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    Clinical Trial Results:
    A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age

    Summary
    EudraCT number
    		 2004-000195-13
    Trial protocol
    		 GB  
    Global end of trial date
    02 Oct 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2018
    First version publication date
    04 Nov 2018
    Other versions
    Summary report(s)
    		 V59P5 results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V59P5
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00262002
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccine and Diagnostics S.r.l
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure OFfice, Novartis Pharma AG, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000032-PIP01-07
    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
    02 Oct 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2004
    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 Kingdom: 316
    Country: Number of subjects enrolled
    Canada: 285
    Worldwide total number of subjects
    601
    EEA total number of subjects
    316
    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)
    601
    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
    		 Participants were enrolled at two centers in Canada and one in UK.

    Pre-assignment
    Screening details
    		 The two selected countries provided data on different infant vaccination schedules (at 2 and 4 months of age; at 2, 3, and 4 months of age: and at 2, 4, and 6 months of age), and on different recommended concomitant vaccinations.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Data analyst [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 UK234+ (MenACWY Ad+ at 2,3,4 m)
    Arm description
    		 Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY Conjugate vaccine was obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be resuspended with the MenCWY component.

    Arm title
    		 UK24+ (MenACWY Ad+ at 2,4 m)
    Arm description
    		 Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY Conjugate vaccine was obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be resuspended with the MenCWY component.

    Arm title
    		 UKMenC (Menjugate at 2,4m)
    Arm description
    		 Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menjugate C
    Investigational medicinal product code
    Other name
    Menomune
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menjugate C vaccine was reconstituted before injection.

    Arm title
    		 CA246+ (MenACWY Ad+ at 2,4,6m)
    Arm description
    		 Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY Conjugate vaccine was obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be resuspended with the MenCWY component.

    Arm title
    		 CA24+ (MenACWY Ad+ at 2,4m)
    Arm description
    		 Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY Conjugate vaccine was obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be resuspended with the MenCWY component.

    Arm title
    		 UK24- (MenACWY Ad- at 2,4m)
    Arm description
    		 Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY Ad- Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY Conjugate vaccine without adjuvant was obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be resuspended with the MenCWY component.

    Arm title
    		 CA24- (MenACWY Ad- at 2,4m)
    Arm description
    		 Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY Ad- Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenACWY Conjugate vaccine without adjuvant was obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be resuspended with the MenCWY component.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: open-label trial but the people who analyzed the data were blinded.
    Number of subjects in period 1
    		UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m)
    Started
    90
    90
    45
    98
    98
    90
    90
    Completed
    79
    84
    45
    93
    91
    83
    84
    Not completed
    11
    6
    0
    5
    7
    7
    6
         Consent withdrawn by subject
    4
    2
    -
    1
    2
    2
    2
         Adverse event, non-fatal
    2
    1
    -
    -
    -
    1
    -
         Unable to classify
    -
    -
    -
    -
    -
    -
    2
         Lost to follow-up
    2
    -
    -
    2
    -
    1
    -
         Protocol deviation
    3
    2
    -
    2
    5
    3
    2
         Inapropriate enrollment
    -
    1
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    UK234+ (MenACWY Ad+ at 2,3,4 m)
    Reporting group description
    		 Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.

    Reporting group title
    UK24+ (MenACWY Ad+ at 2,4 m)
    Reporting group description
    		 Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Reporting group title
    UKMenC (Menjugate at 2,4m)
    Reporting group description
    		 Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Reporting group title
    CA246+ (MenACWY Ad+ at 2,4,6m)
    Reporting group description
    		 Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Reporting group title
    CA24+ (MenACWY Ad+ at 2,4m)
    Reporting group description
    		 Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Reporting group title
    UK24- (MenACWY Ad- at 2,4m)
    Reporting group description
    		 Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.

    Reporting group title
    CA24- (MenACWY Ad- at 2,4m)
    Reporting group description
    		 Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Reporting group values
    		 UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m) Total
    Number of subjects
    		 90 90 45 98 98 90 90 601
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 90 90 45 98 98 90 90 601
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0 0
    Age Continuous
    Units: days
        arithmetic mean (standard deviation)
    		 62.1 ( 5.4 ) 61.3 ( 5.0 ) 62.6 ( 6.5 ) 65.6 ( 6.9 ) 65.8 ( 6.9 ) 64.1 ( 5.5 ) 69.4 ( 10.0 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 44 41 26 52 49 48 44 304
        Male
    		 46 49 19 46 49 42 46 297

    End points

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    End points reporting groups
    Reporting group title
    UK234+ (MenACWY Ad+ at 2,3,4 m)
    Reporting group description
    		 Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.

    Reporting group title
    UK24+ (MenACWY Ad+ at 2,4 m)
    Reporting group description
    		 Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Reporting group title
    UKMenC (Menjugate at 2,4m)
    Reporting group description
    		 Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Reporting group title
    CA246+ (MenACWY Ad+ at 2,4,6m)
    Reporting group description
    		 Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Reporting group title
    CA24+ (MenACWY Ad+ at 2,4m)
    Reporting group description
    		 Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Reporting group title
    UK24- (MenACWY Ad- at 2,4m)
    Reporting group description
    		 Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.

    Reporting group title
    CA24- (MenACWY Ad- at 2,4m)
    Reporting group description
    		 Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK234+ (MenACWY Ad+ at 2, 3, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK234+ (MenACWY Ad+ at 2, 3, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Subject analysis set title
    UK24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.

    Subject analysis set title
    UK234+ (MenACWY Ad+ at 2, 3, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UKMenC (Menjugate 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Subject analysis set title
    UK24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Subject analysis set title
    UK24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose ( of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UKMenC (Menjugate at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK234+ (MenACWY Ad+ at 2, 3, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK234+ (MenACWY Ad+ at 2, 3, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2,4,6 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4,6 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK234+ (MenACWY Ad+ at 2, 3, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.

    Subject analysis set title
    UK24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK234+ (MenACWY Ad+ at 2, 3, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UKMenC (Menjugate at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK234+ (MenACWY Ad+ at 2, 3, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.

    Subject analysis set title
    UK24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Subject analysis set title
    UKMenC (Menjugate at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24+ (MenACWY Ad+ at 2, 4 m) - PS
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    UK24- (MenACWY Ad- at 2, 4 m)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m) - ACWY
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Subject analysis set title
    CA24- (MenACWY Ad- at 2, 4 m) - PS
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Primary: Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine [1]
    End point description
    Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.
    End point type
    Primary
    End point timeframe
    Baseline and at 1 month after the 3 dose primary vaccination series
    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 statistics.
    End point values
    		 UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Number of subjects analysed
    81
    87
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A - baseline (n=69,80)|
    6 (2 to 14)
    0 (0 to 5)
        Ser A - 1 month after primary vacc (n=69,80)|
    93 (84 to 98)
    81 (71 to 89)
        Ser C - baseline (n=79,86)|
    18 (10 to 28)
    15 (8 to 24)
        Ser C - 1 month after primary vacc (n=79,86)|
    96 (89 to 99)
    98 (92 to 100)
        Ser W - baseline (n=69,78)|
    54 (41 to 66)
    31 (21 to 42)
        Ser W - 1 month after primary vacc (n=69,78)|
    97 (90 to 100)
    99 (93 to 100)
        Ser Y - baseline|
    21 (13 to 31)
    17 (10 to 27)
        Ser Y - 1 month after primary vacc|
    94 (86 to 98)
    98 (92 to 100)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 doses of MenACWY Ad+ conjugate vaccine

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 doses of MenACWY Ad+ conjugate vaccine
    End point description
    Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.
    End point type
    Secondary
    End point timeframe
    Baseline and 1 month after the 3 dose primary vaccination series
    End point values
    		 UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6m)
    Number of subjects analysed
    81
    87
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A - baseline (n=69,80)|
    4 (1 to 12)
    0 (0 to 5)
        Ser A - 1 month after primary vacc (n=69,80)|
    88 (78 to 95)
    76 (65 to 85)
        Ser C - baseline (n=79,86)|
    9 (4 to 17)
    5 (1 to 11)
        Ser C - 1 month after primary vacc (n=79,86)|
    92 (84 to 97)
    98 (92 to 100)
        Ser W - baseline (n=69,78)|
    46 (34 to 59)
    28 (19 to 40)
        Ser W - 1 month after primary vacc (n=69,78)|
    88 (78 to 95)
    96 (89 to 99)
        Ser Y - baseline|
    14 (7 to 23)
    11 (6 to 20)
        Ser Y - 1 month after primary vaccination|
    93 (85 to 97)
    89 (80 to 94)
    No statistical analyses for this end point

    Secondary: Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine

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    End point title
    		 Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
    End point description
    Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.
    End point type
    Secondary
    End point timeframe
    Baseline and 1 month after the 3 dose primary vaccination series
    End point values
    		 UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Number of subjects analysed
    81
    87
    Units: titers
    geometric mean (confidence interval 95%)
        Ser A - baseline (n=69,80)|
    2.2 (2.04 to 2.38)
    2 (1.86 to 2.15)
        Ser A - 1 month after primary vacc (n=69,80)|
    53 (38 to 74)
    21 (15 to 29)
        Ser C - baseline (n=79,86)|
    2.79 (2.36 to 3.31)
    2.64 (2.25 to 3.11)
        Ser C - 1 month after primary vacc (n=79,86)|
    79 (56 to 112)
    124 (89 to 172)
        Ser W - baseline (n=69,78)|
    5.76 (4.39 to 7.57)
    4.03 (3.12 to 5.21)
        Ser W - 1 month after primary vacc (n=69,78)|
    65 (46 to 92)
    73 (53 to 102)
        Ser Y - baseline|
    2.72 (2.34 to 3.17)
    2.64 (2.28 to 3.05)
        Ser Y - 1 month after primary vacc|
    56 (41 to 77)
    2.64 (2.28 to 3.05)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines
    End point description
    Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.
    End point type
    Secondary
    End point timeframe
    Baseline and 1 month after second vaccination
    End point values
    		 UK24+ (MenACWY Ad+ at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
    Number of subjects analysed
    77
    79
    79
    85
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A-hSBA≥1:4, baseline (N=68,79,78,83)
    4 (1 to 12)
    3 (0 to 9)
    3 (0 to 9)
    4 (1 to 10)
        Ser A-hSBA≥1:4, 1m after 2nd vac(N=68,79,78,83)
    60 (48 to 72)
    66 (54 to 76)
    50 (38 to 62)
    57 (45 to 67)
        Ser A-hSBA≥1:8, baseline (N=68,79,78,83)
    3 (0 to 10)
    1 (0.032 to 7)
    0 (0 to 5)
    1 (0.03 to 7)
        Ser A-hSBA≥1:8,1m after 2nd vac(N=68,79,78,83)
    54 (42 to 67)
    58 (47 to 69)
    44 (32 to 55)
    49 (38 to 61)
        Ser C-hSBA≥1:4,baseline (N=77,74,79,85)
    13 (6 to 23)
    15 (8 to 25)
    20 (12 to 31)
    20 (12 to 30)
        Ser C-hSBA ≥1:4,1m after 2nd vac(N=77,74,79,85)
    84 (74 to 92)
    91 (81 to 96)
    86 (76 to 93)
    93 (85 to 97)
        Ser C-hSBA≥1:8,baseline (N=77,74,79,85)
    9 (4 to 18)
    15 (8 to 25)
    5 (1 to 12)
    11 (5 to 19)
        Ser C-hSBA≥1:8,1m after 2nd vac(N=77,74,79,85)
    83 (73 to 91)
    85 (75 to 92)
    82 (72 to 90)
    89 (81 to 95)
        Ser W-hSB≥1:4, baseline (N=73,74,72,75)
    45 (34 to 57)
    24 (15 to 36)
    43 (31 to 55)
    19 (11 to 29)
        Ser W-hSBA≥1:4,1m after 2nd vac(N=73,74,72,75)
    92 (83 to 97)
    91 (81 to 96)
    82 (71 to 90)
    95 (87 to 99)
        Ser W-hSBA≥1:8, baseline (N=73,74,72,75)
    37 (26 to 49)
    19 (11 to 30)
    36 (25 to 48)
    16 (9 to 26)
        Ser W-hSBA≥1:8,1m after 2nd vac(N=73,74,72,75)
    84 (73 to 91)
    85 (75 to 92)
    75 (63 to 84)
    92 (83 to 97)
        Ser Y-hSBA≥1:4, baseline (N=76,74,77,85)
    18 (10 to 29)
    9 (4 to 19)
    35 (25 to 47)
    18 (10 to 27)
        Ser Y-hSBA ≥1:4,1m after 2nd vac(N=76,74,77,85)
    84 (74 to 92)
    86 (77 to 93)
    74 (63 to 83)
    91 (82 to 96)
        Ser Y-hSBA≥1:8, baseline (N=76,74,77,85)
    7 (2 to 15)
    4 (1 to 11)
    16 (8 to 26)
    11 (5 to 19)
        Ser Y-hSBA≥1:8,1m after 2nd vacc(N=76,74,77,85)
    76 (65 to 85)
    80 (69 to 88)
    70 (59 to 80)
    86 (77 to 92)
    No statistical analyses for this end point

    Secondary: Geometric Mean hSBA titer (GMTs) following 2 doses of MenACWY Ad+ and MenACWY Ad- conjugate vaccines

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    End point title
    		 Geometric Mean hSBA titer (GMTs) following 2 doses of MenACWY Ad+ and MenACWY Ad- conjugate vaccines
    End point description
    Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.
    End point type
    Secondary
    End point timeframe
    Baseline and 1 month after second vaccination
    End point values
    		 UK24+ (MenACWY Ad+ at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
    Number of subjects analysed
    77
    79
    79
    85
    Units: titers
    geometric mean (confidence interval 95%)
        Ser A - baseline (n=68,79,78,83)|
    2.17 (2.01 to 2.35)
    2.07 (1.93 to 2.23)
    2.05 (1.91 to 2.21)
    2.08 (1.94 to 2.23)
        Ser A - 1 month after 2nd vacc (n=68,79,78,83)|
    12 (8.36 to 16)
    11 (7.91 to 15)
    7.3 (5.31 to 10)
    7.16 (5.26 to 9.73)
        Ser C - baseline (n=77,74,79,85)|
    2.54 (2.14 to 3.02)
    2.77 (2.33 to 3.31)
    2.48 (2.09 to 2.94)
    2.87 (2.44 to 3.39)
        Ser C - 1 month after 2nd vacc (n=77,74,79,85)|
    52 (37 to 74)
    55 (38 to 79)
    40 (28 to 57)
    69 (49 to 96)
        Ser W - baseline (n=73,74,79,75)|
    5.33 (4.09 to 6.94)
    3.6 (2.77 to 4.69)
    5.14 (3.94 to 6.71)
    3.02 (2.33 to 3.93)
        Ser W - 1 month after 2nd vacc (n=73,74,79,75)|
    48 (34 to 67)
    44 (31 to 61)
    29 (20 to 40)
    69 (50 to 96)
        Ser Y - baseline (n=76,74,77,85)|
    2.56 (2.19 to 2.99)
    2.27 (1.94 to 2.66)
    3.39 (2.9 to 3.96)
    2.76 (2.38 to 3.21)
        Ser Y - 1 month after 2nd vacc (n=76,74,77,85)|
    26 (19 to 37)
    27 (19 to 38)
    21 (15 to 29)
    41 (30 to 56)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 against N. Meningitidis serogroups A, C, W & Y after a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 against N. Meningitidis serogroups A, C, W & Y after a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
    End point description
    Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.
    End point type
    Secondary
    End point timeframe
    at 12 months of age and 1 month after booster vaccination
    End point values
    		 UK24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
    Number of subjects analysed
    67
    63
    65
    40
    40
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A-hSBA≥1:4,at 12m of age(n=64,61,62,39,38)
    8 (3 to 17)
    7 (2 to 16)
    21 (12 to 33)
    5 (1 to 17)
    3 (0.067 to 14)
        Ser A-hSBA≥1:4, 1m after booster vac
    86 (75 to 93)
    79 (66 to 88)
    94 (84 to 98)
    92 (79 to 98)
    95 (82 to 99)
        Ser A-hSBA ≥1:8, at 12 m of age
    5 (1 to 13)
    5 (1 to 14)
    13 (6 to 24)
    3 (0.065 to 13)
    3 (0.067 to 14)
        Ser A-hSBA ≥1:8, 1 m after booster vaccination
    83 (71 to 91)
    77 (65 to 87)
    92 (82 to 97)
    90 (76 to 97)
    92 (79 to 98)
        Ser C-hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40)
    40 (28 to 53)
    33 (22 to 46)
    60 (47 to 72)
    48 (32 to 64)
    33 (19 to 49)
        Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40)
    96 (87 to 99)
    94 (85 to 98)
    98 (92 to 100)
    98 (87 to 100)
    100 (91 to 100)
        Ser C-hSBA≥1:8, at 12 m of age(n=67,40,65,40,40)
    34 (23 to 47)
    27 (17 to 40)
    52 (40 to 65)
    35 (21 to 52)
    25 (13 to 41)
        Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40)
    96 (87 to 99)
    94 (85 to 98)
    98 (92 to 100)
    95 (83 to 99)
    100 (91 to 100)
        Ser W-hSBA≥1:4, at 12 m of age(n=57,41,57,35,35)
    56 (42 to 69)
    54 (37 to 69)
    81 (68 to 90)
    74 (57 to 88)
    69 (51 to 83)
        Ser W-hSBA≥1:4, 1m after booster vaccination
    100 (94 to 100)
    100 (91 to 100)
    100 (94 to 100)
    100 (90 to 100)
    100 (90 to 100)
        Ser W-hSBA≥1:8, at 12 m of age(n=57,41,40,35,35)
    47 (34 to 61)
    41 (26 to 58)
    68 (55 to 80)
    49 (31 to 66)
    54 (37 to 71)
        Ser W-hSBA≥1:8,1m after booster(n=57,41,57,35,35)
    100 (94 to 100)
    100 (91 to 100)
    100 (94 to 100)
    100 (90 to 100)
    100 (90 to 100)
        Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38)|
    52 (39 to 64)
    52 (39 to 65)
    86 (75 to 93)
    65 (48 to 79)
    63 (46 to 78)
        Ser Y-hSBA≥1:4, 1 m after booster vaccination
    100 (95 to 100)
    100 (94 to 100)
    100 (94 to 100)
    100 (91 to 100)
    100 (91 to 100)
        Ser Y-hSBA ≥1:8, at 12 months of age
    39 (28 to 52)
    41 (29 to 54)
    72 (60 to 83)
    45 (29 to 62)
    53 (36 to 69)
        Ser Y-hSBA≥1:8, 1 m after booster vaccination
    100 (95 to 100)
    100 (94 to 100)
    100 (94 to 100)
    100 (91 to 100)
    100 (91 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean hSBA Titers (GMT) after a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines

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    End point title
    		 Geometric Mean hSBA Titers (GMT) after a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
    End point description
    Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.
    End point type
    Secondary
    End point timeframe
    at 12 months of age and 1 month after booster vaccination
    End point values
    		 UK24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA24- (MenACWY Ad- at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4m)
    Number of subjects analysed
    67
    63
    65
    40
    40
    Units: titers
    geometric mean (confidence interval 95%)
        Ser A - at 12 months of age (n=64,61,62,39,38)|
    2.31 (2 to 2.66)
    2.22 (1.92 to 2.57)
    2.97 (2.57 to 3.44)
    2.07 (1.65 to 2.6)
    2.18 (1.74 to 2.73)
        Ser A - 1 month after booster (n=64,61,62,39,38)|
    47 (31 to 72)
    30 (19 to 47)
    134 (87 to 207)
    59 (38 to 93)
    67 (43 to 106)
        Ser C - at 12 months of age(n=67,63,65,40,40)|
    5.18 (3.83 to 7.02)
    3.94 (2.88 to 5.39)
    7.94 (5.84 to 11)
    4.07 (2.73 to 6.06)
    4.64 (3.11 to 6.91)
        Ser C - 1 month after booster(n=67,63,65,40,40)|
    236 (159 to 349)
    129 (86 to 194)
    429 (288 to 639)
    258 (56 to 426)
    216 (130 to 356)
        Ser W - at 12 months of age(n=57,41,57,35,35)|
    8.1 (5.76 to 11)
    6.49 (4.34 to 9.7)
    16 (11 to 23)
    11 (7.04 to 17)
    8.84 (5.63 to 14)
        Ser W - 1 month after booster (n=57,41,57,35,35)|
    503 (347 to 732)
    311 (200 to 485)
    792 (544 to 1154)
    402 (236 to 684)
    381 (224 to 650)
        Ser Y - at 12 months of age (n=66,63,65,40,38)|
    6.65 (4.88 to 9.06)
    6.83 (4.98 to 9.37)
    19 (14 to 26)
    7.63 (5 to 12)
    7.99 (5.29 to 12)
        Ser Y- 1 month after booster(n=66,63,65,40,38)|
    508 (358 to 723)
    438 (305 to 628)
    1395 (979 to 1989)
    527 (322 to 862)
    308 (191 to 499)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W and Y following 2 doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- vaccine or Novartis Menjugate vaccine

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W and Y following 2 doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- vaccine or Novartis Menjugate vaccine
    End point description
    The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.
    End point type
    Secondary
    End point timeframe
    at 12 months of age
    End point values
    		 UKMenC (Menjugate 2, 4 m) UK24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
    Number of subjects analysed
    38
    69
    66
    77
    81
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A-hSBA≥1:4, at 12m of age(n=36,62,65,77,78)
    0 (0 to 10)
    8 (3 to 18)
    6 (2 to 15)
    8 (3 to 16)
    5 (1 to 13)
        Ser A-hSBA≥1:8, at 12m of age(n=36,62,65,77,78)
    0 (0 to 10)
    5 (1 to 13)
    5 (1 to 13)
    5 (1 to 13)
    4 (1 to 11)
        Ser C-hSBA≥1:4, at 12m of age(n=38,69,69,73,81)
    89 (75 to 97)
    41 (29 to 53)
    32 (21 to 44)
    48 (36 to 60)
    35 (24 to 46)
        Ser C-hSBA≥1:8, at 12m of age(n=38,69,69,73,81)
    87 (72 to 96)
    33 (22 to 46)
    26 (16 to 38)
    40 (28 to 52)
    30 (20 to 41)
        Ser W-hSBA≥1:4, at 12m of age(n=34,62,42,69,69)
    9 (2 to 24)
    58 (45 to 70)
    57 (41 to 72)
    64 (51 to 75)
    75 (64 to 85)
        Ser W-hSBA≥1:8, at 12m of age(n=34,62,42,69,69)
    6 (1 to 20)
    48 (35 to 61)
    45 (30 to 61)
    52 (40 to 64)
    61 (48 to 72)
        Ser Y-hSBA≥1:4, at 12m of age(n=38,69,66,73,79)
    5 (1 to 18)
    51 (38 to 63)
    56 (43 to 68)
    60 (48 to 72)
    59 (48 to 70)
        Ser Y-hSBA≥1:8, at 12m of age(n=38,69,66,73,79)
    3 (0.067 to 14)
    42 (30 to 55)
    45 (33 to 58)
    51 (39 to 63)
    46 (34 to 57)
    No statistical analyses for this end point

    Secondary: Geometric Mean hSBA Titers (GMTs) after 2 doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate vaccine.

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    End point title
    		 Geometric Mean hSBA Titers (GMTs) after 2 doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate vaccine.
    End point description
    The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.
    End point type
    Secondary
    End point timeframe
    at 12 months of age
    End point values
    		 UK24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m) UKMenC (Menjugate at 2, 4 m)
    Number of subjects analysed
    69
    66
    77
    81
    38
    Units: titers
    geometric mean (confidence interval 95%)
        Ser A - at 12 months of age (n=36,62,65,77,78)|
    2.32 (1.97 to 2.73)
    2.2 (1.88 to 2.58)
    2.29 (1.98 to 2.65)
    2.18 (1.89 to 2.52)
    2 (1.62 to 2.48)
        Ser C - at 12 months of age (n=36,69,69,73,82)|
    5.04 (3.73 to 6.81)
    3.85 (2.85 to 5.21)
    5.43 (4.05 to 7.27)
    4.42 (3.35 to 5.84)
    27 (18 to 40)
        Ser W - at 12 months of age (n=34,62,42,69,69)|
    8.38 (6.03 to 12)
    7.02 (4.71 to 10)
    8.15 (5.97 to 11)
    12 (8.81 to 16)
    2.42 (1.55 to 3.78)
        Ser Y - at 12 months of age (n=38,69,66,73,79)|
    6.72 (4.92 to 9.18)
    7.64 (5.55 to 11)
    7.84 (5.79 to 11)
    7.12 (5.32 to 9.54)
    2.15 (1.41 to 3.28)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y following 3 doses of Novartis MenACWY Ad+ conjugate vaccine

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y following 3 doses of Novartis MenACWY Ad+ conjugate vaccine
    End point description
    The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.
    End point type
    Secondary
    End point timeframe
    at 12 months of age
    End point values
    		 UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Number of subjects analysed
    71
    86
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A - hSBA ≥1:4, at 12 months of age (n=58,79)|
    21 (11 to 33)
    35 (25 to 47)
        Ser A - hSBA ≥1:8, at 12 months of age(n=58,79)|
    16 (7 to 27)
    29 (19 to 40)
        Ser C - hSBA ≥1:4, at 12 months of age(n=70,84)|
    59 (46 to 70)
    75 (64 to 84)
        Ser C - hSBA ≥1:8, at 12 months of age(n=70,84)|
    47 (35 to 59)
    68 (57 to 78)
        Ser W - hSBA ≥1:4, at 12 months of age(n=58,75)|
    78 (65 to 87)
    89 (80 to 95)
        Ser W - hSBA ≥1:8, at 12 months of age(n=58,75)|
    66 (52 to 78)
    81 (71 to 89)
        Ser Y - hSBA ≥1:4, at 12 months of age(n=71,86)|
    85 (74 to 92)
    87 (78 to 93)
        Ser Y - hSBA ≥1:8, at 12 months of age(n=71,86)|
    70 (58 to 81)
    79 (69 to 87)
    No statistical analyses for this end point

    Secondary: Geometric Mean hSBA Titers (GMTs) following 3 doses of Novartis MenACWY Ad+ conjugate vaccine

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    End point title
    		 Geometric Mean hSBA Titers (GMTs) following 3 doses of Novartis MenACWY Ad+ conjugate vaccine
    End point description
    The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.
    End point type
    Secondary
    End point timeframe
    at 12 months of age
    End point values
    		 UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Number of subjects analysed
    71
    86
    Units: Titers
    geometric mean (confidence interval 95%)
        Ser A - at 12 months of age (n=58,79)|
    3.02 (2.55 to 3.57)
    3.93 (3.4 to 4.54)
        Ser C - at 12 months of age (n=70,84)|
    7.56 (5.61 to 10)
    14 (10 to 18)
        Ser W - at 12 months of age (n=58,75)|
    15 (10 to 21)
    20 (15 to 27)
        Ser Y - at 12 months of age (n=71,86)|
    18 (13 to 24)
    22 (17 to 29)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in subjects challenged with a reduced dose of licensed Meningococcal ACWY PS vaccine following 3 doses of Novartis MenACWY Ad+ conjugate vaccine

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in subjects challenged with a reduced dose of licensed Meningococcal ACWY PS vaccine following 3 doses of Novartis MenACWY Ad+ conjugate vaccine
    End point description
    The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.
    End point type
    Secondary
    End point timeframe
    before challenge at 12 months of age and 1 month after PS challenge.
    End point values
    		 CA246+ (MenACWY Ad+ at 2,4,6 m)
    Number of subjects analysed
    44
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A-hSBA≥1:4,before challenge at 12m (n=44)|
    27 (15 to 43)
        Ser A - hSBA ≥1:4, 1 month after PS (n=44)|
    89 (75 to 96)
        Ser A-hSBA ≥1:8,before challenge at 12m (n=44)|
    23 (11 to 38)
        Ser A - hSBA ≥1:8, 1 month after PS (n=44)|
    86 (73 to 95)
        Ser C-hSBA ≥1:4,before challenge at 12m (n=43)|
    74 (59 to 86)
        Ser C - hSBA ≥1:4, 1 month after PS (n=43)|
    95 (84 to 99)
        Ser C-hSBA ≥1:8, before challenge at 12m (n=43)|
    65 (49 to 79)
        Ser C - hSBA ≥1:8, 1 month after PS (n=43)|
    91 (78 to 97)
        Ser W-hSBA ≥1:4,before challenge at 12m (n=40)|
    83 (67 to 93)
        Ser W - hSBA ≥1:4, 1 month after PS (n=40)|
    98 (87 to 100)
        Ser W-hSBA ≥1:8,before challenge at 12m (n=40)|
    73 (56 to 85)
        Ser W - hSBA ≥1:8, 1 month after PS (n=40)|
    95 (83 to 99)
        Ser Y-hSBA ≥1:4,before challenge at 12m (n=44)|
    89 (75 to 96)
        Ser Y - hSBA ≥1:4, 1 month after PS (n=44)|
    98 (88 to 100)
        Ser Y-hSBA ≥1:8,before challenge at 12m (N=44)|
    77 (62 to 89)
        Ser Y - hSBA ≥1:8, 1 month after PS (n=44)|
    98 (88 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean hSBA Titers (GMTs) in subjects challenged with a reduced dose of licensed Meningococcal ACWY PS vaccine following 3 doses of Novartis MenACWY Ad+ conjugate vaccine

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    End point title
    		 Geometric Mean hSBA Titers (GMTs) in subjects challenged with a reduced dose of licensed Meningococcal ACWY PS vaccine following 3 doses of Novartis MenACWY Ad+ conjugate vaccine
    End point description
    The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.
    End point type
    Secondary
    End point timeframe
    before challenge at 12 months of age and 1 month after PS challenge.
    End point values
    		 CA246+ (MenACWY Ad+ at 2, 4,6 m)
    Number of subjects analysed
    44
    Units: titers
    geometric mean (confidence interval 95%)
        Ser A-before challenge at 12m of age(n=44)
    3.4 (2.75 to 4.2)
        Ser A-1 m after PS challenge (n=44)
    32 (21 to 48)
        Ser C-before challenge at 12m of age(n=43)
    12 (8.41 to 18)
        Ser C-1m after PS challenge (n=43)
    82 (50 to 133)
        Ser W-before challenge at 12m of age(n=40)
    17 (11 to 25)
        Ser W-1m after PS challenge (n=40)
    249 (152 to 410)
        Ser Y-before challenge at 12m of age(n=44)
    19 (13 to 28)
        Ser Y-1m after PS challenge (n=44)
    186 (117 to 294)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in subjects challenged with a reduced dose of licensed Meningococcal ACWY PS vaccine following two doses of Novartis MenACWY Ad+ or MenACWY Ad- conjugate vaccine

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    End point title
    		 Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in subjects challenged with a reduced dose of licensed Meningococcal ACWY PS vaccine following two doses of Novartis MenACWY Ad+ or MenACWY Ad- conjugate vaccine
    End point description
    The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.
    End point type
    Secondary
    End point timeframe
    Before challenge at 12 months of age and 1 month after PS challenge.
    End point values
    		 CA24+ (MenACWY Ad+ at 2, 4m) CA24- (MenACWY Ad- at 2, 4m)
    Number of subjects analysed
    42
    39
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A-hSBA≥1:4,before challenge @ 12m (n=40,39)
    8 (2 to 20)
    8 (2 to 21)
        Ser A-hSBA≥1:4,1m after PS (n=40,39)|
    78 (62 to 89)
    92 (79 to 98)
        Ser A-hSBA≥1:8,before challenge at 12m (n=40,39)|
    5 (1 to 17)
    5 (1 to 17)
        Ser A-hSBA ≥1:8, 1m after PS (n=40,39)|
    78 (62 to 89)
    87 (73 to 96)
        Ser C-hSBA≥1:4,before challenge at 12m (n=41,39)|
    44 (28 to 60)
    38 (23 to 55)
        Ser C hSBA ≥1:4, 1m after PS (n=41,39)|
    95 (83 to 99)
    95 (83 to 99)
        Ser C-hSBA≥1:8,before challenge at 12m(n=41,39)|
    39 (24 to 55)
    36 (21 to 53)
        Ser C-hSBA ≥1:8, 1m after PS (n=41,39)
    93 (80 to 98)
    90 (76 to 97)
        Ser W-hSBA≥1:4,before challenge at 12m(n=41,38)
    59 (42 to 74)
    71 (54 to 85)
        Ser W-hSBA≥1:4, 1m after PS (n=41,38)
    98 (87 to 100)
    100 (91 to 100)
        Ser W-hSBA≥1:8,before challenge at 12m(n=41,38)
    51 (35 to 67)
    58 (41 to 74)
        Ser W-hSBA≥1:8, 1m after PS (n=41,38)
    98 (87 to 100)
    100 (91 to 100)
        Ser Y-hSBA ≥1:4,before challenge at 12m(n=42,38)
    55 (39 to 70)
    55 (38 to 71)
        Ser Y-hSBA ≥1:4, 1m after PS (n=42,38)
    98 (87 to 100)
    100 (91 to 100)
        Ser Y-hSBA≥1:8,before challenge at 12m (n=42,38)
    50 (34 to 66)
    42 (26 to 59)
        Ser Y-hSBA≥1:8, 1m after PS (n=42,38)
    98 (87 to 100)
    97 (86 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean hSBA Titers (GMTs) in subjects challenged with a reduced dose of licensed Meningococcal ACWY PS vaccine following two doses of Novartis MenACWY Ad+ or MenACWY Ad- conjugate vaccine

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    End point title
    		 Geometric Mean hSBA Titers (GMTs) in subjects challenged with a reduced dose of licensed Meningococcal ACWY PS vaccine following two doses of Novartis MenACWY Ad+ or MenACWY Ad- conjugate vaccine
    End point description
    Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.
    End point type
    Secondary
    End point timeframe
    Before challenge at 12 months of age and 1 month after PS challenge.
    End point values
    		 CA24+ (MenACWY Ad+ at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
    Number of subjects analysed
    42
    39
    Units: titers
    geometric mean (confidence interval 95%)
        Ser A - before challenge at 12 months (n=40,39)|
    2.22 (1.77 to 2.76)
    2.31 (1.84 to 2.89)
        Ser A - 1 month after PS challenge (n=40,39)|
    28 (18 to 44)
    55 (35 to 86)
        Ser C - before challenge at 12 months (n=41,39)|
    5.21 (3.51 to 7.72)
    5.07 (3.38 to 7.59)
        Ser C - 1 month after PS challenge (n=41,39)|
    140 (85 to 231)
    181 (109 to 301)
        Ser W - before challenge at 12 months (n=41,38)|
    7.48 (4.94 to 11)
    11 (7.08 to 17)
        Ser W - 1 month after PS challenge (n=41,38)|
    365 (224 to 597)
    555 (333 to 924)
        Ser Y - before challenge at 12 months (n=42,38)|
    6.73 (4.51 to 10)
    6.79 (4.45 to 10)
        Ser Y - 1 month after PS challenge (n=42,38)|
    280 (175 to 448)
    288 (176 to 472)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ conjugate vaccine

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    End point title
    		 Percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ conjugate vaccine
    End point description
    The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.
    End point type
    Secondary
    End point timeframe
    Baseline and 1 month after the 2 or 3 dose primary vaccination series
    End point values
    		 UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6m) UK24+ (MenACWY Ad+ at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4m)
    Number of subjects analysed
    81
    87
    77
    79
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A-hSBA≥1:4, baseline (n=69,80,38,79)
    6 (2 to 14)
    0 (0 to 5)
    4 (1 to 12)
    3 (0 to 9)
        Ser A-hSBA≥1:4,1m after 1st vac(n=69,80,38,79)
    93 (84 to 98)
    81 (71 to 89)
    60 (48 to 72)
    66 (54 to 76)
        Ser A-hSBA≥1:8, baseline (n=69,80,38,79)
    4 (1 to 12)
    0 (0 to 5)
    3 (0 to 10)
    1 (0.032 to 7)
        Ser A-hSBA≥1:8,1m after 1st vac (n=69,80,38,79)
    88 (78 to 95)
    76 (65 to 85)
    54 (42 to 67)
    58 (47 to 69)
        Ser C -hSBA≥1:4, baseline (n=79,86,40,74)
    18 (10 to 28)
    15 (8 to 24)
    13 (6 to 23)
    15 (8 to 25)
        Ser C-hSBA≥1:4,1m after 1st vac(n=79,86,40,74)
    96 (89 to 99)
    98 (92 to 100)
    84 (74 to 92)
    91 (81 to 96)
        Ser C-hSBA≥1:8, baseline (n=79,86,40,74)
    9 (4 to 17)
    5 (1 to 11)
    9 (4 to 18)
    15 (8 to 25)
        Ser C-hSBA≥1:8,1m after 1st vac(n=79,86,40,74)
    92 (84 to 97)
    98 (92 to 100)
    83 (73 to 91)
    85 (75 to 92)
        Ser W - hSBA ≥1:4, baseline (n=69,78,73,74)|
    54 (41 to 66)
    31 (21 to 42)
    45 (34 to 57)
    24 (15 to 36)
        Ser W-hSBA≥1:4,1m after 1st vac(n=69,78,73,74)
    97 (90 to 100)
    99 (93 to 100)
    92 (83 to 97)
    91 (81 to 96)
        Ser W-hSBA≥1:8, baseline (n=69,78,73,74)
    46 (34 to 59)
    28 (19 to 40)
    37 (26 to 49)
    19 (11 to 30)
        Ser W-hSBA≥1:8,1m after 1st vac(n=69,78,73,74)
    88 (78 to 95)
    96 (89 to 99)
    84 (73 to 91)
    85 (75 to 92)
        Ser Y-hSBA≥1:4, baseline (n=81,87,76,74)
    21 (13 to 31)
    17 (10 to 27)
    18 (10 to 29)
    9 (4 to 19)
        Ser Y-hSBA≥1:4,1m after 1st vac(n=81,87,76,74)
    94 (86 to 98)
    98 (92 to 100)
    84 (74 to 92)
    86 (77 to 93)
        Ser Y-hSBA ≥1:8, baseline (n=81,87,76,74)
    14 (7 to 23)
    11 (6 to 20)
    7 (2 to 15)
    4 (1 to 11)
        Ser Y-hSBA≥1:8,1m after 1st vac(n=81,87,76,74)
    93 (85 to 97)
    89 (80 to 94)
    76 (65 to 85)
    80 (69 to 88)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 in subjects challenged with a reduced dose of a licensed Meningococcal ACWY PS vaccine following 2 or 3 doses of MenACWY Ad+ conjugate vaccine

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    End point title
    		 Percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 in subjects challenged with a reduced dose of a licensed Meningococcal ACWY PS vaccine following 2 or 3 doses of MenACWY Ad+ conjugate vaccine
    End point description
    The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.
    End point type
    Secondary
    End point timeframe
    at 12 months of age and 1 month after PS challenge
    End point values
    		 CA24+ (MenACWY Ad+ at 2, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6m)
    Number of subjects analysed
    42
    44
    Units: percentages of subjects
    number (confidence interval 95%)
        Ser A - hSBA ≥1:4, at 12 months of age (n=44,40)|
    8 (2 to 20)
    27 (15 to 43)
        Ser A - hSBA ≥1:4, at 1 month after PS (n=44,40)|
    78 (62 to 89)
    89 (75 to 96)
        Ser A - hSBA ≥1:8, at 12 months of age (n=44,40)|
    5 (1 to 17)
    23 (11 to 38)
        Ser A - hSBA ≥1:8, at 1 month after PS (n=44,40)|
    78 (62 to 89)
    86 (73 to 95)
        Ser C - hSBA ≥1:4, at 12 months of age (n=43,41)|
    44 (28 to 60)
    74 (59 to 86)
        Ser C - hSBA ≥1:4, at 1 month after PS (n=43,41)|
    95 (83 to 99)
    95 (84 to 99)
        Ser C - hSBA ≥1:8, at 12 months of age (n=43,41)|
    39 (24 to 55)
    65 (49 to 79)
        Ser C - hSBA ≥1:8, at 1 month after PS (n=43,41)|
    93 (80 to 98)
    91 (78 to 97)
        Ser W - hSBA ≥1:4, at 12 months of age (n=40,41)|
    59 (42 to 74)
    83 (67 to 93)
        Ser W - hSBA ≥1:4, at 1 month after PS (n=40,41)|
    98 (87 to 100)
    98 (87 to 100)
        Ser W - hSBA ≥1:8, at 12 months of age (n=40,41)|
    51 (35 to 67)
    73 (56 to 85)
        Ser W - hSBA ≥1:8, at 1 month after PS (n=40,41)|
    98 (87 to 100)
    95 (83 to 99)
        Ser Y - hSBA ≥1:4, at 12 months of age (n=44,42)|
    55 (39 to 70)
    89 (75 to 96)
        Ser Y - hSBA ≥1:4, at 1 month after PS (n=44,42)|
    98 (87 to 100)
    98 (88 to 100)
        Ser Y - hSBA ≥1:8, at 12 months of age (n=44,42)|
    50 (34 to 66)
    77 (62 to 89)
        Ser Y - hSBA ≥1:8, at 1 month after PS (n=44,42)|
    98 (87 to 100)
    98 (88 to 100)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with Antibody response to routine vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) when routine vaccines are given concomitantly with Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines

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    End point title
    		 Percentages of subjects with Antibody response to routine vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) when routine vaccines are given concomitantly with Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines
    End point description
    To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.
    End point type
    Secondary
    End point timeframe
    Baseline and 1 month after the 2 or 3 dose primary vaccination series
    End point values
    		 CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m) UK234+ (MenACWY Ad+ at 2, 3, 4 m) UK24+ (MenACWY Ad+ at 2, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
    Number of subjects analysed
    70
    77
    70
    73
    72
    73
    Units: percentages of subjects
    number (confidence interval 95%)
        Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72)
    75 (64 to 85)
    79 (68 to 88)
    70 (58 to 80)
    93 (83 to 98)
    87 (77 to 94)
    71 (59 to 81)
        Antitetanus≥0.1 IU/mL-1m post (69,71,70,67,69,72)
    100 (95 to 100)
    100 (95 to 100)
    99 (92 to 100)
    100 (95 to 100)
    100 (95 to 100)
    100 (95 to 100)
        antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72)
    17 (9 to 28)
    14 (7 to 24)
    3 (0 to 10)
    18 (10 to 29)
    19 (10 to 30)
    15 (8 to 26)
        antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72)
    96 (88 to 99)
    97 (90 to 100)
    100 (95 to 100)
    97 (90 to 100)
    96 (88 to 99)
    100 (95 to 100)
        antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73)
    36 (25 to 48)
    42 (30 to 53)
    17 (9 to 28)
    25 (15 to 36)
    49 (37 to 61)
    37 (26 to 49)
        antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73)
    74 (62 to 84)
    95 (87 to 99)
    67 (54 to 78)
    97 (90 to 100)
    97 (90 to 100)
    100 (95 to 100)
        antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73)
    10 (4 to 20)
    17 (9 to 27)
    3 (0 to 10)
    7 (2 to 15)
    17 (9 to 27)
    11 (5 to 20)
        antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73)
    33 (22 to 45)
    86 (76 to 93)
    35 (24 to 47)
    82 (71 to 90)
    82 (71 to 90)
    86 (76 to 93)
        antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67)
    23 (14 to 35)
    999 (999 to 999)
    11 (4 to 21)
    999 (999 to 999)
    999 (999 to 999)
    22 (13 to 34)
        antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67)
    85 (74 to 92)
    999 (999 to 999)
    92 (83 to 97)
    999 (999 to 999)
    999 (999 to 999)
    97 (90 to 100)
    No statistical analyses for this end point

    Secondary: ELISA GMT Concentrations for routine vaccines (Hib, diphtheria, tetanus, Hepatitis B) when given concomitantly with Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines for Hib, Diphtheria, Tetanus, Hepatitis B

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    End point title
    		 ELISA GMT Concentrations for routine vaccines (Hib, diphtheria, tetanus, Hepatitis B) when given concomitantly with Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
    End point description
    To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.
    End point type
    Secondary
    End point timeframe
    Baseline and 1 month after the 2 or 3 dose primary vaccination series
    End point values
    		 UK24+ (MenACWY Ad+ at 2, 4 m) UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m) CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
    Number of subjects analysed
    77
    70
    70
    73
    72
    73
    Units: titers
    geometric mean (confidence interval 95%)
        Tetanus - baseline (n=69,71,70,67,69,72)
    0.31 (0.24 to 0.4)
    0.32 (0.24 to 0.41)
    0.23 (0.18 to 0.29)
    0.28 (0.22 to 0.37)
    0.25 (0.19 to 0.32)
    0.18 (0.14 to 0.23)
        Tetanus - 1 m after 1st vac(n=69,71,70,67,69,72)
    0.92 (0.75 to 1.13)
    0.7 (0.57 to 0.87)
    1.4 (1.14 to 1.72)
    0.6 (0.48 to 0.73)
    0.97 (0.79 to 1.19)
    0.68 (0.55 to 0.83)
        Diphtheria - baseline (n=69,71,70,67,69,72)
    0.04 (0.03 to 0.053)
    0.035 (0.026 to 0.047)
    0.027 (0.02 to 0.035)
    0.031 (0.024 to 0.042)
    0.032 (0.024 to 0.042)
    0.016 (0.012 to 0.021)
        Diphtheria -1m after 1st vac(n=69,71,70,67,69,72)
    1.02 (0.82 to 1.28)
    1.02 (0.81 to 1.29)
    1.72 (1.38 to 2.14)
    1.06 (0.84 to 1.32)
    0.98 (0.78 to 1.22)
    1.49 (1.19 to 1.87)
        Hib - baseline (n=70,77,69,73,72,73)
    0.15 (0.11 to 0.21)
    0.078 (0.056 to 0.11)
    0.11 (0.078 to 0.15)
    0.089 (0.063 to 0.12)
    0.15 (0.11 to 0.21)
    0.064 (0.045 to 0.09)
        Hib - 1 m after 1st vac(n=70,77,69,73,72,73)
    4.55 (3.08 to 6.72)
    4.63 (3.14 to 6.83)
    4.53 (3.07 to 6.68)
    0.47 (0.32 to 0.7)
    5.67 (3.89 to 8.28)
    0.42 (0.28 to 0.63)
        Hepatitis B - baseline (n=65,na,66,na,na,67)
    999 (999 to 999)
    999 (999 to 999)
    5.9 (4.25 to 8.2)
    5.79 (4.15 to 8.09)
    999 (999 to 999)
    4.21 (3.03 to 5.87)
        Hepatitis B-1m after 1st vac(n=65,na,66,na,na,67)
    999 (999 to 999)
    999 (999 to 999)
    378 (258 to 554)
    69 (47 to 102)
    999 (999 to 999)
    133 (90 to 195)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis Serogroup C following 2 doses of MenACWY Ad+ or Ad- conjugate vaccine (containing 5 μg of MenC oligosaccharide) or 2 doses of Menjugate (containing 10 μg of MenC oligosaccharide)

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    End point title
    		 Percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis Serogroup C following 2 doses of MenACWY Ad+ or Ad- conjugate vaccine (containing 5 μg of MenC oligosaccharide) or 2 doses of Menjugate (containing 10 μg of MenC oligosaccharide)
    End point description
    The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.
    End point type
    Secondary
    End point timeframe
    Baseline and 1 month after second vaccination
    End point values
    		 UK24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m) UKMenC (Menjugate at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m)
    Number of subjects analysed
    77
    79
    85
    40
    74
    Units: percentages of subjects
    number (confidence interval 95%)
        hSBA ≥1:4, baseline
    13 (6 to 23)
    20 (12 to 31)
    20 (12 to 30)
    23 (11 to 38)
    15 (8 to 25)
        hSBA ≥1:4, 1 month after second vaccination
    84 (74 to 92)
    86 (76 to 93)
    93 (85 to 97)
    98 (87 to 100)
    91 (81 to 96)
        hSBA ≥1:8, baseline
    9 (4 to 18)
    5 (1 to 12)
    11 (5 to 19)
    10 (3 to 24)
    15 (8 to 25)
        hSBA ≥1:8, 1 month after second vaccination
    83 (73 to 91)
    82 (72 to 90)
    89 (81 to 95)
    98 (87 to 100)
    85 (75 to 92)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination series with MenACWY Ad+ or MenACWY Ad-

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    End point title
    		 Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination series with MenACWY Ad+ or MenACWY Ad-
    End point description
    Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.
    End point type
    Secondary
    End point timeframe
    7 days after each vaccination
    End point values
    		 UK234+ (MenACWY Ad+ at 2, 3, 4 m) UK24+ (MenACWY Ad+ at 2, 4 m) UKMenC (Menjugate at 2, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m) CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
    Number of subjects analysed
    90
    90
    45
    98
    98
    90
    90
    Units: subjects
        Tenderness
    40
    31
    18
    46
    32
    41
    35
        Erythema
    69
    64
    34
    73
    67
    78
    66
        Induration
    21
    24
    12
    36
    18
    40
    24
        Eating habit Change
    28
    25
    9
    35
    27
    21
    20
        Sleepiness
    56
    49
    25
    64
    62
    45
    52
        Persistent Crying
    7
    7
    6
    15
    4
    5
    4
        Irritability
    63
    71
    31
    80
    70
    61
    73
        Vomiting
    19
    26
    9
    23
    15
    14
    11
        Diarrhea
    29
    27
    12
    30
    22
    18
    16
        Fever (≥38°C)
    7
    4
    1
    14
    7
    5
    5
        Analgesics/Antipyretics
    43
    35
    18
    61
    46
    36
    45
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 months of age

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    End point title
    		 Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 months of age [2]
    End point description
    The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.
    End point type
    Secondary
    End point timeframe
    7 days after vaccination at 12 months of age
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: descriptive statistics.
    End point values
    		 UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2, 4 m) UKMenC (Menjugate at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY CA24+ (MenACWY Ad+ at 2, 4 m) - PS CA24- (MenACWY Ad- at 2, 4 m) - ACWY CA24- (MenACWY Ad- at 2, 4 m) - PS
    Number of subjects analysed
    90
    90
    45
    90
    48
    48
    47
    48
    44
    43
    Units: subjects
        Tenderness
    7
    11
    10
    10
    0
    10
    7
    10
    7
    12
        Erythema
    62
    58
    36
    66
    0
    21
    27
    30
    21
    26
        Induration
    21
    32
    18
    36
    0
    12
    9
    9
    10
    15
        Eating habit change
    11
    16
    5
    13
    10
    12
    6
    10
    10
    8
        Sleepiness
    11
    14
    9
    16
    10
    8
    7
    13
    9
    7
        Persistent crying
    0
    4
    3
    4
    3
    3
    0
    2
    5
    0
        Irritability
    26
    32
    20
    28
    24
    23
    19
    24
    17
    20
        Vomiting
    4
    6
    4
    8
    2
    7
    0
    4
    5
    4
        Diarrhea
    9
    9
    4
    9
    4
    7
    6
    5
    3
    4
        Fever (≥38°C)
    3
    7
    2
    14
    3
    6
    1
    8
    4
    1
        Analgesics/Antipyretics
    14
    21
    12
    22
    13
    15
    8
    17
    14
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
    Adverse event reporting additional description
    Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician’s visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    UK234+ (MenACWY Ad+ at 2,3,4 m)
    Reporting group description
    		 Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.

    Reporting group title
    UK24+ (MenACWY Ad+ at 2,4 m)
    Reporting group description
    		 Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.

    Reporting group title
    UKMenC (Menjugate at 2,4m)
    Reporting group description
    		 Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.

    Reporting group title
    CA246+ (MenACWY Ad+ at 2,4,6m)
    Reporting group description
    		 Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.

    Reporting group title
    CA24+ (MenACWY Ad+ at 2,4m)
    Reporting group description
    		 Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Reporting group title
    UK24- (MenACWY Ad- at 2,4m)
    Reporting group description
    		 Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.

    Reporting group title
    CA24- (MenACWY Ad- at 2,4m)
    Reporting group description
    		 Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.

    Serious adverse events
    		 UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 90 (22.22%)
    17 / 90 (18.89%)
    6 / 45 (13.33%)
    9 / 98 (9.18%)
    4 / 98 (4.08%)
    10 / 90 (11.11%)
    7 / 90 (7.78%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    ACROCHORDON EXCISION
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    CIRCUMCISION
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    HYDROCELE OPERATION
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    INGUINAL HERNIA REPAIR
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    2 / 98 (2.04%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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
    TENDON SHEATH INCISION
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    1 / 45 (2.22%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    General disorders and administration site conditions
    VOMITING
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    CYST
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    DEVELOPMENTAL DELAY
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    2 / 90 (2.22%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    FOOD ALLERGY
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    ASTHMA
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    2 / 90 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BRONCHIAL HYPERREACTIVITY
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 90 (0.00%)
    1 / 90 (1.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    WHEEZING
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    1 / 45 (2.22%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    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
    Injury, poisoning and procedural complications
    BURNS FIRST DEGREE
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 90 (1.11%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    BURNS SECOND DEGREE
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    FEMUR FRACTURE
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    HEAD INJURY
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 90 (1.11%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    INJURY
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    LIMB CRUSHING INJURY
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    1 / 45 (2.22%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    TRAUMATIC FRACTURE
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    1 / 45 (2.22%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Congenital, familial and genetic disorders
    CONGENITAL MEGACOLON
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    HYPOSPADIAS
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    PLAGIOCEPHALY
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    Cardiac disorders
    SUPRAVENTRICULAR TACHYCARDIA
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    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
    Nervous system disorders
    CONVULSION
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    FEBRILE CONVULSION
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    IDIOPATHIC THROMBOCYTOPENIC PURPURA
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Gastrointestinal disorders
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    1 / 90 (1.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    Skin and subcutaneous tissue disorders
    ERYTHEMA MULTIFORME
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 90 (1.11%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    PETECHIAE
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    RASH
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    1 / 45 (2.22%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Renal and urinary disorders
    URINARY RETENTION
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    ARTHRITIS BACTERIAL
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 90 (1.11%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    BRONCHIOLITIS
         subjects affected / exposed
    4 / 90 (4.44%)
    3 / 90 (3.33%)
    1 / 45 (2.22%)
    2 / 98 (2.04%)
    1 / 98 (1.02%)
    2 / 90 (2.22%)
    2 / 90 (2.22%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 1
    0 / 2
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CROUP INFECTIOUS
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 90 (0.00%)
    1 / 90 (1.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 90 (0.00%)
    2 / 90 (2.22%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    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
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 90 (1.11%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    INFECTED CYST
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    INFLUENZA
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 90 (1.11%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 90 (1.11%)
    1 / 45 (2.22%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    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
    PNEUMONIA
         subjects affected / exposed
    0 / 90 (0.00%)
    2 / 90 (2.22%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    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
    RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY SYNCYTIAL VIRUS INFECTION
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    SALMONELLOSIS
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 90 (1.11%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    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
    VARICELLA
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    VIRAL INFECTION
         subjects affected / exposed
    4 / 90 (4.44%)
    2 / 90 (2.22%)
    1 / 45 (2.22%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    0 / 1
    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
    VIRAL RASH
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    0 / 90 (0.00%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    90 / 90 (100.00%)
    89 / 90 (98.89%)
    45 / 45 (100.00%)
    97 / 98 (98.98%)
    97 / 98 (98.98%)
    90 / 90 (100.00%)
    89 / 90 (98.89%)
    Nervous system disorders
    SOMNOLENCE
    alternative assessment type: Systematic
         subjects affected / exposed
    58 / 90 (64.44%)
    57 / 90 (63.33%)
    29 / 45 (64.44%)
    68 / 98 (69.39%)
    70 / 98 (71.43%)
    57 / 90 (63.33%)
    63 / 90 (70.00%)
         occurrences all number
    58
    57
    29
    68
    70
    57
    63
    General disorders and administration site conditions
    CRYING
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 90 (7.78%)
    11 / 90 (12.22%)
    8 / 45 (17.78%)
    19 / 98 (19.39%)
    8 / 98 (8.16%)
    14 / 90 (15.56%)
    9 / 90 (10.00%)
         occurrences all number
    7
    11
    8
    19
    8
    14
    9
    INJECTION SITE ERYTHEMA
    alternative assessment type: Systematic
         subjects affected / exposed
    79 / 90 (87.78%)
    79 / 90 (87.78%)
    40 / 45 (88.89%)
    73 / 98 (74.49%)
    78 / 98 (79.59%)
    84 / 90 (93.33%)
    68 / 90 (75.56%)
         occurrences all number
    79
    79
    40
    73
    78
    84
    68
    INJECTION SITE INDURATION
    alternative assessment type: Systematic
         subjects affected / exposed
    39 / 90 (43.33%)
    43 / 90 (47.78%)
    25 / 45 (55.56%)
    42 / 98 (42.86%)
    25 / 98 (25.51%)
    59 / 90 (65.56%)
    36 / 90 (40.00%)
         occurrences all number
    39
    43
    25
    42
    25
    59
    36
    INJECTION SITE PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    42 / 90 (46.67%)
    39 / 90 (43.33%)
    23 / 45 (51.11%)
    50 / 98 (51.02%)
    41 / 98 (41.84%)
    45 / 90 (50.00%)
    45 / 90 (50.00%)
         occurrences all number
    42
    39
    23
    50
    41
    45
    45
    IRRITABILITY
    alternative assessment type: Systematic
         subjects affected / exposed
    69 / 90 (76.67%)
    82 / 90 (91.11%)
    39 / 45 (86.67%)
    85 / 98 (86.73%)
    85 / 98 (86.73%)
    77 / 90 (85.56%)
    82 / 90 (91.11%)
         occurrences all number
    69
    82
    39
    85
    85
    77
    82
    PYREXIA
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 90 (12.22%)
    13 / 90 (14.44%)
    3 / 45 (6.67%)
    30 / 98 (30.61%)
    22 / 98 (22.45%)
    19 / 90 (21.11%)
    21 / 90 (23.33%)
         occurrences all number
    11
    13
    3
    30
    22
    19
    21
    Eye disorders
    CONJUNCTIVITIS
         subjects affected / exposed
    3 / 90 (3.33%)
    9 / 90 (10.00%)
    3 / 45 (6.67%)
    3 / 98 (3.06%)
    1 / 98 (1.02%)
    12 / 90 (13.33%)
    1 / 90 (1.11%)
         occurrences all number
    3
    9
    3
    3
    1
    12
    1
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    7 / 90 (7.78%)
    1 / 90 (1.11%)
    2 / 45 (4.44%)
    8 / 98 (8.16%)
    6 / 98 (6.12%)
    1 / 90 (1.11%)
    2 / 90 (2.22%)
         occurrences all number
    7
    1
    2
    8
    6
    1
    2
    DIARRHOEA
    alternative assessment type: Systematic
         subjects affected / exposed
    41 / 90 (45.56%)
    40 / 90 (44.44%)
    18 / 45 (40.00%)
    37 / 98 (37.76%)
    34 / 98 (34.69%)
    36 / 90 (40.00%)
    25 / 90 (27.78%)
         occurrences all number
    41
    40
    18
    37
    34
    36
    25
    VOMITING
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 90 (26.67%)
    37 / 90 (41.11%)
    13 / 45 (28.89%)
    29 / 98 (29.59%)
    23 / 98 (23.47%)
    28 / 90 (31.11%)
    20 / 90 (22.22%)
         occurrences all number
    24
    37
    13
    29
    23
    28
    20
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    10 / 90 (11.11%)
    7 / 90 (7.78%)
    9 / 45 (20.00%)
    3 / 98 (3.06%)
    6 / 98 (6.12%)
    16 / 90 (17.78%)
    2 / 90 (2.22%)
         occurrences all number
    10
    7
    9
    3
    6
    16
    2
    NASAL CONGESTION
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    3 / 98 (3.06%)
    6 / 98 (6.12%)
    0 / 90 (0.00%)
    4 / 90 (4.44%)
         occurrences all number
    0
    0
    0
    3
    6
    0
    4
    RHINORRHOEA
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    1 / 45 (2.22%)
    5 / 98 (5.10%)
    2 / 98 (2.04%)
    0 / 90 (0.00%)
    3 / 90 (3.33%)
         occurrences all number
    0
    0
    1
    5
    2
    0
    3
    Skin and subcutaneous tissue disorders
    DERMATITIS DIAPER
         subjects affected / exposed
    6 / 90 (6.67%)
    3 / 90 (3.33%)
    1 / 45 (2.22%)
    6 / 98 (6.12%)
    7 / 98 (7.14%)
    2 / 90 (2.22%)
    1 / 90 (1.11%)
         occurrences all number
    6
    3
    1
    6
    7
    2
    1
    DRY SKIN
         subjects affected / exposed
    4 / 90 (4.44%)
    0 / 90 (0.00%)
    1 / 45 (2.22%)
    4 / 98 (4.08%)
    1 / 98 (1.02%)
    5 / 90 (5.56%)
    0 / 90 (0.00%)
         occurrences all number
    4
    0
    1
    4
    1
    5
    0
    ECZEMA
         subjects affected / exposed
    8 / 90 (8.89%)
    13 / 90 (14.44%)
    5 / 45 (11.11%)
    15 / 98 (15.31%)
    8 / 98 (8.16%)
    8 / 90 (8.89%)
    7 / 90 (7.78%)
         occurrences all number
    8
    13
    5
    15
    8
    8
    7
    RASH
         subjects affected / exposed
    3 / 90 (3.33%)
    4 / 90 (4.44%)
    3 / 45 (6.67%)
    5 / 98 (5.10%)
    3 / 98 (3.06%)
    2 / 90 (2.22%)
    8 / 90 (8.89%)
         occurrences all number
    3
    4
    3
    5
    3
    2
    8
    RASH PAPULAR
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    5 / 98 (5.10%)
    1 / 98 (1.02%)
    0 / 90 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    0
    0
    5
    1
    0
    1
    Psychiatric disorders
    EATING DISORDER
    alternative assessment type: Systematic
         subjects affected / exposed
    34 / 90 (37.78%)
    42 / 90 (46.67%)
    17 / 45 (37.78%)
    45 / 98 (45.92%)
    42 / 98 (42.86%)
    37 / 90 (41.11%)
    38 / 90 (42.22%)
         occurrences all number
    34
    42
    17
    45
    42
    37
    38
    Infections and infestations
    BRONCHIOLITIS
         subjects affected / exposed
    8 / 90 (8.89%)
    4 / 90 (4.44%)
    1 / 45 (2.22%)
    3 / 98 (3.06%)
    5 / 98 (5.10%)
    3 / 90 (3.33%)
    0 / 90 (0.00%)
         occurrences all number
    8
    4
    1
    3
    5
    3
    0
    CROUP INFECTIOUS
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 90 (0.00%)
    0 / 45 (0.00%)
    3 / 98 (3.06%)
    5 / 98 (5.10%)
    1 / 90 (1.11%)
    2 / 90 (2.22%)
         occurrences all number
    1
    0
    0
    3
    5
    1
    2
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    9 / 90 (10.00%)
    8 / 90 (8.89%)
    0 / 45 (0.00%)
    2 / 98 (2.04%)
    0 / 98 (0.00%)
    9 / 90 (10.00%)
    0 / 90 (0.00%)
         occurrences all number
    9
    8
    0
    2
    0
    9
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    13 / 98 (13.27%)
    14 / 98 (14.29%)
    0 / 90 (0.00%)
    14 / 90 (15.56%)
         occurrences all number
    0
    1
    0
    13
    14
    0
    14
    ORAL CANDIDIASIS
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 45 (0.00%)
    2 / 98 (2.04%)
    5 / 98 (5.10%)
    1 / 90 (1.11%)
    0 / 90 (0.00%)
         occurrences all number
    0
    1
    0
    2
    5
    1
    0
    OTITIS MEDIA
         subjects affected / exposed
    6 / 90 (6.67%)
    7 / 90 (7.78%)
    1 / 45 (2.22%)
    9 / 98 (9.18%)
    7 / 98 (7.14%)
    12 / 90 (13.33%)
    4 / 90 (4.44%)
         occurrences all number
    6
    7
    1
    9
    7
    12
    4
    RHINITIS
         subjects affected / exposed
    30 / 90 (33.33%)
    34 / 90 (37.78%)
    15 / 45 (33.33%)
    2 / 98 (2.04%)
    0 / 98 (0.00%)
    39 / 90 (43.33%)
    0 / 90 (0.00%)
         occurrences all number
    30
    34
    15
    2
    0
    39
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    7 / 90 (7.78%)
    10 / 90 (11.11%)
    8 / 45 (17.78%)
    21 / 98 (21.43%)
    25 / 98 (25.51%)
    3 / 90 (3.33%)
    20 / 90 (22.22%)
         occurrences all number
    7
    10
    8
    21
    25
    3
    20
    VIRAL INFECTION
         subjects affected / exposed
    6 / 90 (6.67%)
    7 / 90 (7.78%)
    1 / 45 (2.22%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    4 / 90 (4.44%)
    0 / 90 (0.00%)
         occurrences all number
    6
    7
    1
    0
    1
    4
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jul 2004
    A telephone call to be performed during the 6-month follow-up after LPLV, remove OPV vaccine in the UK routine infant vaccination, the administration of diphtheria, tetanus, whole cell pertussis, H influenzae type b vaccine, and poliomyelitis vaccine was replaced by diphtheria, tetanus, acellular pertussis, H influenzae type b, inactivated polio vaccine.
    26 Oct 2004
    Two new study groups were added to the study design.
    30 Nov 2004
    to get confirmatory data on the final vaccine formulation without adjuvant
    09 May 2005
    the criterion for visit 5 was updated.
    22 Jun 2005
    this amendment was implemented to reassess the use f a booster dose in the UK arm.

    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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