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    Clinical Trial Results:
    A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria and Acellular Pertussis (Tdap) Vaccine (GSK Boostrix®) and Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Boostrix®, or One Dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2005-005519-12
    Trial protocol
    		 IT  
    Global end of trial date
    08 May 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Jun 2016
    First version publication date
    07 Dec 2014
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    re-QC of the study needed because of EudraCT system glitch and updates are required.

    Trial information

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    Trial identification
    Sponsor protocol code
    V59P11
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00329901
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines
    Sponsor organisation address
    Via Fiorentina, 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000032-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Dec 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immunogenicity of a single dose of Tdap vaccine, separately but concomitantly administered with Chiron Men ACWY, is not inferior to that of a single dose of Tdap, concomitantly administered with a saline placebo
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, and the Japanese Ministry of Health, Labor, and Welfare, Novartis codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Apr 2006
    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
    Italy: 1072
    Worldwide total number of subjects
    1072
    EEA total number of subjects
    1072
    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)
    106
    Adolescents (12-17 years)
    834
    Adults (18-64 years)
    132
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled from 14 centers located in Italy.

    Pre-assignment
    Screening details
    		 A total of 1072 subjects were enrolled in the study, of which 1069 were vaccinated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tdap + MenACWY-CRM
    Arm description
    		 Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tdap vaccine (GSK Boostrix vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of the vaccine was administered by IM injection in the deltoid area.

    Investigational medicinal product name
    Novartis (formerly Chiron) Men ACWY Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of the vaccine was administered by IM injection in the deltoid area.

    Arm title
    		 Tdap + Saline
    Arm description
    		 Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    saline placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose was administered by IM injection in the deltoid area.

    Investigational medicinal product name
    Tdap vaccine (GSK Boostrix vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of the vaccine was administered by IM injection in the deltoid area.

    Arm title
    		 MenACWY-CRM +Saline
    Arm description
    		 Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Novartis (formerly Chiron) Men ACWY Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of the vaccine was administered by IM injection in the deltoid area.

    Investigational medicinal product name
    saline placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose was administered by IM injection in the deltoid area.

    Number of subjects in period 1
    		Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM +Saline
    Started
    361
    354
    357
    Completed
    352
    349
    353
    Not completed
    9
    5
    4
         Consent withdrawn by subject
    4
    3
    2
         Unable to classify
    2
    2
    -
         Lost to follow-up
    2
    -
    1
         Protocol deviation
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tdap + MenACWY-CRM
    Reporting group description
    		 Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms.

    Reporting group title
    Tdap + Saline
    Reporting group description
    		 Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms.

    Reporting group title
    MenACWY-CRM +Saline
    Reporting group description
    		 Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms.

    Reporting group values
    		 Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM +Saline Total
    Number of subjects
    		 361 354 357 1072
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 36 39 31 106
        Adolescents (12-17 years)
    		 277 273 284 834
        Adults (18-64 years)
    		 48 42 42 132
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.4 ( 3.4 ) 14.1 ( 3.2 ) 14.3 ( 3.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 189 164 165 518
        Male
    		 172 190 192 554

    End points

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    End points reporting groups
    Reporting group title
    Tdap + MenACWY-CRM
    Reporting group description
    		 Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms.

    Reporting group title
    Tdap + Saline
    Reporting group description
    		 Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms.

    Reporting group title
    MenACWY-CRM +Saline
    Reporting group description
    		 Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms.

    Subject analysis set title
    Enrolled Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who had data in the demography panel; it was used for the analysis of demographics and all subject listings.

    Subject analysis set title
    Immunogenicity PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the MITT population who received all the relevant doses of vaccine correctly, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to unblinding. A major deviation was defined as a protocol deviation that was considered to have a significant impact on the immunogenicity results of the subject.

    Subject analysis set title
    Immunogenicity MITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who actually received a study vaccination and provided at least one evaluable serum sample both before and after baseline.

    Subject analysis set title
    Exposed
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled subjects who actually received a study vaccination.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed population who provided postbaseline safety data.

    Primary: 1. Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo

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    End point title
    		 1. Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo [1]
    End point description
    To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of: - the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and - the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    1 month after vaccination (Day 29)
    Notes
    [1] - 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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM Tdap + Saline
    Number of subjects analysed
    350
    345
    Units: Percentages of subjects
    number (confidence interval 95%)
        Day 1 (diphtheria)
    4 (2 to 7)
    5 (3 to 7)
        Day 29 (diphtheria)
    94 (91 to 96)
    85 (80 to 88)
        Day 1 (tetanus)
    25 (20 to 30)
    36 (31 to 42)
        Day 29 (tetanus)
    100 (99 to 100)
    99 (98 to 100)
        Day 29 (PT) 4-fold increase (N=286, 287)
    76 (70 to 80)
    81 (76 to 85)
        Day 29 (FHA)4-fold increase (N=286, 287)
    83 (78 to 87)
    86 (82 to 90)
        Day 29 (PRN) 4-fold increase (N=285, 287)
    84 (79 to 88)
    91 (87 to 94)
    Statistical analysis title
    		 Non-inferiority of anti-diphtheria immune response
    Statistical analysis description
    Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline.
    Comparison groups
    Tdap + MenACWY-CRM v Tdap + Saline
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Vaccine group difference
    Point estimate
    9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 14
    Notes
    [2] - The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus(Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination.
    Statistical analysis title
    		 Non-inferiority of anti-tetanus immune response
    Statistical analysis description
    Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with MenACWY-CRM compared to Tdap given concomitantly with saline placebo.
    Comparison groups
    Tdap + MenACWY-CRM v Tdap + Saline
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Vaccine group difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 2
    Notes
    [3] - The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus (Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination.
    Statistical analysis title
    		 Non-inferiority of antiPT antigen immune response
    Statistical analysis description
    Non-inferiority of anti-PT antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo.
    Comparison groups
    Tdap + MenACWY-CRM v Tdap + Saline
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Vaccine group difference
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12
         upper limit
    		 1
    Notes
    [4] - The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus(Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination.
    Statistical analysis title
    		 Non-inferiority of antiFHA antigen immune response
    Statistical analysis description
    Non-inferiority of anti-FHA antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo.
    Comparison groups
    Tdap + MenACWY-CRM v Tdap + Saline
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Vaccine group difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 3
    Notes
    [5] - The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus(Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination.
    Statistical analysis title
    		 Non-inferiority of antiPRN antigen immune response
    Statistical analysis description
    Non-inferiority of anti-PRN antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo.
    Comparison groups
    Tdap + MenACWY-CRM v Tdap + Saline
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Vaccine group difference
    Point estimate
    -7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13
         upper limit
    		 -2
    Notes
    [6] - The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus(Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination.

    Secondary: 2. Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo

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    End point title
    		 2. Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo [7]
    End point description
    The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination (Day 29)
    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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM Tdap + Saline
    Number of subjects analysed
    350
    345
    Units: Percentages of subjects
    number (confidence interval 95%)
        Day 1 (diphtheria)
    55 (50 to 60)
    63 (57 to 68)
        Day 29 (diphtheria)
    100 (99 to 100)
    100 (98 to 100)
        Day 1 (tetanus)
    97 (95 to 99)
    97 (95 to 99)
        Day 29 (tetanus)
    100 (99 to 100)
    100 (99 to 100)
    No statistical analyses for this end point

    Secondary: 3. Geometric Mean Concentrations of Antibodies Against Diphtheria, Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWYCRM Compared to Tdap Given Concomitantly With Saline Placebo

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    End point title
    		 3. Geometric Mean Concentrations of Antibodies Against Diphtheria, Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWYCRM Compared to Tdap Given Concomitantly With Saline Placebo [8]
    End point description
    The geometric mean concentrations (GMCs) of antibodies against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination (Day 29)
    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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM Tdap + Saline
    Number of subjects analysed
    350
    345
    Units: Concentrations of antibodies
    geometric mean (confidence interval 95%)
        Day 1 (diphtheria)
    0.11 (0.085 to 0.14)
    0.12 (0.096 to 0.16)
        Day 29 (diphtheria)
    7.96 (6.19 to 10)
    2.77 (2.15 to 3.57)
        Day 1 (tetanus)
    0.62 (0.5 to 0.76)
    0.75 (0.61 to 0.92)
        Day 29 (tetanus)
    12 (9.84 to 14)
    15 (13 to 18)
        Day 1 (PT ) (N=286,287)
    2.68 (1.97 to 3.66)
    2.85 (2.1 to 3.86)
        Day 29 (PT) (N=286,287)
    62 (52 to 74)
    79 (66 to 93)
        Day 1 (FHA) (N=286,287)
    15 (13 to 18)
    17 (14 to 20)
        Day 29 (FHA) (N=286,287)
    186 (165 to 209)
    219 (194 to 246)
        Day 1 (PRN) (N=285,287)
    6.45 (5.18 to 8.03)
    8.7 (7.01 to 11)
        Day 29 (PRN) (N=285,287)
    157 (131 to 189)
    254 (211 to 304)
    No statistical analyses for this end point

    Secondary: 4. Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWYCRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo

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    End point title
    		 4. Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWYCRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo [9]
    End point description
    The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus prevaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWYCRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination (Day 29)
    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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM Tdap + Saline
    Number of subjects analysed
    350
    345
    Units: Ratios of Antibody Concentrations
    geometric mean (confidence interval 95%)
        diphtheria
    72 (58 to 91)
    22 (18 to 28)
        tetanus
    19 (14 to 25)
    20 (15 to 26)
        PT (N=286,287)
    23 (18 to 30)
    28 (21 to 36)
        FHA (N=286,287)
    12 (10 to 14)
    13 (11 to 15)
        PRN (N=285,287)
    24 (20 to 30)
    29 (24 to 35)
    No statistical analyses for this end point

    Secondary: 5. Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo

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    End point title
    		 5. Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo [10]
    End point description
    The percentage of subjects with serum bactericidal antibody titers (hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo. The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA).
    End point type
    Secondary
    End point timeframe
    1 month after vaccination (Day 29)
    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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM MenACWY-CRM +Saline
    Number of subjects analysed
    119
    126
    Units: Percentages of subjects
    number (confidence interval 95%)
        Day 1 (Men A) hSBA ≥ 1:4
    3 (1 to 7)
    5 (2 to 10)
        Day 29 (Men A) hSBA ≥ 1:4
    79 (71 to 86)
    83 (75 to 89)
        Day 1 (Men C) hSBA ≥ 1:4 (N=118,124)
    36 (28 to 46)
    30 (22 to 39)
        Day 29 (Men C) hSBA ≥ 1:4 (N=118,124)
    94 (88 to 98)
    90 (84 to 95)
        Day 1 (Men W) hSBA ≥ 1:4 (N=116,124)
    57 (47 to 66)
    56 (47 to 65)
        Day 29 (Men W) hSBA ≥ 1:4 (N=116,124)
    97 (93 to 99)
    97 (92 to 99)
        Day 1 (Men Y) hSBA ≥ 1:4 (N=117,125)
    47 (38 to 56)
    42 (33 to 51)
        Day 29 (Men Y) hSBA ≥ 1:4 (N=117,125)
    96 (90 to 99)
    97 (92 to 99)
        Day 1 (Men A) hSBA ≥ 1:8
    2 (0 to 6)
    4 (1 to 9)
        Day 29 (Men A) hSBA ≥ 1:8
    74 (65 to 82)
    80 (72 to 87)
        Day 1 (Men C) hSBA ≥ 1:8 (N=118,124)
    25 (17 to 33)
    25 (18 to 34)
        Day 29 (Men C) hSBA ≥ 1:8 (N=118,124)
    92 (86 to 96)
    88 (81 to 93)
        Day 1 (Men W) hSBA ≥ 1:8 (N=116,124)
    53 (43 to 62)
    56 (46 to 65)
        Day 29 (Men W) hSBA ≥ 1:8 (N=116,124)
    96 (90 to 99)
    97 (92 to 99)
        Day 1 (Men Y) hSBA ≥ 1:8 (N=117,125)
    38 (30 to 48)
    38 (29 to 47)
        Day 29 (Men Y) hSBA ≥ 1:8 (N=117,125)
    93 (87 to 97)
    94 (89 to 98)
    No statistical analyses for this end point

    Secondary: 6. The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo

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    End point title
    		 6. The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo [11]
    End point description
    The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWYCRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination (Day 29)
    Notes
    [11] - 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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM MenACWY-CRM +Saline
    Number of subjects analysed
    119
    126
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 1 (Men A)
    2.14 (1.99 to 2.31)
    2.21 (2.05 to 2.38)
        Day 29 (Men A)
    34 (23 to 50)
    50 (34 to 74)
        Day 1 (Men C) (N=118,124)
    4 (3.23 to 4.96)
    3.92 (3.16 to 4.86)
        Day 29 (Men C) (N=118,124)
    89 (58 to 136)
    92 (60 to 140)
        Day 1 (Men W) (N=116,124)
    11 (7.7 to 15)
    9.49 (6.93 to 13)
        Day 29 (Men W) (N=116,124)
    73 (54 to 98)
    77 (57 to 103)
        Day 1 (Men Y) (N=117,125)
    5.38 (4.2 to 6.89)
    5 (3.91 to 6.39)
        Day 29 (Men Y) (N=117,125)
    73 (54 to 98)
    70 (52 to 94)
    No statistical analyses for this end point

    Secondary: 7. Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo

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    End point title
    		 7. Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo [12]
    End point description
    The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus prevaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination (Day 29)
    Notes
    [12] - 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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM MenACWY-CRM +Saline
    Number of subjects analysed
    119
    126
    Units: Geometric Mean Ratios
    geometric mean (confidence interval 95%)
        Men A
    16 (11 to 23)
    23 (16 to 33)
        Men C (N=118,124)
    22 (15 to 33)
    23 (16 to 35)
        Men W (N=116,124)
    6.9 (4.84 to 9.85)
    8.09 (5.69 to 12)
        Men Y (N=117,125)
    14 (9.41 to 19)
    14 (9.79 to 20)
    No statistical analyses for this end point

    Secondary: 8. Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo

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    End point title
    		 8. Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo [13]
    End point description
    The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo. Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a postvaccinationtiter of at least four times the baseline hSBA titer.
    End point type
    Secondary
    End point timeframe
    1 month after vaccination (Day 29)
    Notes
    [13] - 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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM MenACWY-CRM +Saline
    Number of subjects analysed
    119
    126
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A
    74 (65 to 82)
    80 (72 to 87)
        Men C (N=118,124)
    82 (74 to 89)
    78 (70 to 85)
        Men W (N=116,124)
    58 (48 to 67)
    59 (50 to 68)
        Men Y (N=117,125)
    70 (61 to 78)
    70 (61 to 78)
    No statistical analyses for this end point

    Secondary: 9. Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo.

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    End point title
    		 9. Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo. [14]
    End point description
    The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo.
    End point type
    Secondary
    End point timeframe
    Day 1-7 after any vaccination
    Notes
    [14] - 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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM MenACWY-CRM +Saline
    Number of subjects analysed
    359
    357
    Units: Participants
        Local
    278
    179
        Injection site pain (MenACWY)
    82
    116
        Injection site erythema (MenACWY)
    48
    66
        Injection site induration (MenACWY)
    41
    59
        Injection site pain (Tdap or saline)
    227
    57
        Injection site erythema (Tdap or saline)
    103
    37
        Injection site induration (Tdap or saline)
    110
    23
        Systemic
    198
    171
        Chills
    39
    47
        Nausea
    43
    28
        Malaise
    65
    43
        Myalgia
    118
    79
        Arthralgia
    57
    40
        Headache
    129
    128
        Fever ≥ 38°C
    11
    14
        Other
    42
    33
        Stayed home due to reaction (N=358,357)
    12
    12
        Analgesic Antipyretic medication used
    38
    31
    No statistical analyses for this end point

    Secondary: 10. Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo

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    End point title
    		 10. Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo [15]
    End point description
    The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo.
    End point type
    Secondary
    End point timeframe
    Day 1-7 after any vaccination
    Notes
    [15] - 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: there was no statistical analyses for this endpoint.
    End point values
    		 Tdap + MenACWY-CRM Tdap + Saline
    Number of subjects analysed
    359
    353
    Units: Participants
        Local
    278
    282
        Injection site pain (Tdap)
    227
    246
        Injection site erythema (Tdap)
    103
    103
        Injection site induration (Tdap)
    110
    118
        Injection site pain (MenACWY or saline)
    82
    41
        Injection site erythema (MenACWY or saline)
    48
    34
        Injection site induration (MenACWY or saline)
    41
    27
        Systemic
    198
    202
        Chills
    39
    41
        Nausea
    43
    35
        Malaise
    65
    57
        Myalgia
    118
    127
        Arthralgia
    57
    60
        Headache
    129
    110
        Fever ≥ 38°C
    11
    7
        Other
    42
    39
        Stayed home due to reaction (N=358,357)
    12
    15
        Analgesic Antipyretic medication used
    38
    38
    No statistical analyses for this end point

    Secondary: 11. Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo

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    End point title
    		 11. Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
    End point description
    The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWYCRM vaccine or Tdap vaccine was concomitantly administered with saline placebo.
    End point type
    Secondary
    End point timeframe
    Throughout the study (Day 1 to Day 181)
    End point values
    		 Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM +Saline
    Number of subjects analysed
    359
    353
    357
    Units: Participants
        Any AE (Day 1 to 29)
    43
    31
    48
        Possibly/probably related AE (Day 1 to 29)
    8
    6
    6
        Serious AEs (Day 1 to 29)
    0
    0
    0
        Possibly/probably related SAE(Day 1 to 29)
    0
    0
    0
        AE's leading to discontinuation (Day 1 to 29)
    0
    0
    0
        Death ( Day 1 to 29)
    0
    0
    0
        Any AE (Day 30 to 181)
    42
    36
    39
        Possibly/probably related AE (Day 30 to 181)
    0
    0
    0
        Serious AEs (Day 30 to 181)
    1
    2
    0
        Possibly/probably related SAE (Day 30 to 181)
    0
    0
    0
        AE's leading to discontinuation (Day 30 to 181)
    0
    0
    0
        Death (Day 30 to 181)
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All SAEs were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181. Solicited events after day 7 were counted as unsolicited events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Tdap + MenACWYCRM
    Reporting group description
    		 Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms

    Reporting group title
    Tdap + Saline
    Reporting group description
    		 Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms

    Reporting group title
    MenACWY-CRM + Saline
    Reporting group description
    		 Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms

    Serious adverse events
    		 Tdap + MenACWYCRM Tdap + Saline MenACWY-CRM + Saline
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 359 (0.28%)
    2 / 353 (0.57%)
    0 / 357 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Heat stroke
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 353 (0.00%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 353 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 353 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tdap + MenACWYCRM Tdap + Saline MenACWY-CRM + Saline
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    296 / 359 (82.45%)
    309 / 353 (87.54%)
    232 / 357 (64.99%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    131 / 359 (36.49%)
    113 / 353 (32.01%)
    136 / 357 (38.10%)
         occurrences all number
    169
    148
    166
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    39 / 359 (10.86%)
    41 / 353 (11.61%)
    47 / 357 (13.17%)
         occurrences all number
    41
    44
    51
    Injection site erythema
         subjects affected / exposed
    119 / 359 (33.15%)
    110 / 353 (31.16%)
    83 / 357 (23.25%)
         occurrences all number
    156
    140
    109
    Injection site induration
         subjects affected / exposed
    125 / 359 (34.82%)
    131 / 353 (37.11%)
    72 / 357 (20.17%)
         occurrences all number
    156
    150
    86
    Injection site pain
         subjects affected / exposed
    259 / 359 (72.14%)
    262 / 353 (74.22%)
    139 / 357 (38.94%)
         occurrences all number
    315
    296
    188
    Malaise
         subjects affected / exposed
    67 / 359 (18.66%)
    57 / 353 (16.15%)
    43 / 357 (12.04%)
         occurrences all number
    73
    64
    46
    Pyrexia
         subjects affected / exposed
    21 / 359 (5.85%)
    14 / 353 (3.97%)
    21 / 357 (5.88%)
         occurrences all number
    28
    17
    25
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    44 / 359 (12.26%)
    38 / 353 (10.76%)
    31 / 357 (8.68%)
         occurrences all number
    49
    41
    40
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    57 / 359 (15.88%)
    60 / 353 (17.00%)
    40 / 357 (11.20%)
         occurrences all number
    60
    62
    45
    Myalgia
         subjects affected / exposed
    119 / 359 (33.15%)
    128 / 353 (36.26%)
    80 / 357 (22.41%)
         occurrences all number
    124
    135
    95

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2006
    Amendment 1 issues dealt with: - The addition of 6 new sites. - The extension of the enrollment period and therefore, the total duration of the study - The addition of a second location involved in the subjects enrollment at the site 04 - The change of the corporate denominations of the sponsor
    05 Jul 2006
    Amendment 2 issues dealt with administrative change at the trial site number 11, it has been substituted with a new trial site name and address.
    17 Apr 2007
    Amendment 3 issues dealt with modification of study endpoints and expand analyses to address regulatory concerns.

    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/20164251
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