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    Clinical Trial Results:
    A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine Menjugate® When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age with a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2005-000924-18
    Trial protocol
    		 DE  
    Global end of trial date
    17 Apr 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Jun 2016
    First version publication date
    19 Mar 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    M14P6
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00311415
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l.
    Sponsor organisation address
    Via Fiorentina 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Apr 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority, 10 days after the booster vaccination, of the memory antibody response (in terms of percent responders) to Neisseria meningitidis serogroup C after 1 dose of Menjugate® at 2 months of age plus a booster in the second year of life (study group 2) in comparison with the memory antibody response after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (study group 1), as measured by bactericidal assay using rabbit complement (rBCA).
    Protection of trial subjects
    The procedures established in this study protocol were designed to ensure that the Sponsor and Investigator abide by the principles of Good Clinical Practice (GCP) established by the International Conference on Harmonisation (ICH), the current version of the Declaration of Helsinki, and the Standard Operating Procedures of the Sponsor.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    28 Oct 2005
    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
    Germany: 111
    Country: Number of subjects enrolled
    Poland: 146
    Worldwide total number of subjects
    257
    EEA total number of subjects
    257
    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)
    257
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 5 sites in Germany and 4 sites in Poland.

    Pre-assignment
    Screening details
    		 All enrolled subjects were included in the trial.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The trial was designed as an open-label study; after the randomization both the study personnel and the subject knew which vaccine was being administered.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 (2+4 Months)
    Arm description
    		 Subjects received 2 doses of Menjugate®, at 2 and 4 months of age, together with the 1st and 3rd (Germany) or 1st and 2nd (Poland) dose of routine hexavalent infant immunization, and a booster at 12-16 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal C conjugated vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of 0.5 mL reconstituted vaccine.

    Arm title
    		 Group 2 (2 Months)
    Arm description
    		 Subjects received 1 dose of Menjugate®, at 2 months of age, together with the 1st dose of routine hexavalent infant immunization, and a booster at 12-16 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal C conjugated vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two doses of 0.5 mL reconstituted vaccine.

    Arm title
    		 Group 3 (6 Months)
    Arm description
    		 Subjects received 1 dose of Menjugate®, at 6 months of age, together with the 3rd dose (in Poland), but respectively 2 months after the 3rd dose (in Germany), of routine hexavalent infant immunization, and a booster at 12-16 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal C conjugated vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two doses of 0.5 mL reconstituted vaccine.

    Arm title
    		 Group 4 (12-16 Months)
    Arm description
    		 Subjects received 1 dose of Menjugate® at 12-16 months of age (together with the 4th dose of routine hexavalent infant immunization)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal C conjugated vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of 0.5 mL reconstituted vaccine.

    Number of subjects in period 1
    		Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Started
    64
    64
    63
    66
    Completed
    64
    62
    57
    61
    Not completed
    0
    2
    6
    5
         Consent withdrawn by subject
    -
    1
    3
    3
         Unable to classify
    -
    -
    2
    -
         Lost to follow-up
    -
    1
    1
    1
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1 (2+4 Months)
    Reporting group description
    		 Subjects received 2 doses of Menjugate®, at 2 and 4 months of age, together with the 1st and 3rd (Germany) or 1st and 2nd (Poland) dose of routine hexavalent infant immunization, and a booster at 12-16 months of age.

    Reporting group title
    Group 2 (2 Months)
    Reporting group description
    		 Subjects received 1 dose of Menjugate®, at 2 months of age, together with the 1st dose of routine hexavalent infant immunization, and a booster at 12-16 months of age.

    Reporting group title
    Group 3 (6 Months)
    Reporting group description
    		 Subjects received 1 dose of Menjugate®, at 6 months of age, together with the 3rd dose (in Poland), but respectively 2 months after the 3rd dose (in Germany), of routine hexavalent infant immunization, and a booster at 12-16 months of age.

    Reporting group title
    Group 4 (12-16 Months)
    Reporting group description
    		 Subjects received 1 dose of Menjugate® at 12-16 months of age (together with the 4th dose of routine hexavalent infant immunization)

    Reporting group values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months) Total
    Number of subjects
    		 64 64 63 66 257
    Age categorical
    Units: Subjects
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 62.1 ( 10.3 ) 63 ( 10.4 ) 61.6 ( 10.1 ) 63.1 ( 9.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 32 30 27 27 116
        Male
    		 32 34 36 39 141

    End points

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    End points reporting groups
    Reporting group title
    Group 1 (2+4 Months)
    Reporting group description
    		 Subjects received 2 doses of Menjugate®, at 2 and 4 months of age, together with the 1st and 3rd (Germany) or 1st and 2nd (Poland) dose of routine hexavalent infant immunization, and a booster at 12-16 months of age.

    Reporting group title
    Group 2 (2 Months)
    Reporting group description
    		 Subjects received 1 dose of Menjugate®, at 2 months of age, together with the 1st dose of routine hexavalent infant immunization, and a booster at 12-16 months of age.

    Reporting group title
    Group 3 (6 Months)
    Reporting group description
    		 Subjects received 1 dose of Menjugate®, at 6 months of age, together with the 3rd dose (in Poland), but respectively 2 months after the 3rd dose (in Germany), of routine hexavalent infant immunization, and a booster at 12-16 months of age.

    Reporting group title
    Group 4 (12-16 Months)
    Reporting group description
    		 Subjects received 1 dose of Menjugate® at 12-16 months of age (together with the 4th dose of routine hexavalent infant immunization)

    Subject analysis set title
    All enrolled population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects enrolled in the study.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects with at least one vaccination and with some post-baseline safety data.

    Subject analysis set title
    Per protocol (PP) population, Immunogenicity
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All randomized subjects who received all the relevant doses of vaccine correctly, provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.

    Primary: 1. Percentages of subjects with rBCA ≥ 1:128 at 10 days after booster dose

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    End point title
    		 1. Percentages of subjects with rBCA ≥ 1:128 at 10 days after booster dose [1]
    End point description
    The percentages of subject showing a rabbit bactericidal complement assay (rBCA) titer of at least 1:128 after vaccination, i.e. rBCA ≥ 1:128, 10 days after the booster vaccination, were measured to demonstrate non-inferiority of the memory antibody response to Neisseria meningitidis serogroup C after 1 dose of Menjugate® at 2 months of age plus a booster in the second year of life (2 Months group) in comparison with the memory antibody response after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (2+4 Months group). The analysis was done on the PP population, Immunogenicity.
    End point type
    Primary
    End point timeframe
    10 days after the booster vaccination
    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: statistical analyses not applicable for this endpoint.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months)
    Number of subjects analysed
    41
    36
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Pre-Booster
    10 (3 to 23)
    3 (0.07 to 15)
        10 Days After Booster (N=36,29)
    100 (90 to 100)
    90 (73 to 98)
    Statistical analysis title
    		 Statistical Analysis for outcome measure 1
    Statistical analysis description
    The null hypothesis associated with the primary immunogenicity objective was that the proportion of responders, defined as subjects showing a rBCA ≥ 1:128, after 1 dose of Menjugate® at 2 months of age plus a booster in the second year of life (2 Months group) is inferior to the proportion of responders after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (2+4 Months group), by more than 10%.
    Comparison groups
    Group 1 (2+4 Months) v Group 2 (2 Months)
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Clopper-Pearson method
    Parameter type
    		 Percentage group difference
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26
         upper limit
    		 0

    Secondary: 2. Percentages of subjects with rBCA ≥ 1:128 after 1 (at 6 months) or 2 (at 2 and 4 months) doses and booster

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    End point title
    		 2. Percentages of subjects with rBCA ≥ 1:128 after 1 (at 6 months) or 2 (at 2 and 4 months) doses and booster [2]
    End point description
    The percentages of subject showing a rabbit bactericidal complement assay (rBCA) titer of at least 1:128 after 1 dose of Menjugate at 6 months of age plus a booster in the second year of life (6 Months group) as well as after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (2+4 Months group) were measured to compare memory antibody response to Neisseria meningitidis serogroup C. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    10 days after the booster vaccination
    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: statistical analyses not applicable for this endpoint.
    End point values
    		 Group 1 (2+4 Months) Group 3 (6 Months)
    Number of subjects analysed
    41
    36
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Pre-Booster at 12-16 mo
    10 (3 to 23)
    3 (0.07 to 15)
        10 Days After Booster (N=36,32)
    100 (90 to 100)
    100 (89 to 100)
    Statistical analysis title
    		 Statistical Analysis for outcome measure 2
    Statistical analysis description
    Proportion of subjects achieving protective titers (rBCA ≥ 128) against Neisseria meningitidis serogroup C at 10 days after booster in 2+4 Months and 6 Months groups and associated 95% Clopper-Pearson CIs was computed by vaccine group. Vaccine group differences and 95% CIs were computed using the normal approximation where appropriate. 6 Months group was considered non-inferior to 2+4 Months group if the lower limit of 95% CI of the difference in percentages was greater than –10%.
    Comparison groups
    Group 1 (2+4 Months) v Group 3 (6 Months)
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Clopper-Pearson method
    Parameter type
    		 Percentage group difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 10

    Secondary: 3. Percentages of subjects with rBCA ≥ 1:128 after 2 (at 2 and 4 months) doses and booster or after a single dose (12-16 months)

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    End point title
    		 3. Percentages of subjects with rBCA ≥ 1:128 after 2 (at 2 and 4 months) doses and booster or after a single dose (12-16 months) [3]
    End point description
    The percentages of subject showing a rabbit bactericidal complement assay (rBCA) titer of at least 1:128 after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (2+4 Months group) as well as one month after a single dose of Menjugate given in the second year of life (12-16 Months group) were measured to compare memory antibody response to Neisseria meningitidis serogroup C. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    10 or 28 days after the booster vaccination.
    Notes
    [3] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 Group 1 (2+4 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    41
    37
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Pre-Booster at 12-16 mo
    10 (3 to 23)
    0 (0 to 9)
        10 or 28 Days After Vacc at 12-16 mo (N=36,31)
    100 (90 to 100)
    52 (33 to 70)
    Statistical analysis title
    		 Statistical Analysis for outcome measure 3
    Statistical analysis description
    Proportion of subjects achieving protective titers (rBCA ≥ 128) against Neisseria meningitidis serogroup C at 10 days after the booster dose in 2+4 Months and one months after primary vaccination at 12-16 Months groups and associated 95% Clopper-Pearson CIs was computed by vaccine group. The 12-16 Months group was considered non-inferior to the 2+4 Months group if the lower limit of 95% CI of the difference in percentages was greater than –10%.
    Comparison groups
    Group 1 (2+4 Months) v Group 4 (12-16 Months)
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Clopper-Pearson method
    Parameter type
    		 Percentage group difference
    Point estimate
    -48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -65
         upper limit
    		 -32

    Secondary: 4. Geometric mean antibody titers (GMTs) as measured by rBCA at 10 days after booster dose

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    End point title
    		 4. Geometric mean antibody titers (GMTs) as measured by rBCA at 10 days after booster dose [4]
    End point description
    Geometric mean antibody titers (GMTs) as measured by rabbit bactericidal complement assay (rBCA) were measured after 1 dose of Menjugate® at 2 or 6 months of age plus a booster in the second year of life (2 and 6 Months group) in comparison with the memory antibody response after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (2+4 Months group). The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    10 days after the booster vaccination.
    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: statistical analyses not applicable for this endpoint.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months)
    Number of subjects analysed
    41
    36
    36
    Units: Titers
    geometric mean (confidence interval 95%)
        Pre-Booster
    6.64 (4.05 to 11)
    4 (2.56 to 6.24)
    6.6 (4 to 11)
        10 Days After Booster (N=36,29,32)
    2953 (2023 to 4309)
    2664 (1411 to 5031)
    3922 (2653 to 5799)
    No statistical analyses for this end point

    Secondary: 5. Geometric mean antibody titers (GMTs) as measured by rBCA at 10 days after booster dose for the 2+4 Months group and at one month after one dose given at 12-16 months of age

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    End point title
    		 5. Geometric mean antibody titers (GMTs) as measured by rBCA at 10 days after booster dose for the 2+4 Months group and at one month after one dose given at 12-16 months of age [5]
    End point description
    Geometric mean antibody titers (GMTs) as measured by rabbit bactericidal complement assay (rBCA) were measured after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (2+4 Months group) in comparison with that measured after 1 dose of Menjugate® given at 12-16 months of age for the 12-16 Months group. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    10 or 28 days after the booster vaccination.
    Notes
    [5] - 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: statistical analyses not applicable for this endpoint.
    End point values
    		 Group 1 (2+4 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    41
    37
    Units: Titers
    geometric mean (confidence interval 95%)
        Pre-Booster at 12-16 mo
    6.64 (4.05 to 11)
    2.2 (1.82 to 2.66)
        10 or 28 Days After Vacc at 12-16 mo (N=36,31)
    2953 (2023 to 4309)
    60 (29 to 123)
    No statistical analyses for this end point

    Secondary: 6. Percentages of subjects with rBCA ≥ 1:128 at 1 Month After Infant Vaccination

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    End point title
    		 6. Percentages of subjects with rBCA ≥ 1:128 at 1 Month After Infant Vaccination
    End point description
    The percentages of subjects achieving protective titers (i.e., rBCA ≥ 128) against Neisseria meningitidis serogroup C and the rBCA GMTs at 1 month after two doses of Menjugate given at 2 and 4 months of age were evaluated. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    1 Month After Infant Vaccination.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    40
    35
    36
    36
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Day 0 N=(0,0,0,36)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    3 (0.07 to 15)
        1 Mo after Primary Infant Vacc (N=40,35,36,0)
    93 (80 to 98)
    51 (34 to 69)
    64 (46 to 79)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: 7. Geometric Mean rBCA Titers (95% CI) Against N.meningitidis serogroup C at 1 Month After Infant Vaccination

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    End point title
    		 7. Geometric Mean rBCA Titers (95% CI) Against N.meningitidis serogroup C at 1 Month After Infant Vaccination
    End point description
    The rBCA GMTs 1 month after primary immunization in subjects receiving one dose of Menjugate at either 2 or 6 months of age (2 Months group and 6 Months group) were compared to those in subjects receiving two doses of Menjugate at 2 and 4 months of age (2+4 Months group). The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    1 Month After Infant Vaccination.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    40
    35
    36
    36
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 0 N=(0,0,0,36)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    2.33 (1.71 to 3.19)
        1 Mo after Primary Infant Vacc (N=40,35,36,0)
    653 (436 to 977)
    57 (32 to 100)
    108 (78 to 149)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: 8. Percentages of subjects with rBCA titers ≥ 1:128 (95% CI) against N.meningitidis serogroup C - Persistence of antibody after infant vaccination or vaccination at 12-16 months of age

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    End point title
    		 8. Percentages of subjects with rBCA titers ≥ 1:128 (95% CI) against N.meningitidis serogroup C - Persistence of antibody after infant vaccination or vaccination at 12-16 months of age
    End point description
    To evaluate the persistence of the antibody response (in terms of percent responders) to Neisseria meningitidis serogroup C after one dose of Menjugate® at either 2 or 6 months of age (2 Months and 6 Months groups, respectively) and the persistence of antibody response after 2 doses of Menjugate at 2 and 4 months of age (2+4 Months group), before the administration of the booster at 12-16 months of age as measured by rBCA. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    at ≥8 to ≤10 months of age after the primary vaccination, at 12 to 16 months of age before the booster vaccination, and at 24 months of age after booster vaccination (2+4 Months, 2 Months and 6 Months groups) or primary vaccination (12-16 Months group)
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    41
    36
    36
    31
    Units: Percentages of Subjects
    number (confidence interval 95%)
        1 Mo after Primary Infant Vacc (N=40,35,36,0)
    93 (80 to 98)
    51 (34 to 69)
    64 (46 to 79)
    0 (0 to 0)
        Persistence at 8-10 mo of age (N=37,35,35,0)
    46 (29 to 63)
    0 (0 to 10)
    14 (5 to 30)
    0 (0 to 0)
        Persistence at 12-16 mo of age (N=41,36,36,0)
    10 (3 to 23)
    3 (0.07 to 15)
    3 (0.07 to 15)
    0 (0 to 0)
        10 days after booster (N=36,29,32,0)
    100 (90 to 100)
    90 (73 to 98)
    100 (89 to 100)
    0 (0 to 0)
        28 days after 1st dose at 12-16 mo age (N=0,0,0,31
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    52 (33 to 70)
        Persistence at 24 mo of age (N=31,25,23,22)
    26 (12 to 45)
    44 (24 to 65)
    43 (23 to 66)
    0 (0 to 15)
    No statistical analyses for this end point

    Secondary: 9. Geometric Mean rBCA Titers - Persistence of antibody after infant vaccination or vaccination at 12-16 months of age

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    End point title
    		 9. Geometric Mean rBCA Titers - Persistence of antibody after infant vaccination or vaccination at 12-16 months of age
    End point description
    To evaluate the persistence of the antibody response (in terms of rBCA GMTs) to Neisseria meningitidis serogroup C after one dose of Menjugate® at either 2 or 6 months of age (2 Months and 6 Months groups, respectively) and the persistence of antibody response after 2 doses of Menjugate at 2 and 4 months of age (2+4 Months group), before the administration of the booster at 12-16 months of age as measured by rBCA. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    at ≥8 to ≤10 months of age after the primary vaccination, at 12 to 16 months of age before the booster vaccination, and at 24 months of age after booster vaccination (2+4 Months, 2 Months and 6 Months groups) or primary vaccination (12-16 Months group)
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    41
    36
    36
    31
    Units: Titers
    geometric mean (confidence interval 95%)
        1 Mo after Primary Infant Vacc (N=40,35,36,0)
    653 (436 to 977)
    57 (32 to 100)
    108 (78 to 149)
    0 (0 to 0)
        Persistence at 8-10 mo of age (N=37,35,35,0)
    61 (35 to 106)
    5.07 (3.23 to 7.96)
    37 (26 to 52)
    0 (0 to 0)
        Persistence at 12-16 mo of age (N=41,36,36,0)
    6.64 (4.05 to 11)
    4 (2.56 to 6.24)
    6.6 (4 to 11)
    0 (0 to 0)
        10 days after booster (N=36,29,32,0)
    2953 (2023 to 4309)
    2664 (1411 to 5031)
    3922 (2653 to 5799)
    0 (0 to 0)
        28 days after 1st dose at 12-16 mo age N=0,0,0,31
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    60 (29 to 123)
        Persistence at 24 mo of age (N=31,25,23,22)
    28 (14 to 57)
    36 (14 to 93)
    47 (21 to 105)
    2.83 (2.17 to 3.68)
    No statistical analyses for this end point

    Secondary: 10. Percentages of subjects with anti-Diphtheria antibody titer ≥0.1 IU/mL

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    End point title
    		 10. Percentages of subjects with anti-Diphtheria antibody titer ≥0.1 IU/mL
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    20
    19
    19
    20
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Germany Day 0 (N=0,0,0,20)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    45 (23 to 68)
        Poland Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    18 (4 to 43)
        Germany 1 mo after Primary vacc (N=20,0,0,0)
    100 (83 to 100)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,17,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=16,15,0,0)
    100 (79 to 100)
    100 (78 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,15,0)
    0 (0 to 0)
    0 (0 to 0)
    93 (68 to 100)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,19,0,0)
    0 (0 to 0)
    100 (82 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,19)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    79 (54 to 94)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    82 (57 to 96)
        Germany 10 days after booster (N=19,15,14,0)
    100 (82 to 100)
    100 (78 to 100)
    100 (77 to 100)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    100 (81 to 100)
    100 (78 to 100)
    100 (82 to 100)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,14)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (77 to 100)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (81 to 100)
    No statistical analyses for this end point

    Secondary: 11. Percentages of subjects with anti-Tetanus antibody titer ≥0.1 IU/mL

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    End point title
    		 11. Percentages of subjects with anti-Tetanus antibody titer ≥0.1 IU/mL
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    20
    19
    19
    20
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Germany Day 0 (N=0,0,0,20)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    85 (62 to 97)
        Poland Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
        Germany 1 mo after Primary vacc (N=20,0,0,0)
    100 (83 to 100)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,17,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=16,15,0,0)
    100 (79 to 100)
    100 (78 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,15,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (78 to 100)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,19,0,0)
    0 (0 to 0)
    100 (82 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,19)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    95 (74 to 100)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
        Germany 10 days after booster (N=19,15,14,0)
    100 (82 to 100)
    100 (78 to 100)
    100 (77 to 100)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    100 (81 to 100)
    100 (78 to 100)
    100 (82 to 100)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,14)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (77 to 100)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (81 to 100)
    No statistical analyses for this end point

    Secondary: 12. Percentages of subjects with anti-Polyribosylribitol phosphate (PRP) antibody titer ≥0.15 ug/mL

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    End point title
    		 12. Percentages of subjects with anti-Polyribosylribitol phosphate (PRP) antibody titer ≥0.15 ug/mL
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life-
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    20
    19
    19
    20
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Germany Day 0 (N=0,0,0,20)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    95 (75 to 100)
        Poland Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    88 (64 to 99)
        Germany 1 mo after Primary vacc (N=20,0,0,0)
    100 (83 to 100)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,17,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=16,15,0,0)
    100 (79 to 100)
    100 (78 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,15,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (78 to 100)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,19,0,0)
    0 (0 to 0)
    95 (74 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,19)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    95 (74 to 100)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
        Germany 10 days after booster (N=19,15,14,0)
    100 (82 to 100)
    100 (78 to 100)
    100 (77 to 100)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    94 (73 to 100)
    100 (78 to 100)
    100 (82 to 100)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,14)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (77 to 100)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    94 (73 to 100)
    No statistical analyses for this end point

    Secondary: 13. Percentages of subjects with anti-Polio I antibody titer ≥1:8

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    End point title
    		 13. Percentages of subjects with anti-Polio I antibody titer ≥1:8
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    20
    19
    19
    20
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Germany Day 0 (N=0,0,0,20)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    75 (51 to 91)
        Poland Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    71 (44 to 90)
        Germany 1 mo after Primary vacc (N=20,0,0,0)
    100 (83 to 100)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,17,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=16,15,0,0)
    100 (79 to 100)
    100 (78 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,13,0)
    0 (0 to 0)
    0 (0 to 0)
    92 (64 to 100)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,19,0,0)
    0 (0 to 0)
    95 (74 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (81 to 100)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    82 (57 to 96)
        Germany 10 days after booster (N=18,15,13,0)
    100 (81 to 100)
    100 (78 to 100)
    100 (75 to 100)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    100 (81 to 100)
    100 (78 to 100)
    100 (82 to 100)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,14)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (77 to 100)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (81 to 100)
    No statistical analyses for this end point

    Secondary: 14. Percentages of subjects with anti-Polio II antibody titer ≥1:8

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    End point title
    		 14. Percentages of subjects with anti-Polio II antibody titer ≥1:8
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    20
    19
    19
    20
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Germany Day 0 (N=0,0,0,20)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    40 (19 to 64)
        Poland Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    65 (38 to 86)
        Germany 1 mo after Primary vacc (N=20,0,0,0)
    95 (75 to 100)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,17,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=16,15,0,0)
    100 (79 to 100)
    100 (78 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,13,0)
    0 (0 to 0)
    0 (0 to 0)
    92 (64 to 100)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,19,0,0)
    0 (0 to 0)
    74 (49 to 91)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    89 (65 to 99)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    88 (64 to 99)
        Germany 10 days after booster (N=18,15,13,0)
    100 (81 to 100)
    100 (78 to 100)
    100 (75 to 100)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    100 (81 to 100)
    100 (78 to 100)
    100 (82 to 100)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,14)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (77 to 100)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (81 to 100)
    No statistical analyses for this end point

    Secondary: 15. Percentages of subjects with anti-Polio III antibody titer ≥1:8

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    End point title
    		 15. Percentages of subjects with anti-Polio III antibody titer ≥1:8
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    20
    19
    19
    20
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Germany Day 0 (N=0,0,0,20)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    65 (41 to 85)
        Poland Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    6 (0 to 29)
        Germany 1 mo after Primary vacc (N=20,0,0,0)
    100 (83 to 100)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,17,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=16,15,0,0)
    100 (79 to 100)
    100 (78 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,13,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (75 to 100)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,19,0,0)
    0 (0 to 0)
    89 (67 to 99)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (81 to 100)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    82 (57 to 96)
        Germany 10 days after booster (N=18,15,13,0)
    100 (81 to 100)
    100 (78 to 100)
    100 (75 to 100)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    100 (81 to 100)
    100 (78 to 100)
    100 (82 to 100)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,14)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (77 to 100)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (81 to 100)
    No statistical analyses for this end point

    Secondary: 16. Percentages of subjects with Anti-HbsAg (Hepatitis B) Antibody Titer ≥ 10 mIU/mL

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    End point title
    		 16. Percentages of subjects with Anti-HbsAg (Hepatitis B) Antibody Titer ≥ 10 mIU/mL
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    21
    16
    19
    18
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Germany Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    24 (7 to 50)
        Poland Day 0 (N=0,0,0,16)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    25 (7 to 52)
        Germany 1 mo after Primary vacc (N=21,0,0,0)
    95 (76 to 100)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,19,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (82 to 100)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=18,14,0,0)
    100 (81 to 100)
    100 (77 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,11,0)
    0 (0 to 0)
    0 (0 to 0)
    100 (72 to 100)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,16,0,0)
    0 (0 to 0)
    94 (70 to 100)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (80 to 100)
        Germany 10 days after booster (N=15,14,10,0)
    100 (78 to 100)
    100 (77 to 100)
    90 (55 to 100)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    100 (81 to 100)
    100 (78 to 100)
    100 (82 to 100)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,13)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (75 to 100)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    100 (81 to 100)
    No statistical analyses for this end point

    Secondary: 17. Geometric mean anti-Pertussis Toxin (PT) antibody titers

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    End point title
    		 17. Geometric mean anti-Pertussis Toxin (PT) antibody titers
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    20
    19
    19
    20
    Units: Titers
    geometric mean (confidence interval 95%)
        Germany Day 0 (N=0,0,0,20)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    2.91 (2.34 to 3.62)
        Poland Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    2.92 (2.29 to 3.73)
        Germany 1 mo after Primary vacc (N=20,0,0,0)
    34 (24 to 47)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,17,0)
    0 (0 to 0)
    0 (0 to 0)
    41 (27 to 63)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=16,15,0,0)
    29 (21 to 41)
    17 (12 to 24)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,15,0)
    0 (0 to 0)
    0 (0 to 0)
    27 (19 to 38)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,19,0,0)
    0 (0 to 0)
    14 (9.68 to 21)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,19)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    5.83 (4 to 8.48)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    6.14 (3.99 to 9.47)
        Germany 10 days after booster (N=19,15,14,0)
    68 (43 to 106)
    52 (29 to 92)
    59 (31 to 109)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    72 (46 to 113)
    33 (20 to 56)
    42 (27 to 68)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,14)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    70 (45 to 109)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    75 (50 to 112)
    No statistical analyses for this end point

    Secondary: 18. Geometric mean anti-Filamentous Hemagglutinin (FHA) antibody titers

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    End point title
    		 18. Geometric mean anti-Filamentous Hemagglutinin (FHA) antibody titers
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    20
    19
    19
    19
    Units: Titers
    geometric mean (confidence interval 95%)
        Germany Day 0 (N=0,0,0,19)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    8.36 (5.01 to 14)
        Poland Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    9.91 (7.09 to 14)
        Germany 1 mo after Primary vacc (N=20,0,0,0)
    138 (101 to 189)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,17,0)
    0 (0 to 0)
    0 (0 to 0)
    167 (133 to 209)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=16,15,0,0)
    98 (77 to 123)
    77 (52 to 115)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,15,0)
    0 (0 to 0)
    0 (0 to 0)
    101 (69 to 147)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,19,0,0)
    0 (0 to 0)
    71 (53 to 95)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,19)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    53 (33 to 83)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    52 (31 to 87)
        Germany 10 days after booster (N=19,15,14,0)
    606 (356 to 1032)
    294 (181 to 477)
    278 (172 to 450)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    220 (156 to 309)
    223 (136 to 367)
    226 (162 to 317)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,14)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    348 (241 to 502)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    355 (257 to 490)
    No statistical analyses for this end point

    Secondary: 19. Geometric mean anti-Pertactin (PRN) antibody titers

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    End point title
    		 19. Geometric mean anti-Pertactin (PRN) antibody titers
    End point description
    To evaluate the immunological response to the components of the hexavalent vaccine (diphtheria, tetanus, acellular Pertussis, polio, Haemophilus influenza type b and hepatitis B), with a priority on Haemophilus influenzae type b, when administered concomitantly to Menjugate®, in as many subjects as possible, depending on the availability of serum in those young children. The analysis was done on the PP population, Immunogenicity.
    End point type
    Secondary
    End point timeframe
    After completion of the primary hexavalent schedule and after the concomitantly received hexavalent booster vaccination in the second year of life.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    20
    19
    19
    20
    Units: Titers
    geometric mean (confidence interval 95%)
        Germany Day 0 (N=0,0,0,20)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    8.53 (5.08 to 14)
        Poland Day 0 (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    7.76 (5.53 to 11)
        Germany 1 mo after Primary vacc (N=20,0,0,0)
    94 (65 to 136)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Poland1 mo after Primary vacc (N=0,0,17,0)
    0 (0 to 0)
    0 (0 to 0)
    119 (82 to 171)
    0 (0 to 0)
        Poland 2-4 mo after Primary vacc (N=16,15,0,0)
    66 (41 to 106)
    46 (23 to 91)
    0 (0 to 0)
    0 (0 to 0)
        Germany 3 mo after Primary vacc (N=0,0,15,0)
    0 (0 to 0)
    0 (0 to 0)
    86 (49 to 151)
    0 (0 to 0)
        Germany 4-6 mo after Primary vacc (N=0,19,0,0)
    0 (0 to 0)
    49 (33 to 73)
    0 (0 to 0)
    0 (0 to 0)
        Poland 6-10 mo after Primary vacc (N=0,0,0,19)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    37 (24 to 56)
        Germany 8-12 mo after Primary vacc (N=0,0,0,17)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    35 (18 to 69)
        Germany 10 days after booster (N=19,15,14,0)
    464 (289 to 745)
    524 (343 to 799)
    394 (192 to 810)
    0 (0 to 0)
        Poland 10 days after booster (N=18,15,19,0)
    380 (236 to 614)
    276 (155 to 490)
    398 (250 to 633)
    0 (0 to 0)
        Germany 28 days after booster (N=0,0,0,14)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    465 (314 to 689)
        Poland 28 days after booster (N=0,0,0,18)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    509 (347 to 747)
    No statistical analyses for this end point

    Secondary: 20. Number of Subjects Reporting Local and Systemic Reactions by Vaccination

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    End point title
    		 20. Number of Subjects Reporting Local and Systemic Reactions by Vaccination
    End point description
    To evaluate the safety and tolerability of the administration of Menjugate® administered to healthy infants at 2 to 6 months of age, and as first, second or third dose in the second year of life, the number of subjects experiencing local and systemic reactions were summarized, according to severity and relatedness. The analysis was done on the safety population.
    End point type
    Secondary
    End point timeframe
    For 30 min after each immunization and on the following seven days, including the day of vaccination.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    64
    64
    58
    62
    Units: Subjects
        Tenderness 1st vacc N=(64,64,58,61)
    6
    17
    8
    26
        Tenderness 2nd vacc (N=64,62,57,0)
    8
    28
    18
    0
        Tenderness 3rd vacc (N=63,0,0,0)
    21
    0
    0
    0
        Swelling 1st vacc N=(64,64,58,61)
    1
    5
    5
    10
        Swelling 2nd vacc (N=64,62,57,0)
    7
    16
    13
    0
        Swelling 3rd vacc (N=63,0,0,0)
    10
    0
    0
    0
        Erythema 1st vacc N=(64,64,58,61)
    13
    7
    20
    24
        Erythema 2nd vacc (N=64,62,57,0)
    15
    24
    22
    0
        Erythema 3rd vacc (N=63,0,0,0)
    25
    0
    0
    0
        Induration 1st vacc N=(64,64,58,61)
    7
    9
    22
    15
        Induration 2nd vacc (N=64,62,57,0)
    15
    21
    16
    0
        Induration 3rd vacc (63,0,0,0)
    17
    0
    0
    0
        Diarrhea 1st vacc N=(64,64,58,61)
    8
    6
    11
    9
        Diarrhea 2nd vacc (N=64,62,57,0)
    6
    8
    10
    0
        Diarrhea 3rd vacc (N=63,0,0,0)
    6
    0
    0
    0
        Change Eat. Habits 1st vacc N=(64,64,58,61)
    17
    13
    8
    15
        Change Eat. Habits 2nd vacc (N=64,62,57,0)
    12
    16
    14
    0
        Change Eat. Habits 3rd vacc (N=63,0,0,0)
    14
    0
    0
    0
        Sleepiness 1st vacc N=(64,64,58,61)
    29
    29
    9
    29
        Sleepiness 2nd vacc (N=64,62,57,0)
    21
    15
    9
    0
        Sleepiness 3rd vacc (N=63,0,0,0)
    20
    0
    0
    0
        Unusual Crying 1st vacc N=(64,64,58,61)
    15
    19
    8
    9
        Unusual Crying 2nd vacc (N=64,62,57,0)
    19
    12
    7
    0
        Unusual Crying 3rd vacc (N=63,0,0,0)
    10
    0
    0
    0
        Irritability 1st vacc N=(64,64,58,61)
    14
    16
    11
    10
        Irritability 2nd vacc (N=64,62,57,0)
    14
    11
    11
    0
        Irritability 3rd vacc (N=63,0,0,0)
    15
    0
    0
    0
        Vomiting 1st vacc N=(64,64,58,61)
    6
    2
    3
    7
        Vomiting 2nd vacc (N=64,62,57,0)
    4
    4
    3
    0
        Vomiting 3rd vacc (N=63,0,0,0)
    2
    0
    0
    0
        Fever (≥ 38.5C) 1st vacc (N=64,64,57,60)
    5
    7
    8
    9
        Fever (≥ 38.5C) 2nd vacc (N=64,61,57,0)
    8
    9
    7
    0
        Fever (≥ 38.5C) 3rd vacc (N=61,0,0,0)
    12
    0
    0
    0
        Analg. Antipyr. Med.Used 1st vacc (N=64,64,58,62)
    7
    7
    8
    13
        Analg. Antipyr. Med.Used 2nd vacc (N=64,63,57,0)
    8
    15
    6
    0
        Analg. Antipyr. Med.Used 3rd vacc (N=64,0,0,0)
    11
    0
    0
    0
    No statistical analyses for this end point

    Secondary: 21. Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

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    End point title
    		 21. Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
    End point description
    To evaluate the safety and tolerability of the Menjugate® administered to healthy infants at 2 to 6 months of age, and as first, second or third dose in the second year of life, the number of subjects experiencing serious adverse events (SAEs), adverse events (AEs) necessitating a physician’s visit and resulting in premature withdrawal from the study were summarized, according to severity and relatedness. The analysis was done on the safety population.
    End point type
    Secondary
    End point timeframe
    SAEs and AEs medically significant and/or resulting in premature withdrawal from the study were collected throughout the study and recorded by study personnel during each of the study visits.
    End point values
    		 Group 1 (2+4 Months) Group 2 (2 Months) Group 3 (6 Months) Group 4 (12-16 Months)
    Number of subjects analysed
    64
    64
    63
    66
    Units: Subjects
        Serious AEs
    6
    8
    8
    5
        Any AEs
    56
    56
    52
    55
        At least possibly related AEs
    3
    11
    1
    4
        AEs leading to premature withdrawal
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All solicited adverse events (AEs) were collected up to Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Group 1 2+4 Months
    Reporting group description
    		 Subjects received 2 doses of Menjugate®, at 2 and 4 months of age, together with the 1st and 3rd (Germany) or 1st and 2nd (Poland) dose of routine hexavalent infant immunization, and a booster at 12-16 months of age.

    Reporting group title
    Group 2 2 Months
    Reporting group description
    		 Subjects received 1 dose of Menjugate®, at 2 months of age, together with the 1st dose of routine hexavalent infant immunization, and a booster at 12-16 months of age.

    Reporting group title
    Group 3 6 Months
    Reporting group description
    		 Subjects received 1 dose of Menjugate®, at 6 months of age, together with the 3rd dose (in Poland), but respectively 2 months after the 3rd dose (in Germany), of routine hexavalent infant immunization, and a booster at 12-16 months of age.

    Reporting group title
    Group 4 12-16 Months
    Reporting group description
    		 Subjects received 1 dose of Menjugate® at 12-16 months of age (together with the 4th dose of routine hexavalent infant immunization)

    Serious adverse events
    		 Group 1 2+4 Months Group 2 2 Months Group 3 6 Months Group 4 12-16 Months
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 64 (9.38%)
    8 / 64 (12.50%)
    8 / 63 (12.70%)
    5 / 66 (7.58%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Craniocerebral injury
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Near drowning
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 66 (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
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki's disease
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 66 (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
    Nervous system disorders
    Convulsion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 66 (1.52%)
         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
    Febrile convulsion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hypothermia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 66 (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
    Diarrhoea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 66 (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
    Intussusception
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular disorder
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 66 (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
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 66 (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
    Skin and subcutaneous tissue disorders
    Purpura
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 66 (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
    Seborrhoeic dermatitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 66 (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
    Infections and infestations
    Bronchiolitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 66 (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
    Eczema herpeticum
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    2 / 63 (3.17%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 66 (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
    Pneumonia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    2 / 63 (3.17%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 66 (1.52%)
         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
    Varicella
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 66 (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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 66 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1 2+4 Months Group 2 2 Months Group 3 6 Months Group 4 12-16 Months
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 64 (100.00%)
    64 / 64 (100.00%)
    59 / 63 (93.65%)
    62 / 66 (93.94%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    46 / 64 (71.88%)
    38 / 64 (59.38%)
    14 / 63 (22.22%)
    29 / 66 (43.94%)
         occurrences all number
    154
    102
    42
    72
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 64 (1.56%)
    4 / 64 (6.25%)
    2 / 63 (3.17%)
    0 / 66 (0.00%)
         occurrences all number
    1
    5
    3
    0
    General disorders and administration site conditions
    Crying
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    29 / 64 (45.31%)
    28 / 64 (43.75%)
    12 / 63 (19.05%)
    9 / 66 (13.64%)
         occurrences all number
    92
    73
    36
    18
    Injection site erythema
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    28 / 64 (43.75%)
    29 / 64 (45.31%)
    31 / 63 (49.21%)
    24 / 66 (36.36%)
         occurrences all number
    378
    208
    329
    198
    Injection site induration
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    27 / 64 (42.19%)
    26 / 64 (40.63%)
    27 / 63 (42.86%)
    15 / 66 (22.73%)
         occurrences all number
    363
    275
    334
    146
    Injection site pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    26 / 64 (40.63%)
    32 / 64 (50.00%)
    21 / 63 (33.33%)
    26 / 66 (39.39%)
         occurrences all number
    72
    90
    52
    52
    Pyrexia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    19 / 64 (29.69%)
    17 / 64 (26.56%)
    18 / 63 (28.57%)
    12 / 66 (18.18%)
         occurrences all number
    30
    24
    21
    14
    Injection site swelling
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    14 / 64 (21.88%)
    21 / 64 (32.81%)
    14 / 63 (22.22%)
    10 / 66 (15.15%)
         occurrences all number
    134
    169
    131
    84
    Gastrointestinal disorders
    Diarrhoea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    18 / 64 (28.13%)
    16 / 64 (25.00%)
    18 / 63 (28.57%)
    13 / 66 (19.70%)
         occurrences all number
    49
    34
    47
    29
    Dyspepsia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    7 / 64 (10.94%)
    3 / 64 (4.69%)
    5 / 63 (7.94%)
    6 / 66 (9.09%)
         occurrences all number
    7
    3
    8
    6
    Infantile colic
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    2 / 63 (3.17%)
    4 / 66 (6.06%)
         occurrences all number
    1
    1
    3
    5
    Teething
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 64 (3.13%)
    7 / 63 (11.11%)
    1 / 66 (1.52%)
         occurrences all number
    3
    2
    8
    1
    Vomiting
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    11 / 64 (17.19%)
    8 / 64 (12.50%)
    6 / 63 (9.52%)
    8 / 66 (12.12%)
         occurrences all number
    24
    14
    16
    15
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 64 (3.13%)
    4 / 64 (6.25%)
    1 / 63 (1.59%)
    1 / 66 (1.52%)
         occurrences all number
    2
    4
    1
    2
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    5 / 64 (7.81%)
    4 / 64 (6.25%)
    6 / 63 (9.52%)
    6 / 66 (9.09%)
         occurrences all number
    6
    6
    10
    11
    Eczema infantile
         subjects affected / exposed
    3 / 64 (4.69%)
    1 / 64 (1.56%)
    4 / 63 (6.35%)
    3 / 66 (4.55%)
         occurrences all number
    3
    2
    5
    3
    Rash
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 64 (7.81%)
    3 / 64 (4.69%)
    3 / 63 (4.76%)
    3 / 66 (4.55%)
         occurrences all number
    5
    3
    3
    3
    Psychiatric disorders
    Eating disorder
         subjects affected / exposed
    31 / 64 (48.44%)
    25 / 64 (39.06%)
    18 / 63 (28.57%)
    15 / 66 (22.73%)
         occurrences all number
    96
    59
    52
    32
    Irritability
         subjects affected / exposed
    33 / 64 (51.56%)
    19 / 64 (29.69%)
    19 / 63 (30.16%)
    11 / 66 (16.67%)
         occurrences all number
    96
    61
    50
    25
    Restlessness
         subjects affected / exposed
    1 / 64 (1.56%)
    4 / 64 (6.25%)
    1 / 63 (1.59%)
    3 / 66 (4.55%)
         occurrences all number
    1
    6
    1
    5
    Infections and infestations
    Bronchitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    18 / 64 (28.13%)
    20 / 64 (31.25%)
    14 / 63 (22.22%)
    25 / 66 (37.88%)
         occurrences all number
    29
    31
    24
    46
    Conjunctivitis
         subjects affected / exposed
    6 / 64 (9.38%)
    9 / 64 (14.06%)
    8 / 63 (12.70%)
    7 / 66 (10.61%)
         occurrences all number
    7
    9
    10
    8
    Ear infection
         subjects affected / exposed
    6 / 64 (9.38%)
    5 / 64 (7.81%)
    2 / 63 (3.17%)
    5 / 66 (7.58%)
         occurrences all number
    7
    5
    3
    11
    Exanthema subitum
         subjects affected / exposed
    6 / 64 (9.38%)
    5 / 64 (7.81%)
    2 / 63 (3.17%)
    6 / 66 (9.09%)
         occurrences all number
    6
    5
    2
    6
    Febrile infection
         subjects affected / exposed
    2 / 64 (3.13%)
    7 / 64 (10.94%)
    2 / 63 (3.17%)
    2 / 66 (3.03%)
         occurrences all number
    2
    10
    3
    2
    Gastroenteritis
         subjects affected / exposed
    8 / 64 (12.50%)
    4 / 64 (6.25%)
    4 / 63 (6.35%)
    10 / 66 (15.15%)
         occurrences all number
    10
    4
    5
    13
    Laryngitis
         subjects affected / exposed
    3 / 64 (4.69%)
    2 / 64 (3.13%)
    4 / 63 (6.35%)
    2 / 66 (3.03%)
         occurrences all number
    3
    2
    4
    3
    Nasopharyngitis
         subjects affected / exposed
    4 / 64 (6.25%)
    2 / 64 (3.13%)
    6 / 63 (9.52%)
    9 / 66 (13.64%)
         occurrences all number
    5
    2
    8
    10
    Oral candidiasis
         subjects affected / exposed
    3 / 64 (4.69%)
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    4 / 66 (6.06%)
         occurrences all number
    3
    0
    1
    4
    Otitis media
         subjects affected / exposed
    18 / 64 (28.13%)
    11 / 64 (17.19%)
    11 / 63 (17.46%)
    9 / 66 (13.64%)
         occurrences all number
    18
    17
    13
    18
    Pharyngitis
         subjects affected / exposed
    13 / 64 (20.31%)
    14 / 64 (21.88%)
    16 / 63 (25.40%)
    14 / 66 (21.21%)
         occurrences all number
    22
    24
    28
    26
    Rhinitis
         subjects affected / exposed
    17 / 64 (26.56%)
    18 / 64 (28.13%)
    21 / 63 (33.33%)
    8 / 66 (12.12%)
         occurrences all number
    27
    28
    32
    16
    Tonsillitis
         subjects affected / exposed
    3 / 64 (4.69%)
    6 / 64 (9.38%)
    5 / 63 (7.94%)
    5 / 66 (7.58%)
         occurrences all number
    3
    10
    7
    8
    Viral infection
         subjects affected / exposed
    5 / 64 (7.81%)
    5 / 64 (7.81%)
    4 / 63 (6.35%)
    4 / 66 (6.06%)
         occurrences all number
    10
    10
    8
    8
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    25 / 64 (39.06%)
    27 / 64 (42.19%)
    22 / 63 (34.92%)
    22 / 66 (33.33%)
         occurrences all number
    48
    63
    34
    54
    Vulvitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    4 / 66 (6.06%)
         occurrences all number
    0
    1
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Mar 2005
    Two site addresses have changed.
    27 Jun 2005
    One exclusion criteria was added due to German EC request; serology of hexavalent components was to be performed and Infanrix Hexa was therefore defined as study vaccine; biostatistician was changed.
    22 Jul 2005
    Valid for Germany only - prepared on request of German EC, as amendment no 2 was not accepted due to formal reasons (infanrix hexa becoming a study vaccine was judged as such essential, that is need to be described in a separate amendment. Therefore all changes regarding Infanrix hexa have been removed with amendment no 3).
    13 Sep 2005
    Valid for Germany only - Infanrix hexa was defined as study vaccine.
    04 Oct 2005
    Valid for Germany only - due to liability concerns raised by the German EC and only supportive data collection on hexavalent antibody titer Infanrix was defined as concomitant vaccine instead of study vaccine.

    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.
    N/A
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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