Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix®, and When Administered Alone or Concomitantly with 9vHPV and Tdap-IPV Vaccines in Healthy Adolescents

    Summary
    EudraCT number
    		 2020-001665-37
    Trial protocol
    		 HU   IT  
    Global end of trial date
    11 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2023
    First version publication date
    18 Aug 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MEQ00071
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1249-2973
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    14, Espace Henry Vallée, Lyon, France, 69007
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.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
    01 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement [hSBA] titer greater than or equal to [>=] 1:8) to meningococcal serogroups A, C, W and Y following the administration of a single dose of MenACYW conjugate vaccine (Group 1) compared to a single dose of Nimenrix® (Group 2).
    Protection of trial subjects
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 2021
    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
    Hungary: 168
    Country: Number of subjects enrolled
    Italy: 90
    Country: Number of subjects enrolled
    Spain: 202
    Country: Number of subjects enrolled
    Singapore: 3
    Worldwide total number of subjects
    463
    EEA total number of subjects
    460
    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)
    229
    Adolescents (12-17 years)
    234
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 21 active sites in Hungary, Italy, Spain and Singapore between 16 March 2021 to 11 May 2022.

    Pre-assignment
    Screening details
    		 A total of 463 subjects were enrolled and randomised in this study.

    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, Carer, Assessor
    Blinding implementation details
    Study was performed in partially observer-blind fashion: Groups 1 and 2: Investigators and study staff who conducted safety assessment, subjects, parents/legally acceptable representatives, Sponsor & laboratory personnel performing serology testing were kept blinded to vaccine received. Only study staff who prepared & administered the vaccine an were not involved with safety evaluation know which vaccine was administered. Group 3: Everyone involved in study know which vaccine was administered.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially)
    Arm description
    		 Subjects received 0.5 milliliter (mL) intramuscular injection of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 01 and 0.5 mL intramuscular injection of 9-valent human papilloma virus (9vHPV) + tetanus, diphtheria, and acellular pertussis - inactivated polio vaccines (Tdap-IPV) (sequentially after MenACYW vaccine) at Day 31.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)
    Investigational medicinal product code
    Other name
    MenQuadfi®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection on Day 01.

    Investigational medicinal product name
    Human Papillomavirus 9-valent Vaccine (9vHPV)
    Investigational medicinal product code
    Other name
    Gardasil® 9
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection on Day 31.

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
    Investigational medicinal product code
    Other name
    Repevax®/Triaxis®/Adacel®Polio
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection on Day 31.

    Arm title
    		 Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Arm description
    		 Subjects received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5 mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningococcal group A, C, W-135, and Y Conjugate vaccine
    Investigational medicinal product code
    Other name
    Nimenrix®
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5-mL intramuscular injection on Day 01.

    Investigational medicinal product name
    Human Papillomavirus 9-valent Vaccine (9vHPV)
    Investigational medicinal product code
    Other name
    Gardasil® 9
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection on Day 31.

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
    Investigational medicinal product code
    Other name
    Repevax®/Triaxis®/Adacel®Polio
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection on Day 31.

    Arm title
    		 Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Arm description
    		 Subjects received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)
    Investigational medicinal product code
    Other name
    MenQuadfi®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection on Day 01.

    Investigational medicinal product name
    Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
    Investigational medicinal product code
    Other name
    Repevax®/Triaxis®/Adacel®Polio
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5-mL intramuscular injection on Day 01.

    Investigational medicinal product name
    Human Papillomavirus 9-valent Vaccine (9vHPV)
    Investigational medicinal product code
    Other name
    Gardasil® 9
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5-mL intramuscular injection on Day 01.

    Number of subjects in period 1
    		Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Started
    173
    173
    117
    Safety Analysis Set
    171
    171
    116
    Vaccinated at Day 01
    170
    172
    116
    Vaccinated at Day 31
    168
    169
    0
    Completed
    167
    165
    116
    Not completed
    6
    8
    1
         Lost to follow-up
    2
    2
    -
         Withdrawal by parent/guardian
    2
    3
    -
         Withdrawal by subject
    2
    1
    -
         Protocol deviation
    -
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially)
    Reporting group description
    		 Subjects received 0.5 milliliter (mL) intramuscular injection of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 01 and 0.5 mL intramuscular injection of 9-valent human papilloma virus (9vHPV) + tetanus, diphtheria, and acellular pertussis - inactivated polio vaccines (Tdap-IPV) (sequentially after MenACYW vaccine) at Day 31.

    Reporting group title
    Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Reporting group description
    		 Subjects received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5 mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.

    Reporting group title
    Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Reporting group description
    		 Subjects received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.

    Reporting group values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly) Total
    Number of subjects
    		 173 173 117 463
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.4 ( 2.32 ) 12.8 ( 2.38 ) 12.5 ( 2.47 ) -
    Gender categorical
    Units: Subjects
        Female
    		 49 57 45 151
        Male
    		 124 116 72 312
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 1 0 3
        Asian
    		 2 2 1 5
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 3 1 1 5
        White
    		 165 169 115 449
        More than one race
    		 1 0 0 1
        Unknown or Not Reported
    		 0 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially)
    Reporting group description
    		 Subjects received 0.5 milliliter (mL) intramuscular injection of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 01 and 0.5 mL intramuscular injection of 9-valent human papilloma virus (9vHPV) + tetanus, diphtheria, and acellular pertussis - inactivated polio vaccines (Tdap-IPV) (sequentially after MenACYW vaccine) at Day 31.

    Reporting group title
    Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Reporting group description
    		 Subjects received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5 mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.

    Reporting group title
    Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Reporting group description
    		 Subjects received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.

    Primary: Percentage of Subjects With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis): Groups 1 and 2

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis): Groups 1 and 2 [1]
    End point description
    Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this endpoint was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately. Analysis was performed on hSBA Per-Protocol Analysis Set for meningococcal vaccines (PPASM) which was a subset that included all subjects who received a dose of the study vaccine and had a valid post-vaccination serology result. The subjects who presented protocol deviations were excluded from PPASM. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Primary
    End point timeframe
    Day 31 (post-vaccination)
    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: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    159
    161
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A (n=159,160)
    97.5 (93.7 to 99.3)
    92.5 (87.3 to 96.1)
        Serogroup C (n=159,161)
    100 (97.7 to 100)
    95.0 (90.4 to 97.8)
        Serogroup W (n=159,161)
    100 (97.7 to 100)
    98.8 (95.6 to 99.8)
        Serogroup Y (n=158,160)
    99.4 (96.5 to 100)
    98.1 (94.6 to 99.6)
    Statistical analysis title
    		 Serogroup A
    Comparison groups
    Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) v Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 10.36
    Notes
    [2] - The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater than (>) -10%.
    Statistical analysis title
    		 Serogroup W
    Comparison groups
    Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) v Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 4.42
    Notes
    [3] - The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater > -10%.
    Statistical analysis title
    		 Serogroup Y
    Comparison groups
    Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) v Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.88
         upper limit
    		 4.77
    Notes
    [4] - The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater > -10%.
    Statistical analysis title
    		 Serogroup C
    Comparison groups
    Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) v Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.58
         upper limit
    		 9.5
    Notes
    [5] - The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater > -10%.

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W

    		 Close Top of page
    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
    End point description
    GMT titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on hSBA PPASM. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    159
    161
    113
    Units: titers
    geometric mean (confidence interval 95%)
        Serogroup A: Day 01 (n=158,160,112)
    6.95 (6.18 to 7.83)
    6.41 (5.67 to 7.26)
    7.38 (6.23 to 8.75)
        Serogroup A: Day 31 (n=159,160,113)
    78.2 (64.6 to 94.7)
    56.0 (44.0 to 71.2)
    42.2 (32.5 to 54.7)
        Serogroup C: Day 01 (n=158,160,113)
    6.40 (5.17 to 7.92)
    5.51 (4.59 to 6.62)
    5.67 (4.51 to 7.14)
        Serogroup C: Day 31 (n=159,161,113)
    2294 (1675 to 3142)
    619 (411 to 931)
    1938 (1365 to 2752)
        Serogroup Y: Day 01 (n=159,161,113)
    2.56 (2.27 to 2.89)
    3.14 (2.63 to 3.75)
    2.43 (2.09 to 2.84)
        Serogroup Y: Day 31 (n=158,160,113)
    169 (141 to 202)
    84.8 (68.3 to 105)
    171 (138 to 211)
        Serogroup W: Day 01 (n=159,161,112)
    3.76 (3.22 to 4.40)
    4.36 (3.68 to 5.17)
    3.98 (3.18 to 4.96)
        Serogroup W: Day 31 (n=159,161,113)
    134 (109 to 164)
    64.6 (52.5 to 79.4)
    74.6 (61.8 to 90.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W

    		 Close Top of page
    End point title
    		 Percentage of Subjects With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
    End point description
    Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Percentage of subjects With hSBA antibody titers >=1:4 and >=1:8 for serogroups A, C, Y, and W were reported in the endpoint. Analysis was performed on hSBA PPASM. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    159
    161
    113
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A: >= 1:4: Day 01 (n=158,160,112)
    94.3 (89.5 to 97.4)
    88.1 (82.1 to 92.7)
    83.9 (75.8 to 90.2)
        Serogroup A: >= 1:8: Day 01 (n=158,160,112)
    56.3 (48.2 to 64.2)
    50.6 (42.6 to 58.6)
    58.9 (49.2 to 68.1)
        Serogroup A: >= 1:4: Day 31 (n=159,160,113)
    98.7 (95.5 to 99.8)
    95.0 (90.4 to 97.8)
    96.5 (91.2 to 99.0)
        Serogroup A: >= 1:8: Day 31 (n=159,160,113)
    97.5 (93.7 to 99.3)
    92.5 (87.3 to 96.1)
    91.2 (84.3 to 95.7)
        Serogroup C: >= 1:4: Day 01 (n=158,160,113)
    61.4 (53.3 to 69.0)
    61.3 (53.2 to 68.8)
    57.5 (47.9 to 66.8)
        Serogroup C: >= 1:8: Day 01 (n=158,160,113)
    41.1 (33.4 to 49.2)
    35.6 (28.2 to 43.6)
    41.6 (32.4 to 51.2)
        Serogroup C: >= 1:4: Day 31 (n=159,161,113)
    100 (97.7 to 100)
    96.3 (92.1 to 98.6)
    99.1 (95.2 to 100)
        Serogroup C: >= 1:8: Day 31 (n=159,161,113)
    100 (97.7 to 100)
    95.0 (90.4 to 97.8)
    99.1 (95.2 to 100)
        Serogroup Y: >= 1:4: Day 01 (n=159,161,113)
    14.5 (9.4 to 20.9)
    17.4 (11.9 to 24.1)
    8.8 (4.3 to 15.7)
        Serogroup Y: >= 1:8: Day 01 (n=159,161,113)
    9.4 (5.4 to 15.1)
    15.5 (10.3 to 22.1)
    6.2 (2.5 to 12.3)
        Serogroup Y: >= 1:4: Day 31 (n=158,160,113)
    99.4 (96.5 to 100)
    98.8 (95.6 to 99.8)
    100 (96.8 to 100)
        Serogroup Y: >= 1:8: Day 31 (n=158,160,113)
    99.4 (96.5 to 100)
    98.1 (94.6 to 99.6)
    100 (96.8 to 100)
        Serogroup W: >= 1:4: Day 01 (n=159,161,112)
    39.6 (32.0 to 47.7)
    46.6 (38.7 to 54.6)
    30.4 (22.0 to 39.8)
        Serogroup W: >= 1:8: Day 01 (n=159,161,112)
    22.6 (16.4 to 29.9)
    28.6 (21.7 to 36.2)
    26.8 (18.9 to 36.0)
        Serogroup W: >= 1:4: Day 31 (n=159,161,113)
    100 (97.7 to 100)
    98.8 (95.6 to 99.8)
    100 (96.8 to 100)
        Serogroup W: >= 1:8: Day 31 (n=159,161,113)
    100 (97.7 to 100)
    98.8 (95.6 to 99.8)
    99.1 (95.2 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W

    		 Close Top of page
    End point title
    		 Percentage of Subjects With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W
    End point description
    Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Fold-rise was calculated as ratio of post-dose titer on Day 31 to pre-dose titer on Day 01. Analysis was performed on hSBA PPASM. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 01) to Day 31 (post-vaccination)
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    159
    161
    113
    Units: percentage of Subjects
    number (confidence interval 95%)
        Serogroup A (n=158,159,112)
    88.0 (81.9 to 92.6)
    76.1 (68.7 to 82.5)
    65.2 (55.6 to 73.9)
        Serogroup C (n=158,160,113)
    99.4 (96.5 to 100)
    91.9 (86.5 to 95.6)
    97.3 (92.4 to 99.4)
        Serogroup Y (n=158,160,113)
    98.7 (95.5 to 99.8)
    92.5 (87.3 to 96.1)
    99.1 (95.2 to 100)
        Serogroup W (n=159,161,112)
    94.3 (89.5 to 97.4)
    88.2 (82.2 to 92.7)
    86.6 (78.9 to 92.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (>=) 1:16 for subjects with pre-vaccination hSBA titer less than (<) 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Analysis was performed on hSBA PPASM. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 31 (post-vaccination)
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    159
    161
    113
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroups A (n=158,159,112)
    88.0 (81.9 to 92.6)
    75.5 (68.0 to 81.9)
    63.4 (53.8 to 72.3)
        Serogroups C (n=158,160,113)
    99.4 (96.5 to 100)
    88.8 (82.8 to 93.2)
    97.3 (92.4 to 99.4)
        Serogroups Y (n=158,160,113)
    98.7 (95.5 to 99.8)
    88.1 (82.1 to 92.7)
    99.1 (95.2 to 100)
        Serogroups W (n=159,161,112)
    93.1 (88.0 to 96.5)
    81.4 (74.5 to 87.1)
    85.7 (77.8 to 91.6)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed subjects in Groups 1 and 2

    		 Close Top of page
    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed subjects in Groups 1 and 2 [6]
    End point description
    GMT titers against Serogroup C in MenC primed subjects (subjects who received monovalent MenC priming in infancy < 2 years of age) were measured by rSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on subjects who were MenC primed subjects. Here, “number of subjects analysed” signifies subjects with available data for this endpoint. Data for this endpoint was not planned to be collected and analysed for Group 3.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    37
    37
    Units: titers
    geometric mean (confidence interval 95%)
        Day 01
    6.51 (3.56 to 11.9)
    3.32 (2.24 to 4.91)
        Day 31
    19760 (13308 to 29338)
    7052 (4706 to 10567)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Subjects in Groups 1 and 2

    		 Close Top of page
    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Subjects in Groups 1 and 2 [7]
    End point description
    GMT titers against Serogroup C in MenC primed subjects (subjects who received monovalent MenC priming in infancy < 2 years of age) were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on subjects who were MenC primed, received a dose of the study vaccine and had a valid post-vaccination serology result. The subjects who presented protocol deviations were excluded. Here, ‘n’ = subjects with available data for specified category. Data for this endpoint was not planned to be collected and analysed for Group 3.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    114
    112
    Units: titers
    geometric mean (confidence interval 95%)
        Day 01 (n=113,111)
    7.30 (5.64 to 9.45)
    7.06 (5.57 to 8.95)
        Day 31 (n=114,112)
    4222 (3166 to 5632)
    2361 (1740 to 3204)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 [8]
    End point description
    Geometric mean concentrations to anti-Diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for subjects at Day 31 and at Day 61, respectively. Analysis performed on Per-Protocol Analysis Set for concomitant vaccines (PPASC) which was a subset that included all subjects who received a dose of study vaccine and had a valid post-vaccination serology result. Subjects who presented protocol deviations and who did not produce a valid test result were excluded from PPASC. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 31 (post-vaccination) and Day 61 (post-vaccination)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    149
    147
    Units: International units/millilitre(IU/mL)
    geometric mean (confidence interval 95%)
        Anti-Tetanus: Day 31 (n=147,147)
    25.5 (22.0 to 29.5)
    18.4 (15.8 to 21.5)
        Anti-Tetanus: Day 61 (n=149,147)
    17.3 (14.9 to 20.1)
    16.1 (14.1 to 18.5)
        Anti-Diphtheria: Day 31 (n=147,147)
    0.200 (0.169 to 0.238)
    0.215 (0.181 to 0.254)
        Anti-Diphtheria: Day 61 (n=149,147)
    3.75 (3.24 to 4.35)
    3.88 (3.37 to 4.47)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 [9]
    End point description
    GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for subjects at Day 31 and at Day 61, respectively. Analysis was performed on PPASC. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 31 (post-vaccination) and Day 61 (post-vaccination)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    149
    147
    Units: titers
    geometric mean (confidence interval 95%)
        Anti-Polio type 1: Day 31 (n=147,146)
    94.7 (75.5 to 119)
    109 (86.0 to 138)
        Anti-Polio type 1: Day 61 (n=149,147)
    3135 (2692 to 3650)
    3266 (2778 to 3840)
        Anti-Polio type 2: Day 31 (n=147,147)
    227 (184 to 281)
    234 (188 to 292)
        Anti-Polio type 2: Day 61 (n=147,147)
    3344 (2635 to 4245)
    2648 (2074 to 3381)
        Anti-Polio type 3: Day 31 (n=147,147)
    135 (105 to 174)
    155 (120 to 200)
        Anti-Polio type 3: Day 61 (n=149,147)
    7059 (5861 to 8502)
    5591 (4647 to 6728)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 [10]
    End point description
    GMCs of anti-pertussis antibodies (pertussis toxoid [PT], filamentous hemagglutinin [FHA],pertactin [PRN]) and fimbriae types 2 and 3 [FIM] were measured by electro chemiluminescent method. Blood samples were assessed for subjects at Day 31 and at Day 61, respectively. Analysis was performed on PPASC. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 31 (post-vaccination) and Day 61 (post-vaccination)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    149
    147
    Units: Endotoxin units per millilitre (EU/mL)
    geometric mean (confidence interval 95%)
        Anti-PT: Day 31 (n=145,147)
    11.9 (10.2 to 13.8)
    12.3 (10.5 to 14.4)
        Anti-PT: Day 61 (n=149,147)
    58.4 (50.6 to 67.4)
    59.3 (51.1 to 68.8)
        Anti-FHA: Day 31 (n=147,147)
    47.3 (40.9 to 54.7)
    58.3 (51.4 to 66.1)
        Anti-FHA: Day 61 (n=149,147)
    177 (156 to 200)
    210 (187 to 236)
        Anti-PRN: Day 31 (n=147,147)
    14.5 (11.2 to 18.8)
    18.2 (14.0 to 23.7)
        Anti-PRN: Day 61 (n=149,147)
    331 (265 to 414)
    394 (316 to 491)
        Anti-FIM: Day 31 (n=147,147)
    2.74 (2.23 to 3.37)
    3.18 (2.56 to 3.95)
        Anti-FIM: Day 61 (n=149,147)
    152 (112 to 207)
    194 (140 to 271)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 [11]
    End point description
    GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralisation assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for subjects at Day 01 and at Day 31, respectively. Analysis was performed on PPASC.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    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: Data is reported for all applicable arms in the study.
    End point values
    		 Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    113
    Units: titers
    geometric mean (confidence interval 95%)
        Anti-Polio type 1: Day 01
    146 (112 to 190)
        Anti-Polio type 1: Day 31
    1593 (1306 to 1943)
        Anti-Polio type 2: Day 01
    225 (178 to 285)
        Anti-Polio type 2: Day 31
    2950 (2409 to 3613)
        Anti-Polio type 3: Day 01
    221 (162 to 302)
        Anti-Polio type 3: Day 31
    3166 (2553 to 3926)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 [12]
    End point description
    Geometric mean concentrations to anti-Diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for subjects at Day 01 and at Day 31, respectively. Analysis was performed on PPASC.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    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: Data is reported for all applicable arms in the study.
    End point values
    		 Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    113
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-Tetanus: Day 01
    0.708 (0.574 to 0.874)
        Anti-Tetanus: Day 31
    34.5 (30.1 to 39.6)
        Anti-Diphtheria: Day 01
    0.256 (0.208 to 0.316)
        Anti-Diphtheria: Day 31
    2.91 (2.46 to 3.44)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 [13]
    End point description
    GMCs of anti-pertussis antibodies (PT, FHA, PRN and FIM) antibodies were measured by electro chemiluminescent method. Blood samples were assessed for subjects at Day 01 and at Day 31, respectively. Analysis was performed on PPASC.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    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: Data is reported for all applicable arms in the study.
    End point values
    		 Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    113
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PT: Day 01
    8.77 (7.07 to 10.9)
        Anti-PT: Day 31
    41.4 (36.1 to 47.4)
        Anti-FHA: Day 01
    44.5 (37.5 to 52.9)
        Anti-FHA: Day 31
    146 (128 to 166)
        Anti-PRN: Day 01
    11.4 (8.40 to 15.6)
        Anti-PRN: Day 31
    236 (184 to 303)
        Anti-FIM: Day 01
    2.32 (1.84 to 2.94)
        Anti-FIM: Day 31
    106 (75.3 to 149)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 [14]
    End point description
    Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralisation assay. GMCRs were calculated as the ratio of GMCs at Day 61 and Day 31. Blood samples were assessed for subjects at Day 31 and at Day 61, respectively. Analysis was performed on PPASC. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 31 (post-vaccination) and Day 61 (post-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: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    149
    147
    Units: ratio
    geometric mean (confidence interval 95%)
        Anti-Tetanus (n=147,147)
    0.677 (0.646 to 0.710)
    0.876 (0.824 to 0.931)
        Anti-Diphtheria (n=147,147)
    18.5 (15.3 to 22.5)
    18.1 (15.1 to 21.7)
        Anti-Polio type 1 (n=147,146)
    32.9 (24.5 to 44.2)
    29.5 (22.1 to 39.4)
        Anti-Polio type 2 (n=145,147)
    14.9 (10.8 to 20.5)
    11.3 (8.09 to 15.8)
        Anti-Polio type 3 (n=147,147)
    51.8 (38.0 to 70.5)
    36.1 (26.7 to 48.8)
        Anti-PT (n=145,147)
    4.90 (4.36 to 5.51)
    4.83 (4.33 to 5.38)
        Anti-FHA (n=147,147)
    3.76 (3.24 to 4.35)
    3.61 (3.18 to 4.09)
        Anti-PRN (n=147,147)
    22.4 (17.9 to 27.9)
    21.6 (16.9 to 27.7)
        Anti-FIM (n=147,147)
    55.3 (44.4 to 68.9)
    61.2 (49.4 to 75.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 [15]
    End point description
    Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralisation assay. GMCRs were calculated as the ratio of GMCs at Day 31/Day 01. Blood samples were assessed for subjects at Day 01 and at Day 31, respectively. Analysis was performed on PPASC.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-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: Data is reported for all applicable arms in the study.
    End point values
    		 Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    113
    Units: ratio
    geometric mean (confidence interval 95%)
        Anti-Tetanus
    48.7 (40.1 to 59.3)
        Anti-Diphtheria
    11.4 (9.17 to 14.1)
        Anti-Polio type 1
    10.9 (7.77 to 15.4)
        Anti-Polio type 2
    13.1 (9.66 to 17.8)
        Anti-Polio type 3
    14.3 (10.1 to 20.3)
        Anti-PT
    4.72 (4.05 to 5.49)
        Anti-FHA
    3.27 (2.82 to 3.80)
        Anti-PRN
    20.6 (15.7 to 27.1)
        Anti-FIM
    45.7 (35.7 to 58.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 [16]
    End point description
    Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers >= 0.1 IU/mL, and >= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers >= 8 (1/dilution). Blood samples were assessed for subjects at Day 31 and at Day 61, respectively. Analysis was performed on PPASC. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 31 (post-vaccination) and Day 61 (post-vaccination)
    Notes
    [16] - 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: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    149
    147
    Units: percentage of subjects
    number (confidence interval 95%)
        Anti-T: Day 31: >=0.1 (n=147,147)
    100 (97.5 to 100)
    100 (97.5 to 100)
        Anti-T: Day 31: >=1.0 (n=147,147)
    100 (97.5 to 100)
    98.0 (94.2 to 99.6)
        Anti-T: Day 61: >=0.1 (n=149,147)
    100 (97.6 to 100)
    100 (97.5 to 100)
        Anti-T: Day 61: >=1.0 (n=149,147)
    99.3 (96.3 to 100)
    100 (97.5 to 100)
        Anti-D: Day 31: >=0.1 (n=147,147)
    76.9 (69.2 to 83.4)
    79.6 (72.2 to 85.8)
        Anti-D: Day 31: >=1.0 (n=147,147)
    4.8 (1.9 to 9.6)
    4.8 (1.9 to 9.6)
        Anti-D: Day 61: >=0.1 (n=149,147)
    100 (97.6 to 100)
    100 (97.5 to 100)
        Anti-D: Day 61: >=1.0 (n=149,147)
    93.3 (88.0 to 96.7)
    92.5 (87.0 to 96.2)
        Anti-Polio 1: Day 31: >=8 (n=147,146)
    95.2 (90.4 to 98.1)
    95.2 (90.4 to 98.1)
        Anti-Polio 1: Day 61: >=8 (n=149,147)
    100 (97.6 to 100)
    100 (97.5 to 100)
        Anti-Polio 2: Day 31: >=8 (n=147,147)
    99.3 (96.3 to 100)
    100 (97.5 to 100)
        Anti-Polio 2: Day 61: >=8 (n=147,147)
    100 (97.5 to 100)
    100 (97.5 to 100)
        Anti-Polio 3: Day 31: >=8 (n=147,147)
    95.9 (91.3 to 98.5)
    96.6 (92.2 to 98.9)
        Anti-Polio 3: Day 61: >=8 (n=149,147)
    100 (97.6 to 100)
    100 (97.5 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 [17]
    End point description
    Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers >= 0.1 IU/mL, and >= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers >= 8 (1/dilution). Blood samples were assessed for subjects at Day 01 and at Day 31, respectively. Analysis was performed on PPASC.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    Notes
    [17] - 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: Data is reported for all applicable arms in the study.
    End point values
    		 Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    113
    Units: percentage of subjects
    number (confidence interval 95%)
        Anti-T: Day 01: >=0.1
    96.5 (91.2 to 99.0)
        Anti-T: Day 01: >=1.0
    38.9 (29.9 to 48.6)
        Anti-T: Day 31: >=0.1
    100 (96.8 to 100)
        Anti-T: Day 31: >=1.0
    100 (96.8 to 100)
        Anti-D: Day 01: >=0.1
    85.0 (77.0 to 91.0)
        Anti-D: Day 01: >=1.0
    9.7 (5.0 to 16.8)
        Anti-D: Day 31: >=0.1
    99.1 (95.2 to 100)
        Anti-D: Day 31: >=1.0
    90.3 (83.2 to 95.0)
        Anti-Polio 1: Day 01: >=8
    99.1 (95.2 to 100)
        Anti-Polio 1: Day 31: >=8
    100 (96.8 to 100)
        Anti-Polio 2: Day 01: >=8
    100 (96.8 to 100)
        Anti-Polio 2: Day 31: >=8
    100 (96.8 to 100)
        Anti-Polio 3: Day 01: >=8
    96.5 (91.2 to 99.0)
        Anti-Polio 3: Day 31: >=8
    100 (96.8 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Seroresponse Against Pertussis Antigens

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Vaccine Seroresponse Against Pertussis Antigens
    End point description
    Vaccine seroresponse was defined as post-vaccination concentration >= 4 * Baseline concentration, if the anti-pertussis antibody concentration at Baseline was < 4*lower limit of quantification (LLOQ), or >= 2*Baseline concentration, if the anti-pertussis antibody concentration at Baseline was >= 4*LLOQ. Analysis was performed on PPASC. Here, ‘n’=subjects with available data for each specified category. Post vaccine seroresponse for anti-pertussis antigens was Day 31 for Group 3 and Day 61 for Groups 1 and 2.
    End point type
    Secondary
    End point timeframe
    Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    149
    147
    113
    Units: percentage of subjects
    number (confidence interval 95%)
        Anti-PT (n=145,147,113)
    81.4 (74.1 to 87.4)
    83.0 (75.9 to 88.7)
    76.1 (67.2 to 83.6)
        Anti-FHA (n=147,147,113)
    74.8 (67.0 to 81.6)
    76.2 (68.5 to 82.8)
    70.8 (61.5 to 79.0)
        Anti-PRN (n=147,147,113)
    98.0 (94.2 to 99.6)
    94.6 (89.6 to 97.6)
    91.2 (84.3 to 95.7)
        Anti-FIM (n=147,147,113)
    93.9 (88.7 to 97.2)
    97.3 (93.2 to 99.3)
    95.6 (90.0 to 98.5)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2

    		 Close Top of page
    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 [18]
    End point description
    Anti-HPV antibodies were measured by the direct virus-like particle (VLP) electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for subjects at Day 31 and at Day 61, respectively. Analysis was performed on PPASC. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 31 (post-vaccination) and Day 61 (post-vaccination)
    Notes
    [18] - 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: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    149
    147
    Units: titers
    geometric mean (confidence interval 95%)
        Anti-HPV type-6: Day 31 (n=147,147)
    2.30 (1.94 to 2.73)
    2.03 (1.74 to 2.37)
        Anti-HPV type-6: Day 61 (n=149,147)
    73.9 (64.3 to 85.0)
    64.8 (55.8 to 75.4)
        Anti-HPV type-11: Day 31 (n=147,147)
    1.11 (1.05 to 1.18)
    1.08 (1.03 to 1.13)
        Anti-HPV type-11: Day 61 (n=149,147)
    43.9 (38.9 to 49.5)
    39.3 (33.9 to 45.5)
        Anti-HPV type-16: Day 31 (n=147,147)
    2.06 (1.95 to 2.17)
    2.08 (1.97 to 2.19)
        Anti-HPV type-16: Day 61 (n=149,147)
    199 (171 to 231)
    168 (142 to 199)
        Anti-HPV type-18: Day 31 (n=147,147)
    1.59 (1.50 to 1.70)
    1.52 (1.49 to 1.54)
        Anti-HPV type-18: Day 61 (n=149,147)
    46.5 (38.4 to 56.4)
    38.5 (31.3 to 47.4)
        Anti-HPV type-31: Day 31 (n=147,147)
    1.08 (0.995 to 1.18)
    1.05 (1.01 to 1.10)
        Anti-HPV type-31: Day 61 (n=149,147)
    31.7 (26.5 to 38.1)
    28.9 (24.0 to 34.9)
        Anti-HPV type-33: Day 31 (n=147,147)
    1.01 (0.987 to 1.04)
    1.02 (0.997 to 1.04)
        Anti-HPV type-33: Day 61 (n=149,147)
    21.1 (17.8 to 24.9)
    19.1 (16.1 to 22.7)
        Anti-HPV type-45: Day 31 (n=147,147)
    0.520 (0.499 to 0.543)
    0.509 (0.492 to 0.527)
        Anti-HPV type-45: Day 61 (n=149,147)
    11.5 (9.35 to 14.1)
    9.54 (7.68 to 11.9)
        Anti-HPV type-52: Day 31 (n=147,147)
    0.535 (0.503 to 0.569)
    0.514 (0.498 to 0.530)
        Anti-HPV type-52: Day 61 (n=149,147)
    47.4 (41.1 to 54.7)
    39.3 (33.5 to 46.1)
        Anti-HPV type-58: Day 31 (n=147,147)
    1.09 (1.02 to 1.16)
    1.05 (1.00 to 1.10)
        Anti-HPV type-58: Day 61 (n=149,147)
    29.6 (25.5 to 34.3)
    26.0 (22.2 to 30.4)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3

    		 Close Top of page
    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 [19]
    End point description
    Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for subjects at Day 01 and at Day 31, respectively. Analysis was performed on PPASC. Here,-9999 and '99999' was used as a space fillers and denotes that 95% CI was not computable as the standard deviation of the sample was 0, since all subjects had the same value.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    Notes
    [19] - 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: Data is reported for all applicable arms in the study.
    End point values
    		 Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    113
    Units: titers
    geometric mean (confidence interval 95%)
        Anti-HPV type-6: Day 01
    2.12 (1.76 to 2.55)
        Anti-HPV type-6: Day 31
    50.6 (42.0 to 60.9)
        Anti-HPV type-11: Day 01
    1.07 (1.02 to 1.13)
        Anti-HPV type-11: Day 31
    36.3 (30.8 to 42.8)
        Anti-HPV type-16: Day 01
    2.02 (1.98 to 2.07)
        Anti-HPV type-16: Day 31
    146 (118 to 179)
        Anti-HPV type-18: Day 01
    1.50 (-9999 to 99999)
        Anti-HPV type-18: Day 31
    31.2 (24.0 to 40.6)
        Anti-HPV type-31: Day 01
    1.07 (1.02 to 1.13)
        Anti-HPV type-31: Day 31
    24.7 (19.2 to 31.8)
        Anti-HPV type-33: Day 01
    1.01 (0.989 to 1.03)
        Anti-HPV type-33: Day 31
    15.0 (12.2 to 18.6)
        Anti-HPV type-45: Day 01
    0.524 (0.493 to 0.556)
        Anti-HPV type-45: Day 31
    8.24 (6.30 to 10.8)
        Anti-HPV type-52: Day 01
    0.521 (0.500 to 0.544)
        Anti-HPV type-52: Day 31
    40.9 (33.5 to 49.8)
        Anti-HPV type-58: Day 01
    1.08 (1.02 to 1.14)
        Anti-HPV type-58: Day 31
    20.6 (16.9 to 25.1)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2

    		 Close Top of page
    End point title
    		 Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 [20]
    End point description
    Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 61/Day 31. Blood samples were assessed for subjects at Day 31 and at Day 61, respectively. Analysis was performed on PPASC. Here, “number of subjects analysed” signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 31 (post-vaccination) and Day 61 (post-vaccination)
    Notes
    [20] - 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: Data is reported for all applicable arms in the study.
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Number of subjects analysed
    147
    147
    Units: ratio
    geometric mean (confidence interval 95%)
        Anti-HPV type-6
    32.0 (26.5 to 38.6)
    31.9 (26.5 to 38.5)
        Anti-HPV type-11
    39.0 (34.2 to 44.5)
    36.5 (31.3 to 42.7)
        Anti-HPV type-16
    96.6 (83.4 to 112)
    80.8 (68.1 to 95.8)
        Anti-HPV type-18
    29.7 (24.4 to 36.2)
    25.4 (20.6 to 31.2)
        Anti-HPV type-31
    29.8 (25.1 to 35.4)
    27.5 (22.8 to 33.2)
        Anti-HPV type-33
    20.8 (17.7 to 24.4)
    18.7 (15.8 to 22.2)
        Anti-HPV type-45
    21.9 (17.9 to 26.9)
    18.8 (15.1 to 23.3)
        Anti-HPV type-52
    88.0 (77.1 to 100)
    76.5 (65.0 to 90.1)
        Anti-HPV type-58
    27.1 (23.3 to 31.4)
    24.8 (21.2 to 29.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3

    		 Close Top of page
    End point title
    		 Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 [21]
    End point description
    Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 31/Day 01. Blood samples were assessed for subjects at Day 01 and at Day 31, respectively. Analysis was performed on PPASC.
    End point type
    Secondary
    End point timeframe
    Day 01 (pre-vaccination) and Day 31 (post-vaccination)
    Notes
    [21] - 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: Data is reported for all applicable arms in the study.
    End point values
    		 Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    113
    Units: ratio
    geometric mean (confidence interval 95%)
        Anti-HPV type-6
    23.9 (19.4 to 29.3)
        Anti-HPV type-11
    33.9 (28.6 to 40.1)
        Anti-HPV type-16
    71.9 (58.6 to 88.2)
        Anti-HPV type-18
    20.8 (16.0 to 27.1)
        Anti-HPV type-31
    23.1 (17.9 to 29.6)
        Anti-HPV type-33
    14.9 (12.0 to 18.4)
        Anti-HPV type-45
    15.7 (12.0 to 20.7)
        Anti-HPV type-52
    78.4 (64.3 to 95.5)
        Anti-HPV type-58
    19.1 (15.8 to 23.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
    End point description
    Vaccine Seroconversion was defined as changing serostatus from seronegative (subjects with a titer inferior to the serostatus cut-off value) at Baseline to seropositive after vaccination. A subject with a titer at or above the serostatus cut-off for a given HPV type was considered seropositive for that type. The serostatus cut-offs for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 are 9, 6, 5, 5, 3, 4, 3, 5 and 5 milli-Merck units (mMU)/mL, respectively. Post vaccine seroconversion for antigens contained in HPV vaccine was Day 31 for Group 3 and Day 61 for Groups 1 and 2. Analysis was performed on PPASC. Here, ‘number of subjects analysed’ = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    147
    147
    113
    Units: percentage of subjects
    number (confidence interval 95%)
        Anti-HPV type-6
    87.8 (81.3 to 92.6)
    88.4 (82.1 to 93.1)
    85.0 (77.0 to 91.0)
        Anti-HPV type-11
    99.3 (96.3 to 100)
    97.3 (93.2 to 99.3)
    97.3 (92.4 to 99.4)
        Anti-HPV type-16
    99.3 (96.3 to 100)
    96.6 (92.2 to 98.9)
    98.2 (93.8 to 99.8)
        Anti-HPV type-18
    94.6 (89.6 to 97.6)
    92.5 (87.0 to 96.2)
    88.5 (81.1 to 93.7)
        Anti-HPV type-31
    96.6 (92.2 to 98.9)
    93.2 (87.8 to 96.7)
    88.5 (81.1 to 93.7)
        Anti-HPV type-33
    95.2 (90.4 to 98.1)
    91.8 (86.2 to 95.7)
    87.6 (80.1 to 93.1)
        Anti-HPV type-45
    81.6 (74.4 to 87.5)
    83.0 (75.9 to 88.7)
    75.2 (66.2 to 82.9)
        Anti-HPV type-52
    99.3 (96.3 to 100)
    98.0 (94.2 to 99.6)
    96.5 (91.2 to 99.0)
        Anti-HPV type-58
    95.2 (90.4 to 98.1)
    92.5 (87.0 to 96.2)
    92.0 (85.4 to 96.3)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Immediate Unsolicited Adverse Events (AEs)

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Immediate Unsolicited Adverse Events (AEs)
    End point description
    An AE was any untoward medical occurrence in a patient or in a clinical investigation subject administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All subjects were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol. Analysis was performed on safety analysis set that included all subjects who had received at least one dose of the study vaccines and had any safety data available. Here, ‘n’=subjects with available data for each specified category and “n=0 and 99999 (a space filler)” in the number analysed field signifies that at Day 31, subjects of Group 3 received no vaccination.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    171
    171
    116
    Units: subjects
        Post-any vaccination (n=171,171,116)
    0
    0
    0
        Post-vaccination 1 (n=171,171,116)
    0
    0
    0
        Post-vaccination 2 (n=169,168,0)
    0
    0
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Injection Site Reactions

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Solicited Injection Site Reactions
    End point description
    SR: expected AR (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Injection site reactions: pain, erythema, and swelling. Safety set. Here, ‘n’=subjects with available data for specified category and “n=0” for MenACYW categories signifies no subjects were evaluable as in Group (Gps.)2 MenACYW vaccine was not administered; for Gps.1&3:“n=0” for Nimenrix categories signifies no subjects were evaluable as in Gps.1 & 3 Nimenrix was not administered. At Vaccination (vac.)1(Gps.1 & 2): “n=0”for 9vHPV & Tadp-IPV signifies no subjects were evaluable as these vaccines were not administered at vac.1 (D01). At Vacc2 (Gps.1, 2 & 3):“n=0” for MenACYW and Nimenrix signifies no subjects were evaluable as these vaccines were not administered at vacc.2(D31);for Gps. 3 “n=0” for 9vHPV and Tadp-IPV signifies no subjects were evaluable as these vaccines were not administered. "99999"=space filler.
    End point type
    Secondary
    End point timeframe
    Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    171
    171
    116
    Units: subjects
        MenACYW: Pain: Post-any vacc. (n=169,0,116)
    91
    99999
    69
        MenACYW: Erythema: Post-any vacc. (n=169,0,116)
    19
    99999
    11
        MenACYW: Swelling: Post-any vacc. (n=169,0,116)
    17
    99999
    12
        Nimenrix: Pain: Post-any vacc. (n=0,170,0)
    99999
    87
    99999
        Nimenrix: Erythema: Post-any vacc. (n=0,170,0)
    99999
    3
    99999
        Nimenrix: Swelling: Post-any vacc. (n=0,170,0)
    99999
    7
    99999
        9vHPV: Pain: Post-any vacc. (n=168,165,116)
    113
    125
    97
        9vHPV: Erythema: Post-any vacc. (n=168,165,116)
    7
    3
    6
        9vHPV: Swelling: Post-any vacc. (n=168,165,116)
    4
    3
    7
        Tdap-IPV: Pain: Post-any vacc. (n=168,164,116)
    116
    117
    95
        Tdap-IPV: Erythema: Post-any vacc. (n=168,164,116)
    9
    5
    13
        Tdap-IPV: Swelling: Post-any vacc. (n=168,164,116)
    9
    3
    10
        MenACYW: Pain: Post-vacc. 1 (n=169,0,116)
    91
    99999
    69
        MenACYW: Erythema: Post-vacc. 1 (n=169,0,116)
    19
    99999
    11
        MenACYW: Swelling: Post-vacc. 1 (n=169,0,116)
    17
    99999
    12
        Nimenrix: Pain: Post-vacc. 1 (n=0,170,0)
    99999
    87
    99999
        Nimenrix: Erythema: Post-vacc. 1 (n=0,170,0)
    99999
    3
    99999
        Nimenrix: Swelling: Post-vacc. 1 (n=0,170,0)
    99999
    7
    99999
        9vHPV: Pain: Post-vacc. 1 (n=0,0,116)
    99999
    99999
    97
        9vHPV: Erythema: Post-vacc. 1 (n=0,0,116)
    99999
    99999
    6
        9vHPV: Swelling: Post-vacc. 1 (n=0,0,116)
    99999
    99999
    7
        Tdap-IPV: Pain: Post-vacc. 1 (n=0,0,116)
    99999
    99999
    95
        Tdap-IPV: Erythema: Post-vacc. 1 (n=0,0,116)
    99999
    99999
    13
        Tdap-IPV: Swelling: Post-vacc. 1 (n=0,0,116)
    99999
    99999
    10
        MenACYW: Pain: Post-vacc. 2 (n=0,0,0)
    99999
    99999
    99999
        MenACYW: Erythema: Post-vacc. 2 (n=0,0,0)
    99999
    99999
    99999
        MenACYW: Swelling: Post-vacc. 2 (n=0,0,0)
    99999
    99999
    99999
        Nimenrix: Pain: Post-vacc. 2 (n=0,0,0)
    99999
    99999
    99999
        Nimenrix: Erythema: Post-vacc. 2 (n=0,0,0)
    99999
    99999
    99999
        Nimenrix: Swelling: Post-vacc. 2 (n=0,0,0)
    99999
    99999
    99999
        9vHPV: Pain: Post-vacc. 2 (n=168,165,0)
    113
    125
    99999
        9vHPV: Erythema: Post-vacc. 2 (n=168,165,0)
    7
    3
    99999
        9vHPV: Swelling: Post-vacc. 2 (n=168,165,0)
    4
    3
    99999
        Tdap-IPV: Pain: Post-vacc. 2 (n=168,164,0)
    116
    117
    99999
        Tdap-IPV: Erythema: Post-vacc. 2 (n=168,164,0)
    9
    5
    99999
        Tdap-IPV: Swelling: Post-vacc. 2 (n=168,164,0)
    9
    3
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Systemic Reactions

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Solicited Systemic Reactions
    End point description
    A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, and myalgia. Reported AEs for each arm were presented as pre-specified in the study protocol. Analysis was performed on safety analysis set. Here, ‘number of subjects analysed’ = subjects with available data for this endpoint. Here, ‘n’ = subjects with available data for each specified category and “n=0” and 99999 (a space filler) signifies that at Day 31, subjects of Group 3 received no vaccination.
    End point type
    Secondary
    End point timeframe
    Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    169
    170
    116
    Units: subjects
        Fever: Post-any vaccination (n=169,170,116)
    12
    11
    6
        Headache: Post-any vaccination (n=169,170,116)
    75
    64
    52
        Malaise: Post-any vaccination (n=169,170,116)
    65
    48
    42
        Myalgia: Post-any vaccination (n=169,170,116)
    84
    81
    67
        Fever: Post-vaccination 1 (n=169,170,116)
    7
    4
    6
        Headache: Post-vaccination 1 (n=168,170,116)
    59
    44
    52
        Malaise: Post-vaccination 1 (n=169,170,116)
    46
    32
    42
        Myalgia: Post-vaccination 1 (n=169,170,116)
    51
    53
    67
        Fever: Post-vaccination 2 (n=168,165,0)
    6
    7
    99999
        Headache: Post-vaccination 2 (n=168,165,0)
    37
    40
    99999
        Malaise: Post-vaccination 2 (n=168,165,0)
    40
    26
    99999
        Myalgia: Post-vaccination 2 (n=168,165,0)
    67
    61
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events (AEs)
    End point description
    An AE was any untoward medical occurrence in a patient or in a clinical investigation subject administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. Analysis was performed on safety analysis set. Here, ‘n’ = subjects with available data for each specified category and “n=0” and 99999 (a space filler) signifies that at Day 31, subjects of Group 3 received no vaccination.
    End point type
    Secondary
    End point timeframe
    From Day 01 up to Day 31 post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    171
    171
    116
    Units: subjects
        Post-any vaccination (n=171,171,116)
    69
    49
    37
        Post-vaccination 1 (n=171,171,116)
    49
    31
    37
        Post-vaccination 2 (n=169,168,0)
    34
    27
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI)

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI)
    End point description
    A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the subject was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol. Analysis was performed on safety analysis set.
    End point type
    Secondary
    End point timeframe
    From Day 01 up to the last study day (i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3)
    End point values
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Number of subjects analysed
    171
    171
    116
    Units: subjects
        SAE
    0
    1
    0
        AESI
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited AE data: from Day 01 up to Day 31 post-any vaccination. SR data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
    Adverse event reporting additional description
    SR: expected AR that was prelisted in CRF and considered to be related to vaccination. Unsolicited AE: observed AE that did not fulfill the conditions prelisted in CRF (i.e., solicited). Safety analysis set. In AE section, SR Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially)
    Reporting group description
    		 Subjects received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.

    Reporting group title
    Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially)
    Reporting group description
    		 Subjects received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.

    Reporting group title
    Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Reporting group description
    		 Subjects received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.

    Serious adverse events
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 171 (0.58%)
    0 / 116 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Metabolism and nutrition disorders
    Type 1 Diabetes Mellitus
         subjects affected / exposed
    0 / 171 (0.00%)
    1 / 171 (0.58%)
    0 / 116 (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
    		 Group1:MenACYW Conjugate+9vHPV+Tdap-IPV Vaccines(Sequentially) Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequentially) Group3:MenACYW Conjugate+9vHPV+TdapIPV Vaccines(Concomitantly)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    153 / 171 (89.47%)
    151 / 171 (88.30%)
    112 / 116 (96.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    76 / 171 (44.44%)
    66 / 171 (38.60%)
    52 / 116 (44.83%)
         occurrences all number
    98
    87
    52
    General disorders and administration site conditions
    Injection Site Swelling
         subjects affected / exposed
    25 / 171 (14.62%)
    13 / 171 (7.60%)
    15 / 116 (12.93%)
         occurrences all number
    30
    13
    30
    Injection Site Bruising
         subjects affected / exposed
    7 / 171 (4.09%)
    9 / 171 (5.26%)
    3 / 116 (2.59%)
         occurrences all number
    8
    10
    3
    Pyrexia
         subjects affected / exposed
    14 / 171 (8.19%)
    11 / 171 (6.43%)
    6 / 116 (5.17%)
         occurrences all number
    15
    11
    6
    Injection Site Pain
         subjects affected / exposed
    144 / 171 (84.21%)
    140 / 171 (81.87%)
    107 / 116 (92.24%)
         occurrences all number
    320
    329
    261
    Injection Site Erythema
         subjects affected / exposed
    27 / 171 (15.79%)
    9 / 171 (5.26%)
    18 / 116 (15.52%)
         occurrences all number
    35
    11
    30
    Malaise
         subjects affected / exposed
    65 / 171 (38.01%)
    48 / 171 (28.07%)
    42 / 116 (36.21%)
         occurrences all number
    86
    58
    42
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    84 / 171 (49.12%)
    81 / 171 (47.37%)
    67 / 116 (57.76%)
         occurrences all number
    118
    114
    67
    Infections and infestations
    Covid-19
         subjects affected / exposed
    9 / 171 (5.26%)
    1 / 171 (0.58%)
    2 / 116 (1.72%)
         occurrences all number
    9
    1
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2020
    Following changes were implemented: The third observational objective and the respective endpoints have been reclassified as secondary ones; countries in which the study was conducted were updated; removed the cross in the column “Collection of information in the CRF” for the item “Review of temporary contraindications for blood sampling”; blood samples labeling updated per Operating Guidelines in Tables 8.1 and 8.2; classification of 9vHPV and Tdap-IPV vaccines modified from NIMP to IMP. These vaccines were referred as co-administered vaccines; wording adjustment to provide more clarity about the assent Form and inform consent form signing; Inclusion criterion #10 modified (split into two) and a new exclusion criterion #23 created; the right classification of 9vHPV and Tdap- IPV vaccines were IMP according to STD-000017 (i.e., co-administered products); to complement information about Tdap-IPV; to update information regarding the IMPs’ batch numbers used; concomitant therapy definition was updated; in the event of a local or national immunization program with a pandemic influenza vaccine, COVID-19 vaccine or any other vaccine as needed, subjects who received the vaccine mentioned above at any time during the study were not withdrawn from the study; blood samples labelling in Tables 8.1 and 8.2 had been updated as per the Operational guidelines; the definition of Safety analysis set, FAS & PPAS were updated to clarify populations used for the statistical analyses and be homogeneous with other MenACYW conjugate studies; minor changes to be homogeneous with other MenACYW conjugate studies from the program; new section created to provide information about the impact of the COVID-19 pandemic in statistical analysis; section 10.3.1 created to incorporate list of contraceptive methods.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 09:17:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA