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    Clinical Trial Results:
    One-, Three-, Five-, Eight- and Ten-Year Data on the Long- Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adults and Adolescents

    Summary
    EudraCT number
    		 2015-005843-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Feb 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Apr 2016
    First version publication date
    16 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TC9704-LT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Limited
    Sponsor organisation address
    1755 Steeles Ave. West, Toronto, Canada, M2R 3T4
    Public contact
    Clinical Team Leader, Sanofi Pasteur Limited, 416 667-2273, antigona.tomovici@sanofipasteur.com
    Scientific contact
    Clinical Team Leader, Sanofi Pasteur Limited, 416 667-2273, antigona.tomovici@sanofipasteur.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 Feb 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the antibody levels for tetanus, diphtheria and pertussis at 1 year, 3 years, 5 years, 8 years and 10 years after vaccination with Tdap Vaccine.
    Protection of trial subjects
    Subjects were vaccinated in the main TC9704 study. No vaccination was administered as part of this long-term immunogenicity follow-up study.
    Background therapy
    		 Subjects in the original TC9704 study were randomized to 1 of 5 groups: 2 groups received Tetanus and Diphtheria Toxoids Adsorbed Vaccine and Acellular Pertussis Vaccine Adsorbed administered separately and 3 groups received Tdap vaccine (ADACEL®; Lots 21-11, 22-11, 23-11). For the follow-up studies, only subjects from the 2 British Columbia sites, who received Tdap vaccine were invited to participate in the long-term immunogenicity follow-up visits to provide blood samples at 1, 3, 5, 8 and 10 years post-vaccination.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    07 Oct 1998
    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
    Canada: 449
    Worldwide total number of subjects
    449
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    449
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study subjects were enrolled from 07 October 1998 (1-year follow up) to 19 February 2008 (10-year follow up) at 2 clinic centers in Canada.

    Pre-assignment
    Screening details
    		 A total of 449 subjects who met all of the inclusion and none of the exclusion criteria were included in the long-term immunogenicity analysis.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tdap Vaccine (Lot 21-11)
    Arm description
    		 Subjects received 1 dose of Tdap vaccine (ADACEL®) Lot 21-11 on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the deltoid muscle, 1 injection on Day 0.

    Arm title
    		 Tdap Vaccine (Lot 22-11)
    Arm description
    		 Subjects received 1 dose of Tdap vaccine (ADACEL®) Lot 22-11 on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the deltoid muscle, 1 injection on Day 0.

    Arm title
    		 Tdap Vaccine (Lot 23-11)
    Arm description
    		 Subjects received 1 dose of Tdap vaccine (ADACEL®) Lot 23-11 on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the deltoid muscle, 1 injection on Day 0.

    Number of subjects in period 1
    		Tdap Vaccine (Lot 21-11) Tdap Vaccine (Lot 22-11) Tdap Vaccine (Lot 23-11)
    Started
    151
    149
    149
    Completed
    51
    43
    50
    Not completed
    100
    106
    99
         Lost to follow-up
    100
    106
    99

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tdap Vaccine (Lot 21-11)
    Reporting group description
    		 Subjects received 1 dose of Tdap vaccine (ADACEL®) Lot 21-11 on Day 0.

    Reporting group title
    Tdap Vaccine (Lot 22-11)
    Reporting group description
    		 Subjects received 1 dose of Tdap vaccine (ADACEL®) Lot 22-11 on Day 0.

    Reporting group title
    Tdap Vaccine (Lot 23-11)
    Reporting group description
    		 Subjects received 1 dose of Tdap vaccine (ADACEL®) Lot 23-11 on Day 0.

    Reporting group values
    		 Tdap Vaccine (Lot 21-11) Tdap Vaccine (Lot 22-11) Tdap Vaccine (Lot 23-11) Total
    Number of subjects
    		 151 149 149 449
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 151 149 149 449
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.1 ( 10.4 ) 33.7 ( 10.6 ) 33.6 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 108 104 92 304
        Male
    		 43 45 57 145
    Subject analysis sets

    Subject analysis set title
    Combined Tdap Vaccine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received 1 of 3 lots of Tdap Vaccine on Day 0 and returned for the long-term immunogenicity follow-up visits to provide blood samples at 1, 3, 5, 8, and 10 years post-vaccination.

    Subject analysis sets values
    		 Combined Tdap Vaccine
    Number of subjects
    449
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    449
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    33.8 ( 10.3 )
    Gender categorical
    Units: Subjects
        Female
    304
        Male
    145

    End points

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    End points reporting groups
    Reporting group title
    Tdap Vaccine (Lot 21-11)
    Reporting group description
    		 Subjects received 1 dose of Tdap vaccine (ADACEL®) Lot 21-11 on Day 0.

    Reporting group title
    Tdap Vaccine (Lot 22-11)
    Reporting group description
    		 Subjects received 1 dose of Tdap vaccine (ADACEL®) Lot 22-11 on Day 0.

    Reporting group title
    Tdap Vaccine (Lot 23-11)
    Reporting group description
    		 Subjects received 1 dose of Tdap vaccine (ADACEL®) Lot 23-11 on Day 0.

    Subject analysis set title
    Combined Tdap Vaccine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who received 1 of 3 lots of Tdap Vaccine on Day 0 and returned for the long-term immunogenicity follow-up visits to provide blood samples at 1, 3, 5, 8, and 10 years post-vaccination.

    Primary: Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL® [1]
    End point description
    Anti-Diphtheria antibody responses were assessed using the micro metabolic inhibition test (MIT). Anti-Tetanus antibody responses were assessed using enzyme-linked immunosorbent assay (ELISA). Seroprotection for diphtheria was defined as titers ≥ 0.01 IU/mL and ≥ 0.1 IU/mL. Seroprotection for tetanus was defined as titers ≥ 0.01 EU/mL and ≥ 0.1 EU/mL.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, 8, and 10 years post-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: Descriptive analyses were performed, based on the vaccine groups from the primary series for the long term follow-up period.
    End point values
    		 Tdap Vaccine (Lot 21-11) Tdap Vaccine (Lot 22-11) Tdap Vaccine (Lot 23-11) Combined Tdap Vaccine
    Number of subjects analysed
    151
    149
    149
    449
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria; ≥ 0.01 IU/mL; Pre-injection
    84.1
    79.2
    79.9
    81.1
        Diphtheria; ≥ 0.01 IU/mL; 1 month Post-injection
    98.7
    97.3
    98
    98
        Diphtheria; ≥ 0.01 IU/mL; 1 year Post-injection
    95.5
    96.9
    98.5
    97
        Diphtheria; ≥ 0.01 IU/mL; 3 year Post-injection
    97
    98.5
    95.7
    97
        Diphtheria; ≥ 0.01 IU/mL; 5 year Post-injection
    90
    96.4
    93.5
    93.3
        Diphtheria; ≥ 0.01 IU/mL; 8 year Post-injection
    92
    96
    96.1
    94.7
        Diphtheria; ≥ 0.01 IU/mL; 10 year Post-injection
    85.1
    97.5
    95.8
    92.6
        Tetanus; ≥ 0.01 EU/mL; Pre-injection
    98.7
    98.6
    99.3
    98.9
        Tetanus; ≥ 0.01 EU/mL; 1 month Post-injection
    100
    100
    100
    100
        Tetanus; ≥ 0.01 EU/mL; 1 year Post-injection
    100
    100
    100
    100
        Tetanus; ≥ 0.01 EU/mL; 3 year Post-injection
    100
    100
    100
    100
        Tetanus; ≥ 0.01 EU/mL; 5 year Post-injection
    100
    100
    100
    100
        Tetanus; ≥ 0.01 EU/mL; 8 year Post-injection
    100
    100
    98
    99.3
        Tetanus; ≥ 0.01 EU/mL; 10 year Post-injection
    100
    100
    97.8
    99.2
        Diphtheria; ≥ 0.1 IU/mL; Pre-injection
    31.8
    26.8
    26.2
    28.3
        Diphtheria; ≥ 0.1 IU/mL; 1 month Post-injection
    84.8
    85.7
    84.5
    85
        Diphtheria; ≥ 0.1 IU/mL; 1 year Post-injection
    63.6
    71.9
    67.6
    67.7
        Diphtheria; ≥ 0.1 IU/mL; 3 year Post-injection
    59.7
    59.1
    61.4
    60.1
        Diphtheria; ≥ 0.1 IU/mL; 5 year Post-injection
    61.7
    44.6
    50
    52.2
        Diphtheria; ≥ 0.1 IU/mL; 8 year Post-injection
    56
    48
    54.9
    53
        Diphtheria; ≥ 0.1 IU/mL; 10 year Post-injection
    51.1
    40
    54.2
    48.9
        Tetanus; ≥ 0.1 EU/mL; Pre-injection
    97.4
    95.9
    97.3
    96.9
        Tetanus; ≥ 0.1 EU/mL; 1 month Post-injection
    100
    100
    100
    100
        Tetanus; ≥ 0.1 EU/mL; 1 year Post-injection
    100
    100
    100
    100
        Tetanus; ≥ 0.1 EU/mL; 3 year Post-injection
    100
    100
    100
    100
        Tetanus; ≥ 0.1 EU/mL; 5 year Post-injection
    100
    100
    98.4
    99.4
        Tetanus; ≥ 0.1 EU/mL; 8 year Post-injection
    98
    100
    98
    98.6
        Tetanus; ≥ 0.1 EU/mL; 10 year Post-injection
    100
    100
    97.8
    99.2
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers of Anti-Tetanus and Anti-Diphtheria Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Summary of Geometric Mean Titers of Anti-Tetanus and Anti-Diphtheria Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®
    End point description
    Anti-Diphtheria antibody responses were assessed using the micro metabolic inhibition test (MIT). Anti-Tetanus antibody responses were assessed using enzyme-linked immunosorbent assay (ELISA).
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, 8, and 10 years post-vaccination
    End point values
    		 Tdap Vaccine (Lot 21-11) Tdap Vaccine (Lot 22-11) Tdap Vaccine (Lot 23-11) Combined Tdap Vaccine
    Number of subjects analysed
    151
    149
    149
    449
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Diphtheria; Pre-injection
    0.05 (0.04 to 0.07)
    0.04 (0.03 to 0.05)
    0.03 (0.02 to 0.04)
    0.04 (0.03 to 0.05)
        Diphtheria; 1 month Post-injection
    0.93 (0.67 to 1.29)
    0.84 (0.59 to 1.2)
    0.83 (0.59 to 1.17)
    0.86 (0.71 to 1.05)
        Diphtheria; 1 year Post-injection
    0.22 (0.14 to 0.33)
    0.25 (0.17 to 0.36)
    0.27 (0.18 to 0.4)
    0.24 (0.19 to 0.31)
        Diphtheria; 3 year Post-injection
    0.15 (0.1 to 0.23)
    0.15 (0.11 to 0.21)
    0.16 (0.11 to 0.24)
    0.16 (0.13 to 0.19)
        Diphtheria; 5 year Post-injection
    0.12 (0.07 to 0.19)
    0.1 (0.07 to 0.15)
    0.1 (0.07 to 0.16)
    0.11 (0.08 to 0.14)
        Diphtheria; 8 year Post-injection
    0.13 (0.07 to 0.25)
    0.12 (0.08 to 0.17)
    0.13 (0.08 to 0.2)
    0.13 (0.1 to 0.17)
        Diphtheria; 10 year Post-injection
    0.11 (0.06 to 0.2)
    0.1 (0.06 to 0.16)
    0.09 (0.06 to 0.14)
    0.1 (0.07 to 0.13)
        Tetanus; Pre-injection
    1.11 (0.92 to 1.34)
    1.1 (0.88 to 1.37)
    1.08 (0.9 to 1.31)
    1.1 (0.98 to 1.23)
        Tetanus; 1 month Post-injection
    16.78 (14.84 to 18.97)
    16.67 (14.58 to 19.06)
    14.82 (12.76 to 17.21)
    16.07 (14.86 to 17.37)
        Tetanus; 1 year Post-injection
    4.61 (3.8 to 5.59)
    4.26 (3.52 to 5.17)
    3.83 (3.14 to 4.66)
    4.22 (3.77 to 4.71)
        Tetanus; 3 year Post-injection
    2.38 (1.98 to 2.86)
    2.48 (2.03 to 3.02)
    2.3 (1.87 to 2.83)
    2.38 (2.13 to 2.67)
        Tetanus; 5 year Post-injection
    2.56 (1.95 to 3.36)
    2.95 (2.35 to 3.7)
    2.5 (1.88 to 3.34)
    2.65 (2.28 to 3.09)
        Tetanus; 8 year Post-injection
    2.73 (1.93 to 3.85)
    3.54 (2.69 to 4.66)
    2.46 (1.63 to 3.7)
    2.86 (2.35 to 3.49)
        Tetanus; 10 year Post-injection
    1.93 (1.41 to 2.66)
    3.06 (2.13 to 4.4)
    1.47 (0.98 to 2.22)
    2.01 (1.63 to 2.49)
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers of Anti-Pertussis Antibodies Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Summary of Geometric Mean Titers of Anti-Pertussis Antibodies Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®
    End point description
    Anti-Pertussis (Pertussis toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae types 2 and 3) antibody responses were assessed using enzyme-linked immunosorbent assay (ELISA).
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, 8, and 10 years post-vaccination
    End point values
    		 Tdap Vaccine (Lot 21-11) Tdap Vaccine (Lot 22-11) Tdap Vaccine (Lot 23-11) Combined Tdap Vaccine
    Number of subjects analysed
    151
    149
    149
    449
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis toxoid; Pre-injection
    8.82 (7.07 to 11)
    7.66 (6.11 to 9.59)
    10.5 (8.49 to 12.99)
    8.92 (7.86 to 10.12)
        Pertussis toxoid; 1 month Post-injection
    147.08 (126.85 to 170.54)
    168.29 (145.32 to 194.88)
    120.63 (105.17 to 138.35)
    144.02 (132.48 to 156.57)
        Pertussis toxoid; 1 year Post-injection
    51.52 (41.07 to 64.62)
    63.41 (49.94 to 80.52)
    51.58 (41.74 to 63.74)
    55.14 (48.48 to 62.71)
        Pertussis toxoid; 3 year Post-injection
    49.11 (37.66 to 64.06)
    57.92 (43.88 to 76.46)
    41.65 (32.19 to 53.89)
    49.12 (42.16 to 57.23)
        Pertussis toxoid; 5 year Post-injection
    39.84 (31.41 to 50.54)
    56.72 (44.55 to 72.21)
    37.8 (30.24 to 47.25)
    43.85 (38.31 to 50.19)
        Pertussis toxoid; 8 year Post-injection
    25.15 (19.32 to 32.74)
    21.66 (16.18 to 28.98)
    23.82 (17.7 to 32.06)
    23.47 (19.97 to 27.57)
        Pertussis toxoid; 10 year Post-injection
    25.91 (19.56 to 34.32)
    18.56 (12.84 to 26.83)
    18.07 (13.01 to 25.1)
    20.6 (17.12 to 24.78)
        Filamentous hemagglutinin; Pre-injection
    22.64 (18.29 to 28.03)
    23.59 (19.63 to 28.36)
    24.87 (20.06 to 30.84)
    23.68 (21.06 to 26.63)
        Filamentous hemagglutinin; 1 month Post-injection
    311.86 (271.8 to 357.82)
    327.8 (286.94 to 374.48)
    360.42 (311.29 to 417.3)
    332.62 (307.07 to 360.3)
        Filamentous hemagglutinin; 1 year Post-injection
    105.55 (84.49 to 131.87)
    101.41 (81.01 to 126.94)
    132.09 (109.61 to 159.18)
    112.44 (99.62 to 126.92)
        Filamentous hemagglutinin; 3 year Post-injection
    59.06 (47.57 to 73.32)
    58.25 (47.58 to 71.32)
    74.96 (59.46 to 94.51)
    63.7 (56.25 to 72.13)
        Filamentous hemagglutinin; 5 year Post-injection
    40.5 (32.44 to 50.56)
    50.75 (41.27 to 62.41)
    51.96 (41.68 to 64.78)
    47.46 (41.92 to 53.72)
        Filamentous hemagglutinin; 8 year Post-injection
    52.91 (41.2 to 67.95)
    55.33 (45.25 to 67.65)
    75.04 (58.92 to 95.58)
    60.37 (52.83 to 68.99)
        Filamentous hemagglutinin; 10 year Post-injection
    38.35 (29.7 to 49.52)
    37.31 (29.6 to 47.04)
    43.07 (32.33 to 57.38)
    39.63 (34.16 to 45.96)
        Pertactin; Pre-injection
    5.83 (4.38 to 7.76)
    4.27 (3.26 to 5.59)
    5.27 (3.92 to 7.1)
    5.09 (4.32 to 5.99)
        Pertactin; 1 month Post-injection
    286.16 (225.87 to 362.54)
    347.4 (273.86 to 440.7)
    217.67 (165.67 to 285.99)
    278.58 (241.19 to 321.76)
        Pertactin; 1 year Post-injection
    81.07 (54.69 to 120.17)
    87.04 (60.08 to 126.08)
    68.78 (48.5 to 97.56)
    78.45 (63.52 to 96.91)
        Pertactin; 3 year Post-injection
    79.99 (57.27 to 111.74)
    76.76 (55.72 to 105.76)
    79.01 (55.21 to 113.08)
    78.56 (64.85 to 95.18)
        Pertactin; 5 year Post-injection
    36.56 (24.54 to 54.47)
    45.05 (30.44 to 66.67)
    34.07 (22.44 to 51.73)
    38.17 (30.35 to 48.01)
        Pertactin; 8 year Post-injection
    37.41 (25.94 to 53.94)
    47.27 (32.63 to 68.46)
    43.88 (28.51 to 67.52)
    42.59 (34.15 to 53.12)
        Pertactin; 10 year Post-injection
    43.18 (29.25 to 63.74)
    35.91 (23.55 to 54.75)
    41.72 (26.88 to 64.75)
    40.38 (31.9 to 51.11)
        Fimbriae types 2 and 3; Pre-injection
    22.31 (17.43 to 28.55)
    18.76 (14.01 to 25.12)
    19.35 (14.26 to 26.27)
    20.09 (17.09 to 23.62)
        Fimbriae types 2 and 3; 1 month Post-injection
    1314.62 (1097.33 to 1574.94)
    1048.31 (844.83 to 1300.81)
    690.27 (557.86 to 854.1)
    985.27 (874.58 to 1109.97)
        Fimbriae types 2 and 3; 1 year Post-injection
    319.3 (247.19 to 412.43)
    338.34 (248.93 to 459.85)
    251.7 (188.03 to 336.92)
    300.08 (254.99 to 353.15)
        Fimbriae types 2 and 3; 3 year Post-injection
    249.23 (194.9 to 318.69)
    249.68 (183.89 to 399.01)
    194.11 (141.26 to 266.73)
    229.44 (194.23 to 271.04)
        Fimbriae types 2 and 3; 5 year Post-injection
    205.51 (153.54 to 275.06)
    226.5 (159.48 to 321.69)
    160.79 (114.47 to 225.84)
    194.9 (161.63 to 235.02)
        Fimbriae types 2 and 3; 8 year Post-injection
    147.85 (113.86 to 191.97)
    180.23 (129.37 to 251.08)
    133.39 (95.38 to 186.54)
    152.45 (127.76 to 181.92)
        Fimbriae types 2 and 3; 10 year Post-injection
    130.67 (97.63 to 174.9)
    145.36 (98.48 to 214.55)
    113.72 (81.71 to 158.26)
    128.43 (106.32 to 155.13)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seropositivity to Pertussis antigens Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Percentage of Subjects with Seropositivity to Pertussis antigens Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®
    End point description
    Anti-Pertussis (Pertussis toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae types 2 and 3) antibody responses were assessed using enzyme-linked immunosorbent assay (ELISA). Seropositivity was defined as subjects with titers ≥ 5 EU/mL for Pertussis Toxoid, ≥ 3 EU/mL for Filamentous Hemagglutinin, ≥ 17 EU/mL for Fimbriae types 2 and 3, and ≥ 3 EU/mL for Pertactin at 1 month and 1, 3, 5 years post-vaccination; and with titers ≥ 4 EU/mL for Pertussis Toxoid, ≥ 3 EU/mL for Filamentous Hemagglutinin, ≥ 4 EU/mL for Fimbriae types 2 and 3 and Pertactin at 8 and 10 years post-vaccination.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, 8, and 10 years post-vaccination
    End point values
    		 Tdap Vaccine (Lot 21-11) Tdap Vaccine (Lot 22-11) Tdap Vaccine (Lot 23-11) Combined Tdap Vaccine
    Number of subjects analysed
    151
    149
    149
    449
    Units: Percentage of subjects
    number (not applicable)
        Pertussis toxoid; Pre-injection
    68.5
    62.3
    77.6
    69.5
        Pertussis toxoid; 1 month Post-injection
    100
    100
    100
    100
        Pertussis toxoid; 1 year Post-injection
    98.5
    100
    98.5
    99
        Pertussis toxoid; 3 year Post-injection
    97.1
    97.1
    94.3
    96.2
        Pertussis toxoid; 5 year Post-injection
    96.8
    100
    98.5
    98.4
        Pertussis toxoid; 8 year Post-injection
    97.9
    92.2
    92.2
    94
        Pertussis toxoid; 10 year Post-injection
    97.6
    88.9
    86.7
    91.1
        Filamentous hemagglutinin; Pre-injection
    92.1
    95.3
    93.3
    93.5
        Filamentous hemagglutinin; 1 month Post-injection
    100
    100
    100
    100
        Filamentous hemagglutinin; 1 year Post-injection
    100
    98.5
    100
    99.5
        Filamentous hemagglutinin; 3 year Post-injection
    100
    100
    100
    100
        Filamentous hemagglutinin; 5 year Post-injection
    100
    100
    100
    100
        Filamentous hemagglutinin; 8 year Post-injection
    100
    100
    100
    100
        Filamentous hemagglutinin; 10 year Post-injection
    100
    100
    100
    100
        Pertactin; Pre-injection
    63.6
    57.7
    64.4
    61.9
        Pertactin; 1 month Post-injection
    99.3
    100
    98.6
    99.3
        Pertactin; 1 year Post-injection
    95.5
    100
    98.5
    98
        Pertactin; 3 year Post-injection
    100
    100
    98.6
    99.5
        Pertactin; 5 year Post-injection
    95.2
    98.4
    90.8
    94.7
        Pertactin; 8 year Post-injection
    92.6
    100
    90.6
    94.3
        Pertactin; 10 year Post-injection
    94.1
    100
    90
    94.4
        Fimbriae types 2 and 3; Pre-injection
    57.6
    54.4
    60.4
    57.5
        Fimbriae types 2 and 3; 1 month Post-injection
    100
    99.3
    99.3
    99.6
        Fimbriae types 2 and 3; 1 year Post-injection
    100
    95.4
    97.1
    97.5
        Fimbriae types 2 and 3; 3 year Post-injection
    98.5
    94.3
    92.8
    95.2
        Fimbriae types 2 and 3; 5 year Post-injection
    98.4
    93.4
    92.3
    94.7
        Fimbriae types 2 and 3; 8 year Post-injection
    100
    100
    98.1
    99.4
        Fimbriae types 2 and 3; 10 year Post-injection
    100
    97.6
    98
    98.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Safety was not assessed in this 10-year immunogenicity follow-up study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Safety end points were not assessed in the 10-year follow-up study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 May 2001
    Allowed for the collection of additional blood samples for long-term follow-up serology studies.
    23 Jun 2005
    The major changes included adding the 8-year follow-up study, including details of collection, storage, and and shipment of long-term follow up blood samples and sera, providing details of the study population for the long-term follow-up studies (including inclusion/exclusion criteria), and clarified the statistical analysis for the long-term follow-up studies.

    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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