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    Clinical Trial Results:
    A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers

    Summary
    EudraCT number
    		 2014-004367-20
    Trial protocol
    		 FI  
    Global end of trial date
    19 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2016
    First version publication date
    09 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MET54
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1143-8912
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    Public contact
    Responsible Medical Officer, Clinical Development, Sanofi Pasteur Inc., +1 570-957-3570, emilia.jordanov@sanofipasteur.com
    Scientific contact
    Responsible Medical Officer, Clinical Development, Sanofi Pasteur Inc., +1 570-957-3570, emilia.jordanov@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    11 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Observational objectives: - To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present in MenACYW conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using baby rabbit complement (rSBA) and by serum bactericidal assay using human complement (hSBA) - To evaluate the antibody responses against tetanus in subjects who received MenACYW conjugate vaccine or NIMENRIX vaccine - To evaluate the safety profile of MenACYW conjugate vaccine and NIMENRIX®
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    31 Mar 2015
    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
    Finland: 188
    Worldwide total number of subjects
    188
    EEA total number of subjects
    188
    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)
    188
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled from 31 March 2015 to 17 July 2015 at 8 clinic centers in Finland.

    Pre-assignment
    Screening details
    		 A total of 188 subjects who met all inclusion and none of the exclusion criteria were randomized and vaccinated in the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenACYW conjugate vaccine
    Arm description
    		 Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW conjugate vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) 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

    Arm title
    		 Group 2: NIMENRIX®
    Arm description
    		 Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NIMENRIX®: Meningococcal group A, C, W-135 and Y conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 ml, intramuscular, single dose

    Number of subjects in period 1
    		Group 1: MenACYW conjugate vaccine Group 2: NIMENRIX®
    Started
    94
    94
    Completed
    94
    94

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenACYW conjugate vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW conjugate vaccine.

    Reporting group title
    Group 2: NIMENRIX®
    Reporting group description
    		 Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.

    Reporting group values
    		 Group 1: MenACYW conjugate vaccine Group 2: NIMENRIX® Total
    Number of subjects
    		 94 94 188
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 94 94 188
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 1.44 ( 0.302 ) 1.47 ( 0.314 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 53 90
        Male
    		 57 41 98

    End points

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    End points reporting groups
    Reporting group title
    Group 1: MenACYW conjugate vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW conjugate vaccine.

    Reporting group title
    Group 2: NIMENRIX®
    Reporting group description
    		 Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.

    Primary: Percentage of Subjects Reporting Solicited Injection-Site or Systemic Reaction Following Vaccination with Either MenACYW Conjugate Vaccine or NIMENRIX®

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-Site or Systemic Reaction Following Vaccination with Either MenACYW Conjugate Vaccine or NIMENRIX® [1]
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥ 50 mm. Grade 3 systemic reactions: Fever, > 39.5°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1: MenACYW conjugate vaccine Group 2: NIMENRIX®
    Number of subjects analysed
    94
    94
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    29.8
    33
        Grade 3 Any Injection site Tenderness
    0
    1.1
        Any Injection site Erythema
    30.9
    35.1
        Grade 3 Injection site Erythema
    2.1
    1.1
        Any Injection site Swelling
    14.9
    18.1
        Grade 3 Injection site Swelling
    1.1
    3.2
        Any Fever
    7.4
    4.4
        Grade 3 Fever
    1.1
    0
        Any Vomiting
    4.3
    5.3
        Grade 3 Vomiting
    0
    0
        Any Abnormal Crying
    33
    39.4
        Grade 3 Abnormal Crying
    1.1
    0
        Any Drowsiness
    34
    27.7
        Grade 3 Drowsiness
    0
    0
        Any Loss of appetite
    23.4
    36.2
        Grade 3 Loss of appetite
    1.1
    1.1
        Any Irritability
    52.1
    56.4
        Grade 3 Irritability
    0
    2.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 up to Day 30 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Group 1: MenACYW conjugate vaccine
    Reporting group description
    		 Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW conjugate vaccine.

    Reporting group title
    Group 2: NIMENRIX®
    Reporting group description
    		 Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.

    Serious adverse events
    		 Group 1: MenACYW conjugate vaccine Group 2: NIMENRIX®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 94 (1.06%)
    0 / 94 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Ligament injury
         subjects affected / exposed
    1 / 94 (1.06%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 94 (1.06%)
    0 / 94 (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: NIMENRIX®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 94 (52.13%)
    53 / 94 (56.38%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    32 / 94 (34.04%)
    26 / 94 (27.66%)
         occurrences all number
    32
    26
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 94 (2.13%)
    6 / 94 (6.38%)
         occurrences all number
    2
    7
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    28 / 94 (29.79%)
    31 / 94 (32.98%)
         occurrences all number
    28
    31
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    29 / 94 (30.85%)
    33 / 94 (35.11%)
         occurrences all number
    29
    33
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 94 (14.89%)
    17 / 94 (18.09%)
         occurrences all number
    14
    17
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 94 (7.45%)
    4 / 94 (4.26%)
         occurrences all number
    7
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 94 (8.51%)
    4 / 94 (4.26%)
         occurrences all number
    8
    4
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 94 (4.26%)
    5 / 94 (5.32%)
         occurrences all number
    4
    5
    Psychiatric disorders
    Abnormal crying
    alternative assessment type: Systematic
         subjects affected / exposed
    31 / 94 (32.98%)
    37 / 94 (39.36%)
         occurrences all number
    31
    37
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    49 / 94 (52.13%)
    53 / 94 (56.38%)
         occurrences all number
    49
    53
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 94 (2.13%)
    7 / 94 (7.45%)
         occurrences all number
    2
    7
    Nasopharyngitis
         subjects affected / exposed
    9 / 94 (9.57%)
    5 / 94 (5.32%)
         occurrences all number
    9
    5
    Otitis media
         subjects affected / exposed
    4 / 94 (4.26%)
    6 / 94 (6.38%)
         occurrences all number
    4
    6
    Respiratory tract infection
         subjects affected / exposed
    5 / 94 (5.32%)
    1 / 94 (1.06%)
         occurrences all number
    7
    1
    Rhinitis
         subjects affected / exposed
    7 / 94 (7.45%)
    5 / 94 (5.32%)
         occurrences all number
    7
    5
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 94 (8.51%)
    16 / 94 (17.02%)
         occurrences all number
    8
    16
    Metabolism and nutrition disorders
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 94 (23.40%)
    34 / 94 (36.17%)
         occurrences all number
    22
    34

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2015
    Updated the coordinating investigator, provided trial center information, updated the planned trial period and planned trial calendar information, updated the Control Product information, clarified the vaccine injection sites and labeling and packaging for the investigational and control vaccines, and also updated the description of the rSBA method.

    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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