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    Clinical Trial Results:
    A phase III, randomized, open, controlled, multicenter primary vaccination study to demonstrate the non inferiority of the immunogenicity of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine when given as one dose with Twinrix™ versus GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine alone and versus Twinrix™ alone in healthy subjects aged 11 through 17 years

    Summary
    EudraCT number
    		 2006-005999-41
    Trial protocol
    		 SE   DK  
    Global end of trial date
    28 Apr 2008

    Results information
    Results version number
    		 v1
    This version publication date
    11 May 2016
    First version publication date
    26 Feb 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    109063
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00465816
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jan 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine co-administered with Twinrix as compared to the MenACWY-TT conjugate vaccine administered alone with respect to the serum bactericidal antibody geometric mean titres as measured using baby rabbit complement (rSBA GMTs) for N. meningitidis serogroups A, C, W-135 and Y. To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine co-administered with Twinrix as compared to Twinrix administered alone with respect to the percentage of seroconversion for hepatitis A and percentage of seroprotection for hepatitis B.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Apr 2007
    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
    Sweden: 337
    Country: Number of subjects enrolled
    Denmark: 274
    Worldwide total number of subjects
    611
    EEA total number of subjects
    611
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    611
    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
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix + Twinrix Group
    Arm description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix (Meningococcal vaccine 134612)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection

    Investigational medicinal product name
    Twinrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.

    Arm title
    		 Nimenrix Group
    Arm description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nimenrix (Meningococcal vaccine 134612)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection

    Arm title
    		 Twinrix Group
    Arm description
    		 Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Twinrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.

    Number of subjects in period 1
    		Nimenrix + Twinrix Group Nimenrix Group Twinrix Group
    Started
    367
    122
    122
    Completed
    367
    122
    120
    Not completed
    0
    0
    2
         Lost to follow-up
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix + Twinrix Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0.

    Reporting group title
    Twinrix Group
    Reporting group description
    		 Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

    Reporting group values
    		 Nimenrix + Twinrix Group Nimenrix Group Twinrix Group Total
    Number of subjects
    		 367 122 122 611
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        log mean (standard deviation)
    		 14.3 ± 1.89 14.3 ± 1.84 14.3 ± 1.94 -
    Gender categorical
    Units: Subjects
        Female
    		 195 61 68 324
        Male
    		 172 61 54 287

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix + Twinrix Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0.

    Reporting group title
    Twinrix Group
    Reporting group description
    		 Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

    Primary: Antibody titers for meningococcal polysaccharide serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY)

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    End point title
    		 Antibody titers for meningococcal polysaccharide serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) [1]
    End point description
    At 1 month after vaccination with Nimenrix vaccine (Month 1)
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination with Nimenrix vaccine (Month 1)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    360
    115
    Units: Titer
    geometric mean (confidence interval 95%)
        rSBA-MenA (N= 353; 113)
    5263.9 (4818 to 5751)
    5211.7 (4509.8 to 6022.8)
        rSBA-MenC (N= 360; 115)
    4344.6 (3800.3 to 4966.8)
    4926.9 (3684.8 to 6587.7)
        rSBA-MenW-135 (N= 360; 115)
    8922.1 (8278.4 to 9615.9)
    8987.7 (7628.9 to 10588.6)
        rSBA-MenY (N= 360; 115)
    9291.5 (8537.7 to 10111.9)
    9492.8 (8172.4 to 11026.6)
    Statistical analysis title
    		 Non-inferiority in term of rSBA-MenA GMT
    Statistical analysis description
    To assess the Non-inferiority of the Nimenrix + Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre. Non-inferiority criterion: Lower limit of the two-sided 95% CI ≥ 0.5.
    Comparison groups
    Nimenrix + Twinrix Group v Nimenrix Group
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.22
    Statistical analysis title
    		 Non-inferiority in term of rSBA-MenC GMT
    Statistical analysis description
    To assess the Non-inferiority of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre. Non-inferiority criterion: Lower limit of the two-sided 95% CI ≥ 0.5.
    Comparison groups
    Nimenrix + Twinrix Group v Nimenrix Group
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.21
    Statistical analysis title
    		 Non-inferiority in term of rSBA-MenW-135 GMT
    Statistical analysis description
    To assess the Non-inferiority of the Nimenrix+Twinrixgroup compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre. Non-inferiority criterion: Lower limit of the two-sided 95% CI ≥ 0.5.
    Comparison groups
    Nimenrix Group v Nimenrix + Twinrix Group
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.19
    Statistical analysis title
    		 Non-inferiority in term of rSBA-MenY GMT
    Statistical analysis description
    To assess the Non-inferiority of the Nimenrix+Twinrixgroup compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre. Non-inferiority criterion: Lower limit of the two-sided 95% CI ≥ 0.5.
    Comparison groups
    Nimenrix + Twinrix Group v Nimenrix Group
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.19

    Primary: Number of subjects seroconverted for hepatitis A

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    End point title
    		 Number of subjects seroconverted for hepatitis A [2]
    End point description
    A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
    End point type
    Primary
    End point timeframe
    At 1 month after the third dose of Twinrix vaccine (Month 7)
    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: This analysis was made only for subjects who received hepatitis vaccination (Twinrix).
    End point values
    		 Nimenrix + Twinrix Group Twinrix Group
    Number of subjects analysed
    321
    95
    Units: Subjects
        Subjects
    321
    95
    Statistical analysis title
    		 Non-inferiority in term of seroconversion rate
    Comparison groups
    Nimenrix + Twinrix Group v Twinrix Group
    Number of subjects included in analysis
    416
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Percentage difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 3.9
    Notes
    [3] - To assess the Non-inferiority of the Nimenrix+Twinrix group compared to Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroconversion rates (Nimenrix+Twinrix group minus Twinrix group) was computed. Non-inferiority criterion: Lower limit of the two-sided standardized asymptotic 95% CI ≥ -10%

    Primary: Number of subjects seroprotected for hepatitis B

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    End point title
    		 Number of subjects seroprotected for hepatitis B [4]
    End point description
    A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
    End point type
    Primary
    End point timeframe
    At 1 month after the third dose of Twinrix vaccine (Month 7)
    Notes
    [4] - 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: This analysis was made only for subjects who received hepatitis vaccination (Twinrix).
    End point values
    		 Nimenrix + Twinrix Group Twinrix Group
    Number of subjects analysed
    330
    97
    Units: Subjects
        Subjects
    327
    97
    Statistical analysis title
    		 Non-inferiority in term of seroprotection rate
    Comparison groups
    Twinrix Group v Nimenrix + Twinrix Group
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Percentage difference
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.64
         upper limit
    		 2.92
    Notes
    [5] - To assess the Non-inferiority of the Nimenrix+Twinrix group compared to the Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroprotection rates (Nimenrix+Twinrix group minus Twinrix group) was computed. Non-inferiority criterion: Lower limit of the two-sided standardized asymptotic 95% CI ≥ -10%

    Secondary: Number of subjects with a vaccine response to MenA, MenC, MenY and MenW-135

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    End point title
    		 Number of subjects with a vaccine response to MenA, MenC, MenY and MenW-135 [6]
    End point description
    Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8].
    End point type
    Secondary
    End point timeframe
    At 1 month after vaccination with Nimenrix vaccine (Month 1)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    355
    114
    Units: Subjects
        rSBA-MenA (N= 261; 84)
    246
    76
        rSBA-MenC (N= 355; 112)
    333
    101
        rSBA-MenW-135 (N= 349; 114)
    346
    112
        rSBA-MenY (N= 354; 113)
    335
    105
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers above predefined cut-off values

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers above predefined cut-off values [7]
    End point description
    The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
    End point type
    Secondary
    End point timeframe
    Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    360
    115
    Units: Subjects
        rSBA-MenA ≥ 1:8 [Month 0] (N= 266; 85)
    105
    33
        rSBA-MenA ≥ 1:8 [Month 1] (N= 353; 113)
    352
    113
        rSBA-MenC ≥ 1:8 [Month 0] (N= 355; 112)
    187
    67
        rSBA-MenC ≥ 1:8 [Month 1] (N= 360; 115)
    359
    114
        rSBA-MenW-135 ≥ 1:8 [Month 0] (N= 349; 114)
    277
    96
        rSBA-MenW-135 ≥ 1:8 [Month 1] (N= 360; 115)
    360
    115
        rSBA-MenY ≥ 1:8 [Month 0] (N= 354; 113)
    275
    95
        rSBA-MenY ≥ 1:8 [Month 1] (N= 360; 115)
    359
    115
        rSBA-MenA ≥ 1:128 [Month 0] (N= 266; 85)
    91
    30
        rSBA-MenA ≥ 1:128 [Month 1] (N= 353; 113)
    352
    113
        rSBA-MenC ≥ 1:128 [Month 0] (N= 355; 112)
    122
    44
        rSBA-MenC ≥ 1:128 [Month 1] (N= 360; 115)
    358
    113
        rSBA-MenW-135 ≥ 1:128 [Month 0] (N= 349; 114)
    180
    64
        rSBA-MenW-135 ≥ 1:128 [Month 1] (N= 360; 115)
    359
    115
        rSBA-MenY ≥ 1:128 [Month 0] (N= 354; 113)
    218
    80
        rSBA-MenY ≥ 1:128 [Month 1] (N= 360; 115)
    359
    115
    No statistical analyses for this end point

    Secondary: Anti-PSA (polysaccharide A), anti-PSC (polysaccharide C), anti-PSW-135 (polysaccharide W-135), and anti-PSY (polysaccharide Y) antibody concentrations

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    End point title
    		 Anti-PSA (polysaccharide A), anti-PSC (polysaccharide C), anti-PSW-135 (polysaccharide W-135), and anti-PSY (polysaccharide Y) antibody concentrations [8]
    End point description
    Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    180
    58
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [Month 0] (N= 176; 55)
    0.25 (0.21 to 0.3)
    0.24 (0.19 to 0.31)
        Anti-PSA [Month 1] (N= 179; 56)
    27.23 (22.19 to 32.38)
    18.47 (12.02 to 28.38)
        Anti-PSC [Month 0] (N= 176; 55)
    0.22 (0.19 to 0.26)
    0.26 (0.19 to 0.35)
        Anti-PSC [Month 1] (N= 180; 55)
    18.58 (15.44 to 22.37)
    21.15 (14.87 to 30.09)
        Anti-PSW-135 [Month 0] (N= 176; 58)
    0.19 (0.17 to 0.21)
    0.16 (0.15 to 0.17)
        Anti-PSW-135 [Month 1] (N= 178; 58)
    6.78 (5.52 to 8.32)
    6.72 (4.62 to 9.76)
        Anti-PSY [Month 0] (N= 175; 58)
    0.22 (0.18 to 0.25)
    0.17 (0.14 to 0.21)
        Anti-PSY [Month 1] (N= 180; 55)
    14.04 (11.52 to 17.1)
    12.5 (8.49 to 18.41)
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-PSA, anti-PSC, anti-PSW-135, and anti-PSY antibody concentrations above pre-defined cut-off values

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    End point title
    		 Number of subjects with Anti-PSA, anti-PSC, anti-PSW-135, and anti-PSY antibody concentrations above pre-defined cut-off values [9]
    End point description
    The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
    End point type
    Secondary
    End point timeframe
    Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    180
    58
    Units: Subjects
        Anti-PSA ≥ 0.3 μg/mL [Month 0] (N= 176; 55)
    45
    13
        Anti-PSA ≥ 0.3 μg/mL [Month 1] (N= 179; 56)
    179
    54
        Anti-PSC ≥ 0.3 μg/mL [Month 0] (N= 176; 55)
    32
    13
        Anti-PSC ≥ 0.3 μg/mL [Month 1] (N= 180; 55)
    179
    43
        Anti-PSW-135 ≥ 0.3 μg/mL [Month 0] (N= 176; 58)
    19
    2
        Anti-PSW-135 ≥ 0.3 μg/mL [Month 1] (N= 178; 58)
    176
    56
        Anti-PSY ≥ 0.3 μg/mL [Month 0] (N= 175; 58)
    24
    2
        Anti-PSY ≥ 0.3 μg/mL [Month 1] (N= 180; 55)
    178
    54
        Anti-PSA ≥ 2.0 μg/mL [Month 0] (N= 176; 55)
    14
    3
        Anti-PSA ≥ 2.0 μg/mL [Month 1] (N= 179; 56)
    178
    52
        Anti-PSC ≥ 2.0 μg/mL [Month 0] (N= 176; 55)
    10
    6
        Anti-PSC ≥ 2.0 μg/mL [Month 1] (N= 180; 55)
    176
    53
        Anti-PSW-135 ≥ 2.0 μg/mL [Month 0] (N= 176; 58)
    3
    0
        Anti-PSW-135 ≥ 2.0 μg/mL [Month 1] (N= 178; 58)
    146
    48
        Anti-PSY ≥ 2.0 μg/mL [Month 0] (N= 175; 58)
    10
    2
        Anti-PSY ≥ 2.0 μg/mL [Month 1] (N= 180; 55)
    172
    51
    No statistical analyses for this end point

    Secondary: Anti-Tetanus toxoid (TT) antibody concentrations

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    End point title
    		 Anti-Tetanus toxoid (TT) antibody concentrations [10]
    End point description
    Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
    End point type
    Secondary
    End point timeframe
    Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    355
    114
    Units: International Units per milliliter
    geometric mean (confidence interval 95%)
        Month 0 (N= 312; 114)
    0.8 (0.692 to 0.926)
    1.02 (0.795 to 1.308)
        Month 1 (N= 355; 112)
    16.794 (15.318 to 18.411)
    17.252 (14.603 to 20.381)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-tetanus toxoid antibody concentrations above the pre-defines cut-off value

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    End point title
    		 Number of subjects with anti-tetanus toxoid antibody concentrations above the pre-defines cut-off value [11]
    End point description
    The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    355
    114
    Units: Subjects
        Month 0 (N= 312; 114)
    293
    111
        Month 1 (N= 355; 112)
    354
    112
    No statistical analyses for this end point

    Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers at Month 7

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    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers at Month 7 [12]
    End point description
    The rSBA titers were expressed as geometric mean titers.
    End point type
    Secondary
    End point timeframe
    At Month 7
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    334
    112
    Units: Titer
    geometric mean (confidence interval 95%)
        rSBA-MenA (N= 332; 108)
    2121.6 (1913.5 to 2352.2)
    2298.3 (1909 to 2767)
        rSBA-MenC (N= 334; 112)
    952.4 (826.2 to 1097.8)
    1053.9 (803.1 to 1382.9)
        rSBA-MenW-135 (N= 334; 112)
    3283.4 (2998.4 to 3595.4)
    3497.7 (3008 to 4067.2)
        rSBA-MenY (N= 334; 112)
    4432.7 (4027.4 to 4878.8)
    4455.6 (3821.4 to 5195.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers above predefined cut-off values at Month 7

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers above predefined cut-off values at Month 7 [13]
    End point description
    The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
    End point type
    Secondary
    End point timeframe
    At Month 7
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    334
    112
    Units: Subjects
        rSBA-MenA ≥ 1:8 (N= 332; 108)
    330
    107
        rSBA-MenC ≥ 1:8 (N= 334; 112)
    332
    110
        rSBA-MenW-135 ≥ 1:8 (N= 334; 112)
    334
    112
        rSBA-MenY ≥ 1:8 (N= 334; 112)
    333
    112
        rSBA-MenA ≥ 1:128 (N= 332; 108)
    329
    107
        rSBA-MenC ≥ 1:128 (N= 334; 112)
    318
    108
        rSBA-MenW-135 ≥ 1:128 (N= 334; 112)
    333
    112
        rSBA-MenY ≥ 1:128 (N= 334; 112)
    332
    112
    No statistical analyses for this end point

    Secondary: Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations at Month 7

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    End point title
    		 Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations at Month 7 [14]
    End point description
    Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    At Month 7
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    167
    56
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA (N= 163; 56)
    4.14 (3.34 to 5.15)
    3.88 (2.44 to 6.16)
        Anti-PSC (N= 164; 56)
    3.28 (2.6 to 4.14)
    4.15 (2.59 to 6.67)
        Anti-PSW-135 (N= 167; 56)
    2.46 (1.99 to 3.05)
    3.08 (2.11 to 4.5)
        Anti-PSY (N= 161; 54)
    3.76 (2.95 to 4.78)
    4.28 (2.9 to 6.31)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations above pre-defined cut-off values at Month 7

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    End point title
    		 Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations above pre-defined cut-off values at Month 7 [15]
    End point description
    The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 7
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    167
    56
    Units: Subjects
        Anti-PSA ≥ 0.3 μg/mL (N= 163; 56)
    160
    52
        Anti-PSC ≥ 0.3 μg/mL (N= 164; 56)
    157
    52
        Anti-PSW-135 ≥ 0.3 μg/mL (N= 167; 56)
    157
    51
        Anti-PSY ≥ 0.3 μg/mL (N= 161; 54)
    154
    53
        Anti-PSA ≥ 2.0 μg/mL (N= 163; 56)
    110
    34
        Anti-PSC ≥ 2.0 μg/mL (N= 164; 56)
    94
    35
        Anti-PSW-135 ≥ 2.0 μg/mL (N= 167; 56)
    93
    41
        Anti-PSY ≥ 2.0 μg/mL (N= 161; 54)
    104
    37
    No statistical analyses for this end point

    Secondary: Immunoglobulin G (IgG) anti-HAV antibody concentrations

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    End point title
    		 Immunoglobulin G (IgG) anti-HAV antibody concentrations [16]
    End point description
    Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received hepatitis vaccination (Twinrix).
    End point values
    		 Nimenrix + Twinrix Group Twinrix Group
    Number of subjects analysed
    333
    99
    Units: milli-Internatinal Units per Milliliter
    geometric mean (confidence interval 95%)
        Month 0 (N= 333; 99)
    7.9 (7.6 to 8.1)
    7.6 (7.4 to 7.9)
        Month 7 (N= 331; 97)
    5876.7 (5362.9 to 6439.8)
    6739 (5757.4 to 7887.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with IgG anti-HAV antibody concentrations above the pre-defined cut-off value

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    End point title
    		 Number of subjects with IgG anti-HAV antibody concentrations above the pre-defined cut-off value [17]
    End point description
    The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received hepatitis vaccination (Twinrix).
    End point values
    		 Nimenrix + Twinrix Group Twinrix Group
    Number of subjects analysed
    333
    99
    Units: Subjects
        Month 0 (N= 333; 99)
    10
    2
        Month 7 (N= 331; 97)
    331
    97
    No statistical analyses for this end point

    Secondary: IgG anti-HBs antibody concentrations

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    End point title
    		 IgG anti-HBs antibody concentrations [18]
    End point description
    Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received hepatitis vaccination (Twinrix).
    End point values
    		 Nimenrix + Twinrix Group Twinrix Group
    Number of subjects analysed
    333
    100
    Units: milli-Internatinal Units per Milliliter
    geometric mean (confidence interval 95%)
        Month 0 (N= 333; 100)
    1.7 (1.6 to 1.7)
    1.7 (1.6 to 1.8)
        Month 7 (N= 330; 97)
    6088.2 (4977.5 to 7446.7)
    7654.7 (5518.8 to 10617.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with IgG anti-HB antibody concentrations above the pre-defined cut-off value

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    End point title
    		 Number of subjects with IgG anti-HB antibody concentrations above the pre-defined cut-off value [19]
    End point description
    The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received hepatitis vaccination (Twinrix).
    End point values
    		 Nimenrix + Twinrix Group Twinrix Group
    Number of subjects analysed
    333
    100
    Units: Subjects
        Month 0 (N= 333; 100)
    1
    0
        Month 7 (N= 330; 97)
    327
    97
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local symptoms post-meningococcal vaccination

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    End point title
    		 Number of subjects reporting any solicited local symptoms post-meningococcal vaccination [20]
    End point description
    Solicited local symptoms assessed include pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    During a 4-day period after Nimenrix vaccination
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received meningitis vaccination (Nimenrix).
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group
    Number of subjects analysed
    365
    119
    Units: Subjects
        Pain
    181
    58
        Redness
    75
    19
        Swelling
    71
    18
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local symptoms post-Twinrix vaccination

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    End point title
    		 Number of subjects reporting any solicited local symptoms post-Twinrix vaccination [21]
    End point description
    Solicited local symptoms assessed include pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    During a 4-day period after each Twinrix vaccination
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was made only for subjects who received hepatitis vaccination (Twinrix).
    End point values
    		 Nimenrix + Twinrix Group Twinrix Group
    Number of subjects analysed
    366
    122
    Units: Subjects
        Pain
    228
    73
        Redness
    63
    19
        Swelling
    49
    19
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited general symptoms

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    End point title
    		 Number of subjects reporting any solicited general symptoms
    End point description
    Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache.
    End point type
    Secondary
    End point timeframe
    During a 4-day period after any vaccination
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group Twinrix Group
    Number of subjects analysed
    366
    119
    122
    Units: Subjects
        Fatigue
    149
    30
    48
        Fever
    17
    1
    4
        Gastrointestinal symptoms
    72
    10
    23
        Headache
    126
    26
    48
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs)
    End point description
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after each vaccine dose
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group Twinrix Group
    Number of subjects analysed
    367
    122
    122
    Units: Subjects
        Post Dose 1
    62
    13
    18
        Post Dose 2
    26
    0
    7
        Post Dose 3
    52
    0
    16
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any specific AEs of new onset of chronic illnesses

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    End point title
    		 Number of subjects reporting any specific AEs of new onset of chronic illnesses
    End point description
    Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.
    End point type
    Secondary
    End point timeframe
    During the entire study (up to Month 7)
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group Twinrix Group
    Number of subjects analysed
    367
    122
    122
    Units: Subjects
        Subjects
    5
    0
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any rash

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    End point title
    		 Number of subjects reporting any rash
    End point description
    Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.
    End point type
    Secondary
    End point timeframe
    During the entire study (up to Month 7)
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group Twinrix Group
    Number of subjects analysed
    367
    122
    122
    Units: Subjects
        Subjects
    5
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any conditions prompting emergency room visits

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    End point title
    		 Number of subjects reporting any conditions prompting emergency room visits
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study (up to Month 7)
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group Twinrix Group
    Number of subjects analysed
    367
    122
    122
    Units: Subjects
        Subjects
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any serious adverse events (SAEs)

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    During the entire study (up to Month 7)
    End point values
    		 Nimenrix + Twinrix Group Nimenrix Group Twinrix Group
    Number of subjects analysed
    367
    122
    122
    Units: Subjects
        Subjects
    4
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events (AE) were reported up to one month after each vaccine dose.
    Adverse event reporting additional description
    Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Nimenrix + Twinrix Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix™ vaccine at Month 0.

    Reporting group title
    Twinrix Group
    Reporting group description
    		 Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

    Serious adverse events
    		 Nimenrix + Twinrix Group Nimenrix Group Twinrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 367 (1.09%)
    0 / 122 (0.00%)
    1 / 122 (0.82%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    0 / 367 (0.00%)
    0 / 122 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 367 (0.27%)
    0 / 122 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug toxicity
         subjects affected / exposed
    1 / 367 (0.27%)
    0 / 122 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hydrocephalus
         subjects affected / exposed
    1 / 367 (0.27%)
    0 / 122 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 367 (0.27%)
    0 / 122 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 367 (0.27%)
    0 / 122 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix + Twinrix Group Nimenrix Group Twinrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    228 / 367 (62.13%)
    58 / 122 (47.54%)
    73 / 122 (59.84%)
    General disorders and administration site conditions
    Pain at the injection site (Solicited Symptom)
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    181 / 365 (49.59%)
    58 / 119 (48.74%)
    0 / 122 (0.00%)
         occurrences all number
    181
    58
    0
    Swelling at the injection site (Solicited Symptom)
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    71 / 365 (19.45%)
    18 / 119 (15.13%)
    0 / 122 (0.00%)
         occurrences all number
    71
    18
    0
    Redness at the injection site (Solicited Symptom)
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    75 / 365 (20.55%)
    19 / 119 (15.97%)
    0 / 122 (0.00%)
         occurrences all number
    75
    19
    0
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    149 / 366 (40.71%)
    30 / 119 (25.21%)
    48 / 122 (39.34%)
         occurrences all number
    149
    30
    48
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    72 / 366 (19.67%)
    10 / 119 (8.40%)
    23 / 122 (18.85%)
         occurrences all number
    72
    10
    23
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    126 / 366 (34.43%)
    26 / 119 (21.85%)
    48 / 122 (39.34%)
         occurrences all number
    126
    26
    48
    Pain at the injection site (AE)
    alternative assessment type: Systematic
         subjects affected / exposed
    228 / 367 (62.13%)
    0 / 122 (0.00%)
    73 / 122 (59.84%)
         occurrences all number
    228
    0
    73
    Swelling at the injection site (AE)
    alternative assessment type: Systematic
         subjects affected / exposed
    49 / 367 (13.35%)
    0 / 122 (0.00%)
    19 / 122 (15.57%)
         occurrences all number
    49
    0
    19
    Redness at the injection site (AE)
    alternative assessment type: Systematic
         subjects affected / exposed
    63 / 367 (17.17%)
    0 / 122 (0.00%)
    19 / 122 (15.57%)
         occurrences all number
    63
    0
    19
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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