38
    32
    29
    35
    36
    39
    28
    12
    21
    31
    23
    23
    18
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    3 / 79 (3.80%)
    7 / 71 (9.86%)
    3 / 77 (3.90%)
    5 / 77 (6.49%)
    3 / 75 (4.00%)
    2 / 75 (2.67%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    3
    10
    3
    5
    5
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pharyngitis Streptococcal
         subjects affected / exposed
    5 / 79 (6.33%)
    4 / 71 (5.63%)
    5 / 77 (6.49%)
    5 / 77 (6.49%)
    2 / 75 (2.67%)
    4 / 75 (5.33%)
    0 / 76 (0.00%)
    1 / 73 (1.37%)
    1 / 76 (1.32%)
    0 / 76 (0.00%)
    1 / 76 (1.32%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    5
    4
    7
    5
    2
    5
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Viral Pharyngitis
         subjects affected / exposed
    3 / 79 (3.80%)
    4 / 71 (5.63%)
    2 / 77 (2.60%)
    2 / 77 (2.60%)
    0 / 75 (0.00%)
    1 / 75 (1.33%)
    0 / 76 (0.00%)
    0 / 73 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 76 (0.00%)
    0 / 72 (0.00%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 78 (0.00%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    3
    4
    3
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2015
    Following amendments were made: - To add an unscheduled visit for subjects who presented a Grade 3 solicited adverse event. - To include a 6-month follow-up after vaccination.
    13 May 2016
    Amendment 2.0 was to adjust the number of sites were the trial was going to be conducted. - To clarify that sites should follow state law with regard to the age of majority for consent. - The definition of Category 2 concomitant medication was also revised such that allergy hyposensitization therapy and topical analgesics were not to be recorded as Category 2.

    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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