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    Clinical Trial Results:
    A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2, 3, 4, 5 and 6 years after a booster dose of meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate vaccine (MenACWY-TT) or Meningitec ® administered in healthy 5-year-old children in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), who were primed with the same vaccine in study MENACWY-TT-039 (109670) at 12 through 23 months of age.

    Summary
    EudraCT number
    		 2012-005816-25
    Trial protocol
    		 FI  
    Global end of trial date
    08 Nov 2017

    Results information
    Results version number
    		 v1
    This version publication date
    12 May 2018
    First version publication date
    12 May 2018
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    C0921001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01900899
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 110017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the persistence and safety of meningococcal antibodies in terms of the percentage of subjects with rSBA antibody titres >=1:8, 1:128; hSBA antibody titers >=1:4, 1:8 and geometric mean titers for each of the four serogroups at 2, 3, 4, 5, 6 years after booster vaccination of children with MenACWY-TT or Meningitec.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jul 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 6 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 184
    Worldwide total number of subjects
    184
    EEA total number of subjects
    184
    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)
    184
    Adolescents (12-17 years)
    0
    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
    		 -

    Pre-assignment
    Screening details
    		 In this study, subjects from the study MENACWY-TT-039 (NCT01900899) and MENACWY-TT-048 EXT (NCT01900899) were followed up for persistence of immune response and safety for a maximum duration of 6 years.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenACWY-TT vaccine
    Arm description
    		 Subjects who received single 0.5 milliliter (mL) dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY-TT vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.

    Arm title
    		 MenCCRM vaccine
    Arm description
    		 Subjects who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MenCCRM vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects who received single 0.5 mL dose of meningococcal serogroup CCRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.

    Number of subjects in period 1
    		MenACWY-TT vaccine MenCCRM vaccine
    Started
    159
    25
    Completed
    150
    24
    Not completed
    9
    1
         Consent withdrawn by subject
    7
    1
         Migrated from study area
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenACWY-TT vaccine
    Reporting group description
    		 Subjects who received single 0.5 milliliter (mL) dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.

    Reporting group title
    MenCCRM vaccine
    Reporting group description
    		 Subjects who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.

    Reporting group values
    		 MenACWY-TT vaccine MenCCRM vaccine Total
    Number of subjects
    		 159 25 184
    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)
    		 159 25 184
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 90.2 ( 6.06 ) 89.6 ( 5.56 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 74 10 84
        Male
    		 85 15 100
    Race/Ethnicity, Customized
    Units: Subjects
        Race: White-Caucasian
    		 158 24 182
        Race: Other
    		 1 1 2
    Race/Ethnicity, Customized
    Units: Subjects
        Ethnicity: American hispanic
    		 0 1 1
        Ethnicity: Non American hispanic
    		 159 24 183

    End points

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    End points reporting groups
    Reporting group title
    MenACWY-TT vaccine
    Reporting group description
    		 Subjects who received single 0.5 milliliter (mL) dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.

    Reporting group title
    MenCCRM vaccine
    Reporting group description
    		 Subjects who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.

    Primary: Percentage of Subjects With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 24 months After Booster Vaccination

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    End point title
    		 Percentage of Subjects With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 24 months After Booster Vaccination [1]
    End point description
    Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N (overall number of subjects analyzed)=number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    24 months after booster 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: Only descriptive data was planned to be analysed for this endpoint.
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    123
    21
    Units: percentage of subjects
    number (confidence interval 95%)
        rSBA-MenA
    98.4 (94.2 to 99.8)
    23.8 (8.2 to 47.2)
        rSBA-MenC
    97.6 (93.0 to 99.5)
    100.0 (83.9 to 100.0)
        rSBA-MenW-135
    96.7 (91.9 to 99.1)
    9.5 (1.2 to 30.4)
        rSBA-MenY
    100.0 (97.0 to 100.0)
    33.3 (14.6 to 57.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 months After Booster Vaccination

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    End point title
    		 Percentage of Subjects With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 months After Booster Vaccination [2]
    End point description
    Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    36 months after booster Vaccination
    Notes
    [2] - 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: Only descriptive data was planned to be analysed for this endpoint.
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    135
    22
    Units: percentage of subjects
    number (confidence interval 95%)
        rSBA-MenA
    95.6 (90.6 to 98.4)
    18.2 (5.2 to 40.3)
        rSBA-MenC
    88.1 (81.5 to 93.1)
    77.3 (54.6 to 92.2)
        rSBA-MenW-135
    97.8 (93.6 to 99.5)
    9.1 (1.1 to 29.2)
        rSBA-MenY
    94.8 (89.6 to 97.9)
    36.4 (17.2 to 59.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination

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    End point title
    		 Percentage of Subjects With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination [3]
    End point description
    Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of subjects evaluable for this endpoint and n=number of subjects evaluable at specified time points only.
    End point type
    Primary
    End point timeframe
    48 months after booster Vaccination
    Notes
    [3] - 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: Only descriptive data was planned to be analysed for this endpoint.
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    139
    23
    Units: percentage of subjects
    number (confidence interval 95%)
        rSBA-MenA (n =139, 23)
    95.0 (89.9 to 98.0)
    26.1 (10.2 to 48.4)
        rSBA-MenC (n =139, 23)
    88.5 (82.0 to 93.3)
    100.0 (85.2 to 100.0)
        rSBA-MenW-135 (n =138, 23)
    87.0 (80.2 to 92.1)
    17.4 (5.0 to 38.8)
        rSBA-MenY (n =139, 23)
    95.0 (89.9 to 98.0)
    43.5 (23.2 to 65.5)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination

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    End point title
    		 Percentage of Subjects With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination [4]
    End point description
    Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    60 months after booster Vaccination
    Notes
    [4] - 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: Only descriptive data was planned to be analysed for this endpoint.
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    137
    23
    Units: percentage of subjects
    number (confidence interval 95%)
        rSBA-MenA
    89.8 (83.4 to 94.3)
    0.0 (0.0 to 14.8)
        rSBA-MenC
    80.3 (72.6 to 86.6)
    78.3 (56.3 to 92.5)
        rSBA-MenW-135
    88.3 (81.7 to 93.2)
    13.0 (2.8 to 33.6)
        rSBA-MenY
    92.7 (87.0 to 96.4)
    26.1 (10.2 to 48.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination

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    End point title
    		 Percentage of Subjects With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination [5]
    End point description
    Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    72 Months after booster Vaccination
    Notes
    [5] - 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: Only descriptive data was planned to be analysed for this endpoint.
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    134
    23
    Units: percentage of subjects
    number (confidence interval 95%)
        rSBA-MenA
    92.5 (86.7 to 96.4)
    8.7 (1.1 to 28.0)
        rSBA-MenC
    71.6 (63.2 to 79.1)
    65.2 (42.7 to 83.6)
        rSBA-MenW-135
    85.8 (78.7 to 91.2)
    13.0 (2.8 to 33.6)
        rSBA-MenY
    94.0 (88.6 to 97.4)
    13.0 (2.8 to 33.6)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4, >=1:8 and rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups

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    End point title
    		 Percentage of Subjects With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4, >=1:8 and rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
    End point description
    Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of subjects evaluable for this endpoint and n=number of subjects evaluable at specified time points only.
    End point type
    Secondary
    End point timeframe
    24, 36, 48, 60 and 72 months after booster Vaccination
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    139
    23
    Units: percentage of subjects
    number (confidence interval 95%)
        Month 24: rSBA-MenA-1:128 (n =123,21)
    95.1 (89.7 to 98.2)
    14.3 (3.0 to 36.3)
        Month 24: rSBA-MenC-1:128 (n =123,21)
    74.8 (66.2 to 82.2)
    85.7 (63.7 to 97.0)
        Month 24: rSBA-MenW-135-1:128 (n =123,21)
    94.3 (88.6 to 97.7)
    9.5 (1.2 to 30.4)
        Month 24: rSBA-MenY-1:128 (n =123,21)
    94.3 (88.6 to 97.7)
    33.3 (14.6 to 57.0)
        Month 36: rSBA-MenA-1:128 (n =135,22)
    83.0 (75.5 to 88.9)
    13.6 (2.9 to 34.9)
        Month 36: rSBA-MenC-1:128 (n =135,22)
    46.7 (38.0 to 55.4)
    40.9 (20.7 to 63.6)
        Month 36: rSBA-MenW-135-1:128 (n =135,22)
    88.1 (81.5 to 93.1)
    9.1 (1.1 to 29.2)
        Month 36: rSBA-MenY-1:128 (n =135,22)
    84.4 (77.2 to 90.1)
    36.4 (17.2 to 59.3)
        Month 48: rSBA-MenA-1:128 (n =139,23)
    83.5 (76.2 to 89.2)
    17.4 (5.0 to 38.8)
        Month 48: rSBA-MenC-1:128 (n =139,23)
    46.0 (37.6 to 54.7)
    47.8 (26.8 to 69.4)
        Month 48: rSBA-MenW-135-1:128 (n =138,23)
    73.9 (65.8 to 81.0)
    17.4 (5.0 to 38.8)
        Month 48: rSBA-MenY-1:128 (n =139,23)
    82.0 (74.6 to 88.0)
    43.5 (23.2 to 65.5)
        Month 60: rSBA-MenA-1:128 (n =137,23)
    73.0 (64.7 to 80.2)
    0.0 (0.0 to 14.8)
        Month 60: rSBA-MenC-1:128 (n =137,23)
    47.4 (38.9 to 56.1)
    43.5 (23.2 to 65.5)
        Month 60: rSBA-MenW-135-1:128 (n =137,23)
    69.3 (60.9 to 76.9)
    13.0 (2.8 to 33.6)
        Month 60: rSBA-MenY-1:128 (n =137,23)
    77.4 (69.4 to 84.1)
    21.7 (7.5 to 43.7)
        Month 72: rSBA-MenA-1:128 (n =134,23)
    78.4 (70.4 to 85.0)
    8.7 (1.1 to 28.0)
        Month 72: rSBA-MenC-1:128 (n =134,23)
    40.3 (31.9 to 49.1)
    34.8 (16.4 to 57.3)
        Month 72: rSBA-MenW-135-1:128 (n =134,23)
    67.2 (58.5 to 75.0)
    13.0 (2.8 to 33.6)
        Month 72: rSBA-MenY-1:128 (n =134,23)
    75.4 (67.2 to 82.4)
    13.0 (2.8 to 33.6)
    No statistical analyses for this end point

    Secondary: Serum Bactericidal Assay Using hSBA and rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups

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    End point title
    		 Serum Bactericidal Assay Using hSBA and rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
    End point description
    Serogroups included MenA, MenC, MenW-135 and MenY. All eligible subjects who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of subjects evaluable for this endpoint and n=number of subjects evaluable at specified time points only. 99999 represents CI was not estimable due to the lack of variability of geometric means.
    End point type
    Secondary
    End point timeframe
    24, 36, 48, 60 and 72 months after booster Vaccination
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    139
    23
    Units: titers
    geometric mean (confidence interval 95%)
        Month 24: rSBA-MenA (n =123,21)
    1071.2 (821.9 to 1396.2)
    9.1 (3.9 to 21.6)
        Month 24: rSBA-MenC (n =123,21)
    174.5 (137.5 to 221.5)
    224.3 (134.1 to 375.4)
        Month 24: rSBA-MenW-135 (n =123,21)
    859.9 (641.6 to 1152.3)
    6.6 (3.2 to 13.4)
        Month 24: rSBA-MenY (n =123,21)
    734.4 (584.6 to 922.5)
    18.9 (6.6 to 53.7)
        Month 36: rSBA-MenA (n =135,22)
    376.3 (280.7 to 504.3)
    8.8 (3.9 to 19.6)
        Month 36: rSBA-MenC (n =135,22)
    70.6 (53.3 to 93.3)
    54.7 (25.0 to 119.5)
        Month 36: rSBA-MenW-135 (n =135,22)
    544.5 (418.0 to 709.4)
    6.4 (3.3 to 12.7)
        Month 36: rSBA-MenY (n =135,22)
    416.9 (313.3 to 554.9)
    20.6 (7.6 to 56.1)
        Month 48: rSBA-MenA (n =139,23)
    413.2 (310.3 to 550.2)
    10.8 (4.7 to 24.7)
        Month 48: rSBA-MenC (n =139,23)
    69.0 (52.5 to 90.7)
    62.1 (32.1 to 120.3)
        Month 48: rSBA-MenW-135 (n =138,23)
    224.7 (158.6 to 318.2)
    9.3 (4.1 to 21.1)
        Month 48: rSBA-MenY (n =139,23)
    335.1 (254.7 to 440.9)
    28.4 (10.3 to 77.8)
        Month 60: rSBA-MenA (n =137,23)
    229.0 (163.0 to 321.9)
    4.0 (-99999 to 99999)
        Month 60: rSBA-MenC (n =137,23)
    66.0 (48.1 to 90.5)
    47.3 (19.0 to 117.9)
        Month 60: rSBA-MenW-135 (n =137,23)
    184.3 (130.3 to 260.6)
    8.0 (3.6 to 17.8)
        Month 60: rSBA-MenY (n =137,23)
    265.2 (190.9 to 368.4)
    13.0 (5.2 to 32.3)
        Month 72: rSBA-MenA (n =134,23)
    297.4 (214.4 to 412.5)
    5.7 (3.4 to 9.6)
        Month 72: rSBA-MenC (n =134,23)
    39.6 (28.6 to 54.6)
    33.0 (14.7 to 74.2)
        Month 72: rSBA-MenW-135 (n =134,23)
    171.9 (117.5 to 251.4)
    7.3 (3.7 to 14.6)
        Month 72: rSBA-MenY (n =134,23)
    260.6 (188.6 to 358.5)
    8.8 (3.5 to 21.8)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Serious Adverse Events

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    End point title
    		 Number of Subjects With Treatment Emergent Serious Adverse Events
    End point description
    An Adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Serious AE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. All eligible subjects who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen.
    End point type
    Secondary
    End point timeframe
    Baseline up to the Month 72 after booster vaccination (up to 6 years)
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    159
    25
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups

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    End point title
    		 Percentage of Subjects With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
    End point description
    Data regarding the results of the hSBA assays for each of the 4 meningococcal vaccine groups was not summarized within 6 months of primary completion date (PCD). This will be posted once the assay results are available and prior to within 12 months of primary completion date.
    End point type
    Secondary
    End point timeframe
    24, 36, 48, 60 and 72 months after booster Vaccination
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [6] - Data for hSBA assays for each of the four vaccine groups will be reported within 12 months of PCD
    [7] - Data for hSBA assays for each of the four vaccine groups will be reported within 12 months of PCD
    No statistical analyses for this end point

    Secondary: Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups

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    End point title
    		 Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
    End point description
    Data regarding the results of the hSBA assays for each of the 4 meningococcal vaccine groups was not summarized within 6 months of primary completion date. This will be posted once the assay results are available and prior to within 12 months of primary completion date.
    End point type
    Secondary
    End point timeframe
    24, 36, 48, 60 and 72 months after booster Vaccination
    End point values
    		 MenACWY-TT vaccine MenCCRM vaccine
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: titers
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [8] - Data for hSBA assays for each of the four vaccine groups will be reported within 12 months of PCD
    [9] - Data for hSBA assays for each of the four vaccine groups will be reported within 12 months of PCD
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to the Month 72 after booster vaccination (up to 6 years)
    Adverse event reporting additional description
    Same event may appear as both an AE and Serious AE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    MenCCRM vaccine
    Reporting group description
    		 Subjects who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.

    Reporting group title
    MenACWY-TT vaccine
    Reporting group description
    		 Subjects who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.

    Serious adverse events
    		 MenCCRM vaccine MenACWY-TT vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 159 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MenCCRM vaccine MenACWY-TT vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 159 (0.63%)
    Musculoskeletal and connective tissue disorders
    Juvenile idiopathic arthritis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2016
    Protocol was amended to reflect sponsorship change to Pfizer following the acquisition of the GSK meningococcal vaccine Nimenrix by Pfizer on 01 October 2015.

    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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