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    Clinical Trial Results:
    A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants

    Summary
    EudraCT number
    		 2007-004978-16
    Trial protocol
    		 GB  
    Global end of trial date
    20 Sep 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2016
    First version publication date
    18 Nov 2014
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V59P5E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00601731
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l.
    Sponsor organisation address
    Via fiorentina 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.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
    04 Mar 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunity against meningococcal serogroups A, C, W-135 and Y at 40 and 60 months of age in children who were vaccinated with MenACWY Ad- at 2, 4 and 12 months of age, in terms of percentage of participants with human SBA (hSBA) titers ≥ 1:8 for each of meningococcal serogroups A, C, W-135 and Y (Men A, C, W, Y).
    Protection of trial subjects
    Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel.
    Background therapy
    		 In Canada, a preschool booster of MMR and DTaP/IPV was given out of study at the 60-month visit, if not already given in the routine Public Health program after 48 months of age.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Feb 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 186
    Country: Number of subjects enrolled
    Canada: 196
    Worldwide total number of subjects
    382
    EEA total number of subjects
    186
    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)
    382
    Adolescents (12-17 years)
    0
    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
    		 Subjects were enrolled at 2 centers in Canada and 1 center in the UK.

    Pre-assignment
    Screening details
    		 Attempts were made to contact the parents of the 274 UK children and 263 Canadian children who completed V59P5 study, to enroll their child in this follow-on study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 UK Site
    Arm description
    		 UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2 and 4 or 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY Conjugate Vaccine
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 or 4 doses of 0.5 millilitres

    Arm title
    		 UK Control
    Arm description
    		 Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Canada Sites
    Arm description
    		 Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY Conjugate Vaccine
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 or 4 doses of 0.5 millilitres

    Arm title
    		 Canada Control
    Arm description
    		 Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		UK Site UK Control Canada Sites Canada Control
    Started
    143
    43
    166
    30
    Completed
    120
    43
    151
    29
    Not completed
    23
    0
    15
    1
         Consent withdrawn by subject
    10
    -
    3
    -
         Lost to follow-up
    13
    -
    12
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    UK Site
    Reporting group description
    		 UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2 and 4 or 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.

    Reporting group title
    UK Control
    Reporting group description
    		 Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.

    Reporting group title
    Canada Sites
    Reporting group description
    		 Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.

    Reporting group title
    Canada Control
    Reporting group description
    		 Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.

    Reporting group values
    		 UK Site UK Control Canada Sites Canada Control Total
    Number of subjects
    		 143 43 166 30 382
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 44.3 ( 6.4 ) 62 ( 0.2 ) 42.5 ( 4.5 ) 60.6 ( 0.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 74 20 85 15 194
        Male
    		 69 23 81 15 188
    Subject analysis sets

    Subject analysis set title
    UK2,3,4,12+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4,12+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4C/12+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of monovalent MenC-CRM conjugate vaccine at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4,12-, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Subject analysis set title
    UK Control, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.

    Subject analysis set title
    Ca2,4,6+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.

    Subject analysis set title
    Ca2,4,6+/12PS, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM1 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca2,4,12+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4+/12PS, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca2,4,12-, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4-/12PS, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca Control, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.

    Subject analysis set title
    UK2,3,4,12+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4,12+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4C/12+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of monovalent MenC-CRM conjugate vaccine at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4,12-, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4,6+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.

    Subject analysis set title
    Ca2,4,6+/12PS, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca2,4,12+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4+/12PS, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca2,4,12-, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4-/12PS, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis sets values
    		 UK2,3,4,12+, 60 Months UK2,4,12+, 60 Months UK2,4C/12+, 60 Months UK2,4,12-, 60 Months UK Control, 60 Months Ca2,4,6+, 60 Months Ca2,4,6+/12PS, 60 Months Ca2,4,12+, 60 Months Ca2,4+/12PS, 60 Months Ca2,4,12-, 60 Months Ca2,4-/12PS, 60 Months Ca Control, 60 Months UK2,3,4,12+, 40 Months UK2,4,12+, 40 Months UK2,4C/12+, 40 Months UK2,4,12-, 40 Months Ca2,4,6+, 40 Months Ca2,4,6+/12PS, 40 Months Ca2,4,12+, 40 Months Ca2,4+/12PS, 40 Months Ca2,4,12-, 40 Months Ca2,4-/12PS, 40 Months
    Number of subjects
    33
    35
    18
    31
    42
    27
    25
    23
    25
    23
    24
    30
    33
    37
    17
    34
    28
    23
    27
    28
    25
    24
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    61.3 ( 0.8 )
    61.4 ( 0.8 )
    61.2 ( 0.8 )
    61.5 ( 0.6 )
    62 ( 0.2 )
    60.3 ( 0.5 )
    60.6 ( 1 )
    60.3 ( 0.6 )
    60.2 ( 0.4 )
    60.7 ( 0.7 )
    60.4 ( 0.5 )
    60.6 ( 0.6 )
    42.5 ( 0.6 )
    42.6 ( 0.6 )
    42.6 ( 0.5 )
    40.6 ( 0.8 )
    42 ( 1 )
    41.8 ( 1.2 )
    42 ( 0.9 )
    41.6 ( 1 )
    40.7 ( 1 )
    40.9 ( 1.1 )
    Gender categorical
    Units: Subjects
        Female
    11
    19
    12
    18
    19
    19
    12
    13
    10
    12
    12
    15
    13
    19
    12
    19
    19
    9
    15
    10
    12
    13
        Male
    22
    16
    6
    13
    23
    8
    13
    10
    15
    11
    12
    15
    20
    18
    5
    15
    9
    14
    12
    18
    13
    11

    End points

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    End points reporting groups
    Reporting group title
    UK Site
    Reporting group description
    		 UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2 and 4 or 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.

    Reporting group title
    UK Control
    Reporting group description
    		 Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.

    Reporting group title
    Canada Sites
    Reporting group description
    		 Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.

    Reporting group title
    Canada Control
    Reporting group description
    		 Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.

    Subject analysis set title
    UK2,3,4,12+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4,12+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4C/12+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of monovalent MenC-CRM conjugate vaccine at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4,12-, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Subject analysis set title
    UK Control, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.

    Subject analysis set title
    Ca2,4,6+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.

    Subject analysis set title
    Ca2,4,6+/12PS, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM1 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca2,4,12+, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4+/12PS, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca2,4,12-, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4-/12PS, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca Control, 60 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.

    Subject analysis set title
    UK2,3,4,12+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4,12+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4C/12+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of monovalent MenC-CRM conjugate vaccine at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    UK2,4,12-, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4,6+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.

    Subject analysis set title
    Ca2,4,6+/12PS, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca2,4,12+, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4+/12PS, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Subject analysis set title
    Ca2,4,12-, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Subject analysis set title
    Ca2,4-/12PS, 40 Months
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Primary: Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥ 1:8 for each of meningococcal serogroups A, C, W and Y

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    End point title
    		 Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥ 1:8 for each of meningococcal serogroups A, C, W and Y [1]
    End point description
    Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
    End point type
    Primary
    End point timeframe
    40 months and 60 months of age
    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: Statisical analyses are not applicable for this end point.
    End point values
    		 UK2,3,4,12+, 60 Months UK2,4,12+, 60 Months UK2,4C/12+, 60 Months UK2,4,12-, 60 Months UK Control, 60 Months Ca2,4,6+, 60 Months Ca2,4,6+/12PS, 60 Months Ca2,4,12+, 60 Months Ca2,4+/12PS, 60 Months Ca2,4,12-, 60 Months Ca2,4-/12PS, 60 Months Ca Control, 60 Months UK2,3,4,12+, 40 Months UK2,4,12+, 40 Months UK2,4C/12+, 40 Months UK2,4,12-, 40 Months Ca2,4,6+, 40 Months Ca2,4,6+/12PS, 40 Months Ca2,4,12+, 40 Months Ca2,4+/12PS, 40 Months Ca2,4,12-, 40 Months Ca2,4-/12PS, 40 Months
    Number of subjects analysed
    33 [2]
    35 [3]
    18 [4]
    31
    42
    27 [5]
    25 [6]
    23 [7]
    25 [8]
    23 [9]
    24 [10]
    30 [11]
    33 [12]
    37 [13]
    17
    34 [14]
    28 [15]
    23 [16]
    27 [17]
    28 [18]
    25 [19]
    24
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    9 (2 to 24)
    11 (3 to 27)
    11 (1 to 35)
    3 (0.082 to 17)
    0 (0 to 8)
    0 (0 to 13)
    0 (0 to 14)
    4 (0 to 22)
    4 (0 to 20)
    4 (0 to 22)
    0 (0 to 14)
    3 (0.084 to 17)
    27 (13 to 46)
    8 (2 to 22)
    29 (10 to 56)
    3 (0.074 to 15)
    0 (0 to 12)
    4 (0 to 22)
    7 (1 to 24)
    0 (0 to 12)
    8 (1 to 26)
    0 (0 to 14)
        Serogroup C
    34 (19 to 53)
    32 (17 to 51)
    59 (33 to 82)
    45 (27 to 64)
    29 (16 to 45)
    14 (3 to 36)
    13 (3 to 32)
    14 (3 to 35)
    24 (8 to 47)
    27 (11 to 50)
    46 (26 to 67)
    53 (34 to 72)
    41 (24 to 59)
    47 (30 to 65)
    71 (44 to 90)
    33 (18 to 52)
    20 (6 to 44)
    14 (3 to 35)
    31 (14 to 52)
    35 (17 to 56)
    38 (19 to 59)
    46 (26 to 67)
        Serogroup W
    69 (50 to 84)
    85 (68 to 95)
    78 (52 to 94)
    84 (66 to 95)
    36 (22 to 52)
    31 (14 to 52)
    44 (24 to 65)
    57 (34 to 77)
    42 (22 to 63)
    81 (58 to 95)
    67 (45 to 84)
    34 (18 to 54)
    73 (54 to 87)
    69 (52 to 84)
    71 (44 to 90)
    74 (56 to 87)
    29 (13 to 49)
    48 (27 to 69)
    59 (39 to 78)
    43 (24 to 63)
    72 (51 to 88)
    58 (37 to 78)
        Serogroup Y
    61 (42 to 77)
    71 (53 to 85)
    71 (44 to 90)
    42 (25 to 61)
    29 (16 to 45)
    30 (14 to 50)
    24 (9 to 45)
    43 (23 to 66)
    22 (7 to 44)
    57 (34 to 78)
    57 (34 to 77)
    10 (2 to 27)
    76 (58 to 89)
    61 (43 to 77)
    76 (50 to 93)
    53 (35 to 90)
    32 (16 to 52)
    26 (10 to 48)
    44 (25 to 65)
    21 (8 to 41)
    64 (43 to 82)
    63 (41 to 81)
    Notes
    [2] - No. subjects serogroup C: 32 No. subjects serogroup W: 32
    [3] - No. subjects serogroup C: 34 No. subjects serogroup W: 34 No. subjects serogroup Y: 34
    [4] - No. subjects serogroup C: 17 No. subjects serogroup Y: 17
    [5] - No. subjects serogroup C: 21 No. subjects serogroup W: 26
    [6] - No. subjects serogroup C: 24
    [7] - No. subjects serogroup C: 22
    [8] - No. subjects serogroup C: 21 No. subjects serogroup W: 24 No. subjects serogroup Y: 23
    [9] - No. subjects serogroup C: 22 No. subjects serogroup Y: 21 No. subjects serogroup W: 21
    [10] - No. subjects serogroup Y: 23
    [11] - No. subjects serogroup W: 29
    [12] - No. subjects serogroup C: 32
    [13] - No. subjects serogroup C: 36 No. subjects serogroup W: 36 No. subjects serogroup Y: 36
    [14] - No. subjects serogroup C: 33
    [15] - No. subjects serogroup C: 20
    [16] - No. subjects serogroup C: 22
    [17] - No. subjects serogroup C: 26
    [18] - No. subjects serogroup C: 26
    [19] - No. subjects serogroup C: 24
    No statistical analyses for this end point

    Secondary: Percentages of subjects with hSBA ≥1:4 for each of meningococcal serogroups A, C, W and Y

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    End point title
    		 Percentages of subjects with hSBA ≥1:4 for each of meningococcal serogroups A, C, W and Y
    End point description
    Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
    End point type
    Secondary
    End point timeframe
    40 months and 60 months of age
    End point values
    		 UK2,3,4,12+, 60 Months UK2,4,12+, 60 Months UK2,4C/12+, 60 Months UK2,4,12-, 60 Months UK Control, 60 Months Ca2,4,6+, 60 Months Ca2,4,6+/12PS, 60 Months Ca2,4,12+, 60 Months Ca2,4+/12PS, 60 Months Ca2,4,12-, 60 Months Ca2,4-/12PS, 60 Months Ca Control, 60 Months UK2,3,4,12+, 40 Months UK2,4,12+, 40 Months UK2,4C/12+, 40 Months UK2,4,12-, 40 Months Ca2,4,6+, 40 Months Ca2,4,6+/12PS, 40 Months Ca2,4,12+, 40 Months Ca2,4+/12PS, 40 Months Ca2,4,12-, 40 Months Ca2,4-/12PS, 40 Months
    Number of subjects analysed
    33 [20]
    35 [21]
    18 [22]
    31
    42
    27 [23]
    25 [24]
    23 [25]
    25 [26]
    23 [27]
    24 [28]
    30 [29]
    33 [30]
    37 [31]
    17
    34 [32]
    28 [33]
    23 [34]
    27 [35]
    28 [36]
    25 [37]
    24
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    15 (5 to 32)
    11 (3 to 27)
    22 (6 to 48)
    3 (0.082 to 17)
    0 (0 to 8)
    4 (0.094 to 19)
    0 (0 to 14)
    9 (1 to 28)
    4 (0 to 20)
    9 (1 to 28)
    0 (0 to 14)
    7 (1 to 22)
    30 (16 to 49)
    8 (2 to 22)
    29 (10 to 56)
    3 (0.074 to 15)
    0 (0 to 12)
    4 (0 to 22)
    11 (2 to 29)
    7 (1 to 24)
    8 (1 to 26)
    0 (0 to 14)
        Serogroup C
    50 (32 to 68)
    44 (27 to 62)
    71 (44 to 90)
    52 (33 to 70)
    40 (26 to 57)
    24 (8 to 47)
    29 (13 to 51)
    32 (14 to 55)
    48 (26 to 70)
    59 (36 to 79)
    58 (37 to 78)
    67 (47 to 83)
    47 (29 to 65)
    53 (35 to 70)
    71 (44 to 90)
    42 (25 to 61)
    20 (6 to 44)
    14 (3 to 35)
    38 (20 to 59)
    54 (33 to 73)
    54 (33 to 74)
    54 (33 to 74)
        Serogroup W
    69 (50 to 84)
    85 (69 to 95)
    83 (59 to 96)
    84 (66 to 95)
    36 (22 to 52)
    31 (14 to 52)
    52 (31 to 72)
    61 (39 to 80)
    50 (29 to 71)
    81 (58 to 95)
    67 (45 to 84)
    34 (18 to 54)
    73 (54 to 87)
    69 (52 to 84)
    71 (44 to 90)
    85 (69 to 95)
    29 (13 to 49)
    52 (31 to 73)
    63 (42 to 81)
    54 (34 to 72)
    72 (51 to 88)
    71 (49 to 87)
        Serogroup Y
    73 (54 to 87)
    79 (62 to 91)
    76 (50 to 93)
    55 (36 to 73)
    33 (20 to 50)
    48 (29 to 68)
    40 (21 to 61)
    57 (34 to 77)
    35 (16 to 57)
    62 (38 to 82)
    61 (39 to 80)
    13 (4 to 31)
    76 (58 to 89)
    78 (61 to 90)
    88 (64 to 99)
    71 (53 to 85)
    50 (31 to 69)
    35 (16 to 57)
    59 (39 to 78)
    43 (24 to 63)
    68 (46 to 85)
    63 (41 to 81)
    Notes
    [20] - No. subjects serogroup C: 32 No. subjects serogroup W: 32
    [21] - No. subjects serogroup C: 34 No. subjects serogroup W: 34 No. subjects serogroup Y: 34
    [22] - No. subjects serogroup C: 17 No. subjects serogroup Y: 17
    [23] - No. subjects serogroup C: 21 No. subjects serogroup W: 26
    [24] - No. subjects serogroup C: 24
    [25] - No. subjects serogroup C: 22
    [26] - No. subjects serogroup C: 21 No. subjects serogroup W: 24 No. subjects serogroup Y: 23
    [27] - No. subjects serogroup C: 22 No. subjects serogroup W: 21 No. subjects serogroup Y: 21
    [28] - No. subjects serogroup Y: 23
    [29] - No. subjects serogroup W: 29
    [30] - No. subjects serogroup C: 32
    [31] - No. subjects serogroup C: 36 No. subjects serogroup W: 36 No. subjects serogroup Y: 36
    [32] - No. subjects serogroup C: 33
    [33] - No. subjects serogroup C: 20
    [34] - No. subjects serogroup C: 22
    [35] - No. subjects serogroup C: 26
    [36] - No. subjects serogroup C: 26
    [37] - No. subjects serogroup C: 24
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) in subjects within each site and in age-matched control subjects for each of meningococcal serogroups A, C, W and Y

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    End point title
    		 Geometric Mean Titers (GMTs) in subjects within each site and in age-matched control subjects for each of meningococcal serogroups A, C, W and Y
    End point description
    End point type
    Secondary
    End point timeframe
    40 months and 60 months of age
    End point values
    		 UK2,3,4,12+, 60 Months UK2,4,12+, 60 Months UK2,4C/12+, 60 Months UK2,4,12-, 60 Months UK Control, 60 Months Ca2,4,6+, 60 Months Ca2,4,6+/12PS, 60 Months Ca2,4,12+, 60 Months Ca2,4+/12PS, 60 Months Ca2,4,12-, 60 Months Ca2,4-/12PS, 60 Months Ca Control, 60 Months UK2,3,4,12+, 40 Months UK2,4,12+, 40 Months UK2,4C/12+, 40 Months UK2,4,12-, 40 Months Ca2,4,6+, 40 Months Ca2,4,6+/12PS, 40 Months Ca2,4,12+, 40 Months Ca2,4+/12PS, 40 Months Ca2,4,12-, 40 Months Ca2,4-/12PS, 40 Months
    Number of subjects analysed
    33 [38]
    35 [39]
    18 [40]
    31
    42
    27 [41]
    25 [42]
    23 [43]
    25 [44]
    23 [45]
    24 [46]
    30 [47]
    33 [48]
    37 [49]
    17
    34 [50]
    28 [51]
    23 [52]
    27 [53]
    28 [54]
    25 [55]
    24
    Units: titer
    geometric mean (confidence interval 95%)
        Serogroup A
    2.6 (2.12 to 3.19)
    2.69 (2.21 to 3.28)
    2.85 (2.16 to 3.75)
    2.11 (1.71 to 2.61)
    2 (1.67 to 2.39)
    2.08 (1.77 to 2.45)
    2 (1.69 to 2.36)
    2.37 (1.99 to 2.82)
    2.2 (1.86 to 2.6)
    2.36 (1.98 to 2.8)
    2 (1.69 to 2.37)
    2.24 (1.91 to 2.62)
    3.75 (2.76 to 5.11)
    2.58 (1.93 to 3.45)
    4.33 (2.82 to 6.66)
    2.08 (1.54 to 2.82)
    2.01 (1.69 to 2.39)
    2.17 (1.79 to 2.62)
    2.56 (2.15 to 3.05)
    2.11 (1.77 to 2.5)
    2.41 (2.01 to 2.89)
    2 (1.66 to 2.4)
        Serogroup C
    4.98 (3.28 to 7.55)
    4.69 (3.13 to 7.04)
    14 (8.15 to 26)
    6.77 (4.43 to 10)
    3.93 (2.73 to 5.65)
    2.75 (1.77 to 4.26)
    2.86 (1.9 to 4.3)
    3.22 (2.11 to 4.92)
    4.02 (2.6 to 6.21)
    4.85 (3.17 to 7.4)
    6.27 (4.18 to 9.41)
    9.46 (6.48 to 14)
    6.43 (3.85 to 11)
    7.02 (4.33 to 11)
    23 (11 to 46)
    4.29 (2.59 to 7.11)
    3.18 (1.98 to 5.1)
    2.68 (1.71 to 4.2)
    4.17 (2.77 to 6.27)
    5.45 (3.62 to 8.2)
    4.98 (3.26 to 7.62)
    6.45 (4.22 to 9.86)
        Serogroup W
    18 (10 to 32)
    35 (20 to 60)
    34 (16 to 72)
    26 (15 to 45)
    6.51 (3.99 to 11)
    3.77 (2.14 to 6.64)
    7.26 (4.08 to 13)
    10 (5.77 to 19)
    7.02 (3.9 to 13)
    24 (13 to 45)
    19 (11 to 35)
    5.02 (2.88 to 8.73)
    23 (13 to 42)
    27 (15 to 47)
    22 (9.65 to 50)
    26 (14 to 46)
    3.86 (2.15 to 6.93)
    6.77 (3.55 to 13)
    12 (6.72 to 22)
    7.55 (4.22 to 14)
    23 (13 to 43)
    16 (8.63 to 30)
        Serogroup Y
    11 (6.87 to 18)
    17 (10 to 27)
    16 (8.03 to 32)
    7.24 (4.35 to 12)
    4.36 (2.81 to 6.75)
    5.24 (3.32 to 8.27)
    4.49 (2.79 to 7.22)
    6.44 (3.94 to 11)
    3.73 (2.27 to 6.12)
    11 (6.57 to 18)
    11 (6.88 to 18)
    2.82 (1.8 to 4.42)
    22 (13 to 38)
    15 (9.16 to 26)
    27 (13 to 58)
    9.33 (5.48 to 16)
    5.54 (3.39 to 9.06)
    4.3 (2.49 to 7.4)
    7.41 (4.5 to 12)
    3.96 (2.42 to 6.46)
    13 (7.47 to 21)
    11 (6.2 to 18)
    Notes
    [38] - No. subjects serogroup C: 32 No. subjects serogroup W: 32
    [39] - No. subjects serogroup C: 34 No. subjects serogroup W: 34 No. subjects serogroup Y: 34
    [40] - No. subjects serogroup C: 17 No. subjects serogroup Y: 17
    [41] - No. subjects serogroup C: 21 No. subjects serogroup W: 26
    [42] - No. subjects serogroup C: 24
    [43] - No. subjects serogroup C: 22
    [44] - No. subjects serogroup C: 21 No. subjects serogroup W: 24 No. subjects serogroup Y: 23
    [45] - No. subjects serogroup C: 22 No. subjects serogroup W: 21 No. subjects serogroup Y: 21
    [46] - No. subjects serogroup Y: 23
    [47] - No. subjects serogroup W: 29
    [48] - No. subjects serogroup C: 32
    [49] - No. subjects serogroup C: 36 No. subjects serogroup W: 36 No. subjects serogroup Y: 36
    [50] - No. subjects serogroup C: 33
    [51] - No. subjects serogroup C: 20
    [52] - No. subjects serogroup C: 22
    [53] - No. subjects serogroup C: 26
    [54] - No. subjects serogroup C: 26
    [55] - No. subjects serogroup C: 24
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Adverse event reporting additional description
    The medically significant AEs and SAEs were collected among the subjects during the 6-month follow-up after the vaccination visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    UK2,3,4,12+
    Reporting group description
    		 UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Reporting group title
    UK2,4,12+
    Reporting group description
    		 UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Reporting group title
    UK2,4C/12+
    Reporting group description
    		 UK vaccine group receiving primary vaccine of monovalent MenC-CRM conjugate vaccine at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Reporting group title
    UK2,4,12-
    Reporting group description
    		 UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Reporting group title
    UK Control
    Reporting group description
    		 Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.

    Reporting group title
    Ca2,4,6+
    Reporting group description
    		 Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.

    Reporting group title
    Ca2,4,6+/12PS
    Reporting group description
    		 Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM1 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Reporting group title
    Ca2,4,12+
    Reporting group description
    		 Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 12 months of age.

    Reporting group title
    Ca2,4+/12PS
    Reporting group description
    		 Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Reporting group title
    Ca2,4,12-
    Reporting group description
    		 Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 12 months of age.

    Reporting group title
    Ca2,4-/12PS
    Reporting group description
    		 Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (1/5 dose) at 12 months of age.

    Reporting group title
    Ca Control
    Reporting group description
    		 Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.

    Serious adverse events
    		 UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 33 (3.03%)
    0 / 16 (0.00%)
    3 / 29 (10.34%)
    0 / 26 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 16 (0.00%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Asperger's disorder
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 16 (0.00%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 16 (0.00%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 UK2,3,4,12+ UK2,4,12+ UK2,4C/12+ UK2,4,12- UK Control Ca2,4,6+ Ca2,4,6+/12PS Ca2,4,12+ Ca2,4+/12PS Ca2,4,12- Ca2,4-/12PS Ca Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 33 (12.12%)
    3 / 33 (9.09%)
    5 / 16 (31.25%)
    2 / 29 (6.90%)
    0 / 26 (0.00%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    3 / 24 (12.50%)
    1 / 26 (3.85%)
    2 / 22 (9.09%)
    2 / 25 (8.00%)
    0 / 23 (0.00%)
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 16 (6.25%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Otitis media
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 26 (0.00%)
    2 / 22 (9.09%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    3
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    3 / 24 (12.50%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    1
    0
    H1N1 Influenza
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 33 (3.03%)
    0 / 16 (0.00%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    1 / 26 (3.85%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 16 (6.25%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 33 (6.06%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Varicella
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Foot and mouth disease
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 16 (6.25%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 22 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22394992
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