Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase III, open, randomized, controlled, multicentre, primary & booster study to demonstrate the non-inferiority of the MenC & Hib immune responses of GSK Biologicals’ Hib-MenC vaccine co-administered with Infanrix™ penta versus NeisVac-C™ co-administered with Infanrix™ hexa when given as 2 primary doses at 3, 5 m of age & prior to a booster dose at 11 m, as well as the immunogenicity of the Hib-MenC vaccine given as a booster at 11 m & the persistence of antibodies prior to the booster dose.

    Summary
    EudraCT number
    		 2005-005421-59
    Trial protocol
    		 FI   IT  
    Global end of trial date
    29 Jun 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Jul 2016
    First version publication date
    24 Apr 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Data (typos) were corrected in section: End points: - Number of subjects with solicited local symptoms for each dose, - Number of subjects with solicited general symptoms for each dose Adverse Events

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    106388-106390
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00327184
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals,, 004 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals,, 004 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
    01 Mar 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of the Men-C and Hib immune responses induced by GSK Biologicals’ Hib-MenC conjugate vaccine given concomitantly with Infanrix™ penta when administered as a 2-dose primary vaccination course (3-5 month schedule), compared to NeisVac-C™ co-administered with Infanrix™ hexa, in terms of: % of subjects with SBA-MenC titre >= 1:8 and of % of subjects with anti-PRP concentration >= 0.15µg/ml. (Criteria for meeting these objectives: 1 month post Dose II, the lower limit of the standardized asymptotic 95% confidence interval on the difference between the study vaccine group and (minus) the control group is >= to -5 % for the MenC response and >= to -10% for the Hib response).
    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. Only eligible subjects that had no contraindications to any components of the vaccines were vaccinated. Subjects were followed-up for 30 days after each/last vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Apr 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 560
    Country: Number of subjects enrolled
    Italy: 149
    Worldwide total number of subjects
    709
    EEA total number of subjects
    709
    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)
    709
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix™ Group
    Arm description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Menitorix™+ Infanrix™ penta vaccines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

    Investigational medicinal product name
    Infanrix™ penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

    Arm title
    		 NeisVac-C™ Group
    Arm description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

    Investigational medicinal product name
    NeisVac-C™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

    Number of subjects in period 1
    		Menitorix™ Group NeisVac-C™ Group
    Started
    355
    354
    Completed
    346
    349
    Not completed
    9
    5
         Consent withdrawn by subject
    -
    1
         Unspecified
    1
    1
         Non-serious Adverse Event
    5
    2
         Lost to follow-up
    -
    1
         Serious Adverse Event
    3
    -
    Period 2
    Period 2 title
    Booster Study
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix™ Group
    Arm description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Menitorix™+ Infanrix™ penta vaccines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

    Investigational medicinal product name
    Infanrix™ penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

    Arm title
    		 NeisVac-C™ Group
    Arm description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

    Investigational medicinal product name
    NeisVac-C™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

    Number of subjects in period 2 [1]
    		Menitorix™ Group NeisVac-C™ Group
    Started
    340
    350
    Completed
    338
    345
    Not completed
    2
    5
         Consent withdrawn by subject
    2
    1
         Lost to follow-up
    -
    4
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all subjects who participated in the Primary vaccination Phase returned for the Booster vaccination.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Menitorix™ Group
    Reporting group description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Menitorix™+ Infanrix™ penta vaccines.

    Reporting group title
    NeisVac-C™ Group
    Reporting group description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.

    Reporting group values
    		 Menitorix™ Group NeisVac-C™ Group Total
    Number of subjects
    		 355 354 709
    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: weeks
        geometric mean (standard deviation)
    		 10.8 ( 1.19 ) 10.8 ( 1.21 ) -
    Gender categorical
    Units: Subjects
        Female
    		 170 158 328
        Male
    		 185 196 381

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Menitorix™ Group
    Reporting group description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Menitorix™+ Infanrix™ penta vaccines.

    Reporting group title
    NeisVac-C™ Group
    Reporting group description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.
    Reporting group title
    Menitorix™ Group
    Reporting group description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Menitorix™+ Infanrix™ penta vaccines.

    Reporting group title
    NeisVac-C™ Group
    Reporting group description
    		 Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.

    Primary: Number of subjects with rSBA-MenC antibody titers ≥ 1:8

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenC antibody titers ≥ 1:8
    End point description
    End point type
    Primary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    323
    313
    Units: Subjects
        rSBA-MenC PII(M3) [N=323;313]
    320
    313
    Statistical analysis title
    		 Difference in % of subjects with rSBA-MenC titer
    Statistical analysis description
    To demonstrate the non-inferiority of the meningococcal serogroup C immune response induced by Menitorix vaccine given concomitantly with Infanrix™ penta vaccine when administered as a 2-dose primary vaccination course (3-5 month schedule), compared to NeisVac-C vaccine co-administered with Infanrix™ hexa vaccine, in terms of percentage of subjects with functional anti-meningococcal serogroup C activity/antibody (rSBA-MenC) titer ≥ 1:8.
    Comparison groups
    Menitorix™ Group v NeisVac-C™ Group
    Number of subjects included in analysis
    636
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.69
         upper limit
    		 0.29
    Notes
    [1] - Criterion for meeting this objective: One month after the second dose, the lower limit of the standardized asymptotic 95% confidence interval (CI) on the difference between the study vaccine group and (minus) the control group was greater than or equal to -5 %.

    Primary: Number of subjects with anti-PRP antibody concentrations ≥ 0.15 µg/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-PRP antibody concentrations ≥ 0.15 µg/mL
    End point description
    End point type
    Primary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    325
    314
    Units: Subjects
        Anti-PRP PII(M3) [N=325;314]
    315
    300
    Statistical analysis title
    		 Difference in subjects with anti-PRP ≥ 0.15 µg/mL
    Statistical analysis description
    To demonstrate the non-inferiority of the Hib immune response induced by Menitorix vaccine given concomitantly with Infanrix penta vaccine when administered as a 2-dose primary vaccination course (3-5 month schedule), compared to NeisVac-C vaccine co-administered with Infanrix hexa vaccine, in terms of percentage of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 μg/mL.
    Comparison groups
    Menitorix™ Group v NeisVac-C™ Group
    Number of subjects included in analysis
    639
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.67
         upper limit
    		 4.62
    Notes
    [2] - Criterion for meeting this objective: One month after the second dose, the lower limit of the standardized asymptotic 95% CI on the difference between the study vaccine group and (minus) the control group was greater than or equal to -10 %.

    Secondary: Number of subjects with rSBA-MenC antibody titre ≥ 1:128

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenC antibody titre ≥ 1:128
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    323
    313
    Units: Subjects
        rSBA-MenC PII(M3) [N=323;313]
    266
    301
    No statistical analyses for this end point

    Secondary: rSBA-MenC antibody titres

    		 Close Top of page
    End point title
    		 rSBA-MenC antibody titres
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    323
    313
    Units: Titre
        geometric mean (confidence interval 95%)
    466.1 (399.5 to 543.7)
    1362.6 (1189.1 to 1561.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥ 0.3 µg/mL, ≥ 2 µg/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-serogroup C polysaccharide (anti-PSC) antibody concentrations ≥ 0.3 µg/mL, ≥ 2 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    324
    314
    Units: Subjects
        Anti-PSC ≥ 0.3 µg/mL
    324
    314
        Anti-PSC ≥ 2 µg/mL
    316
    313
    No statistical analyses for this end point

    Secondary: Concentration of anti-PSC antibodies

    		 Close Top of page
    End point title
    		 Concentration of anti-PSC antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    324
    314
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC
    9.9 (9.13 to 10.73)
    16.07 (15.03 to 17.19)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥ 1 µg/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibodies ≥ 1 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    325
    314
    Units: Subjects
        Anti-PRP PII(M3) ≥ 1 µg/mL
    256
    231
    No statistical analyses for this end point

    Secondary: Concentration of anti-PRP antibodies

    		 Close Top of page
    End point title
    		 Concentration of anti-PRP antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    325
    314
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP
    4.236 (3.503 to 5.123)
    2.487 (2.105 to 2.94)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibodies ≥ 10 mIU/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibodies ≥ 10 mIU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    302
    296
    Units: Subjects
        Anti-HBs
    297
    282
    No statistical analyses for this end point

    Secondary: Concentration of anti-HBs antibodies

    		 Close Top of page
    End point title
    		 Concentration of anti-HBs antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    One month after the second dose at Month 3 [PII(M3)]
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    302
    296
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs
    704.7 (605.3 to 820.4)
    390.8 (324.8 to 470.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenC antibody titer ≥ 1:8 and ≥ 1:128

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenC antibody titer ≥ 1:8 and ≥ 1:128
    End point description
    End point type
    Secondary
    End point timeframe
    At Pre (Month 11 of age) and Post (Month 12 of age) Booster vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    310
    310
    Units: Subjects
        rSBA-MenC ≥ 1:8 Pre [N=303;308]
    288
    308
        rSBA-MenC ≥ 1:8 Post [N=310;310]
    310
    310
        rSBA-MenC ≥ 1:128 Pre [N=303;308]
    165
    245
        rSBA-MenC ≥ 1:128 Post [N=310;310]
    304
    310
    No statistical analyses for this end point

    Secondary: rSBA-MenC antibody titres

    		 Close Top of page
    End point title
    		 rSBA-MenC antibody titres
    End point description
    End point type
    Secondary
    End point timeframe
    At Pre (Month 11 of age) and Post (Month 12 of age) Booster vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    310
    310
    Units: Titre
    geometric mean (confidence interval 95%)
        rSBA-MenC Pre [N=303;308]
    124.2 (107.5 to 143.4)
    292 (262 to 325.4)
        rSBA-MenC Post [N=310;310]
    1861.8 (1646.2 to 2105.6)
    4317.8 (3912.3 to 4765.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSC antibodies ≥ 0.3 µg/mL and ≥ 2 µg/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-PSC antibodies ≥ 0.3 µg/mL and ≥ 2 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    At Pre (Month 11 of age) and Post (Month 12 of age) Booster vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    311
    313
    Units: Subjects
        Anti-PSC ≥ 0.3 µg/mL Pre [N=306;310]
    284
    303
        Anti-PSC ≥ 0.3 µg/mL Post [N=311;313]
    311
    313
        Anti-PSC ≥ 2 µg/mL Pre [N=306;310]
    70
    99
        Anti-PSC ≥ 2µg/mL Post [N=311;313]
    251
    313
    No statistical analyses for this end point

    Secondary: Concentration of anti-PSC antibodies

    		 Close Top of page
    End point title
    		 Concentration of anti-PSC antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    At Pre (Month 11 of age) and Post (Month 12 of age) Booster vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    311
    313
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSC Pre [N=306;310]
    1.06 (0.96 to 1.17)
    1.34 (1.23 to 1.46)
        Anti-PSC Post [N=311;313]
    4.13 (3.78 to 4.52)
    10.4 (9.79 to 11.05)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PRP antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-PRP antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    At Pre (Month 11 of age) and Post (Month 12 of age) Booster vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    311
    314
    Units: Subjects
        Anti-PRP ≥ 0.15 µg/mL Pre [N=308;309]
    263
    268
        Anti-PRP ≥ 0.15 µg/mL Post [N=311;314]
    311
    314
        Anti-PRP ≥ 1 µg/mL Pre [N=308;309]
    161
    102
        Anti-PRP ≥ 1 µg/mL Post [N=311;314]
    309
    312
    No statistical analyses for this end point

    Secondary: Concentration of anti-PRP antibodies

    		 Close Top of page
    End point title
    		 Concentration of anti-PRP antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    At Pre (Month 11 of age) and Post (Month 12 of age) Booster vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    311
    314
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP Pre [N=308;309]
    0.929 (0.783 to 1.102)
    0.573 (0.498 to 0.66)
        Anti-PRP Post [N=311;314]
    30.49 (26.735 to 34.771)
    17.415 (15.278 to 19.851)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-HBs antibodies ≥ 10 mIU/mL and ≥ 100 mIU/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-HBs antibodies ≥ 10 mIU/mL and ≥ 100 mIU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    At Pre (Month 11 of age) and Post (Month 12 of age) Booster vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    305
    305
    Units: Subjects
        Anti-HBs ≥ 10 mIU/mL Pre [N=296;305]
    291
    286
        Anti-HBs ≥ 10 mIU/mL Post [N=305;304]
    304
    301
        Anti-HBs ≥ 100 mIU/mL Pre [N=296;305]
    204
    166
        Anti-HBs ≥ 100 mIU/mL Post [N=305;304]
    298
    288
    No statistical analyses for this end point

    Secondary: Concentration of anti-HBs antibodies

    		 Close Top of page
    End point title
    		 Concentration of anti-HBs antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    At Pre (Month 11 of age) and Post (Month 12 of age) Booster vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    305
    305
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs Pre [N=296;305]
    176.1 (152.7 to 203.1)
    104.8 (89.9 to 122.2)
        Anti-HBs Post [N=305;304]
    4583.4 (3918.4 to 5361.4)
    2813.5 (2352.5 to 3364.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms for each dose

    		 Close Top of page
    End point title
    		 Number of subjects with solicited local symptoms for each dose
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-days (Day 0-3) post-vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    355
    354
    Units: Subjects
        Pain Dose 1 [N=355;354]
    67
    108
        Redness Dose 1 [N=355;354]
    97
    114
        Swelling Dose 1 [N=355;354]
    51
    77
        Pain Dose 2 [N=346;351]
    55
    83
        Redness Dose 2 [N=346;351]
    142
    163
        Swelling Dose 2 [N=346;351]
    76
    95
        Pain Across Doses [N=355;354]
    92
    146
        Redness Across Doses [N=355;354]
    174
    195
        Swelling Across Doses [N=355;354]
    105
    134
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms for each dose

    		 Close Top of page
    End point title
    		 Number of subjects with solicited general symptoms for each dose
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-days (Day 0-3) post-vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    355
    354
    Units: Subjects
        Drowsiness Dose 1 [N=355;354]
    173
    188
        Fever Dose 1 [N=355;354]
    49
    125
        Irritability Dose 1 [N=355;354]
    193
    217
        Loss of appetite Dose 1 [N=355;354]
    68
    70
        Drowsiness Dose 2 [N=346;351]
    110
    157
        Fever Dose 2 [N=346;351]
    95
    141
        Irritability Dose 2 [N=346;351]
    170
    196
        Loss of appetite Dose 2 [N=346;351]
    68
    77
        Drowsiness Across Doses [N=355;354]
    209
    232
        Fever Across Doses [N=355;354]
    123
    199
        Irritability Across Doses [N=355;354]
    245
    273
        Loss of appetite Across Doses [N=355;354]
    113
    117
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited Adverse Events AE(s)

    		 Close Top of page
    End point title
    		 Number of subjects with unsolicited Adverse Events AE(s)
    End point description
    End point type
    Secondary
    End point timeframe
    During the 30 days after each vaccination (Primary study)
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    355
    354
    Units: Subjects
        Any AE(s)
    149
    149
    No statistical analyses for this end point

    Secondary: Number of subjects with Serious Adverse Events (SAEs)

    		 Close Top of page
    End point title
    		 Number of subjects with Serious Adverse Events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the Primary study
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    355
    354
    Units: Subjects
        Any SAE(s)
    10
    4
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

    		 Close Top of page
    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) post-booster vaccination (Booster study)
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    340
    350
    Units: Subjects
        Pain
    112
    151
        Redness
    159
    176
        Swelling
    101
    122
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

    		 Close Top of page
    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) post-booster vaccination (Booster study)
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    340
    350
    Units: Subjects
        Drowsiness
    123
    153
        Irritability
    176
    199
        Loss of appetite
    95
    109
        Fever
    103
    133
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited Adverse Events

    		 Close Top of page
    End point title
    		 Number of subjects with unsolicited Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    During the 30 days after each vaccination (Booster study)
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    340
    350
    Units: Subjects
        Any AE(s)
    143
    141
    No statistical analyses for this end point

    Secondary: Number of subjects with Serious Adverse Events

    		 Close Top of page
    End point title
    		 Number of subjects with Serious Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    Since the end of the primary phase until the start of the booster vaccination
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    355
    354
    Units: Subjects
        Any SAE(s)
    10
    10
    No statistical analyses for this end point

    Secondary: Number of subjects with Serious Adverse Events

    		 Close Top of page
    End point title
    		 Number of subjects with Serious Adverse Events
    End point description
    8 subjects had their last study visit/last study contact 27–28 days after the last vaccination of the primary phase.
    End point type
    Secondary
    End point timeframe
    From the start of the Booster vaccination until the end of the Booster study
    End point values
    		 Menitorix™ Group NeisVac-C™ Group
    Number of subjects analysed
    355
    354
    Units: Subjects
        Any SAE(s)
    10
    10
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general adverse events: Days 0-3 post-vaccination period after each Primary and Booster dose; Unsolicited AE(s): Days 0-30 after Primary and Booster vaccination; Serious AE(s): From the end of Primary until the start of Booster.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Group Menitorix™ Primary Vaccination
    Reporting group description
    		 Subjects receive 2 primary vaccination doses of Infanrix™ penta and Menitorix™ at 3 and 5 months of age.

    Reporting group title
    Group NeisVac-C Booster Vaccination
    Reporting group description
    		 Subjects received a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.

    Reporting group title
    Group Menitorix™ Booster vaccination
    Reporting group description
    		 Subjects received a booster dose at 11 months of age of Menitorix™ + Infanrix™ penta vaccines.

    Reporting group title
    Group NeisVac-C Primary Vaccination
    Reporting group description
    		 Subjects receive 2 primary vaccination doses of NeisVac-C™ and Infanrix™ hexa at 3 and 5 months of age.

    Serious adverse events
    		 Group Menitorix™ Primary Vaccination Group NeisVac-C Booster Vaccination Group Menitorix™ Booster vaccination Group NeisVac-C Primary Vaccination
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 355 (2.82%)
    8 / 350 (2.29%)
    5 / 340 (1.47%)
    10 / 354 (2.82%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Neurological examination
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body trauma
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 355 (0.00%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Aorticopulmonary septal defect
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interruption of aortic arch
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laurence-moon-bardet-biedl syndrome
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Petit mal epilepsy
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tremor neonatal
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 355 (0.00%)
    1 / 350 (0.29%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Epididymitis
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Fatigue
         subjects affected / exposed
    0 / 355 (0.00%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Sleep apnea syndrome
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 355 (0.00%)
    2 / 350 (0.57%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis reactive
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    6 / 355 (1.69%)
    1 / 350 (0.29%)
    3 / 340 (0.88%)
    3 / 354 (0.85%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    0 / 355 (0.00%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 355 (0.00%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    0 / 355 (0.00%)
    1 / 350 (0.29%)
    0 / 340 (0.00%)
    3 / 354 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 355 (0.28%)
    0 / 350 (0.00%)
    1 / 340 (0.29%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 355 (0.00%)
    1 / 350 (0.29%)
    1 / 340 (0.29%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral tonsillitis
         subjects affected / exposed
    0 / 355 (0.00%)
    0 / 350 (0.00%)
    0 / 340 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 355 (0.00%)
    1 / 350 (0.29%)
    1 / 340 (0.29%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 355 (0.00%)
    1 / 350 (0.29%)
    0 / 340 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group Menitorix™ Primary Vaccination Group NeisVac-C Booster Vaccination Group Menitorix™ Booster vaccination Group NeisVac-C Primary Vaccination
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    245 / 355 (69.01%)
    199 / 350 (56.86%)
    176 / 340 (51.76%)
    273 / 354 (77.12%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    92 / 355 (25.92%)
    151 / 350 (43.14%)
    112 / 340 (32.94%)
    146 / 354 (41.24%)
         occurrences all number
    92
    151
    112
    146
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    174 / 355 (49.01%)
    176 / 350 (50.29%)
    159 / 340 (46.76%)
    195 / 354 (55.08%)
         occurrences all number
    174
    176
    159
    195
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    105 / 355 (29.58%)
    122 / 350 (34.86%)
    101 / 340 (29.71%)
    134 / 354 (37.85%)
         occurrences all number
    105
    122
    101
    134
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    209 / 355 (58.87%)
    153 / 350 (43.71%)
    123 / 340 (36.18%)
    232 / 354 (65.54%)
         occurrences all number
    209
    153
    123
    232
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    123 / 355 (34.65%)
    133 / 350 (38.00%)
    103 / 340 (30.29%)
    199 / 354 (56.21%)
         occurrences all number
    123
    133
    103
    199
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    245 / 355 (69.01%)
    199 / 350 (56.86%)
    176 / 340 (51.76%)
    273 / 354 (77.12%)
         occurrences all number
    245
    199
    176
    273
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    113 / 355 (31.83%)
    109 / 350 (31.14%)
    95 / 340 (27.94%)
    117 / 354 (33.05%)
         occurrences all number
    113
    109
    95
    117
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    33 / 355 (9.30%)
    20 / 350 (5.71%)
    18 / 340 (5.29%)
    26 / 354 (7.34%)
         occurrences all number
    33
    20
    18
    26
    Pyrexia
         subjects affected / exposed
    13 / 355 (3.66%)
    19 / 350 (5.43%)
    18 / 340 (5.29%)
    12 / 354 (3.39%)
         occurrences all number
    13
    19
    18
    12
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    21 / 355 (5.92%)
    11 / 350 (3.14%)
    9 / 340 (2.65%)
    15 / 354 (4.24%)
         occurrences all number
    21
    11
    9
    15
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 355 (1.97%)
    33 / 350 (9.43%)
    17 / 340 (5.00%)
    16 / 354 (4.52%)
         occurrences all number
    7
    33
    17
    16
    Otitis media
         subjects affected / exposed
    8 / 355 (2.25%)
    29 / 350 (8.29%)
    44 / 340 (12.94%)
    9 / 354 (2.54%)
         occurrences all number
    8
    29
    44
    9

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 20 08:05:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA