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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 Adults and Adolescents (11-64 years)

    Summary
    EudraCT number
    		 2015-005845-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Aug 2012

    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
    Td506-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/Medical Monitor, Sanofi Pasteur, 1 570-957-1506, Dr.Johnson@sanofipasteur.com
    Scientific contact
    Clinical/Medical Monitor, Sanofi Pasteur, 1 570-957-1506, Dr.Johnson@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
    29 Aug 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Long-term follow-up study to describe the profile of antibody levels after booster vaccination with Tdap vaccine or Td vaccine at 1-month, 1-, 3-, and 5-years postvaccination and Tdap only at 10 years post-vaccination.
    Protection of trial subjects
    Subjects were vaccinated in a previous study, Td506. No vaccination was administered as part of this long-term immunogenicity study.
    Background therapy
    		 A subset (189) of the Per-Protocol Immunogenicity (PPI) Paired Population from the Tdap vaccine group (2296 subjects) in the main study were in the 10-year follow up immunogenicity follow-up analysis. The Per-Protocol Immunogenicity (PPI) Paired Population for the 10-year follow-up analyses included subjects from the PPI-1 year, PPI-3 year, PPI-5 year, and PPI-10 year populations who provided blood samples at all 4 follow-up visits, i.e., at 1, 3, 5, and 10 years, and who did not receive any diphtheria-, tetanus-,or pertussis-containing vaccine between 1-month and 10-years after vaccination or did not report pertussis illness during this period.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    28 Aug 2002
    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: 189
    Worldwide total number of subjects
    189
    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)
    44
    Adults (18-64 years)
    145
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A subset of the Per-Protocol Immunogenicity (PPI) Paired Population from the Tdap vaccine group in the main study were in the 10-year follow up immunogenicity follow-up study.

    Pre-assignment
    Screening details
    		 A subset (189) of the Tdap vaccine group in the original study (paired per-protocol population) were included in the 10-year 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
    Arm title
    		 Tdap Vaccine
    Arm description
    		 A subset of subjects (paired per-protocol population) that received 1 dose of Tdap vaccine (Adacel®) in the original Td506 study.
    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
    No vaccine was administered in the long-term follow-up study. (Subjects received 1 injection, 0.5 mL by intramuscular route on Day 0 in the original Td506 study)

    Number of subjects in period 1
    		Tdap Vaccine
    Started
    189
    Completed
    189

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tdap Vaccine
    Reporting group description
    		 A subset of subjects (paired per-protocol population) that received 1 dose of Tdap vaccine (Adacel®) in the original Td506 study.

    Reporting group values
    		 Tdap Vaccine Total
    Number of subjects
    		 189 189
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 44 44
        Adults (18-64 years)
    		 145 145
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 29 ( 16.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 129 129
        Male
    		 60 60

    End points

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    End points reporting groups
    Reporting group title
    Tdap Vaccine
    Reporting group description
    		 A subset of subjects (paired per-protocol population) that received 1 dose of Tdap vaccine (Adacel®) in the original Td506 study.

    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 measured by the ability of the test sera to protect Vero cells from a diphtheria toxin challenge. Anti-Tetanus antibody responses were measured by an indirect enzyme-linked immunosorbent assay method. Seroprotection was defined as diphtheria and tetanus titers ≥ 0.01 IU/mL and ≥ 0.1 IU/mL.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, 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
    Number of subjects analysed
    62 [2]
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria; ≥ 0.01 IU/mL; 11-17 yrs; Pre-injection
    100
        Diphtheria; ≥ 0.01 IU/mL; 18-64 yrs; Pre-injection
    91.9
        Diphtheria; ≥ 0.01 IU/mL;11-17 yrs;1 mth;Post-inj.
    100
        Diphtheria; ≥ 0.01 IU/mL;18-64 yrs;1 mth;Post-inj.
    98.4
        Diphtheria; ≥ 0.01 IU/mL;11-17 yrs;1 yr;Post-inj.
    100
        Diphtheria; ≥ 0.01 IU/mL;18-64 yrs;1 yr;Post-inj.
    98.4
        Diphtheria; ≥ 0.01 IU/mL;11-17 yrs;3 yrs;Post-inj.
    100
        Diphtheria; ≥ 0.01 IU/mL;18-64 yrs;3 yrs;Post-inj.
    98.4
        Diphtheria; ≥ 0.01 IU/mL;11-17 yrs;5 yrs;Post-inj.
    100
        Diphtheria; ≥ 0.01 IU/mL;18-64 yrs;5 yrs;Post-inj.
    98.4
        Diphtheria;≥ 0.01 IU/mL;11-17 yrs;10 yrs;Post-inj.
    100
        Diphtheria;≥ 0.01 IU/mL;18-64 yrs;10 yrs;Post-inj.
    98.4
        Tetanus; ≥ 0.01 IU/mL; 11-17 yrs; Pre-injection
    100
        Tetanus; ≥ 0.01 IU/mL; 18-64 yrs; Pre-injection
    100
        Tetanus; ≥ 0.01 IU/mL; 11-17 yrs; 1 mth Post-inj.
    100
        Tetanus; ≥ 0.01 IU/mL; 18-64 yrs; 1 mth Post-inj.
    100
        Tetanus; ≥ 0.01 IU/mL; 11-17 yrs; 1 year Post-inj.
    100
        Tetanus; ≥ 0.01 IU/mL; 18-64 yrs; 1 year Post-inj.
    100
        Tetanus; ≥ 0.01 IU/mL; 11-17 yrs; 3 yrs Post-inj.
    100
        Tetanus; ≥ 0.01 IU/mL; 18-64 yrs; 3 yrs Post-inj.
    100
        Tetanus; ≥ 0.01 IU/mL; 11-17 yrs; 5 yrs Post-inj.
    100
        Tetanus; ≥ 0.01 IU/mL; 18-64 yrs; 5 yrs Post-inj.
    100
        Tetanus; ≥ 0.01 IU/mL; 11-17 yrs; 10 yrs Post-inj.
    100
        Tetanus; ≥ 0.01 IU/mL; 18-64 yrs; 10 yrs Post-inj.
    100
        Diphtheria; ≥ 0.1 IU/mL; 11-17 yrs; Pre-injection
    70.6
        Diphtheria; ≥ 0.1 IU/mL; 18-64 yrs; Pre-injection
    64.5
        Diphtheria; ≥ 0.1 IU/mL; 11-17 yrs;1 mth;Post-inj.
    100
        Diphtheria; ≥ 0.1 IU/mL; 18-64 yrs;1 mth;Post-inj.
    98.4
        Diphtheria; ≥ 0.1 IU/mL; 11-17 yrs;1 yr;Post-inj.
    100
        Diphtheria; ≥ 0.1 IU/mL; 18-64 yrs;1 yr;Post-inj.
    93.5
        Diphtheria; ≥ 0.1 IU/mL; 11-17 yrs;3 yrs;Post-inj.
    100
        Diphtheria; ≥ 0.1 IU/mL; 18-64 yrs;3 yrs;Post-inj.
    88.7
        Diphtheria; ≥ 0.1 IU/mL; 11-17 yrs;5 yrs;Post-inj.
    88.2
        Diphtheria; ≥ 0.1 IU/mL; 18-64 yrs;5 yrs;Post-inj.
    90.3
        Diphtheria; ≥ 0.1 IU/mL;11-17 yrs;10 yrs;Post-inj.
    94.1
        Diphtheria; ≥ 0.1 IU/mL;18-64 yrs;10 yrs;Post-inj.
    85.5
        Tetanus; ≥ 0.1 IU/mL; 11-17 yrs; Pre-injection
    100
        Tetanus; ≥ 0.1 IU/mL; 18-64 yrs; Pre-injection
    100
        Tetanus; ≥ 0.1 IU/mL; 11-17 yrs; 1 mth; Post-inj.
    100
        Tetanus; ≥ 0.1 IU/mL; 18-64 yrs; 1 mth; Post-inj.
    100
        Tetanus; ≥ 0.1 IU/mL; 11-17 yrs; 1 year; Post-inj.
    100
        Tetanus; ≥ 0.1 IU/mL; 18-64 yrs; 1 year; Post-inj.
    100
        Tetanus; ≥ 0.1 IU/mL; 11-17 yrs; 3 yrs; Post-inj.
    100
        Tetanus; ≥ 0.1 IU/mL; 18-64 yrs; 3 yrs; Post-inj.
    98.4
        Tetanus; ≥ 0.1 IU/mL; 11-17 yrs; 5 yrs; Post-inj.
    100
        Tetanus; ≥ 0.1 IU/mL; 18-64 yrs; 5 yrs; Post-inj.
    98.4
        Tetanus; ≥ 0.1 IU/mL; 11-17 yrs; 10 yrs; Post-inj.
    100
        Tetanus; ≥ 0.1 IU/mL; 18-64 yrs; 10 yrs; Post-inj.
    100
    Notes
    [2] - N represents the PPI Paired population subset.
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Concentrations of Anti-Tetanus and Anti-Diphtheria Titers 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 Concentrations of Anti-Tetanus and Anti-Diphtheria Titers Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®
    End point description
    Anti-Diphtheria antibody responses were measured by the ability of the test sera to protect Vero cells from a diphtheria toxin challenge. Anti-Tetanus antibody responses were measured by an indirect enzyme-linked immunosorbent assay method.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, 10 years post-vaccination
    End point values
    		 Tdap Vaccine
    Number of subjects analysed
    62 [3]
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Diphtheria; 11-17 years; Pre-injection
    0.17 (0.09 to 0.32)
        Diphtheria; 18-64 years; Pre-injection
    0.18 (0.11 to 0.29)
        Diphtheria; 11-17 years; 1 month Post-injection
    6.03 (4.08 to 8.89)
        Diphtheria; 18-64 years; 1 month Post-injection
    3.74 (2.41 to 5.81)
        Diphtheria; 11-17 years; 1 year Post-injection
    2.27 (1.34 to 3.82)
        Diphtheria; 18-64 years; 1 year Post-injection
    1.34 (0.89 to 2.02)
        Diphtheria; 11-17 years; 3 years Post-injection
    0.85 (0.53 to 1.37)
        Diphtheria; 18-64 years; 3 years Post-injection
    0.55 (0.39 to 0.79)
        Diphtheria; 11-17 years; 5 years Post-injection
    1 (0.46 to 2.18)
        Diphtheria; 18-64 years; 5 years Post-injection
    0.59 (0.4 to 0.87)
        Diphtheria; 11-17 years; 10 years Post-injection
    0.82 (0.44 to 1.53)
        Diphtheria; 18-64 years; 10 years Post-injection
    0.43 (0.29 to 0.62)
        Tetanus; 11-17 years; Pre-injection
    1.19 (0.71 to 2.01)
        Tetanus; 18-64 years; Pre-injection
    1.68 (1.32 to 2.15)
        Tetanus; 11-17 years; 1 month Post-injection
    12.82 (9.14 to 17.98)
        Tetanus; 18-64 years; 1 month Post-injection
    8.96 (7.65 to 10.5)
        Tetanus; 11-17 years; 1 year Post-injection
    5.46 (4.27 to 6.98)
        Tetanus; 18-64 years; 1 year Post-injection
    4.1 (3.51 to 4.79)
        Tetanus; 11-17 years; 3 years Post-injection
    3.47 (2.55 to 4.73)
        Tetanus; 18-64 years; 3 years Post-injection
    3.31 (2.78 to 3.93)
        Tetanus; 11-17 years; 5 years Post-injection
    2.5 (1.78 to 3.53)
        Tetanus; 18-64 years; 5 years Post-injection
    2.49 (2.08 to 2.97)
        Tetanus; 11-17 years; 10 years Post-injection
    2.08 (1.42 to 3.03)
        Tetanus; 18-64 years; 10 years Post-injection
    3 (2.53 to 3.56)
    Notes
    [3] - N represents the PPI Paired population subset.
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean of Anti-Pertussis Titers 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 of Anti-Pertussis Titers Following Vaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®
    End point description
    Anti-Pertussis Toxoid (PT), anti-Filamentous hemagglutinin (FHA), anti-Fimbriae (FIM), and anti-Pertactin (PRN) immunoglobulin antibody titers were determined by an indirect ELISA method.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, 10 years post-vaccination
    End point values
    		 Tdap Vaccine
    Number of subjects analysed
    62 [4]
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        PT; 11-17 years; Pre-injection
    15.42 (7.1 to 33.48)
        PT; 18-64 years; Pre-injection
    9.92 (7.45 to 13.21)
        PT; 11-17 years; 1 month Post-injection
    318.34 (199.39 to 508.23)
        PT; 18-64 years; 1 month Post-injection
    136.61 (104.68 to 178.27)
        PT; 11-17 years; 1 year Post-injection
    93.28 (48.36 to 179.93)
        PT; 18-64 years; 1 year Post-injection
    58.85 (43.89 to 78.91)
        PT; 11-17 years; 3 years Post-injection
    52.22 (27.19 to 100.3)
        PT; 18-64 years; 3 years Post-injection
    46.26 (34.07 to 62.82)
        PT; 11-17 years; 5 years Post-injection
    11.63 (5.56 to 24.32)
        PT; 18-64 years; 5 years Post-injection
    14.68 (11.43 to 18.84)
        PT; 11-17 years; 10 years Post-injection
    18.4 (7.31 to 46.3)
        PT; 18-64 years; 10 years Post-injection
    11.9 (9.11 to 15.54)
        FHA; 11-17 years; Pre-injection
    20.79 (9.16 to 47.19)
        FHA; 18-64 years; Pre-injection
    14.91 (12 to 18.52)
        FHA; 11-17 years; 1 month Post-injection
    209.85 (146.27 to 301.07)
        FHA; 18-64 years; 1 month Post-injection
    172 (139.91 to 211.44)
        FHA; 11-17 years; 1 year Post-injection
    87.43 (60.95 to 125.43)
        FHA; 18-64 years; 1 year Post-injection
    81.92 (65.97 to 101.71)
        FHA; 11-17 years; 3 years Post-injection
    56.42 (38.75 to 82.15)
        FHA; 18-64 years; 3 years Post-injection
    56.83 (44.84 to 72.01)
        FHA; 11-17 years; 5 years Post-injection
    37.35 (26.48 to 52.69)
        FHA; 18-64 years; 5 years Post-injection
    35.1 (29.42 to 41.87)
        FHA; 11-17 years; 10 years Post-injection
    39.15 (28.03 to 54.67)
        FHA; 18-64 years; 10 years Post-injection
    37.95 (31.26 to 46.08)
        PRN; 11-17 years; Pre-injection
    10.46 (4.42 to 24.73)
        PRN; 18-64 years; Pre-injection
    8.36 (5.93 to 11.78)
        PRN; 11-17 years; 1 month Post-injection
    402.73 (238.34 to 680.49)
        PRN; 18-64 years; 1 month Post-injection
    420.9 (308.31 to 574.61)
        PRN; 11-17 years; 1 year Post-injection
    129.91 (84.26 to 200.28)
        PRN; 18-64 years; 1 year Post-injection
    172.85 (126.71 to 235.8)
        PRN; 11-17 years; 3 years Post-injection
    88.55 (56.21 to 139.49)
        PRN; 18-64 years; 3 years Post-injection
    128.78 (95.3 to 174.03)
        PRN; 11-17 years; 5 years Post-injection
    49.88 (28.63 to 86.9)
        PRN; 18-64 years; 5 years Post-injection
    78.5 (57.26 to 107.62)
        PRN; 11-17 years; 10 years Post-injection
    67.05 (34.34 to 130.91)
        PRN; 18-64 years; 10 years Post-injection
    78.59 (58.37 to 105.82)
        FIM; 11-17 years; Pre-injection
    25.98 (14.37 to 46.97)
        FIM; 18-64 years; Pre-injection
    27.35 (20.18 to 37.06)
        FIM; 11-17 years; 1 month Post-injection
    1627.76 (1078.93 to 2455.75)
        FIM; 18-64 years; 1 month Post-injection
    749.07 (545.32 to 1028.95)
        FIM; 11-17 years; 1 year Post-injection
    653.13 (322.49 to 1322.75)
        FIM; 18-64 years; 1 year Post-injection
    296.74 (217.99 to 403.92)
        FIM; 11-17 years; 3 years Post-injection
    344.71 (193 to 615.64)
        FIM; 18-64 years; 3 years Post-injection
    179.82 (132.58 to 243.88)
        FIM; 11-17 years; 5 years Post-injection
    269.75 (162.47 to 447.86)
        FIM; 18-64 years; 5 years Post-injection
    166.43 (122.72 to 225.7)
        FIM; 11-17 years; 10 years Post-injection
    215.55 (129.09 to 359.91)
        FIM; 18-64 years; 10 years Post-injection
    118.43 (91.88 to 152.65)
    Notes
    [4] - N represents the PPI Paired population subset.
    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 Toxoid (PT), anti-Filamentous hemagglutinin (FHA), anti-Fimbriae (FIM), and anti-Pertactin (PRN) immunoglobulin antibody titers were determined by an indirect ELISA method. Seropositivity ≥ 4X lower limit of quantitation (LLOQ) was ≥ 16 EU/mL for PT, FIM, and PRN and ≥ 12 EU/mL for FHA.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 1, 3, 5, 10 years post-vaccination
    End point values
    		 Tdap Vaccine
    Number of subjects analysed
    62 [5]
    Units: Percentage of subjects
    number (not applicable)
        PT; 11-17 years; Pre-injection
    41.2
        PT; 18-64 years; Pre-injection
    35.5
        PT; 11-17 years; 1 month Post-injection
    100
        PT; 18-64 years; 1 month Post-injection
    95.2
        PT; 11-17 years; 1 year Post-injection
    82.4
        PT; 18-64 years; 1 year Post-injection
    82.3
        PT; 11-17 years; 3 years Post-injection
    88.2
        PT; 18-64 years; 3 years Post-injection
    79
        PT; 11-17 years; 5 years Post-injection
    35.3
        PT; 18-64 years; 5 years Post-injection
    56.5
        PT; 11-17 years; 10 years Post-injection
    54.5
        PT; 18-64 years; 10 years Post-injection
    43.1
        FHA; 11-17 years; Pre-injection
    52.9
        FHA; 18-64 years; Pre-injection
    62.9
        FHA; 11-17 years; 1 month Post-injection
    100
        FHA; 18-64 years; 1 month Post-injection
    100
        FHA; 11-17 years; 1 year Post-injection
    100
        FHA; 18-64 years; 1 year Post-injection
    98.4
        FHA; 11-17 years; 3 years Post-injection
    100
        FHA; 18-64 years; 3 years Post-injection
    96.8
        FHA; 11-17 years; 5 years Post-injection
    94.1
        FHA; 18-64 years; 5 years Post-injection
    93.5
        FHA; 11-17 years; 10 years Post-injection
    100
        FHA; 18-64 years; 10 years Post-injection
    95.2
        PRN; 11-17 years; Pre-injection
    47.1
        PRN; 18-64 years; Pre-injection
    41.9
        PRN; 11-17 years; 1 month Post-injection
    100
        PRN; 18-64 years; 1 month Post-injection
    98.4
        PRN; 11-17 years; 1 year Post-injection
    100
        PRN; 18-64 years; 1 year Post-injection
    98.4
        PRN; 11-17 years; 3 years Post-injection
    100
        PRN; 18-64 years; 3 years Post-injection
    96.8
        PRN; 11-17 years; 5 years Post-injection
    82.4
        PRN; 18-64 years; 5 years Post-injection
    85.5
        PRN; 11-17 years; 10 years Post-injection
    88.2
        PRN; 18-64 years; 10 years Post-injection
    85.5
        FIM; 11-17 years; Pre-injection
    23.5
        FIM; 18-64 years; Pre-injection
    27.4
        FIM; 11-17 years; 1 month Post-injection
    100
        FIM; 18-64 years; 1 month Post-injection
    98.4
        FIM; 11-17 years; 1 year Post-injection
    94.1
        FIM; 18-64 years; 1 year Post-injection
    88.7
        FIM; 11-17 years; 3 years Post-injection
    88.2
        FIM; 18-64 years; 3 years Post-injection
    79
        FIM; 11-17 years; 5 years Post-injection
    100
        FIM; 18-64 years; 5 years Post-injection
    95.2
        FIM; 11-17 years; 10 years Post-injection
    100
        FIM; 18-64 years; 10 years Post-injection
    95.2
    Notes
    [5] - N represents the PPI Paired population subset.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    This long-term immunogenicity study was a follow-up to study Td506 which evaluated the safety and immunogenicity of Tdap compared to Td vaccine. 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 long-term immunogenicity study was a follow-up to study Td506 which evaluated the safety and immunogenicity of Tdap compared to Td vaccine. 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 Jul 2001
    Involved study design changes to increase the safety database, subject follow-up duration, and included administrative changes for clarification.
    30 Apr 2002
    Added the long-term follow up for 1 year.
    10 Jun 2004
    Planned long-term follow up for 3 years and 5 years.
    30 Sep 2005
    Planned long-term follow up for 10 years.
    15 Jun 2006
    Updated study personnel throughout the protocol.
    11 Jul 2011
    Involved study design changes to increase the safety database, subject follow-up duration, and included administrative changes for clarification.

    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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