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    Clinical Trial Results:
    Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) versus Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) in Subjects 11 to 55 Years of Age in South Korea

    Summary
    EudraCT number
    		 2015-005181-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Jan 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2016
    First version publication date
    14 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MTA52
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01642589
    WHO universal trial number (UTN)
    		 U1111-1122-2028
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Medical Product Leader, Sanofi Pasteur SA, 33 4 37 65 96 18, Philipp.oster@sanofipasteur.com
    Scientific contact
    Medical Product Leader, Sanofi Pasteur SA, 33 4 37 65 96 18, Philipp.oster@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?
    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
    19 Apr 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y and W-135, 28 days after a single dose of Menactra® (Group 1)
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    13 Jul 2012
    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
    Korea, Republic of: 300
    Worldwide total number of subjects
    300
    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)
    33
    Adolescents (12-17 years)
    116
    Adults (18-64 years)
    151
    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 13 July 2012 to 17 December 2012 in 8 clinic centers in South Korea.

    Pre-assignment
    Screening details
    		 A total of 300 subjects that met all inclusion but none of the exclusion criteria were randomized and vaccinated in this study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    The investigator (blind observer/assessor) and subject’s parents/guardians did not know the vaccine administered. The blind-observer Investigator was in charge of safety assessment in a separate room away from where the vaccines were prepared. The vaccinator was in charge of the preparation and administration of the vaccine(s) in another room away from the blind-observer Investigator. When necessary the scratch off emergency decoding procedure described in the study protocol were to be followed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menactra® Group
    Arm description
    		 Subjects received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal A/C/Y/W-135 Conjugated Polysaccharide Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0

    Arm title
    		 Tdap-Adacel® Group
    Arm description
    		 Subjects received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap-Adacel®).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tdap 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

    Number of subjects in period 1
    		Menactra® Group Tdap-Adacel® Group
    Started
    200
    100
    Completed
    199
    99
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Menactra® Group
    Reporting group description
    		 Subjects received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)

    Reporting group title
    Tdap-Adacel® Group
    Reporting group description
    		 Subjects received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap-Adacel®).

    Reporting group values
    		 Menactra® Group Tdap-Adacel® Group Total
    Number of subjects
    		 200 100 300
    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)
    		 24 9 33
        Adolescents (12-17 years)
    		 76 40 116
        Adults (18-64 years)
    		 100 51 151
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.9 ( 11.5 ) 24.2 ( 10.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 107 58 165
        Male
    		 93 42 135

    End points

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    End points reporting groups
    Reporting group title
    Menactra® Group
    Reporting group description
    		 Subjects received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)

    Reporting group title
    Tdap-Adacel® Group
    Reporting group description
    		 Subjects received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap-Adacel®).

    Primary: Percentage of Subjects with Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine

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    End point title
    		 Percentage of Subjects with Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine [1]
    End point description
    Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level.
    End point type
    Primary
    End point timeframe
    28 days 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.
    End point values
    		 Menactra® Group Tdap-Adacel® Group
    Number of subjects analysed
    200
    100
    Units: Percentage of subjects
    number (not applicable)
        Serogroup A
    78
    9
        Serogroup C
    88
    8
        Serogroup Y
    75
    12
        Serogroup W-135
    92
    8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Functional Antibody Titers at ≥ 1:8 Dilution Before and After Menactra® or Adacel® Vaccination

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    End point title
    		 Percentage of Subjects with Functional Antibody Titers at ≥ 1:8 Dilution Before and After Menactra® or Adacel® Vaccination
    End point description
    Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 28 days post-vaccination
    End point values
    		 Menactra® Group Tdap-Adacel® Group
    Number of subjects analysed
    200
    100
    Units: Percentage of subjects
    number (not applicable)
        Serogroup A (Pre-vaccination)
    68
    76
        Serogroup A (Post-vaccination)
    100
    78
        Serogroup C (Pre-vaccination)
    28
    19
        Serogroup C (Post-vaccination)
    93
    24
        Serogroup Y (Pre-vaccination)
    75
    75
        Serogroup Y (Post-vaccination)
    99
    81
        Serogroup W-135 (Pre-vaccination)
    50
    44
        Serogroup W-135 (Post-vaccination)
    98
    48
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Functional Antibody Titers at ≥ 1:128 Dilution Before and After Menactra® or Adacel® Vaccination

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    End point title
    		 Percentage of Subjects With Functional Antibody Titers at ≥ 1:128 Dilution Before and After Menactra® or Adacel® Vaccination
    End point description
    Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 28 days post-vaccination
    End point values
    		 Menactra® Group Tdap-Adacel® Group
    Number of subjects analysed
    200
    100
    Units: Percentage of subjects
    number (not applicable)
        Serogroup A (Pre-vaccination)
    57
    64
        Serogroup A (Post-vaccination)
    99
    70
        Serogroup C (Pre-vaccination)
    25
    15
        Serogroup C (Post-vaccination)
    89
    16
        Serogroup Y (Pre-vaccination)
    52
    48
        Serogroup Y (Post-vaccination)
    96
    57
        Serogroup W-135 (Pre-vaccination)
    22
    25
        Serogroup W-135 (Post-vaccination)
    95
    27
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination

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    End point title
    		 Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
    End point description
    Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 28 days post-vaccination
    End point values
    		 Menactra® Group Tdap-Adacel® Group
    Number of subjects analysed
    200
    100
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Serogroup A (pre-vaccination)
    46.1 (33.7 to 63.2)
    75.6 (48.9 to 117)
        Serogroup A (post-vaccination)
    1121 (949 to 1324)
    87.6 (57.1 to 135)
        Serogroup C (pre-vaccination)
    5.8 (4.5 to 7.46)
    4.63 (3.26 to 6.56)
        Serogroup C (post-vaccination)
    667 (504 to 884)
    5.64 (3.82 to 8.32)
        Serotype Y (pre-vaccination)
    50.1 (37.7 to 66.6)
    47.2 (31.9 to 69.8)
        Serotype Y (post-vaccination)
    620 (521 to 738)
    66.8 (45.5 to 98)
        Serotype W-135 (pre-vaccination)
    13 (9.83 to 17.1)
    11.9 (7.79 to 18.1)
        Serotype W-135 (post-vaccination)
    851 (690 to 1050)
    14.9 (9.5 to 23.4)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine

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    End point title
    		 Number of Subjects Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 injection site reactions: Pain – Significant, prevents daily activity; Erythema and Swelling – >100 mm. Grade 3 sytemic reactions: Fever – ≥39.0°C; Headache, Malaise, Myalgia – Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 28 post-vaccination
    End point values
    		 Menactra® Group Tdap-Adacel® Group
    Number of subjects analysed
    200
    100
    Units: Number of subjects
    number (not applicable)
        Injection site Pain
    64
    72
        Grade 3 Injection site Pain
    1
    2
        Injection site Erythema
    5
    9
        Grade 3 Injection site Erythema
    0
    0
        Injection site Swelling
    3
    6
        Grade 3 Injection site Swelling
    0
    0
        Fever
    0
    3
        Grade 3 Fever
    0
    0
        Headache
    37
    24
        Grade 3 Headache
    2
    1
        Malaise
    36
    23
        Grade 3 Malaise
    1
    1
        Myalgia
    51
    42
        Grade 3 Myalgia
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Menactra® Group
    Reporting group description
    		 Subjects received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)

    Reporting group title
    Tdap-Adacel® Group
    Reporting group description
    		 Subjects received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap-Adacel®).

    Serious adverse events
    		 Menactra® Group Tdap-Adacel® Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Menactra® Group Tdap-Adacel® Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 200 (46.00%)
    76 / 100 (76.00%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    37 / 199 (18.59%)
    24 / 99 (24.24%)
         occurrences all number
    37
    24
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    64 / 199 (32.16%)
    72 / 99 (72.73%)
         occurrences all number
    64
    72
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    5 / 199 (2.51%)
    9 / 99 (9.09%)
         occurrences all number
    5
    9
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    3 / 199 (1.51%)
    6 / 99 (6.06%)
         occurrences all number
    3
    6
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    36 / 199 (18.09%)
    23 / 99 (23.23%)
         occurrences all number
    36
    23
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    51 / 199 (25.63%)
    42 / 99 (42.42%)
         occurrences all number
    51
    42
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2012
    Lowered the age of eligible subjects from 12 to 11 years in order to align with US data, clarified that the calculation for the seroconversion rate would be for the overall population, updated the exclusion criteria, and clarified the type of influenza vaccine to be used.
    23 Feb 2012
    Study exclusion criteria were further clarified.
    30 Mar 2012
    As per the Korean Food and Drug Administration, the exclusion criteria were modified such that the language that permitted inactivated influenza vaccine to be given within 2 weeks before or after vaccination was removed.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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