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    Clinical Trial Results:
    Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults

    Summary
    EudraCT number
    		 2018-001470-18
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2019
    First version publication date
    02 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MET56
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02752906
    WHO universal trial number (UTN)
    		 U1111-1161-2710
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, PA, United States, 18370
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001930-PIP01-16
    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
    27 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) conjugate vaccine compared to those observed following the administration of a booster dose of a Menactra® in subjects who were first vaccinated with 1 dose of a quadrivalent meningococcal vaccine 4 to 10 years before the booster dose.
    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 were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 Menactra® was used as active treatment control.
    Actual start date of recruitment
    15 Apr 2016
    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
    United States: 810
    Worldwide total number of subjects
    810
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    427
    Adults (18-64 years)
    383
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled in 30 centers in the United States and Puerto Rico from 15 April 2016 to 02 August 2016.

    Pre-assignment
    Screening details
    		 A total of 810 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenACYW Conjugate Vaccine
    Arm description
    		 Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW conjugate vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine: Meningococcal Polysaccharide (Serogroups A, C, Y, and W-135) Tetanus Toxoid Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Arm title
    		 Group 2: Menactra ®
    Arm description
    		 Healthy, meningococcal- vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menactra ® : Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Number of subjects in period 1
    		Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
    Started
    403
    407
    Vaccinated
    402
    407
    Completed
    396
    402
    Not completed
    7
    5
         Consent withdrawn by subject
    2
    2
         Lost to follow-up
    3
    2
         Protocol deviation
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW conjugate vaccine.

    Reporting group title
    Group 2: Menactra ®
    Reporting group description
    		 Healthy, meningococcal- vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine.

    Reporting group values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ® Total
    Number of subjects
    		 403 407 810
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 20.0 ± 5.96 19.9 ± 5.59 -
    Gender categorical
    Units: Subjects
        Female
    		 207 200 407
        Male
    		 196 207 403

    End points

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    End points reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW conjugate vaccine.

    Reporting group title
    Group 2: Menactra ®
    Reporting group description
    		 Healthy, meningococcal- vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine.

    Primary: Percentage of Subjects With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine

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    End point title
    		 Percentage of Subjects With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
    End point description
    The serum bactericidal assay using human complement (hSBA) vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for subjects with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for subjects with pre-vaccination hSBA titers >= 1:8. Analysis was performed on Per-Protocol Analysis Set-2 (PPAS2) defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 30 after vaccination.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
    Number of subjects analysed
    384
    389
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    92.2 (89.0 to 94.7)
    87.1 (83.4 to 90.3)
        Serogroup C
    97.1 (94.9 to 98.6)
    91.8 (88.6 to 94.3)
        Serogroup Y
    97.4 (95.3 to 98.7)
    95.6 (93.1 to 97.4)
        Serogroup W
    98.2 (96.3 to 99.3)
    90.7 (87.4 to 93.4)
    Statistical analysis title
    		 Serogroup A
    Statistical analysis description
    95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 proportions was > -10%, the non- inferiority assumption was rejected.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: Menactra ®
    Number of subjects included in analysis
    773
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.735
         upper limit
    		 9.38
    Statistical analysis title
    		 Serogroup C
    Statistical analysis description
    95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 proportions was > -10%, the non- inferiority assumption was rejected.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: Menactra ®
    Number of subjects included in analysis
    773
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.16
         upper limit
    		 8.76
    Statistical analysis title
    		 Serogroup Y
    Statistical analysis description
    95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 proportions was > -10%, the non- inferiority assumption was rejected.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: Menactra ®
    Number of subjects included in analysis
    773
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.907
         upper limit
    		 4.55
    Statistical analysis title
    		 Serogroup W
    Statistical analysis description
    95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 proportions was > -10%, the non- inferiority assumption was rejected.
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: Menactra ®
    Number of subjects included in analysis
    773
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.3
         upper limit
    		 10.9

    Secondary: Percentage of Subjects With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 06 After Vaccination

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    End point title
    		 Percentage of Subjects With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 06 After Vaccination
    End point description
    The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for subjects with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for subjects with pre-vaccination hSBA titers >= 1:8. Analysis was performed on Per-Protocol Analysis Set-1 (PPAS1) defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination.
    End point type
    Secondary
    End point timeframe
    Day 06 (post-vaccination)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
    Number of subjects analysed
    55
    62
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    72.7 (59.0 to 83.9)
    66.1 (53.0 to 77.7)
        Serogroup C
    83.6 (71.2 to 92.2)
    87.1 (76.1 to 94.3)
        Serogroup Y
    90.9 (80.0 to 97.0)
    83.9 (72.3 to 92.0)
        Serogroup W
    94.5 (84.9 to 98.9)
    83.9 (72.3 to 92.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
    End point description
    Meningococcal antibody responses against Serogroups A, C, Y, and W were measured by hSBA. Analysis was performed on PPAS2.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination)
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
    Number of subjects analysed
    384
    389
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serogroup A
    497 (436 to 568)
    296 (256 to 343)
        Serogroup C
    2618 (2227 to 3078)
    599 (504 to 711)
        Serogroup Y
    2070 (1807 to 2371)
    811 (699 to 941)
        Serogroup W
    1747 (1508 to 2025)
    723 (614 to 853)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine

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    End point title
    		 Number of Subjects With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
    End point description
    Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema and swelling (Grade 1: >=25 mm to <= 50 mm, Grade 2: >=51 to <=100 mm, Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius (°C) to <=38.4°C, Grade 2: >=38.5°C to <=38.9 °C, Grade 3: >= 39°C), headache, malaise, and myalgia. Number of subjects with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions were reported. Analysis was performed on Safety Analysis Set which included subjects who have received at least one dose of the study vaccine and have any safety data available. Here 'n' signifies number of subjects with available data for specified category,for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Within 7 days post-vaccination
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
    Number of subjects analysed
    402
    407
    Units: Subjects
    number (not applicable)
        Pain- Any Grade (n=398,402)
    178
    196
        Pain- Grade 1 (n=398,402)
    141
    154
        Pain- Grade 2 (n=398,402)
    33
    34
        Pain- Grade 3 (n=398,402)
    4
    8
        Erythema- Any Grade (n=398,402)
    20
    6
        Erythema- Grade 1 (n=398,402)
    18
    5
        Erythema- Grade 2 (n=398,402)
    2
    1
        Erythema- Grade 3 (n=398,402)
    0
    0
        Swelling- Any Grade (n=398,402)
    16
    3
        Swelling- Grade 1 (n=398,402)
    13
    1
        Swelling- Grade 2 (n=398,402)
    3
    2
        Swelling- Grade 3 (n=398,402)
    0
    0
        Fever- Any Grade (n=390,395)
    0
    2
        Fever- Grade 1 (n=390,395)
    0
    0
        Fever- Grade 2 (n=390,395)
    0
    1
        Fever- Grade 3 (n=390,395)
    0
    1
        Headache- Any Grade (n=398,402)
    151
    134
        Headache- Grade 1 (n=398,402)
    90
    73
        Headache- Grade 2 (n=398,402)
    52
    47
        Headache- Grade 3 (n=398,402)
    9
    14
        Malaise- Any Grade (n=398,402)
    110
    108
        Malaise- Grade 1 (n=398,402)
    62
    64
        Malaise- Grade 2 (n=398,402)
    37
    30
        Malaise- Grade 3 (n=398,402)
    11
    14
        Myalgia- Any Grade (n=398,402)
    146
    156
        Myalgia- Grade 1 (n=398,402)
    98
    120
        Myalgia- Grade 2 (n=398,402)
    40
    27
        Myalgia- Grade 3 (n=398,402)
    8
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination.
    Adverse event reporting additional description
    A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety Analysis Set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW conjugate vaccine.

    Reporting group title
    Group 2: Menactra ®
    Reporting group description
    		 Healthy, meningococcal-vaccine naive adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra vaccine.

    Serious adverse events
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 402 (1.24%)
    4 / 407 (0.98%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Clavicle Fracture
         subjects affected / exposed
    1 / 402 (0.25%)
    0 / 407 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 402 (0.00%)
    1 / 407 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy To Arthropod Sting
         subjects affected / exposed
    1 / 402 (0.25%)
    0 / 407 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal Perforation
         subjects affected / exposed
    0 / 402 (0.00%)
    1 / 407 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolism
         subjects affected / exposed
    1 / 402 (0.25%)
    0 / 407 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 402 (0.25%)
    0 / 407 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Major Depression
         subjects affected / exposed
    0 / 402 (0.00%)
    1 / 407 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    0 / 402 (0.00%)
    1 / 407 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 402 (0.25%)
    0 / 407 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    255 / 402 (63.43%)
    263 / 407 (64.62%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    155 / 402 (38.56%)
    137 / 407 (33.66%)
         occurrences all number
    168
    152
    General disorders and administration site conditions
    Injection Site Pain
         subjects affected / exposed
    178 / 402 (44.28%)
    196 / 407 (48.16%)
         occurrences all number
    178
    196
    Malaise
         subjects affected / exposed
    110 / 402 (27.36%)
    108 / 407 (26.54%)
         occurrences all number
    110
    108
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    147 / 402 (36.57%)
    158 / 407 (38.82%)
         occurrences all number
    148
    161

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2016
    Following amendments were made: Clarified that subjects could have received only 1 dose of a quadrivalent meningococcal conjugate vaccine; Clarified actions to be taken if a subject came in at the end of the Day 30 visit window but had received antibiotic therapy within the 3 days before the visit.
    25 Mar 2016
    Provided the batch number of the investigational product; clarified the vaccination history of potential subjects; updated the presentation of the definition of hSBA vaccine seroresponse after feedback received from the Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration (FDA); clarified the location of the laboratories for hSBA and serum bactericidal assay using baby rabbit complement (rSBA) testing; clarified the higher priority of hSBA sample testing.
    29 Nov 2016
    Provided the identity and information for the Coordinating Investigator.

    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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    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.

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