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    Clinical Trial Results:
    One-, Three-, Five- and Ten-Year Data on the Long-Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adolescents 11–14 Years of Age

    Summary
    EudraCT number
    		 2015-005844-32
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Feb 2009

    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
    Td9805-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
    Director, Clinical Development, Sanofi Pasteur Limited, 1 416-667-2273, Miggi.Tomovici@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur Limited, 1 416-667-2273, Miggi.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?
    Yes
    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
    20 Feb 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2009
    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 and 10 years after vaccination with Tdap Vaccine.
    Protection of trial subjects
    Subjects were vaccinated in a previous study, Td9805. No vaccination was administered as part of this long-term immunogenicity follow-up study.
    Background therapy
    		 In Td9805, subjects were randomized to receive either Tdap followed by Hepatitis B vaccine one month later (Group 1) or Tdap and Hepatitis B vaccines concomitantly (Group 2). For the long-term immunogenicity studies, subjects in both groups were recalled for serology at 1, 3, 5, and 10 years post-vaccination.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    17 Nov 1999
    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: 267
    Worldwide total number of subjects
    267
    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)
    193
    Adolescents (12-17 years)
    74
    Adults (18-64 years)
    0
    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 17 November 1999 to 20 February 2009 at 1 clinic center in Canada.

    Pre-assignment
    Screening details
    		 A total of 267 subjects who met all inclusion and none of the exclusion criteria were enrolled in the long-term immunogenicity study.

    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
    		 Group 1; Tdap/Hepatitis
    Arm description
    		 Subjects received Tdap at month 0 and Hepatitis B at months 1, 2, and 7.
    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, 1 injection at Month 0.

    Investigational medicinal product name
    Hepatitis B Vaccine (Recombivax HB®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection each at Months 1, 7, and 7.

    Arm title
    		 Group 2; Tdap and Hepatitis
    Arm description
    		 Subjects received Tdap and Hepatitis B at Month 0 and Hepatitis B at Months 1 and 6.
    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, 1 injection at Month 0.

    Investigational medicinal product name
    Hepatitis B Vaccine (Recombivax HB®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection at Month 0 concurrent with Tdap and 1 injection each at Months 1 and 6.

    Number of subjects in period 1
    		Group 1; Tdap/Hepatitis Group 2; Tdap and Hepatitis
    Started
    135
    132
    Completed
    74
    76
    Not completed
    61
    56
         Lost to follow-up
    61
    56

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1; Tdap/Hepatitis
    Reporting group description
    		 Subjects received Tdap at month 0 and Hepatitis B at months 1, 2, and 7.

    Reporting group title
    Group 2; Tdap and Hepatitis
    Reporting group description
    		 Subjects received Tdap and Hepatitis B at Month 0 and Hepatitis B at Months 1 and 6.

    Reporting group values
    		 Group 1; Tdap/Hepatitis Group 2; Tdap and Hepatitis Total
    Number of subjects
    		 135 132 267
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 93 100 193
        Adolescents (12-17 years)
    		 42 32 74
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.39 ( 0.23 ) 11.32 ( 0.23 ) -
    Gender categorical
    Units: Subjects
        Female
    		 62 61 123
        Male
    		 73 71 144

    End points

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    End points reporting groups
    Reporting group title
    Group 1; Tdap/Hepatitis
    Reporting group description
    		 Subjects received Tdap at month 0 and Hepatitis B at months 1, 2, and 7.

    Reporting group title
    Group 2; Tdap and Hepatitis
    Reporting group description
    		 Subjects received Tdap and Hepatitis B at Month 0 and Hepatitis B at Months 1 and 6.

    Primary: Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently

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    End point title
    		 Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently [1]
    End point description
    Anti-Diphtheria antibody responses were measured using a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured using an enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as post-vaccination antibody titers ≥ 0.01 IU/mL for Diphtheria and ≥ 0.01 EU/mL for Tetanus.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, 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
    		 Group 1; Tdap/Hepatitis Group 2; Tdap and Hepatitis
    Number of subjects analysed
    135
    132
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria; Pre-vaccination
    100
    100
        Diphtheria; 1 month Post-vaccination
    100
    100
        Diphtheria; 1 year Post-vaccination
    100
    100
        Diphtheria; 3 years Post-vaccination
    100
    100
        Diphtheria; 5 years Post-vaccination
    100
    100
        Diphtheria; 10 years Post-vaccination
    100
    98.7
        Tetanus; Pre-vaccination
    100
    98.5
        Tetanus; 1 month Post-vaccination
    100
    100
        Tetanus; 1 year Post-vaccination
    100
    100
        Tetanus; 3 years Post-vaccination
    100
    100
        Tetanus; 5 years Post-vaccination
    100
    100
        Tetanus; 10 years Post-vaccination
    100
    100
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently

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    End point title
    		 Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently
    End point description
    Anti-Diphtheria antibody responses were measured using a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured using an enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as post-vaccination antibody titers ≥ 0.1 IU/mL for Diphtheria and ≥ 0.1 EU/mL for Tetanus.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, and 10 years post-vaccination
    End point values
    		 Group 1; Tdap/Hepatitis Group 2; Tdap and Hepatitis
    Number of subjects analysed
    135
    132
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria; Pre-vaccination
    85.9
    79.5
        Diphtheria; 1 month Post-vaccination
    100
    100
        Diphtheria; 1 year Post-vaccination
    100
    97.4
        Diphtheria; 3 years Post-vaccination
    100
    97.4
        Diphtheria; 5 years Post-vaccination
    76.7
    74
        Diphtheria; 10 years Post-vaccination
    73
    60
        Tetanus; Pre-vaccination
    100
    97.7
        Tetanus; 1 month Post-vaccination
    100
    100
        Tetanus; 1 year Post-vaccination
    100
    100
        Tetanus; 3 years Post-vaccination
    100
    100
        Tetanus; 5 years Post-vaccination
    100
    100
        Tetanus; 10 years Post-vaccination
    98.6
    100
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers of Antibodies for Diphtheria and Tetanus Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently

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    End point title
    		 Summary of Geometric Mean Titers of Antibodies for Diphtheria and Tetanus Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently
    End point description
    Anti-Diphtheria antibody responses were measured using a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured using an 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, and 10 years post-vaccination
    End point values
    		 Group 1; Tdap/Hepatitis Group 2; Tdap and Hepatitis
    Number of subjects analysed
    135
    132
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Diphtheria; Pre-vaccination
    0.38 (0.31 to 0.46)
    0.3 (0.24 to 0.38)
        Diphtheria; 1 month Post-vaccination
    8.13 (7.01 to 9.43)
    6.65 (5.53 to 8)
        Diphtheria; 1 year Post-vaccination
    0.97 (0.82 to 1.16)
    1.01 (0.82 to 1.24)
        Diphtheria; 3 years Post-vaccination
    0.84 (0.7 to 1.02)
    0.75 (0.59 to 0.96)
        Diphtheria; 5 years Post-vaccination
    0.2 (0.17 to 0.24)
    0.18 (0.14 to 0.23)
        Diphtheria; 10 years Post-vaccination
    0.22 (0.17 to 0.29)
    0.19 (0.14 to 0.27)
        Tetanus; Pre-vaccination
    1.19 (1.05 to 1.35)
    0.9 (0.76 to 1.06)
        Tetanus; 1 month Post-vaccination
    28.52 (24.9 to 32.67)
    25.18 (22.04 to 28.77)
        Tetanus; 1 year Post-vaccination
    4.88 (3.99 to 5.98)
    5.82 (5.02 to 6.75)
        Tetanus; 3 years Post-vaccination
    2.48 (2.13 to 2.89)
    2.89 (2.56 to 3.27)
        Tetanus; 5 years Post-vaccination
    2.69 (2.23 to 3.24)
    2.69 (2.29 to 3.17)
        Tetanus; 10 years Post-vaccination
    1.14 (0.9 to 1.45)
    1.28 (1.06 to 1.54)
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers of Antibodies for Pertussis Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently

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    End point title
    		 Summary of Geometric Mean Titers of Antibodies for Pertussis Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently
    End point description
    Anti-Pertussis (Pertussis toxoid, Filamentous hemagglutinin, Fimbriae types 2 and 3, and Pertactin) antibody responses were measured using an indirect 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, and 10 years post-vaccination
    End point values
    		 Group 1; Tdap/Hepatitis Group 2; Tdap and Hepatitis
    Number of subjects analysed
    135
    132
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis toxoid; Pre-vaccination
    11.79 (9.29 to 14.95)
    10.49 (8.4 to 13.09)
        Pertussis toxoid; 1 month Post-vaccination
    163.6 (136.19 to 196.52)
    143.47 (119.12 to 172.8)
        Pertussis toxoid; 1 year Post-vaccination
    54.79 (42.65 to 70.4)
    48.85 (37.54 to 63.56)
        Pertussis toxoid; 3 years Post-vaccination
    34.69 (25.78 to 46.68)
    38.45 (27.54 to 53.68)
        Pertussis toxoid; 5 years Post-vaccination
    29.36 (22.23 to 38.78)
    27.07 (20.87 to 35.1)
        Pertussis toxoid; 10 years Post-vaccination
    13.76 (9.15 to 20.7)
    11.19 (7.95 to 15.77)
        Filamentous hemagglutinin; Pre-vaccination
    32.07 (26.2 to 39.24)
    34.03 (28.2 to 41.06)
        Filamentous hemagglutinin;1 month Post-vaccination
    425.81 (362.52 to 500.15)
    369.06 (315.69 to 431.44)
        Filamentous hemagglutinin; 1 year Post-vaccination
    118.59 (94.26 to 149.21)
    96.28 (77.9 to 119)
        Filamentous hemagglutinin;3 years Post-vaccination
    84.18 (67.83 to 104.47)
    77.18 (61.63 to 96.65)
        Filamentous hemagglutinin;5 years Post-vaccination
    69.96 (56.97 to 85.9)
    59.51 (49.87 to 71.02)
        Filamentous hemagglutinin;10 year Post-vaccination
    41.91 (32.58 to 53.91)
    38.96 (31.09 to 48.81)
        Pertactin; Pre-vaccination
    8.7 (6.88 to 11)
    8.02 (6.34 to 10.15)
        Pertactin; 1 month Post-vaccination
    272.94 (218.43 to 341.06)
    298.73 (242.89 to 367.41)
        Pertactin; 1 year Post-vaccination
    75.29 (55.49 to 102.17)
    76.59 (57.4 to 102.2)
        Pertactin; 3 years Post-vaccination
    53.75 (40.18 to 71.91)
    55.06 (42.28 to 71.7)
        Pertactin; 5 years Post-vaccination
    42.73 (33.38 to 54.71)
    49.26 (38.91 to 62.38)
        Pertactin; 10 years Post-vaccination
    27.68 (21.02 to 36.43)
    25.29 (19.31 to 33.12)
        Fimbriae; Pre-vaccination
    45.58 (36.92 to 56.27)
    45.39 (36.74 to 56.07)
        Fimbriae; 1 month Post-vaccination
    998.38 (834.57 to 1194.3)
    1124 (939.24 to 1345.1)
        Fimbriae; 1 year Post-vaccination
    325.31 (259.6 to 407.65)
    324.38 (251.33 to 418.67)
        Fimbriae; 3 years Post-vaccination
    179.93 (144.63 to 223.84)
    184.24 (146.04 to 232.42)
        Fimbriae; 5 years Post-vaccination
    157.84 (128.35 to 194.11)
    157.74 (126.65 to 196.46)
        Fimbriae; 10 years Post-vaccination
    120.28 (95.98 to 150.72)
    112.76 (88.19 to 144.18)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seropostivity to Pertussis Antigens Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently

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    End point title
    		 Percentage of Subjects with Seropostivity to Pertussis Antigens Following Vaccination with Either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (Tdap) Vaccine or Tdap and Hepatitis B Vaccines Given Concurrently
    End point description
    Anti-Pertussis (Pertussis toxoid, Filamentous hemagglutinin, Fimbriae types 2 and 3, and Pertactin) antibody responses were measured using an indirect enzyme-linked immunosorbent assay (ELISA). Seropositivity rates, defined as the percentage of subjects with ≥ 1, 2, and 4 times the lower limit of quantitation (LLOQ) for the pertussis antigens, was 5 EU/mL for Pertussis toxoid, 3 EU/mL for Filamentous hemagglutinin and Pertactin, 17 EU/mL for Fimbriae types 2 and 3 for 1 month and 1, 3, and 5 years; 4 EU/mL for Pertussis toxoid, Fimbriae types 2 and 3, and Pertactin, and 3 EU/mL for Filamentous hemagglutinin for the 10 years.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, and 10 years post-vaccination
    End point values
    		 Group 1; Tdap/Hepatitis Group 2; Tdap and Hepatitis
    Number of subjects analysed
    135
    132
    Units: Percentage of subjects
    number (not applicable)
        Pertussis toxoid; Pre-vaccination
    68.1
    68.2
        Pertussis toxoid; 1 month Post-vaccination
    99.3
    99.2
        Pertussis toxoid; 1 year Post-vaccination
    97.4
    97.4
        Pertussis toxoid; 3 years Post-vaccination
    92
    93.5
        Pertussis toxoid; 5 years Post-vaccination
    94.2
    92.4
        Pertussis toxoid; 10 years Post-vaccination
    70.6
    69
        Filamentous hemagglutinin; Pre-vaccination
    94.8
    97.7
        Filamentous hemagglutinin;1 month Post-vaccination
    100
    100
        Filamentous hemagglutinin; 1 year Post-vaccination
    98.7
    100
        Filamentous hemagglutinin;3 years Post-vaccination
    98.9
    98.7
        Filamentous hemagglutinin;5 years Post-vaccination
    100
    100
        Filamentous hemagglutinin;10 year Post-vaccination
    100
    100
        Pertactin; Pre-vaccination
    76.3
    75
        Pertactin; 1 month Post-vaccination
    100
    100
        Pertactin; 1 year Post-vaccination
    97.4
    98.7
        Pertactin; 3 years Post-vaccination
    96.6
    98.7
        Pertactin; 5 years Post-vaccination
    98.8
    98.7
        Pertactin; 10 years Post-vaccination
    95.9
    93.4
        Fimbriae; Pre-vaccination
    77.8
    75.8
        Fimbriae; 1 month Post-vaccination
    100
    100
        Fimbriae; 1 year Post-vaccination
    100
    100
        Fimbriae; 3 years Post-vaccination
    97.7
    98.7
        Fimbriae; 5 years Post-vaccination
    97.7
    98.7
        Fimbriae; 10 years Post-vaccination
    100
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    This was a long-term immunogenicity follow-up study of patients that participated in a previous study, Td9805. No vaccines were administered in this study and adverse event data were also not collected.
    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: This was a long-term immunogenicity follow-up study of patients that participated in a previous study, Td9805. No vaccines were administered in this study and adverse event data were also not collected.

    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
    Details regarding the planned long-term follow-up serology studies were included which also involved the collection of additional blood samples at 1, 3, 5, and 10 years post-vaccination.

    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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