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    Clinical Trial Results:
    Six-Month, One-Year, Three-Year, Five-Year and Ten-Year Data on the Long-Term Immunogenicity of Td-mIPV, Tdap-vIPV, Td, aP and Tdap in Adolescents and Adults

    Summary
    EudraCT number
    		 2015-005197-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TD9707-LT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00712959
    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, 1 416-667-2273, Miggi.Tomovici@sanofipasteur.com
    Scientific contact
    Clinical Team Leader, 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
    09 Feb 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To describe the antibody levels for tetanus, diphtheria, pertussis and poliovirus types 1, 2 and 3 at pre-vaccination, 1 month, 6 months, 1 year, 3 years, 5 years and 10 years after vaccination with Td-mIPV, Tdap-vIPV (vero), Td, aP and Tdap.
    Protection of trial subjects
    Subjects were vaccinated in a previous study, Td9707. No vaccination was administered as part of this study.
    Background therapy
    		 In Td9707, adolescents received either Td-mIPV Vaccine at Visit 1 followed by aP Vaccine 1 month later (Visit 2) or one of the three lots of the Tdap-vIPV Vaccine. Adults received separate injections (1 month apart) of Td and aP, Tdap and vIPV Vaccines, or Tdap and aP Vaccines, or they received one of the three lots of the Tdap-vIPV Vaccine at Visit 1. Subjects in groups that did not receive vIPV as a component of the study vaccine were offered vIPV vaccination at their last study visit (Visit 3). For the long-term immunogenicity follow-up study, subjects in all study groups were recalled for serology at 6 months, 1, 3, 5, and 10 years post-vaccination.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    05 Aug 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: 1214
    Worldwide total number of subjects
    1214
    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)
    468
    Adults (18-64 years)
    746
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study subjects were enrolled in the long-term immunogenicity study from 5 August 1998 to 9 February 2009 at 4 clinic centers in Canada.

    Pre-assignment
    Screening details
    		 A total of 1214 subjects who met all inclusion and none of the exclusion criteria were enrolled in the original Td9707 study; 1207 subjects were included in the long-term follow-up 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
    		 Td-mIPV Adolescents
    Arm description
    		 Adolescents who received Td-mIPV on Day 0 followed by aP 1 month later.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tetanus Toxoid and Reduced Diphtheria Toxoid Adsorbed and Inactivated Poliovirus Vaccine (live virus grown on MRC-5 diploid cells); Td-mIPV Vaccine
    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 on Day 0.

    Investigational medicinal product name
    Adult formulation of the 5-component Pertussis Vaccine; aP
    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 on Day 30.

    Arm title
    		 TdaP1-IPV Adolescents
    Arm description
    		 Adolescents received 1 injection of TdaP1-IPV Lot 15001-11 on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TdaP Adsorbed Vaccine combined with inactivated poliovirus vaccine derived from Vero cell culture; TdcP1-IPV Adsorbed Vaccine Lot 15001-11
    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 on Day 0.

    Arm title
    		 TdaP2-IPV Adolescents
    Arm description
    		 Adolescents received 1 injection of TdaP2-IPV Lot 15002-11 on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TdaP Adsorbed Vaccine combined with inactivated poliovirus vaccine derived from Vero cell culture; TdcP2-IPV Adsorbed Vaccine Lot 15002-11
    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 on Day 0.

    Arm title
    		 TdaP3-IPV Adolescents
    Arm description
    		 Adolescents received 1 injection of TdaP3-IPV Lot 15003-11 on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TdaP Adsorbed Vaccine combined with inactivated poliovirus vaccine derived from Vero cell culture; TdcP3-IPV Adsorbed Vaccine Lot 15003-11
    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 on Day 0.

    Arm title
    		 Td/aP Adults
    Arm description
    		 Adults received 1 injection of Tetanus and Diphtheria Toxoids Adsorbed Vaccine (Td Adsorbed Vaccine; Td) on Day 0 and 1 injection of Adult formulation of the 5-component Pertussis Vaccine (aP) 1 month later. An injection of Inactivated Poliovirus Vaccine was optional 1 month post-aP vaccination (Visit 3).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adult formulation of the 5-component Pertussis Vaccine (aP)
    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 1.

    Investigational medicinal product name
    Tetanus and Diphtheria Toxoids Adsorbed Vaccine (Td Adsorbed Vaccine; Td)
    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 on Day 0.

    Investigational medicinal product name
    Inactivated Poliovirus Vaccine derived from Vero cell culture (IPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, optional injection at 1 month post-aP vaccination (Visit 3).

    Arm title
    		 TdaP/IPV Adults
    Arm description
    		 Adults received 1 injection of TdaP on Day 0 and 1 injection of IPV 1 month later.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Td Adsorbed Vaccine combined with aP Vaccine (TdaP Adsorbed Vaccine)
    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 on Day 0.

    Investigational medicinal product name
    Inactivated Poliovirus Vaccine derived from Vero cell culture (IPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, l injection at Month 1.

    Arm title
    		 TdaP/aP Adults
    Arm description
    		 Adults received 1 injection of TdaP on Day 0 and 1 injection of aP one month later. An injection of Inactivated Poliovirus Vaccine was optional 1 month post-aP vaccination (Visit 3).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Td Adsorbed Vaccine combined with aP Vaccine (TdaP Adsorbed Vaccine)
    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 on Day 0.

    Investigational medicinal product name
    Adult formulation of the 5-component Pertussis Vaccine (aP)
    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 1.

    Investigational medicinal product name
    Inactivated Poliovirus Vaccine derived from Vero cell culture (IPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, optional injection at 1 month post-aP vaccination (Visit 3).

    Arm title
    		 TdaP1-IPV Adults
    Arm description
    		 Adults received 1 injection of TdaP1-IPV Lot 15001-11 on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TdaP Adsorbed Vaccine combined with inactivated poliovirus vaccine derived from Vero cell culture; TdcP1-IPV Adsorbed Vaccine Lot 15001-11
    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 on Day 0.

    Arm title
    		 TdaP2-IPV Adults
    Arm description
    		 Adults received 1 injection of TdaP2-IPV Lot 15002-11 on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TdaP Adsorbed Vaccine combined with inactivated poliovirus vaccine derived from Vero cell culture; TdcP2-IPV Adsorbed Vaccine Lot 15002-11
    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 on Day 0.

    Arm title
    		 TdaP3-IPV Adults
    Arm description
    		 Adults received 1 injection of TdaP3-IPV Lot 15003-11 on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TdaP Adsorbed Vaccine combined with inactivated poliovirus vaccine derived from Vero cell culture; TdcP3-IPV Adsorbed Vaccine Lot 15003-11
    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 on Day 0.

    Number of subjects in period 1
    		Td-mIPV Adolescents TdaP1-IPV Adolescents TdaP2-IPV Adolescents TdaP3-IPV Adolescents Td/aP Adults TdaP/IPV Adults TdaP/aP Adults TdaP1-IPV Adults TdaP2-IPV Adults TdaP3-IPV Adults
    Started
    117
    118
    117
    116
    126
    126
    122
    126
    121
    125
    Completed
    117
    118
    115
    116
    121
    121
    117
    124
    121
    121
    Not completed
    0
    0
    2
    0
    5
    5
    5
    2
    0
    4
         Consent withdrawn by subject
    -
    -
    2
    -
    4
    2
    3
    -
    -
    1
         Unable to obtain blood/serum sample
    -
    -
    -
    -
    -
    2
    -
    -
    -
    -
         Failed to meet inclusion criteria
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
         Unable to obtain serum sample
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
         Due to nature of bilateral hip pain
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Tetanus in < 5 years prior to study
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
         Not eligible; Td boost within 5 years
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
         Lost to follow-up
    -
    -
    -
    -
    1
    1
    -
    1
    -
    -
         Pregnancy
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Td-mIPV Adolescents
    Reporting group description
    		 Adolescents who received Td-mIPV on Day 0 followed by aP 1 month later.

    Reporting group title
    TdaP1-IPV Adolescents
    Reporting group description
    		 Adolescents received 1 injection of TdaP1-IPV Lot 15001-11 on Day 0.

    Reporting group title
    TdaP2-IPV Adolescents
    Reporting group description
    		 Adolescents received 1 injection of TdaP2-IPV Lot 15002-11 on Day 0.

    Reporting group title
    TdaP3-IPV Adolescents
    Reporting group description
    		 Adolescents received 1 injection of TdaP3-IPV Lot 15003-11 on Day 0.

    Reporting group title
    Td/aP Adults
    Reporting group description
    		 Adults received 1 injection of Tetanus and Diphtheria Toxoids Adsorbed Vaccine (Td Adsorbed Vaccine; Td) on Day 0 and 1 injection of Adult formulation of the 5-component Pertussis Vaccine (aP) 1 month later. An injection of Inactivated Poliovirus Vaccine was optional 1 month post-aP vaccination (Visit 3).

    Reporting group title
    TdaP/IPV Adults
    Reporting group description
    		 Adults received 1 injection of TdaP on Day 0 and 1 injection of IPV 1 month later.

    Reporting group title
    TdaP/aP Adults
    Reporting group description
    		 Adults received 1 injection of TdaP on Day 0 and 1 injection of aP one month later. An injection of Inactivated Poliovirus Vaccine was optional 1 month post-aP vaccination (Visit 3).

    Reporting group title
    TdaP1-IPV Adults
    Reporting group description
    		 Adults received 1 injection of TdaP1-IPV Lot 15001-11 on Day 0.

    Reporting group title
    TdaP2-IPV Adults
    Reporting group description
    		 Adults received 1 injection of TdaP2-IPV Lot 15002-11 on Day 0.

    Reporting group title
    TdaP3-IPV Adults
    Reporting group description
    		 Adults received 1 injection of TdaP3-IPV Lot 15003-11 on Day 0.

    Reporting group values
    		 Td-mIPV Adolescents TdaP1-IPV Adolescents TdaP2-IPV Adolescents TdaP3-IPV Adolescents Td/aP Adults TdaP/IPV Adults TdaP/aP Adults TdaP1-IPV Adults TdaP2-IPV Adults TdaP3-IPV Adults Total
    Number of subjects
    		 117 118 117 116 126 126 122 126 121 125 1214
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 117 118 117 116 0 0 0 0 0 0 468
        Adults (18-64 years)
    		 0 0 0 0 126 126 122 126 121 125 746
        From 65-84 years
    		 0 0 0 0 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.9 ( 0.96 ) 14.01 ( 1.06 ) 13.97 ( 1.04 ) 13.91 ( 1 ) 37.93 ( 9.55 ) 38.13 ( 9.09 ) 38.28 ( 8.7 ) 37.89 ( 8.69 ) 38.29 ( 8.95 ) 38.55 ( 8.18 ) -
    Gender categorical
    Units: Subjects
        Female
    		 55 63 54 57 82 81 91 93 82 85 743
        Male
    		 62 55 63 59 44 45 31 33 39 40 471

    End points

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    End points reporting groups
    Reporting group title
    Td-mIPV Adolescents
    Reporting group description
    		 Adolescents who received Td-mIPV on Day 0 followed by aP 1 month later.

    Reporting group title
    TdaP1-IPV Adolescents
    Reporting group description
    		 Adolescents received 1 injection of TdaP1-IPV Lot 15001-11 on Day 0.

    Reporting group title
    TdaP2-IPV Adolescents
    Reporting group description
    		 Adolescents received 1 injection of TdaP2-IPV Lot 15002-11 on Day 0.

    Reporting group title
    TdaP3-IPV Adolescents
    Reporting group description
    		 Adolescents received 1 injection of TdaP3-IPV Lot 15003-11 on Day 0.

    Reporting group title
    Td/aP Adults
    Reporting group description
    		 Adults received 1 injection of Tetanus and Diphtheria Toxoids Adsorbed Vaccine (Td Adsorbed Vaccine; Td) on Day 0 and 1 injection of Adult formulation of the 5-component Pertussis Vaccine (aP) 1 month later. An injection of Inactivated Poliovirus Vaccine was optional 1 month post-aP vaccination (Visit 3).

    Reporting group title
    TdaP/IPV Adults
    Reporting group description
    		 Adults received 1 injection of TdaP on Day 0 and 1 injection of IPV 1 month later.

    Reporting group title
    TdaP/aP Adults
    Reporting group description
    		 Adults received 1 injection of TdaP on Day 0 and 1 injection of aP one month later. An injection of Inactivated Poliovirus Vaccine was optional 1 month post-aP vaccination (Visit 3).

    Reporting group title
    TdaP1-IPV Adults
    Reporting group description
    		 Adults received 1 injection of TdaP1-IPV Lot 15001-11 on Day 0.

    Reporting group title
    TdaP2-IPV Adults
    Reporting group description
    		 Adults received 1 injection of TdaP2-IPV Lot 15002-11 on Day 0.

    Reporting group title
    TdaP3-IPV Adults
    Reporting group description
    		 Adults received 1 injection of TdaP3-IPV Lot 15003-11 on Day 0.

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

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    End point title
    		 Percentage of Adolescent Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL® [1] [2]
    End point description
    Anti-Diphtheria antibody responses were measured by a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured by 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
    Pre-vaccination, 1 and 6 months post-vaccination, 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 study groups and the study vaccine administered for this outcome.
    [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: This endpoint is reporting data for only the adolescent subjects; data for adult subjects were reported in a separate outcome.
    End point values
    		 Td-mIPV Adolescents TdaP1-IPV Adolescents TdaP2-IPV Adolescents TdaP3-IPV Adolescents
    Number of subjects analysed
    117
    118
    115
    116
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria; Pre-vaccination
    93.2
    95.8
    95.7
    94
        Diphtheria; 1 month post-vaccination
    99.1
    99.2
    100
    100
        Diphtheria; 6 months post-vaccination
    100
    100
    100
    100
        Diphtheria; 1 year post-vaccination
    100
    100
    100
    100
        Diphtheria; 3 years post-vaccination
    100
    97.6
    100
    100
        Diphtheria; 5 years post-vaccination
    100
    94.7
    93.9
    100
        Diphtheria; 10 years post-vaccination
    100
    97.7
    100
    100
        Tetanus; Pre-vaccination
    100
    100
    100
    100
        Tetanus; 1 month post-vaccination
    100
    100
    100
    100
        Tetanus; 6 months post-vaccination
    100
    100
    100
    100
        Tetanus; 1 year post-vaccination
    100
    100
    100
    100
        Tetanus; 3 years post-vaccination
    100
    100
    100
    100
        Tetanus; 5 years post-vaccination
    100
    100
    100
    100
        Tetanus; 10 years post-vaccination
    100
    100
    100
    100
    No statistical analyses for this end point

    Other pre-specified: Percentage of Adult Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Percentage of Adult Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL® [3]
    End point description
    Anti-Diphtheria antibody responses were measured by a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured by 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. The data of TdaP/IPV Adults and TdaP/aP Adults were combined for this analysis. The collective total (N) for the analysis was 240, the cumulative data are presented for each group in the table for this outcome.
    End point type
    Other pre-specified
    End point timeframe
    Pre-vaccination, 1 and 6 months post-vaccination, and 1, 3, 5, and 10 years post-vaccination
    Notes
    [3] - 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: This endpoint is reporting data for only the adult subjects; data for adolescent subjects were reported in a separate outcome.
    End point values
    		 Td/aP Adults TdaP/IPV Adults TdaP/aP Adults TdaP1-IPV Adults TdaP2-IPV Adults TdaP3-IPV Adults
    Number of subjects analysed
    122
    126
    122
    124
    121
    121
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria; Pre-vaccination
    82.8
    77.5
    77.5
    80.6
    74.4
    76
        Diphtheria; 1 month post-vaccination
    98.4
    97.9
    97.9
    98.4
    94.2
    95.9
        Diphtheria; 6 months post-vaccination
    100
    100
    100
    100
    91.7
    90.9
        Diphtheria; 1 year post-vaccination
    100
    100
    100
    100
    81.8
    90
        Diphtheria; 3 years post-vaccination
    95.7
    89.7
    89.7
    95.8
    88.6
    90.7
        Diphtheria; 5 years post-vaccination
    81.8
    77.8
    77.8
    75
    78.6
    84.6
        Diphtheria; 10 years post-vaccination
    80
    87
    87
    80.6
    92.6
    81
        Tetanus; Pre-vaccination
    99.2
    99.2
    99.2
    98.4
    99.2
    100
        Tetanus; 1 month post-vaccination
    100
    100
    100
    100
    100
    100
        Tetanus; 6 months post-vaccination
    100
    100
    100
    100
    100
    100
        Tetanus; 1 year post-vaccination
    100
    100
    100
    100
    100
    100
        Tetanus; 3 years post-vaccination
    97.8
    100
    100
    100
    100
    100
        Tetanus; 5 years post-vaccination
    100
    100
    100
    100
    100
    100
        Tetanus; 10 years post-vaccination
    100
    100
    100
    100
    96.3
    100
    No statistical analyses for this end point

    Other pre-specified: Percentage of Adolescent Subjects with Seroprotection to Vaccine Poliovirus Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Percentage of Adolescent Subjects with Seroprotection to Vaccine Poliovirus Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL® [4]
    End point description
    Anti-Poliovirus types 1, 2, and 3 titers were measured by a neutralization assay. Seroprotection was defined as post-vaccination titers ≥ 1:8 dilutions.
    End point type
    Other pre-specified
    End point timeframe
    Pre-vaccination, 1 and 6 months post-vaccination, and 1, 3, 5, and 10 years post-vaccination
    Notes
    [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: This endpoint is reporting data for only the adolescent subjects; data for adult subjects were reported in a separate outcome.
    End point values
    		 Td-mIPV Adolescents TdaP1-IPV Adolescents TdaP2-IPV Adolescents TdaP3-IPV Adolescents
    Number of subjects analysed
    117
    116
    115
    116
    Units: Percentage of subjects
    number (not applicable)
        Poliovirus 1; Pre-vaccination
    96.6
    97.4
    95.7
    94
        Poliovirus 1; 1 month post-vaccination
    100
    99.1
    100
    100
        Poliovirus 1; 6 months post-vaccination
    100
    95.7
    100
    100
        Poliovirus 1; 1 year post-vaccination
    100
    95.2
    100
    100
        Poliovirus 1; 3 years post-vaccination
    100
    100
    100
    100
        Poliovirus 1; 5 years post-vaccination
    100
    100
    100
    100
        Poliovirus 2; Pre-vaccination
    99.1
    98.3
    97.4
    98.3
        Poliovirus 2; 1 month post-vaccination
    100
    100
    100
    100
        Poliovirus 2; 6 months post-vaccination
    100
    100
    100
    100
        Poliovirus 2; 1 year post-vaccination
    100
    100
    100
    100
        Poliovirus 2; 3 years post-vaccination
    100
    100
    100
    100
        Poliovirus 2; 5 years post-vaccination
    100
    100
    100
    100
        Poliovirus 3; Pre-vaccination
    96.6
    90.5
    89.6
    96.6
        Poliovirus 3; 1 month post-vaccination
    100
    100
    100
    100
        Poliovirus 3; 6 months post-vaccination
    100
    100
    100
    100
        Poliovirus 3; 1 year post-vaccination
    100
    95.2
    100
    100
        Poliovirus 3; 3 years post-vaccination
    100
    100
    100
    100
        Poliovirus 3; 5 years post-vaccination
    100
    94.7
    100
    100
    No statistical analyses for this end point

    Other pre-specified: Percentage of Adult Subjects with Seroprotection to Vaccine Poliovirus Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Percentage of Adult Subjects with Seroprotection to Vaccine Poliovirus Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL® [5]
    End point description
    Anti-Poliovirus types 1, 2, and 3 titers were measured by a neutralization assay. Seroprotection was defined as post-vaccination titers ≥ 1:8 dilutions. The data of TdaP/IPV Adults and TdaP/aP Adults were combined for this analysis. The collective total (N) for the analysis was 238, the cumulative data are presented for each group in the table for this outcome.
    End point type
    Other pre-specified
    End point timeframe
    Pre-vaccination, 1 and 6 months post-vaccination, and 1, 3, 5, and 10 years post-vaccination
    Notes
    [5] - 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: This endpoint is reporting data for only the adult subjects; data for adolescent subjects were reported in a separate outcome.
    End point values
    		 Td/aP Adults TdaP/IPV Adults TdaP/aP Adults TdaP1-IPV Adults TdaP2-IPV Adults TdaP3-IPV Adults
    Number of subjects analysed
    121
    126
    122
    124
    121
    121
    Units: Percentage of subjects
    number (not applicable)
        Poliovirus 1; Pre-vaccination
    99.2
    98.7
    98.7
    98.4
    99.2
    98.3
        Poliovirus 1; 1 month post-vaccination
    0
    100
    100
    100
    100
    100
        Poliovirus 1; 6 months post-vaccination
    100
    100
    100
    100
    100
    100
        Poliovirus 1; 1 year post-vaccination
    100
    100
    100
    100
    100
    100
        Poliovirus 1; 3 years post-vaccination
    97.8
    100
    100
    100
    100
    100
        Poliovirus 1; 5 years post-vaccination
    100
    98.8
    98.8
    100
    100
    100
        Poliovirus 2; Pre-vaccination
    99.2
    99.6
    99.6
    100
    99.2
    100
        Poliovirus 2; 1 month post-vaccination
    0
    100
    100
    100
    100
    100
        Poliovirus 2; 6 months post-vaccination
    100
    100
    100
    100
    100
    100
        Poliovirus 2; 1 year post-vaccination
    100
    100
    100
    100
    100
    100
        Poliovirus 2; 3 years post-vaccination
    100
    100
    100
    100
    100
    100
        Poliovirus 2; 5 years post-vaccination
    97.7
    98.8
    98.8
    100
    100
    100
        Poliovirus 3; Pre-vaccination
    98.3
    98.7
    98.7
    99.2
    100
    97.5
        Poliovirus 3; 1 month post-vaccination
    0
    100
    100
    100
    100
    100
        Poliovirus 3; 6 months post-vaccination
    100
    100
    100
    100
    100
    100
        Poliovirus 3; 1 year post-vaccination
    100
    100
    100
    100
    100
    100
        Poliovirus 3; 3 years post-vaccination
    97.8
    100
    100
    100
    100
    100
        Poliovirus 3; 5 years post-vaccination
    97.7
    100
    100
    100
    100
    100
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers of Antibodies for Diphtheria, Tetanus, Pertussis and Poliovirus Antibodies in Adolescents After Td-mIPV, or Tdap-vIPV, or Td, or aP or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL

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    End point title
    		 Geometric Mean Titers of Antibodies for Diphtheria, Tetanus, Pertussis and Poliovirus Antibodies in Adolescents After Td-mIPV, or Tdap-vIPV, or Td, or aP or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL [6]
    End point description
    Anti-Diphtheria antibody responses were measured by a micrometabolic inhibition test. Anti-Tetanus and Anti-Pertussis (Pertussis Toxoid, Filamentous hemagglutinin, Pertactin, and Fimbriae types 2 and 3) antibody responses were measured by an enzyme-linked immunosorbent assay (ELISA). Anti-Poliovirus types 1, 2, and 3 titers were measured by a neutralization assay.
    End point type
    Other pre-specified
    End point timeframe
    Pre-vaccination, 1 and 6 months post-vaccination, and 1, 3, 5, and 10 years post-vaccination
    Notes
    [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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Td-mIPV Adolescents TdaP1-IPV Adolescents TdaP2-IPV Adolescents TdaP3-IPV Adolescents
    Number of subjects analysed
    117
    118
    117
    116
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Diphtheria; Pre-vaccination
    0.18 (0.13 to 0.24)
    0.11 (0.08 to 0.14)
    0.11 (0.08 to 0.14)
    0.11 (0.08 to 0.15)
        Diphtheria; 1 month post-vaccination
    3.56 (2.77 to 4.58)
    1.96 (1.48 to 2.59)
    1.97 (1.53 to 2.55)
    1.94 (1.55 to 2.44)
        Diphtheria; 6 months post-vaccination
    0.66 (0.34 to 1.31)
    0.74 (0.43 to 1.3)
    0.49 (0.22 to 1.07)
    0.33 (0.15 to 0.7)
        Diphtheria; 1 year post-vaccination
    0.43 (0.22 to 0.83)
    0.58 (0.31 to 1.07)
    0.31 (0.15 to 0.66)
    0.22 (0.11 to 0.46)
        Diphtheria; 3 years post-vaccination
    0.62 (0.36 to 1.07)
    0.5 (0.26 to 0.96)
    0.74 (0.4 to 1.36)
    0.91 (0.49 to 1.68)
        Diphtheria; 5 years post-vaccination
    0.6 (0.37 to 0.99)
    0.26 (0.14 to 0.49)
    0.31 (0.16 to 0.61)
    0.46 (0.27 to 0.8)
        Diphtheria; 10 years post-vaccination
    0.21 (0.12 to 0.35)
    0.22 (0.13 to 0.36)
    0.2 (0.11 to 0.37)
    0.26 (0.17 to 0.4)
        Tetanus; Pre-vaccination
    0.64 (0.53 to 0.78)
    0.7 (0.57 to 0.87)
    0.61 (0.49 to 0.75)
    0.59 (0.48 to 0.72)
        Tetanus; 1 month post-vaccination
    18.28 (15.44 to 21.64)
    20.07 (17.04 to 23.63)
    16.2 (13.67 to 19.2)
    17.61 (14.82 to 20.93)
        Tetanus; 6 months post-vaccination
    9.72 (5.78 to 16.35)
    6.89 (4.73 to 10.04)
    7.95 (5.4 to 11.71)
    4.24 (2.62 to 6.89)
        Tetanus; 1 year post-vaccination
    5.3 (2.86 to 9.84)
    4.38 (3.06 to 6.28)
    4.45 (2.98 to 6.65)
    2.95 (1.86 to 4.66)
        Tetanus; 3 years post-vaccination
    2.65 (1.91 to 3.68)
    2.14 (1.54 to 2.96)
    2.22 (1.65 to 2.98)
    3.53 (2.8 to 4.44)
        Tetanus; 5 years post-vaccination
    2.08 (1.4 to 3.09)
    1.44 (1.04 to 1.99)
    1.49 (1.12 to 1.98)
    2.46 (1.89 to 3.2)
        Tetanus; 10 years post-vaccination
    1.41 (0.93 to 2.15)
    0.99 (0.65 to 1.53)
    1.28 (0.93 to 1.77)
    1.52 (1.07 to 2.16)
        Pertussis toxoid; Pre-vaccination
    11.98 (9.4 to 15.26)
    10.07 (7.95 to 12.76)
    14.24 (11.25 to 18.03)
    12.42 (9.85 to 15.66)
        Pertussis toxoid; 1 month post-vaccination
    350.95 (304.91 to 403.95)
    173.06 (143.65 to 208.5)
    185.84 (153.64 to 224.79)
    143.63 (121.11 to 170.34)
        Pertussis toxoid; 6 months post-vaccination
    157.43 (104.66 to 236.81)
    82.63 (52.98 to 128.87)
    115.7 (67.19 to 199.25)
    71.51 (46.7 to 109.49)
        Pertussis toxoid; 1 year post-vaccination
    140.16 (91.83 to 213.92)
    83.93 (56.56 to 124.56)
    100.17 (59.44 to 168.8)
    74.16 (50.03 to 109.92)
        Pertussis toxoid; 3 years post-vaccination
    76.71 (55.54 to 105.94)
    55.14 (41.14 to 73.91)
    56.51 (38.94 to 82)
    56.49 (42.35 to 75.36)
        Pertussis toxoid; 5 years post-vaccination
    74.28 (51.17 to 107.82)
    53.45 (39.66 to 72.03)
    53.06 (39.33 to 71.58)
    57.08 (43.87 to 74.27)
        Pertussis toxoid; 10 years post-vaccination
    18.07 (9.78 to 33.41)
    14.35 (10.72 to 19.22)
    21.81 (12.24 to 38.87)
    16.83 (10.58 to 26.75)
        Filamentous hemagglutinin; Pre-vaccination
    26.71 (21.31 to 33.48)
    23.8 (18.46 to 30.7)
    25.79 (20.07 to 33.13)
    23.29 (18.65 to 29.08)
        Filamentous hemagglutinin;1 month post-vaccination
    432.06 (374.55 to 498.39)
    252.42 (210.17 to 303.16)
    215.7 (183.85 to 253.07)
    269.75 (231.03 to 314.96)
        Filamentous hemagglutinin;6 month post-vaccination
    189.05 (109.33 to 326.88)
    91.7 (64.03 to 131.32)
    164.35 (110.83 to 243.72)
    123.22 (84.58 to 179.51)
        Filamentous hemagglutinin; 1 year post-vaccination
    139.45 (100.09 to 194.28)
    85.2 (64.08 to 113.28)
    125.14 (93.06 to 168.28)
    92.37 (63.62 to 134.13)
        Filamentous hemagglutinin;3 years post-vaccination
    77.49 (60.22 to 99.72)
    71.5 (52.4 to 97.56)
    57.86 (44.36 to 75.47)
    66.92 (48.83 to 91.71)
        Filamentous hemagglutinin;5 years post-vaccination
    60.37 (46.27 to 78.77)
    57.54 (42.83 to 77.31)
    45.9 (35.45 to 59.43)
    55.07 (40.89 to 74.17)
        Filamentous hemagglutinin;10 year post-vaccination
    43.53 (28.47 to 66.54)
    30.26 (21.85 to 41.89)
    34.5 (23.45 to 50.76)
    30.26 (20.83 to 43.98)
        Pertactin; Pre-vaccination
    5.47 (4 to 7.49)
    5.24 (3.85 to 7.14)
    5.5 (3.93 to 7.68)
    4.87 (3.64 to 6.51)
        Pertactin; 1 month post-vaccination
    189.64 (153.92 to 233.63)
    272.33 (208.06 to 356.44)
    258.67 (194.65 to 343.74)
    203.11 (157.08 to 262.63)
        Pertactin; 6 months post-vaccination
    94.58 (52.03 to 171.92)
    130.67 (72.22 to 236.44)
    185 (106.53 to 321.25)
    106.78 (61.19 to 186.36)
        Pertactin; 1 year post-vaccination
    87.97 (51.1 to 151.46)
    123.26 (72.5 to 209.55)
    138.29 (81.9 to 233.52)
    85.29 (57.54 to 126.43)
        Pertactin; 3 years post-vaccination
    53.13 (37.43 to 75.43)
    52.15 (33.65 to 80.82)
    51.12 (30.69 to 85.13)
    47.68 (30.71 to 74.02)
        Pertactin; 5 years post-vaccination
    48.76 (33.7 to 70.55)
    42.26 (28.33 to 63.05)
    41.73 (27.38 to 63.61)
    42.66 (28.06 to 64.85)
        Pertactin; 10 years post-vaccination
    22.55 (14.89 to 34.16)
    27.43 (17.45 to 43.11)
    28.9 (15.87 to 52.62)
    28.95 (17.84 to 46.98)
        Fimbriae; Pre-vaccination
    43.88 (34.39 to 55.99)
    30.95 (22.93 to 41.78)
    47.86 (35.87 to 63.87)
    38.26 (29.78 to 49.16)
        Fimbriae; 1 month post-vaccination
    2997.39 (2471.45 to 3635.27)
    1374.6 (1094.61 to 1726.2)
    1178.17 (969.28 to 1432.07)
    1026.2 (846.52 to 1244.02)
        Fimbriae; 6 months post-vaccination
    1403.36 (861.19 to 2286.86)
    521.86 (332.36 to 819.38)
    416.44 (246.89 to 702.43)
    441.87 (273.54 to 713.79)
        Fimbriae; 1 year post-vaccination
    1002.54 (607.77 to 1653.73)
    510.41 (318.77 to 817.29)
    318.22 (187.89 to 538.96)
    376.78 (224.94 to 631.12)
        Fimbriae; 3 years post-vaccination
    449.39 (318.4 to 634.26)
    215.63 (155.37 to 299.26)
    252.82 (174.14 to 367.07)
    219.77 (170.49 to 283.3)
        Fimbriae; 5 years post-vaccination
    361.33 (232.47 to 561.64)
    197.84 (137.21 to 285.26)
    218.1 (159.44 to 298.34)
    211.77 (163.87 to 273.67)
        Fimbriae; 10 years post-vaccination
    228.26 (121.34 to 429.38)
    128.82 (98.91 to 167.79)
    179.95 (109.46 to 295.83)
    106.58 (82.8 to 137.2)
        Poliovirus 1; Pre-vaccination
    84.55 (64.2 to 111.35)
    128 (95.3 to 171.93)
    93.56 (68.43 to 127.92)
    122.03 (88.83 to 167.63)
        Poliovirus 1; 1 month post-vaccination
    18336.02 (13812.49 to 24340.99)
    13055.9 (9656.92 to 17651.23)
    12416.75 (9811.5 to 15713.78)
    18244.48 (14064.25 to 23667.17)
        Poliovirus 1; 6 months post-vaccination
    8466.91 (4109.86 to 17443.04)
    3856.41 (1469.86 to 10117.92)
    1845.76 (931.05 to 3659.11)
    2686.11 (1312.92 to 5495.54)
        Poliovirus 1; 1 year post-vaccination
    7342.75 (3232.91 to 16677.26)
    3145.44 (984.75 to 10047.06)
    1024 (429.9 to 2439.11)
    1303.18 (737.89 to 2301.56)
        Poliovirus 1; 3 years post-vaccination
    2639.14 (1664.56 to 4184.33)
    1342.07 (907.75 to 1984.19)
    1762.96 (1180.81 to 2632.1)
    2702.35 (1882.91 to 3878.41)
        Poliovirus 1; 5 years post-vaccination
    3071.67 (2004.91 to 4706.02)
    1657.77 (1211.07 to 2269.24)
    1767.97 (1232.73 to 2535.62)
    2901.46 (2073.62 to 4059.79)
        Poliovirus 1; 10 years post-vaccination
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poliovirus 2; Pre-vaccination
    152.9 (126.24 to 185.18)
    246.98 (187.38 to 325.54)
    209.83 (156.9 to 280.61)
    245.51 (177.04 to 340.47)
        Poliovirus 2; 1 month post-vaccination
    27924.25 (22493.75 to 34665.79)
    31238.43 (24053.34 to 40569.83)
    35868.62 (27819.46 to 46246.7)
    45950.77 (35136.01 to 60094.27)
        Poliovirus 2; 6 months post-vaccination
    12173.27 (6348.64 to 23341.74)
    3974.4 (1902.2 to 8304)
    4544.8 (2154.82 to 9585.56)
    5372.23 (3039 to 9496.81)
        Poliovirus 2; 1 year post-vaccination
    7342.75 (3790.18 to 14225.17)
    3709.84 (1984.99 to 6933.49)
    2194.99 (1020.88 to 4719.43)
    3974.4 (2160.65 to 7310.71)
        Poliovirus 2; 3 years post-vaccination
    8914.58 (5899.7 to 13470.14)
    4382.57 (2870.58 to 6690.96)
    5033.33 (3202.86 to 7909.94)
    8051.27 (6047.82 to 10718.39)
        Poliovirus 2; 5 years post-vaccination
    4592.47 (3049.45 to 6916.26)
    3304.91 (2201.29 to 4961.84)
    2984.06 (1989.15 to 4476.61)
    4749.27 (3310.9 to 6812.51)
        Poliovirus 2; 10 years post-vaccination
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poliovirus 3; Pre-vaccination
    40.32 (31.7 to 51.27)
    47.76 (34.7 to 65.73)
    47.63 (34.56 to 65.66)
    65.16 (49.32 to 86.08)
        Poliovirus 3; 1 month post-vaccination
    37551.46 (28146.46 to 50099.08)
    53807.41 (36689.54 to 78911.78)
    57286.05 (39802.05 to 82450.31)
    57120.62 (40030.6 to 81506.79)
        Poliovirus 3; 6 months post-vaccination
    8921.64 (4292.5 to 18542.96)
    3630.84 (1243.15 to 10604.52)
    4389.98 (1486.2 to 12967.31)
    7712.82 (3197.67 to 18603.43)
        Poliovirus 3; 1 year post-vaccination
    5484.15 (2292.97 to 13116.57)
    2415.48 (764.64 to 7630.48)
    3565.78 (1227.87 to 10355.09)
    4221.32 (2020.38 to 8819.91)
        Poliovirus 3; 3 years post-vaccination
    4236.86 (2750.81 to 6525.73)
    2970.7 (1799.06 to 4905.35)
    3945.37 (2439.09 to 6381.89)
    3444.31 (2006.98 to 5911.01)
        Poliovirus 3; 5 years post-vaccination
    2249.11 (1597.69 to 3166.13)
    1152.9 (574.32 to 2314.35)
    2190.84 (1509.2 to 3180.35)
    1433.84 (932.95 to 2203.65)
        Poliovirus 3; 10 years post-vaccination
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers for Diphtheria, Tetanus, and Poliovirus Antibodies in Adults After Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL

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    End point title
    		 Geometric Mean Titers for Diphtheria, Tetanus, and Poliovirus Antibodies in Adults After Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL [7]
    End point description
    Anti-Diphtheria antibody responses were measured by a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured by an enzyme-linked immunosorbent assay (ELISA). Anti-Poliovirus types 1, 2, and 3 titers were measured by a neutralization assay. The data of TdaP/IPV Adults and TdaP/aP Adults were combined for this analysis. The collective total (N) for the analysis was 240, the cumulative data are presented for each group in the table for this outcome. Data was not collected for Td/aP Adults for Poliovirus 1, 2, and 3 at 1 month post-vaccination or for any of the groups for Poliovirus 1, 2, and 3 at 10 years post-vaccination.
    End point type
    Other pre-specified
    End point timeframe
    Pre-vaccination, 1 and 6 months post-vaccination, and 1, 3, 5, and 10 years post-vaccination
    Notes
    [7] - 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: This endpoint is reporting data for only the adult subjects; data for adolescent subjects were reported in a separate outcome.
    End point values
    		 Td/aP Adults TdaP/IPV Adults TdaP/aP Adults TdaP1-IPV Adults TdaP2-IPV Adults TdaP3-IPV Adults
    Number of subjects analysed
    126
    126
    122
    126
    121
    125
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Diphtheria; Pre-vaccination
    0.05 (0.04 to 0.07)
    0.04 (0.04 to 0.06)
    0.04 (0.04 to 0.06)
    0.05 (0.03 to 0.06)
    0.04 (0.03 to 0.05)
    0.05 (0.03 to 0.07)
        Diphtheria; 1 month post-vaccination
    0.95 (0.71 to 1.28)
    0.75 (0.6 to 0.95)
    0.75 (0.6 to 0.95)
    0.58 (0.44 to 0.77)
    0.4 (0.28 to 0.57)
    0.45 (0.32 to 0.63)
        Diphtheria; 6 months post-vaccination
    0.4 (0.2 to 0.82)
    0.54 (0.31 to 0.93)
    0.54 (0.31 to 0.93)
    0.38 (0.18 to 0.81)
    0.23 (0.05 to 1.1)
    0.22 (0.06 to 0.87)
        Diphtheria; 1 year post-vaccination
    0.23 (0.12 to 0.44)
    0.34 (0.19 to 0.6)
    0.34 (0.19 to 0.6)
    0.32 (0.14 to 0.74)
    0.11 (0.02 to 0.56)
    0.15 (0.03 to 0.7)
        Diphtheria; 3 years post-vaccination
    0.15 (0.09 to 0.25)
    0.1 (0.06 to 0.14)
    0.1 (0.06 to 0.14)
    0.11 (0.07 to 0.19)
    0.1 (0.05 to 0.18)
    0.12 (0.07 to 0.22)
        Diphtheria; 5 years post-vaccination
    0.06 (0.03 to 0.1)
    0.04 (0.03 to 0.07)
    0.04 (0.03 to 0.07)
    0.03 (0.02 to 0.06)
    0.04 (0.02 to 0.08)
    0.06 (0.03 to 0.13)
        Diphtheria; 10 years post-vaccination
    0.04 (0.02 to 0.08)
    0.05 (0.03 to 0.09)
    0.05 (0.03 to 0.09)
    0.05 (0.02 to 0.1)
    0.07 (0.04 to 0.12)
    0.06 (0.02 to 0.18)
        Tetanus; Pre-vaccination
    1.14 (0.91 to 1.43)
    1.1 (0.94 to 1.29)
    1.1 (0.94 to 1.29)
    1.1 (0.88 to 1.39)
    1.02 (0.81 to 1.28)
    1.12 (0.9 to 1.39)
        Tetanus; 1 month post-vaccination
    15.24 (12.76 to 18.21)
    16.59 (14.88 to 18.49)
    16.59 (14.88 to 18.49)
    12.83 (11.06 to 14.88)
    12.08 (10.21 to 14.29)
    10.89 (9.62 to 12.34)
        Tetanus; 6 months post-vaccination
    6.19 (4.39 to 8.74)
    7.33 (5.55 to 9.68)
    7.33 (5.55 to 9.68)
    4.32 (2.84 to 6.57)
    3.51 (1.84 to 6.68)
    4.21 (2.41 to 7.34)
        Tetanus; 1 year post-vaccination
    4.59 (2.96 to 7.12)
    4.3 (2.99 to 6.17)
    4.3 (2.99 to 6.17)
    3.25 (2.28 to 4.63)
    2.79 (1.37 to 5.66)
    3.26 (1.76 to 6.06)
        Tetanus; 3 years post-vaccination
    2.25 (1.44 to 3.52)
    2.54 (2.08 to 3.11)
    2.54 (2.08 to 3.11)
    2.57 (1.94 to 3.4)
    2.2 (1.46 to 3.3)
    2.27 (1.71 to 3.01)
        Tetanus; 5 years post-vaccination
    2.16 (1.55 to 2.99)
    1.94 (1.5 to 2.51)
    1.94 (1.5 to 2.51)
    1.87 (1.42 to 2.46)
    1.97 (1.38 to 2.83)
    2.02 (1.44 to 2.83)
        Tetanus; 10 years post-vaccination
    1.45 (0.96 to 2.19)
    1.61 (1.28 to 2.03)
    1.61 (1.28 to 2.03)
    1.51 (1 to 2.29)
    1.46 (0.75 to 2.83)
    1.3 (0.61 to 2.76)
        Poliovirus 1; Pre-vaccination
    325.63 (245.26 to 432.35)
    316.65 (258.22 to 388.29)
    316.65 (258.22 to 388.29)
    350.1 (258.22 to 474.66)
    333.18 (243.68 to 455.56)
    416.59 (315.96 to 549.26)
        Poliovirus 1; 1 month post-vaccination
    0 (0 to 0)
    6427.31 (5063.35 to 8158.69)
    6427.31 (5063.35 to 8158.69)
    9315.93 (7201.87 to 12050.56)
    8774.94 (6716.74 to 11463.82)
    7960.69 (6105.39 to 10379.78)
        Poliovirus 1; 6 months post-vaccination
    3649.12 (1308.37 to 10177.6)
    3104.19 (1682.38 to 5727.57)
    3104.19 (1682.38 to 5727.57)
    5160.64 (1690.13 to 15757.46)
    3068.53 (1312.34 to 7174.89)
    2896.31 (961.2 to 8727.24)
        Poliovirus 1; 1 year post-vaccination
    2048 (848.79 to 4941.52)
    3122.95 (1526.44 to 6389.27)
    3122.95 (1526.44 to 6389.27)
    3611 (1056.71 to 12339.52)
    2474.17 (1046 to 5852.31)
    4096 (1243.76 to 13489.08)
        Poliovirus 1; 3 years post-vaccination
    1104.13 (669.1 to 1822.01)
    1198.71 (909.52 to 1579.86)
    1198.71 (909.52 to 1579.86)
    1933.05 (1295.72 to 2883.87)
    1642.66 (1070.48 to 2520.68)
    1805.5 (1166.8 to 2793.82)
        Poliovirus 1; 5 years post-vaccination
    1057.68 (705.07 to 1586.63)
    1026.41 (767.42 to 1372.82)
    1026.41 (767.42 to 1372.82)
    1690.74 (1165.31 to 2453.09)
    1483.77 (1062.04 to 2072.97)
    1259.77 (863.81 to 1837.23)
        Poliovirus 2; Pre-vaccination
    414.21 (322.6 to 531.83)
    432.17 (357.11 to 520.58)
    432.17 (357.11 to 520.58)
    440.27 (333.35 to 581.5)
    433.63 (325.66 to 577.4)
    402.51 (303.86 to 533.19)
        Poliovirus 2; 1 month post-vaccination
    0 (0 to 0)
    14428.83 (10223.31 to 20364.35)
    14428.83 (10223.31 to 20364.35)
    16475.84 (12303.16 to 22063.71)
    17449.63 (12865.7 to 23666.77)
    16012.85 (12413.14 to 20656.44)
        Poliovirus 2; 6 months post-vaccination
    1722.16 (636.15 to 4662.16)
    6562.36 (3309.05 to 13014.21)
    6562.36 (3309.05 to 13014.21)
    5792.62 (2701.43 to 12420.99)
    3251 (1155.69 to 9145.15)
    3649.12 (1548.6 to 8598.8)
        Poliovirus 2; 1 year post-vaccination
    1217.75 (586.65 to 2527.76)
    4350.47 (2124.32 to 8909.49)
    4350.47 (2124.32 to 8909.49)
    5612.96 (2549.3 to 12358.39)
    2048 (608.09 to 6897.53)
    5042.77 (1641.71 to 15489.67)
        Poliovirus 2; 3 years post-vaccination
    2345.46 (1404.56 to 3916.64)
    3337.48 (2451.11 to 4544.38)
    3337.48 (2451.11 to 4544.38)
    1961.17 (1380.85 to 2785.38)
    2323.07 (1519.39 to 3551.85)
    2359.96 (1538.64 to 3619.7)
        Poliovirus 2; 5 years post-vaccination
    1307 (788.25 to 2167.14)
    1428.7 (1016.3 to 2008.45)
    1428.7 (1016.3 to 2008.45)
    1149.83 (795.27 to 1662.48)
    1168.54 (802.22 to 1702.15)
    1146.14 (723.98 to 1814.47)
        Poliovirus 3; Pre-vaccination
    229.6 (169.28 to 311.4)
    190.76 (154.85 to 235.01)
    190.76 (154.85 to 235.01)
    239.39 (174.47 to 328.47)
    260.44 (187.7 to 361.36)
    256 (175.95 to 372.47)
        Poliovirus 3; 1 month post-vaccination
    0 (0 to 0)
    43237.64 (31201.8 to 59916.2)
    43237.64 (31201.8 to 59916.2)
    68917.4 (52375.57 to 90683.66)
    48653.23 (35443.25 to 66786.67)
    65912.5 (47693.21 to 91091.74)
        Poliovirus 3; 6 months post-vaccination
    5467.5 (973.38 to 30711.21)
    9152.82 (4204.96 to 19922.67)
    9152.82 (4204.96 to 19922.67)
    16384 (7916.91 to 33906.6)
    9741.98 (3305.66 to 28710.21)
    6501.99 (2731.22 to 15478.78)
        Poliovirus 3; 1 year post-vaccination
    3774.53 (849.34 to 16774.21)
    6437.01 (2672.5 to 15504.22)
    6437.01 (2672.5 to 15504.22)
    12733.7 (7893.64 to 20541.47)
    8724.82 (3325.35 to 22891.57)
    5042.77 (1920.88 to 13238.45)
        Poliovirus 3; 3 years post-vaccination
    2896.31 (1385.48 to 6054.66)
    3208.6 (2180.34 to 4721.78)
    3208.6 (2180.34 to 4721.78)
    4216.02 (2868.98 to 6195.52)
    3036.48 (1844.13 to 4999.74)
    3726.58 (2203.82 to 6301.52)
        Poliovirus 3; 5 years post-vaccination
    1907.77 (988.71 to 3681.15)
    2081.67 (1503.43 to 2882.31)
    2081.67 (1503.43 to 2882.31)
    3104.18 (2092.54 to 4604.89)
    1829.52 (1209.08 to 2768.35)
    2252.73 (1395.48 to 3636.59)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Adolescents Subjects with Pertussis ≥ 1xLLOQ Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Percentage of Adolescents Subjects with Pertussis ≥ 1xLLOQ Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL® [8]
    End point description
    Anti-Pertussis (Pertussis Toxoid, Filamentous hemagglutinin, Pertactin, and Fimbriae types 2 and 3) antibody responses were measured by an enzyme-linked immunosorbent assay (ELISA). Subjects with Pertussis titers ≥ LLOQ defined as 5 EU/mL for Pertussis toxoid, 3 EU/mL for Filamentous hemagglutinin and Pertactin, and 17 EU/mL for Fimbriae types 2 and 3 for all time points, except for 10 year post-vaccination; 4 EU/mL for Pertussis toxoid, Fimbriae types 2 and 3, and Pertactin and 3 EU/mL for Filamentous hemagglutinin for 10 year post-vaccination.
    End point type
    Other pre-specified
    End point timeframe
    Pre-vaccination, 1 and 6 months post-vaccination, and 1, 3, 5, and 10 years post-vaccination
    Notes
    [8] - 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: This endpoint is reporting data for only the adolescent subjects; data for adult subjects were reported in a separate outcome.
    End point values
    		 Td-mIPV Adolescents TdaP1-IPV Adolescents TdaP2-IPV Adolescents TdaP3-IPV Adolescents
    Number of subjects analysed
    117
    118
    117
    116
    Units: Percentage of subjects
    number (not applicable)
        Pertussis toxoid; Pre-vaccination
    75.9
    70.1
    79.1
    74.1
        Pertussis toxoid; 1 month post-vaccination
    100
    99.1
    100
    99.1
        Pertussis toxoid; 6 months post-vaccination
    100
    100
    100
    95.7
        Pertussis toxoid; 1 year post-vaccination
    100
    100
    100
    95.7
        Pertussis toxoid; 3 years post-vaccination
    100
    97.5
    94.6
    97.5
        Pertussis toxoid; 5 years post-vaccination
    100
    97.3
    100
    100
        Pertussis toxoid; 10 years post-vaccination
    85.7
    89.7
    88
    84.8
        Filamentous hemagglutinin; Pre-vaccination
    96.6
    93.2
    93.9
    94
        Filamentous hemagglutinin;1 month post-vaccination
    100
    100
    100
    100
        Filamentous hemagglutinin;6 month post-vaccination
    100
    100
    100
    100
        Filamentous hemagglutinin; 1 year post-vaccination
    100
    100
    100
    100
        Filamentous hemagglutinin;3 years post-vaccination
    100
    97.5
    100
    100
        Filamentous hemagglutinin;5 years post-vaccination
    100
    97.3
    100
    100
        Filamentous hemagglutinin;10 year post-vaccination
    100
    97.6
    96.7
    100
        Pertactin; Pre-vaccination
    62.4
    62.7
    59.1
    56
        Pertactin; 1 month post-vaccination
    100
    99.2
    100
    100
        Pertactin; 6 months post-vaccination
    100
    100
    100
    100
        Pertactin; 1 year post-vaccination
    100
    100
    100
    100
        Pertactin; 3 years post-vaccination
    100
    100
    100
    97.5
        Pertactin; 5 years post-vaccination
    100
    100
    100
    100
        Pertactin; 10 years post-vaccination
    96.3
    88.1
    83.3
    94.3
        Fimbriae; Pre-vaccination
    79.5
    66.9
    78.3
    76.7
        Fimbriae; 1 month post-vaccination
    100
    100
    100
    100
        Fimbriae; 6 months post-vaccination
    100
    100
    100
    100
        Fimbriae; 1 year post-vaccination
    100
    100
    100
    95.7
        Fimbriae; 3 years post-vaccination
    100
    97.5
    97.3
    100
        Fimbriae; 5 years post-vaccination
    97.1
    94.6
    100
    100
        Fimbriae; 10 years post-vaccination
    96.3
    100
    100
    100
    No statistical analyses for this end point

    Other pre-specified: Percentage of Adult Subjects with Pertussis ≥ 1xLLOQ Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Percentage of Adult Subjects with Pertussis ≥ 1xLLOQ Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL® [9]
    End point description
    Anti-Pertussis (Pertussis Toxoid, Filamentous hemagglutinin, Pertactin, and Fimbriae types 2 and 3) antibody responses were measured by an enzyme-linked immunosorbent assay (ELISA). Subjects with Pertussis titers ≥ LLOQ defined as 5 EU/mL for Pertussis toxoid, 3 EU/mL for Filamentous hemagglutinin and Pertactin, and 17 EU/mL for Fimbriae types 2 and 3 for all time points, except for 10 year post-vaccination; 4 EU/mL for Pertussis toxoid, Fimbriae types 2 and 3, and Pertactin and 3 EU/mL for Filamentous hemagglutinin for 10 year post-vaccination. The data of TdaP/IPV Adults and TdaP/aP Adults were combined for this analysis. The collective total (N) for the analysis was 55 at year 10, the cumulative data are presented for each group in the table for this outcome.
    End point type
    Other pre-specified
    End point timeframe
    10 years post-vaccination
    Notes
    [9] - 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: This endpoint is reporting data for only the adult subjects; data for adolescent subjects were reported in a separate outcome.
    End point values
    		 Td/aP Adults TdaP/IPV Adults TdaP/aP Adults TdaP1-IPV Adults TdaP2-IPV Adults TdaP3-IPV Adults
    Number of subjects analysed
    30
    55
    55
    31
    27
    21
    Units: Percentage of subjects
    number (not applicable)
        Pertussis toxoid; 10 years post-vaccination
    100
    89.6
    89.6
    88.5
    95.2
    90
        Filamentous hemagglutinin;10 year post-vaccination
    100
    100
    100
    100
    100
    100
        Pertactin; 10 years post-vaccination
    86.7
    98.2
    98.2
    93.5
    92.6
    95.2
        Fimbriae; 10 years post-vaccination
    100
    100
    100
    96.8
    100
    100
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers for Pertussis Antibodies in Adult Subjects Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL®

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    End point title
    		 Summary of Geometric Mean Titers for Pertussis Antibodies in Adult Subjects Following Vaccination with Td-mIPV, or Tdap-vIPV, or Td, or aP, or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) - ADACEL® [10]
    End point description
    Anti-Pertussis (Pertussis Toxoid, Filamentous hemagglutinin, Pertactin, and Fimbriae types 2 and 3) antibody responses were measured by an enzyme-linked immunosorbent assay (ELISA).
    End point type
    Other pre-specified
    End point timeframe
    Pre-vaccination, 1 and 6 months post-vaccination, and 1, 3, 5, and 10 years post-vaccination
    Notes
    [10] - 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: This endpoint is reporting data for only the adult subjects; data for adolescent subjects were reported in a separate outcome.
    End point values
    		 Td/aP Adults TdaP/IPV Adults TdaP/aP Adults TdaP1-IPV Adults TdaP2-IPV Adults TdaP3-IPV Adults
    Number of subjects analysed
    126
    126
    122
    126
    121
    125
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis toxoid; Pre-vaccination
    11.21 (8.88 to 14.15)
    11.86 (9.46 to 14.86)
    10.05 (8.19 to 12.32)
    9.71 (7.76 to 12.15)
    10.66 (8.59 to 13.24)
    10.1 (8.03 to 12.7)
        Pertussis toxoid; 1 month post-vaccination
    170.87 (143.34 to 203.7)
    124.53 (102.13 to 151.85)
    137.89 (114.51 to 166.04)
    124.9 (104 to 150)
    123.01 (104.01 to 145.47)
    92.46 (77.88 to 109.76)
        Pertussis toxoid; 6 months post-vaccination
    55.84 (30.26 to 103.05)
    30.68 (18.1 to 52)
    90.95 (67.62 to 122.31)
    49.51 (23.87 to 102.7)
    80.29 (47.71 to 135.13)
    58.37 (37.48 to 90.88)
        Pertussis toxoid; 1 year post-vaccination
    51.57 (27.66 to 96.16)
    31.36 (15.45 to 63.65)
    97.81 (69.37 to 137.91)
    67.89 (41.95 to 109.87)
    82.3 (50 to 135.45)
    72.45 (42.91 to 122.32)
        Pertussis toxoid; 3 years post-vaccination
    45.51 (35.99 to 57.55)
    39.29 (28.92 to 53.37)
    63.42 (47.18 to 85.25)
    42.09 (34.04 to 52.06)
    43.21 (29.39 to 63.54)
    36.18 (26.36 to 49.66)
        Pertussis toxoid; 5 years post-vaccination
    47.49 (37.44 to 60.22)
    45.42 (34.28 to 60.2)
    56.16 (42.86 to 73.58)
    43.9 (34.51 to 55.85)
    40.76 (30.26 to 54.9)
    34.62 (24.77 to 48.37)
        Pertussis toxoid; 10 years post-vaccination
    18.19 (13.93 to 23.75)
    12.24 (7.89 to 18.98)
    25.86 (15.23 to 43.9)
    17.49 (11.07 to 27.64)
    21.51 (12.99 to 35.62)
    14.18 (8.46 to 23.76)
        Filamentous hemagglutinin; Pre-vaccination
    21.34 (16.74 to 27.2)
    21.04 (16.76 to 26.42)
    21.43 (17.51 to 26.24)
    22.62 (17.96 to 28.49)
    19.57 (16.01 to 23.92)
    18.95 (15.39 to 23.33)
        Filamentous hemagglutinin;1 month post-vaccination
    385.08 (326.51 to 454.15)
    360.16 (305.34 to 424.81)
    333.39 (283.49 to 392.09)
    246.8 (212.16 to 287.1)
    221.21 (185.99 to 263.1)
    246.88 (207.89 to 293.19)
        Filamentous hemagglutinin;6 month post-vaccination
    147.85 (70.64 to 309.43)
    62.71 (44.88 to 87.62)
    166.74 (110.67 to 251.22)
    70.2 (47.16 to 104.49)
    81.15 (63.32 to 104)
    83.69 (54.78 to 127.86)
        Filamentous hemagglutinin; 1 year post-vaccination
    120.35 (64.97 to 222.94)
    63.61 (41.91 to 96.54)
    148.02 (114.19 to 191.87)
    82.93 (55.71 to 123.44)
    92.25 (71.97 to 118.25)
    105.13 (74.35 to 148.64)
        Filamentous hemagglutinin;3 years post-vaccination
    67.17 (52.28 to 86.29)
    71.68 (58.25 to 88.21)
    87.03 (67.77 to 111.76)
    55.21 (42.94 to 70.98)
    58.61 (44.75 to 76.76)
    64.52 (49.36 to 84.32)
        Filamentous hemagglutinin;5 years post-vaccination
    55.71 (44.27 to 70.1)
    62.04 (51.53 to 74.69)
    70.85 (56.16 to 89.37)
    46.46 (36.42 to 59.28)
    55.01 (43.08 to 70.24)
    60.43 (47.39 to 77.07)
        Filamentous hemagglutinin;10 year post-vaccination
    44.12 (31.97 to 60.89)
    33.33 (25.21 to 44.07)
    59.23 (41.51 to 84.52)
    33.17 (23.28 to 47.26)
    36.38 (24.81 to 53.35)
    42.49 (28.1 to 64.26)
        Pertactin; Pre-vaccination
    5.49 (4.11 to 7.34)
    5.77 (4.15 to 8.03)
    4.26 (3.19 to 5.7)
    4.81 (3.51 to 6.61)
    4.16 (3 to 5.78)
    4.96 (3.67 to 6.71)
        Pertactin; 1 month post-vaccination
    187.19 (137.04 to 255.68)
    292.38 (222.9 to 383.53)
    213.81 (155.87 to 293.29)
    231.44 (172.06 to 311.32)
    219.62 (162.84 to 296.21)
    177.64 (135.49 to 232.9)
        Pertactin; 6 months post-vaccination
    142.41 (50.42 to 402.2)
    148.11 (56.09 to 391.11)
    265.86 (115.37 to 612.67)
    78.22 (29.84 to 205.03)
    177.46 (79.79 to 394.7)
    72.44 (26.1 to 201.05)
        Pertactin; 1 year post-vaccination
    83.85 (35.81 to 196.35)
    102.31 (36.42 to 287.4)
    200.85 (90.29 to 446.77)
    60.28 (25.78 to 140.95)
    117.54 (55.9 to 247.16)
    75.91 (25.1 to 229.55)
        Pertactin; 3 years post-vaccination
    65.79 (39.83 to 108.66)
    69.7 (45.83 to 105.98)
    74.81 (49.4 to 113.28)
    71.11 (44.3 to 114.13)
    65.61 (41.91 to 102.72)
    79.47 (54.08 to 116.78)
        Pertactin; 5 years post-vaccination
    49.89 (30.76 to 80.93)
    58.95 (40.03 to 86.82)
    53.87 (36.73 to 79)
    58.98 (37.62 to 92.47)
    47.43 (30.23 to 74.43)
    62.4 (43.51 to 89.51)
        Pertactin; 10 years post-vaccination
    24.39 (13.95 to 42.66)
    27.9 (17 to 45.78)
    28.98 (15.65 to 53.68)
    32.28 (19.23 to 54.19)
    37.39 (20.48 to 68.27)
    27.96 (15.24 to 51.3)
        Fimbriae; Pre-vaccination
    21.07 (15.06 to 29.49)
    20.66 (15.08 to 28.3)
    18.89 (14.05 to 25.39)
    23.07 (17.52 to 30.38)
    22.54 (16.57 to 30.66)
    18.93 (13.67 to 26.22)
        Fimbriae; 1 month post-vaccination
    1044.54 (851.74 to 1280.98)
    803.56 (571.19 to 1130.45)
    966.48 (747.74 to 1249.21)
    851.04 (644.03 to 1124.59)
    724.61 (561.38 to 935.3)
    461.68 (363.26 to 586.77)
        Fimbriae; 6 months post-vaccination
    412.35 (189.93 to 895.25)
    172.46 (83.52 to 356.12)
    640.02 (386.87 to 1058.83)
    156.76 (43.98 to 558.66)
    466.05 (241.63 to 898.9)
    316.27 (168.73 to 592.8)
        Fimbriae; 1 year post-vaccination
    333.4 (173.9 to 639.17)
    129.08 (49.84 to 334.29)
    598.59 (391.63 to 914.91)
    187.27 (57.36 to 611.38)
    370.49 (193.93 to 707.78)
    358.2 (192.57 to 666.28)
        Fimbriae; 3 years post-vaccination
    204.28 (141.99 to 293.91)
    143.11 (91.12 to 224.76)
    262.4 (167.53 to 410.99)
    210.66 (151.16 to 293.59)
    165.84 (110.42 to 249.09)
    135.38 (89.11 to 205.68)
        Fimbriae; 5 years post-vaccination
    180.76 (129.47 to 252.36)
    139.55 (91.67 to 212.45)
    198.54 (138.8 to 283.99)
    179.95 (132.27 to 244.81)
    144.74 (100.22 to 209.02)
    108.1 (73.93 to 158.06)
        Fimbriae; 10 years post-vaccination
    204.04 (134.44 to 309.66)
    117.03 (70.21 to 195.07)
    234.26 (152.57 to 359.7)
    117.98 (79.5 to 175.08)
    167.23 (112.19 to 249.28)
    103.57 (59.81 to 179.36)
    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 subjects who participated in a previous study, Td9707. 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 subjects who participated in a previous study, Td9707. 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
    Added details regarding the long-term follow up serology studies, including the collection of additional blood samples and the time of visit for each blood test.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/10783014
    http://www.ncbi.nlm.nih.gov/pubmed/17945400
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