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    Clinical Trial Results:
    Three-, Five-, and Ten-Year Data on the Long-Term Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) in Adolescents 11–14 Years of Age

    Summary
    EudraCT number
    2015-005196-24
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    04 Jun 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    TD9809-LT
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02040636
    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
    04 Jun 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. The objective of this study was to describe the antibody levels for tetanus, diphtheria, pertussis and polio at 3 years, 5 years, and 10 years after vaccination with TdcP-IPV Vaccine.
    Protection of trial subjects
    Subjects were vaccinated in a previous study, Td9809. No vaccination was administered as part of this long-term immunogenicity follow-up study.
    Background therapy
    In Td9809, subjects were randomized to receive either Tetanus and Diphtheria Toxoids Adsorbed and Component Pertussis Vaccine Combined with Inactivated Poliomyelitis Vaccine (TdcP-IPV) followed by Hepatitis B vaccine one month later or TdcP-IPV vaccine and Hepatitis B vaccine concomitantly. For the long-term follow-up study, subjects in both groups were recalled for serology at 3, 5, and 10 years.
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jan 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
    Canada: 277
    Worldwide total number of subjects
    277
    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)
    101
    Adolescents (12-17 years)
    176
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study subjects were enrolled from 23 January 2002 to 04 June 2009 at 1 clinic center in Canada.

    Pre-assignment
    Screening details
    A total of 277 subjects who met all inclusion and none of the exclusion criteria were enrolled in the long-term immunogenicity study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group 1: Tdcp-IPV/Hepatitis B
    Arm description
    Subjects received TdcP-IPV at month 0 and Hepatitis B at months 1, 2, and 7.
    Arm type
    Experimental

    Investigational medicinal product name
    Tetanus and Diphtheria Toxoids Adsorbed and Component Pertussis Vaccine with Inactivated Poliovirus (TdcP-IPV 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 at Month 0.

    Investigational medicinal product name
    Hepatitis B Vaccine (Recombivax HB®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection each at Months 1, 2, and 7.

    Arm title
    Group 2: Tdcp-IPV and Hepatitis B
    Arm description
    Subjects received TdcP-IPV and Hepatitis B at Month 0, Hepatitis B at months 1 and 6.
    Arm type
    Experimental

    Investigational medicinal product name
    Tetanus and Diphtheria Toxoids Adsorbed and Component Pertussis Vaccine with Inactivated Poliovirus (TdcP-IPV 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 at Month 0.

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

    Number of subjects in period 1
    Group 1: Tdcp-IPV/Hepatitis B Group 2: Tdcp-IPV and Hepatitis B
    Started
    144
    133
    Completed
    91
    83
    Not completed
    53
    50
         Lost to follow-up
             53
             50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Tdcp-IPV/Hepatitis B
    Reporting group description
    Subjects received TdcP-IPV at month 0 and Hepatitis B at months 1, 2, and 7.

    Reporting group title
    Group 2: Tdcp-IPV and Hepatitis B
    Reporting group description
    Subjects received TdcP-IPV and Hepatitis B at Month 0, Hepatitis B at months 1 and 6.

    Reporting group values
    Group 1: Tdcp-IPV/Hepatitis B Group 2: Tdcp-IPV and Hepatitis B Total
    Number of subjects
    144 133 277
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    48 53 101
        Adolescents (12-17 years)
    96 80 176
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    12.43 ± 0.83 12.43 ± 0.95 -
    Gender categorical
    Units: Subjects
        Female
    75 60 135
        Male
    69 73 142

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Tdcp-IPV/Hepatitis B
    Reporting group description
    Subjects received TdcP-IPV at month 0 and Hepatitis B at months 1, 2, and 7.

    Reporting group title
    Group 2: Tdcp-IPV and Hepatitis B
    Reporting group description
    Subjects received TdcP-IPV and Hepatitis B at Month 0, Hepatitis B at months 1 and 6.

    Primary: Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently

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    End point title
    Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently [1]
    End point description
    Anti-Diphtheria antibody responses were measured using a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured using an enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as post-vaccination antibody titers ≥ 0.01 IU/mL for Diphtheria and ≥ 0.01 EU/mL for Tetanus.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed, based on the vaccine groups from the primary series for the long term follow-up period.
    End point values
    Group 1: Tdcp-IPV/Hepatitis B Group 2: Tdcp-IPV and Hepatitis B
    Number of subjects analysed
    144
    132
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria; Pre-vaccination
    95.8
    100
        Diphtheria; 1 month Post-vaccination
    100
    100
        Diphtheria; 3 years Post-vaccination
    100
    98
        Diphtheria; 5 years Post-vaccination
    96.4
    100
        Diphtheria; 10 years Post-vaccination
    97.7
    100
        Tetanus; Pre-vaccination
    100
    100
        Tetanus; 1 month Post-vaccination
    100
    100
        Tetanus; 3 years Post-vaccination
    100
    100
        Tetanus; 5 years Post-vaccination
    100
    100
        Tetanus; 10 years Post-vaccination
    100
    100
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently

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    End point title
    Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently
    End point description
    Anti-Diphtheria antibody responses were measured using a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured using an enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as post-vaccination antibody titers ≥ 0.1 IU/mL for Diphtheria and ≥ 0.1 EU/mL for Tetanus.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
    End point values
    Group 1: Tdcp-IPV/Hepatitis B Group 2: Tdcp-IPV and Hepatitis B
    Number of subjects analysed
    144
    132
    Units: Percentage of subjects
    number (not applicable)
        Diphtheria; Pre-vaccination
    63.2
    67.4
        Diphtheria; 1 month Post-vaccination
    98.6
    100
        Diphtheria; 3 years Post-vaccination
    83.6
    82
        Diphtheria; 5 years Post-vaccination
    49.1
    47.9
        Diphtheria; 10 years Post-vaccination
    57
    54.3
        Tetanus; Pre-vaccination
    99.3
    100
        Tetanus; 1 month Post-vaccination
    100
    100
        Tetanus; 3 years Post-vaccination
    100
    100
        Tetanus; 5 years Post-vaccination
    100
    99
        Tetanus; 10 years Post-vaccination
    100
    97.1
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers of Antibodies for Diphtheria and Tetanus Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently

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    End point title
    Summary of Geometric Mean Titers of Antibodies for Diphtheria and Tetanus Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently
    End point description
    Anti-Diphtheria antibody responses were measured using a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured using an enzyme-linked immunosorbent assay (ELISA).
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
    End point values
    Group 1: Tdcp-IPV/Hepatitis B Group 2: Tdcp-IPV and Hepatitis B
    Number of subjects analysed
    144
    132
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Diphtheria; Pre-vaccination
    0.15 (0.12 to 0.19)
    0.2 (0.16 to 0.25)
        Diphtheria; 1 month Post-vaccination
    2.56 (2.11 to 3.11)
    2.95 (2.48 to 3.5)
        Diphtheria; 3 years Post-vaccination
    0.26 (0.21 to 0.32)
    0.29 (0.22 to 0.37)
        Diphtheria; 5 years Post-vaccination
    0.11 (0.09 to 0.13)
    0.11 (0.09 to 0.14)
        Diphtheria; 10 years Post-vaccination
    0.17 (0.13 to 0.23)
    0.15 (0.12 to 0.2)
        Tetanus; Pre-vaccination
    0.82 (0.71 to 0.94)
    0.87 (0.75 to 1.01)
        Tetanus; 1 month Post-vaccination
    19.54 (16.91 to 22.56)
    17.4 (14.88 to 20.35)
        Tetanus; 3 years Post-vaccination
    2.29 (1.99 to 2.64)
    2.24 (1.9 to 2.64)
        Tetanus; 5 years Post-vaccination
    1.4 (1.16 to 1.68)
    1.48 (1.22 to 1.81)
        Tetanus; 10 years Post-vaccination
    0.95 (0.76 to 1.2)
    1.05 (0.83 to 1.34)
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers of Antibodies for Pertussis Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently

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    End point title
    Summary of Geometric Mean Titers of Antibodies for Pertussis Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently
    End point description
    Anti-Pertussis (Pertussis toxoid, Filamentous hemagglutinin, Fimbriae types 2 and 3, and Pertactin) antibody responses were measured using an indirect enzyme-linked immunosorbent assay (ELISA).
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
    End point values
    Group 1: Tdcp-IPV/Hepatitis B Group 2: Tdcp-IPV and Hepatitis B
    Number of subjects analysed
    144
    132
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pertussis toxoid; Pre-vaccination
    17.09 (13.69 to 21.35)
    16.43 (12.91 to 20.92)
        Pertussis toxoid; 1 month Post-vaccination
    267.87 (224.32 to 319.88)
    222.63 (186.1 to 266.32)
        Pertussis toxoid; 3 years Post-vaccination
    61.06 (49.44 to 75.4)
    48.91 (39.25 to 60.95)
        Pertussis toxoid; 5 years Post-vaccination
    47.99 (39.54 to 58.23)
    42.11 (33.35 to 53.16)
        Pertussis toxoid; 10 years Post-vaccination
    10.73 (8.24 to 13.97)
    14.64 (10.73 to 19.98)
        Filamentous hemagglutinin; Pre-vaccination
    33.53 (27.87 to 40.35)
    39.93 (32.15 to 49.59)
        Filamentous hemagglutinin;1 month Post-vaccination
    295 (255.11 to 341.13)
    290.22 (252.95 to 332.97)
        Filamentous hemagglutinin;3 years Post-vaccination
    64.95 (54.19 to 77.85)
    59.77 (49.88 to 71.62)
        Filamentous hemagglutinin;5 years Post-vaccination
    56.9 (47.61 to 68.01)
    55.58 (46.51 to 66.42)
        Filamentous hemagglutinin;10 year Post-vaccination
    33.3 (27.02 to 41.04)
    36.9 (29.34 to 46.41)
        Pertactin; Pre-vaccination
    10.49 (8.31 to 13.23)
    13.36 (10.22 to 17.47)
        Pertactin; 1 month Post-vaccination
    277.03 (220.45 to 348.13)
    240.45 (196.47 to 294.27)
        Pertactin; 3 years Post-vaccination
    62.38 (49.04 to 79.34)
    63.74 (51.23 to 79.29)
        Pertactin; 5 years Post-vaccination
    55.42 (43.57 to 70.49)
    62.5 (49.7 to 78.6)
        Pertactin; 10 years Post-vaccination
    26.66 (20.65 to 34.41)
    36.96 (28.73 to 47.54)
        Fimbriae; Pre-vaccination
    53.29 (42.27 to 67.2)
    62.36 (49.99 to 77.78)
        Fimbriae; 1 month Post-vaccination
    1414.97 (1166.02 to 1717.06)
    1383.72 (1183.05 to 1618.43)
        Fimbriae; 3 years Post-vaccination
    286.41 (237.06 to 346.02)
    266.46 (219.76 to 323.09)
        Fimbriae; 5 years Post-vaccination
    199.91 (166.25 to 240.38)
    213.46 (178.04 to 255.93)
        Fimbriae; 10 years Post-vaccination
    113.09 (92.99 to 137.54)
    122.1 (99.5 to 149.82)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seropositivity to Pertussis Antigens Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently

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    End point title
    Percentage of Subjects with Seropositivity to Pertussis Antigens Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently
    End point description
    Anti-Pertussis (Pertussis toxoid, Filamentous hemagglutinin, Fimbriae types 2 and 3, and Pertactin) antibody responses were measured using an indirect enzyme-linked immunosorbent assay (ELISA). Seropositivity rates, defined as the percentage of subjects with post-vaccination titers ≥ lower limit of quantitation.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
    End point values
    Group 1: Tdcp-IPV/Hepatitis B Group 2: Tdcp-IPV and Hepatitis B
    Number of subjects analysed
    144
    132
    Units: Percentage of subjects
    number (not applicable)
        Pertussis toxoid; Pre-vaccination
    84
    79.5
        Pertussis toxoid; 1 month Post-vaccination
    100
    100
        Pertussis toxoid; 3 years Post-vaccination
    96.4
    96.2
        Pertussis toxoid; 5 years Post-vaccination
    98.3
    94.2
        Pertussis toxoid; 10 years Post-vaccination
    71.6
    76.9
        Filamentous hemagglutinin; Pre-vaccination
    99.3
    98.5
        Filamentous hemagglutinin;1 month Post-vaccination
    100
    100
        Filamentous hemagglutinin;3 years Post-vaccination
    100
    100
        Filamentous hemagglutinin;5 years Post-vaccination
    100
    100
        Filamentous hemagglutinin;10 year Post-vaccination
    98.9
    97.5
        Pertactin; Pre-vaccination
    79.9
    81.8
        Pertactin; 1 month Post-vaccination
    100
    100
        Pertactin; 3 years Post-vaccination
    99.1
    100
        Pertactin; 5 years Post-vaccination
    98.3
    99
        Pertactin; 10 years Post-vaccination
    95.6
    97.5
        Fimbriae; Pre-vaccination
    79
    86.3
        Fimbriae; 1 month Post-vaccination
    100
    100
        Fimbriae; 3 years Post-vaccination
    99.1
    99
        Fimbriae; 5 years Post-vaccination
    100
    98.1
        Fimbriae; 10 years Post-vaccination
    96.7
    97.5
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seroprotection to Poliovirus Antigens Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently

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    End point title
    Percentage of Subjects with Seroprotection to Poliovirus Antigens Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently
    End point description
    Anti-poliovirus types 1, 2, and 3 titers were measured by a neutralization assay. Seroprotection was defined as antibody titers ≥ 1:8 dilution.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
    End point values
    Group 1: Tdcp-IPV/Hepatitis B Group 2: Tdcp-IPV and Hepatitis B
    Number of subjects analysed
    144
    132
    Units: Percentage of subjects
    number (not applicable)
        Poliovirus 1; Pre-vaccination
    97.2
    98.5
        Poliovirus 1; 1 month Post-vaccination
    100
    100
        Poliovirus 1; 3 years Post-vaccination
    100
    100
        Poliovirus 1; 5 years Post-vaccination
    100
    100
        Poliovirus 1; 10 years Post-vaccination
    100
    100
        Poliovirus 2; Pre-vaccination
    100
    100
        Poliovirus 2; 1 month Post-vaccination
    100
    100
        Poliovirus 2; 3 years Post-vaccination
    100
    100
        Poliovirus 2; 5 years Post-vaccination
    100
    100
        Poliovirus 2; 10 years Post-vaccination
    100
    100
        Poliovirus 3; Pre-vaccination
    95.1
    95.5
        Poliovirus 3; 1 month Post-vaccination
    100
    100
        Poliovirus 3; 3 years Post-vaccination
    100
    100
        Poliovirus 3; 5 years Post-vaccination
    100
    100
        Poliovirus 3; 10 years Post-vaccination
    100
    100
    No statistical analyses for this end point

    Other pre-specified: Summary of Geometric Mean Titers of Poliovirus Antibodies Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently

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    End point title
    Summary of Geometric Mean Titers of Poliovirus Antibodies Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently
    End point description
    Anti-poliovirus types 1, 2, and 3 titers were measured by a neutralization assay.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
    End point values
    Group 1: Tdcp-IPV/Hepatitis B Group 2: Tdcp-IPV and Hepatitis B
    Number of subjects analysed
    144
    132
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Poliovirus 1; Pre-vaccination
    134.96 (102.43 to 177.82)
    149.05 (111.01 to 200.14)
        Poliovirus 1; 1 month Post-vaccination
    65216.88 (49464.4 to 85985.9)
    38157.97 (29955.97 to 48605.7)
        Poliovirus 1; 3 years Post-vaccination
    3720.46 (2875.49 to 4813.73)
    2751.55 (2082.42 to 3635.68)
        Poliovirus 1; 5 years Post-vaccination
    993.08 (809.3 to 1218.6)
    858.5 (702.21 to 1049.56)
        Poliovirus 1; 10 years Post-vaccination
    883.71 (701.3 to 1113.57)
    873.49 (703.25 to 1084.93)
        Poliovirus 2; Pre-vaccination
    271.22 (216.94 to 339.08)
    306.04 (251.16 to 372.92)
        Poliovirus 2; 1 month Post-vaccination
    152485.2 (115163.6 to 201901.7)
    90280.15 (71624.22 to 113795.3)
        Poliovirus 2; 3 years Post-vaccination
    10756.89 (8104.16 to 14277.94)
    8928.76 (6640.15 to 12006.17)
        Poliovirus 2; 5 years Post-vaccination
    2296.33 (1827.35 to 2885.67)
    2168.22 (1749.3 to 2687.46)
        Poliovirus 2; 10 years Post-vaccination
    1429.53 (1111.05 to 1839.31)
    1277.51 (988.26 to 1651.42)
        Poliovirus 3; Pre-vaccination
    48.64 (38.32 to 61.75)
    45.97 (36.95 to 57.2)
        Poliovirus 3; 1 month Post-vaccination
    230898.8 (174414 to 305676.4)
    136695.4 (104880.7 to 178161)
        Poliovirus 3; 3 years Post-vaccination
    5827.34 (4431.04 to 7663.63)
    5411.71 (4021.19 to 7283.07)
        Poliovirus 3; 5 years Post-vaccination
    846.01 (664.4 to 1077.27)
    825.26 (641.97 to 1060.89)
        Poliovirus 3; 10 years Post-vaccination
    758.31 (584.66 to 983.55)
    782.8 (583.55 to 1050.08)
    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, Td9809. 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, Td9809. No vaccines were administered in this study and adverse event data were also not collected

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 May 2001
    Details regarding the planned long-term follow-up serology studies were included which also involved the collection of additional blood samples at 1, 3, 5, and 10 years post-vaccination.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/25540274
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