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    Clinical Trial Results:
    A phase III open-label randomised study to evaluate the immunogenicity and safety of the concomitant administration of a new Hexavalent DTaP-IPV-HB-Hib combined vaccine (Hexavalent vaccine) given at 2, 3, and 4 months of age with a meningococcal serogroup C conjugate (MenC) vaccine given at 2 and 4 months of age. Short title: Concomitant administration of a new hexavalent vaccine (Hexavalent vaccine) with a meningococcal serogroup C conjugate vaccine in healthy infants during primary series immunisation followed by booster vaccination

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-005547-24
    Trial protocol
    		 FI  
    Global end of trial date
    11 Feb 2015

    Results information
    Results version number
    		 v1
    This version publication date
    13 Apr 2016
    First version publication date
    18 Mar 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    HXM01C
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01839175
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur MSD SNC
    Sponsor organisation address
    162 avenue Jean Jaurès - CS 50712, Lyon Cedex 07, France, 69367
    Public contact
    Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.com
    Scientific contact
    Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.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
    Interim
    Date of interim/final analysis
    29 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    PRIMARY SERIES (Period 2): - To demonstrate that the concomitant administration of the hexavalent vaccine given at 2, 3 and 4 months of age with a meningococcal serogroup C conjugate (MenC) vaccine given at 2 and 4 months of age is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine. - To demonstrate that the concomitant administration of a MenC vaccine given at 2 and 4 months of age with the hexavalent vaccine given at 2, 3 and 4 months of age induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC. BOOSTER: To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate vaccine either co-administered at 12 months of age or given separately.
    Protection of trial subjects
    Subjects in the study received three injections during primary series (period 2) and one injection during the booster part of a single dose of the study vaccine DTaP-IPV-HB-Hib supplied in a prefilled 0.5 mL syringe that was administered by qualified study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After each vaccination, subjects were also kept under observation for 30 minutes to ensure their safety. Appropriate equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not Applicable
    Evidence for comparator
    		 The control group complies with the recommended vaccination schedules for all vaccines (i.e. Study vaccine and routine vaccines) as per their respective Summaries of Product Characteristics (SmPCs).
    Actual start date of recruitment
    29 Apr 2013
    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: 350
    Worldwide total number of subjects
    350
    EEA total number of subjects
    350
    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)
    350
    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
    		 Study subjects were enrolled from 29 April 2013 to 09 August 2013 in 11 clinical centers in Finland.

    Pre-assignment
    Screening details
    		 A total of 354 subjects were screened out of which 350 subjects who met all the inclusion but none of the exclusion criteria were randomised and vaccinated.

    Period 1
    Period 1 title
    Randomisation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study as the number of vaccines administered in each group was different at several visits. Blinding would have required a placebo injection which was not deemed necessary since the primary endpoints were based on immunological criteria. Serology tests for the hexavalent vaccine antigens were performed by laboratory staff blinded to subject group.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Hexavalent vaccine co-administered with MenC vaccine
    Arm description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age co-administered with 2 doses of MenC vaccine with one dose each at 2, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hexyon (Hexavalent vaccine)
    Investigational medicinal product code
    DTaP-IPV-HB-Hib
    Other name
    Hexacima / Hexaxim
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route, one dose at 2, 3, and 4 months of age.

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    MenC vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route, one dose at 2, and 4 months of age.

    Arm title
    		 Hexavalent vaccine without MenC vaccine
    Arm description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hexyon (Hexavalent vaccine)
    Investigational medicinal product code
    DTaP-IPV-HB-Hib
    Other name
    Hexacima / Hexaxim
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route, one dose at 2, 3, and 4 months of age.

    Number of subjects in period 1
    		Hexavalent vaccine co-administered with MenC vaccine Hexavalent vaccine without MenC vaccine
    Started
    175
    175
    Completed
    175
    175
    Period 2
    Period 2 title
    Primary Series
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study as the number of vaccines administered in each group was different at several visits. Blinding would have required a placebo injection which was not deemed necessary since the primary endpoints were based on immunological criteria. Serology tests for the hexavalent vaccine antigens were performed by laboratory staff blinded to subject group.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Hexavalent vaccine co-administered with MenC vaccine
    Arm description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age co-administered with 2 doses of MenC vaccine with one dose each at 2, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hexyon (Hexavalent vaccine)
    Investigational medicinal product code
    DTaP-IPV-HB-Hib
    Other name
    Hexacima / Hexaxim
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route, one dose at 2, 3, and 4 months of age.

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    MenC vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route, one dose at 2, and 4 months of age.

    Arm title
    		 Hexavalent vaccine without MenC vaccine
    Arm description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hexyon (Hexavalent vaccine)
    Investigational medicinal product code
    DTaP-IPV-HB-Hib
    Other name
    Hexacima / Hexaxim
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route, one dose at 2, 3, and 4 months of age.

    Number of subjects in period 2
    		Hexavalent vaccine co-administered with MenC vaccine Hexavalent vaccine without MenC vaccine
    Started
    175
    175
    Completed
    173
    172
    Not completed
    2
    4
         Adverse event, non-fatal
    1
    2
         Transferred to other arm/group
    1
    -
         Lost to follow-up
    -
    2
    Joined
    0
    1
         Transferred in from other group/arm
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Hexavalent vaccine co-administered with MenC vaccine
    Reporting group description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age co-administered with 2 doses of MenC vaccine with one dose each at 2, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.

    Reporting group title
    Hexavalent vaccine without MenC vaccine
    Reporting group description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.

    Reporting group values
    		 Hexavalent vaccine co-administered with MenC vaccine Hexavalent vaccine without MenC vaccine Total
    Number of subjects
    		 175 175 350
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 175 175 350
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 62.8 ( 7 ) 63.2 ( 7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 83 82 165
        Male
    		 92 93 185

    End points

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    End points reporting groups
    Reporting group title
    Hexavalent vaccine co-administered with MenC vaccine
    Reporting group description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age co-administered with 2 doses of MenC vaccine with one dose each at 2, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.

    Reporting group title
    Hexavalent vaccine without MenC vaccine
    Reporting group description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.
    Reporting group title
    Hexavalent vaccine co-administered with MenC vaccine
    Reporting group description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age co-administered with 2 doses of MenC vaccine with one dose each at 2, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.

    Reporting group title
    Hexavalent vaccine without MenC vaccine
    Reporting group description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.

    Primary: Seroprotection against Hepatitis B one month after vaccination with either Hexavalent vaccine co-administered with MenC vaccine or Hexavalent vaccine without MenC vaccine

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    End point title
    		 Seroprotection against Hepatitis B one month after vaccination with either Hexavalent vaccine co-administered with MenC vaccine or Hexavalent vaccine without MenC vaccine
    End point description
    Percentage of subjects with an anti-Hepatitis B surface antigen (Hep B) concentration ≥10 mIU/mL (measured by hepatitis B enhanced Chemiluminescence assay) Analysis was done on the per protocol set.
    End point type
    Primary
    End point timeframe
    One month post-dose 3 of Hexavalent vaccine.
    End point values
    		 Hexavalent vaccine co-administered with MenC vaccine Hexavalent vaccine without MenC vaccine
    Number of subjects analysed
    160
    155
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-Hep B ≥10 mIU/mL
    97.5 (93.7 to 99.3)
    96.1 (91.8 to 98.6)
    Statistical analysis title
    		 non-inferiority of the immune response
    Statistical analysis description
    To demonstrate the non-inferiority of the immune response of the concomitant administration of the Hexavalent vaccine co-administered with MenC vaccine as compared to the Hexavalent vaccine without Men C vaccine one month after the third dose.
    Comparison groups
    Hexavalent vaccine co-administered with MenC vaccine v Hexavalent vaccine without MenC vaccine
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 Wilson score Method without cc
    Parameter type
    		 Difference in percentages of subjects
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.92
         upper limit
    		 5.95
    Notes
    [1] - The immune response of Hexavalent vaccine co-administered with MenC vaccine was considered as non-inferior to Hexavalent vaccine without MenC vaccine if the lower bound of the two-sided 95.0% Confidence Intervals (CI) of the difference in the percentages of subjects with anti-Hep B ≥10 mIU/mL measured one month after the third dose is greater than -10%. CI was based on the Wilson score method without continuity correction (cc).

    Primary: Seroprotection for MenC one month after vaccination with two doses of MenC

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    End point title
    		 Seroprotection for MenC one month after vaccination with two doses of MenC [2]
    End point description
    Percentages of subjects with an anti-MenC titre ≥8 (1/dilution (dil)) (measured by Serum Bactericidal Antibody assay with rabbit complement) one month after two doses of MenC vaccine. Analysis was done on the per protocol set. The immune response to MenC vaccine was considered as acceptable if the lower bound of the two-sided 95.0% CI of the percentage of subjects with anti-MenC ≥8 (1/dil) one month after the second dose is greater than 90%
    End point type
    Primary
    End point timeframe
    One month post-dose 2 of MenC vaccine.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The immune response to MenC vaccine was considered as acceptable if the lower bound of the two-sided 95.0% CI of the percentage of subjects with anti-MenC ≥8 (1/dil) one month after the second dose is greater than 90%. No comparison between arms was planned.
    End point values
    		 Hexavalent vaccine co-administered with MenC vaccine
    Number of subjects analysed
    162
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-MenC≥8 (1/dil)
    100 (97.7 to 100)
    No statistical analyses for this end point

    Secondary: Response rates for all Hexavalent vaccine antigens one month after 3 doses of Hexavalent vaccine co-administered with MenC vaccine or 3 doses of Hexavalent vaccine without MenC vaccine

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    End point title
    		 Response rates for all Hexavalent vaccine antigens one month after 3 doses of Hexavalent vaccine co-administered with MenC vaccine or 3 doses of Hexavalent vaccine without MenC vaccine
    End point description
    Percentages of subjects with an anti-Hep B concentration ≥10 mIU/mL (measured by Hep B enhanced Chemiluminescence assay), with an anti-PRP concentration ≥0.15ug/mL for Hib by Farr type radioimmunoassay, with an anti-D concentration ≥0.01 IU/mL and ≥0.1 IU/mL for diphtheria by Micrometabolic Inhibition Test (MIT), with an anti-T concentration ≥0.01 IU/mL and ≥0.1 IU/mL for tetanus by enzyme linked immunosorbent assay (ELISA), with an anti-IPV titre ≥8 (1/dil) for poliovirus types 1, 2, and 3 by MIT, with an anti-PT vaccine response (VR), with an anti-FHA VR, with 4-fold increase for PT and FHA by ELISA (EU/mL). Pertussis vaccine response (VR) is defined as: - If pre-vaccination antibody concentration was <4*LLOQ, then the post-vaccination antibody concentration was to be ≥4*LLOQ, - If pre-vaccination antibody concentration was ≥4*LLOQ, then the post-vaccination antibody concentration was to be ≥pre-immunisation levels Analysis was done on the per protocol set
    End point type
    Secondary
    End point timeframe
    One month post-dose 3 of Hexavalent vaccine.
    End point values
    		 Hexavalent vaccine co-administered with MenC vaccine Hexavalent vaccine without MenC vaccine
    Number of subjects analysed
    162
    160
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-Hep B ≥10 mIU/mL (N=160, 155)
    97.5 (93.7 to 99.3)
    96.1 (91.8 to 98.6)
        Anti-PRP ≥0.15 ug/mL (N=160, 158)
    98.1 (94.6 to 99.6)
    94.3 (89.5 to 97.4)
        Anti-D ≥ 0.01 IU/mL (N=160, 158)
    100 (97.7 to 100)
    99.4 (96.5 to 100)
        Anti-D≥ 0.1 IU/mL (N=160, 158)
    35 (27.6 to 42.9)
    41.1 (33.4 to 49.2)
        Anti-T ≥ 0.01 IU/mL (N=159, 156)
    100 (97.7 to 100)
    100 (97.7 to 100)
        Anti-T ≥ 0.1 IU/mL (N=159, 156)
    100 (97.7 to 100)
    99.4 (96.5 to 100)
        Anti-IPV1 (N=159, 152)
    100 (97.7 to 100)
    98.7 (95.3 to 99.8)
        Anti-IPV2 (N=159, 152)
    100 (97.7 to 100)
    100 (97.6 to 100)
        Anti-IPV3 (N=159, 152)
    100 (97.7 to 100)
    99.3 (96.4 to 100)
        Anti-PT VR (N=154, 154)
    98.7 (95.4 to 99.8)
    100 (97.6 to 100)
        Anti-PT 4-fold (N=154, 154)
    88.3 (82.2 to 92.9)
    88.3 (82.2 to 92.9)
        Anti-FHA VR (N=154, 153)
    99.4 (96.4 to 100)
    100 (97.6 to 100)
        Anti-FHA 4-fold (N=154, 153)
    89.6 (83.7 to 93.9)
    91.5 (85.9 to 95.4)
    No statistical analyses for this end point

    Secondary: Response rates for MenC one month after vaccination with one dose or two doses of MenC Vaccine.

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    End point title
    		 Response rates for MenC one month after vaccination with one dose or two doses of MenC Vaccine.
    End point description
    Percentages of subjects with an anti-MenC titre ≥8 (1/dilution (dil)) or with an anti-MenC titre ≥128 (1/dil) (measured by Serum Bactericidal Antibody assay with rabbit complement) one month after one dose or one month after two doses of MenC vaccine. Analysis was done on the per protocol set.
    End point type
    Secondary
    End point timeframe
    One month post-dose 1 or post-dose 2 of MenC vaccine.
    End point values
    		 Hexavalent vaccine co-administered with MenC vaccine
    Number of subjects analysed
    162
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-MenC ≥8 (1/dil) post-dose 1 (N=157)
    99.4 (96.5 to 100)
        Anti-MenC ≥128 (1/dil) post-dose 1 (N=157)
    98.1 (94.5 to 99.6)
        Anti-MenC ≥8 (1/dil) post-dose 2 (N=162)
    100 (97.7 to 100)
        Anti-MenC ≥128 (1/dil) post-dose 2 (N=162)
    96.3 (92.1 to 98.6)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers or Concentrations of Antibodies one month after 3 doses of Hexavalent vaccine co-administered with MenC vaccine or 3 doses of Hexavalent vaccine without MenC vaccine

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    End point title
    		 Geometric Mean Titers or Concentrations of Antibodies one month after 3 doses of Hexavalent vaccine co-administered with MenC vaccine or 3 doses of Hexavalent vaccine without MenC vaccine
    End point description
    Antibody titers or concentrations were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection (mIU/mL), for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay (ug/mL), for diphtheria (D) by Micrometabolic Inhibition Test (IU/mL), for tetanus by enzyme linked immunosorbent assay (IU/mL), for poliovirus (IPV) types 1, 2, and 3 by Micrometabolic Inhibition Test (1/dil), for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA in EU/mL)). Analysis was done on the per protocol set.
    End point type
    Secondary
    End point timeframe
    One month post-dose 3 of Hexavalent vaccine.
    End point values
    		 Hexavalent vaccine co-administered with MenC vaccine Hexavalent vaccine without MenC vaccine
    Number of subjects analysed
    162
    160
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Hep B (N=160, 155)
    242.75 (195.05 to 302.11)
    267.58 (212.65 to 336.7)
        Anti-PRP (N=160, 158)
    3.49 (2.88 to 4.24)
    1.89 (1.49 to 2.38)
        Anti-D (N=160, 158)
    0.08 (0.07 to 0.1)
    0.09 (0.08 to 0.1)
        Anti-T (N=159, 156)
    1.17 (1.07 to 1.29)
    0.78 (0.7 to 0.87)
        Anti-IPV1 (N=159, 152)
    92.49 (75.06 to 113.97)
    126.84 (101.46 to 158.56)
        Anti-IPV2 (N=159, 152)
    90.9 (73.23 to 112.83)
    104.72 (82.66 to 132.67)
        Anti-IPV3 (N=159, 152)
    173.3 (138.2 to 217.31)
    250.78 (197.56 to 318.34)
        Anti-PT (N=160, 159)
    129.74 (118.93 to 141.52)
    139.91 (126.98 to 154.15)
        Anti-FHA (N=158, 156)
    123.54 (112.47 to 135.69)
    147.77 (134.82 to 161.97)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Antibodies one month after 1 dose or 2 doses of MenC vaccine co-administered with Hexavalent vaccine

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    End point title
    		 Geometric Mean Titers of Antibodies one month after 1 dose or 2 doses of MenC vaccine co-administered with Hexavalent vaccine
    End point description
    Antibody titers were measured by Serum Bactericidal Antibody assay with rabbit complement (1/dil) one month after one dose or two doses of MenC vaccine Analysis was done on the per protocol set.
    End point type
    Secondary
    End point timeframe
    One month post-dose 1 or post-dose 2 of MenC vaccine.
    End point values
    		 Hexavalent vaccine co-administered with MenC vaccine
    Number of subjects analysed
    162
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-MenC post-dose 1 (N=157)
    885.17 (737.06 to 1063.04)
        Anti-MenC post-dose 2 (N=162)
    579.64 (505.36 to 664.84)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Injection Site or Systemic Reactions After Hexavalent vaccine co-administered with MenC vaccine or Hexavalent vaccine without MenC

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    End point title
    		 Number of Subjects Reporting Solicited Injection Site or Systemic Reactions After Hexavalent vaccine co-administered with MenC vaccine or Hexavalent vaccine without MenC
    End point description
    Solicited Injection Site Reactions: Erythema, Pain, and Swelling; Solicited Systemic Reactions: Crying, Decreased appetite, Irritability, Pyrexia, Somnolence, and Vomiting within 7 days after any hexavalent vaccine injection with or without MenC vaccine. Analysis was done on the safety analysis set, i.e. all subjects who received at least one dose of the hexavalent vaccine and had any safety follow-up data.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 7 days following any dose.
    End point values
    		 Hexavalent vaccine co-administered with MenC vaccine Hexavalent vaccine without MenC vaccine
    Number of subjects analysed
    174
    176
    Units: Number of subjects
    number (not applicable)
        Solicited reaction any dose
    174
    176
        Solicited Injection site reaction
    155
    130
        Solicited Injection site after Hexavalent vaccine
    147
    130
        Erythema after Hexavalent vaccine
    95
    97
        Pain after Hexavalent vaccine
    120
    109
        Swelling after Hexavalent vaccine
    60
    61
        Solicited Injection site after MenC vaccine
    124
    0
        Erythema after MenC vaccine
    78
    0
        Pain after MenC vaccine
    106
    0
        Swelling after MenC vaccine
    45
    0
        Solicited systemic reaction
    174
    176
        Crying
    148
    125
        Decreased appetite
    98
    96
        Irritability
    166
    166
        Pyrexia
    126
    127
        Somnolence
    144
    151
        Vomiting
    63
    47
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited adverse events were collected from Day 0 up to 30 days after each vaccination. Serious adverse events were collected from the first vaccination and up to the last visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Hexavalent vaccine co-administered with MenC vaccine
    Reporting group description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age co-administered with 2 doses of MenC vaccine with one dose each at 2, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age

    Reporting group title
    Hexavalent without MenC
    Reporting group description
    		 Subjects received 3 doses of hexavalent vaccine with one dose each at 2, 3, and 4 months of age. Subjects received also routine vaccination: RotaTeq at 2, 3, and 4 months of age and Prevenar 13 at 2, and 4 months of age.

    Serious adverse events
    		 Hexavalent vaccine co-administered with MenC vaccine Hexavalent without MenC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 174 (2.30%)
    2 / 176 (1.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin neoplasm bleeding
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Hexavalent vaccine co-administered with MenC vaccine Hexavalent without MenC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    105 / 174 (60.34%)
    108 / 176 (61.36%)
    General disorders and administration site conditions
    Injection site bruising
         subjects affected / exposed
    9 / 174 (5.17%)
    7 / 176 (3.98%)
         occurrences all number
    11
    7
    Injection site induration
         subjects affected / exposed
    14 / 174 (8.05%)
    9 / 176 (5.11%)
         occurrences all number
    25
    10
    Pyrexia
         subjects affected / exposed
    5 / 174 (2.87%)
    10 / 176 (5.68%)
         occurrences all number
    6
    11
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    14 / 174 (8.05%)
    12 / 176 (6.82%)
         occurrences all number
    17
    15
    Flatulence
         subjects affected / exposed
    7 / 174 (4.02%)
    9 / 176 (5.11%)
         occurrences all number
    7
    12
    Teething
         subjects affected / exposed
    9 / 174 (5.17%)
    5 / 176 (2.84%)
         occurrences all number
    12
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 174 (5.17%)
    9 / 176 (5.11%)
         occurrences all number
    12
    9
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    24 / 174 (13.79%)
    26 / 176 (14.77%)
         occurrences all number
    34
    32
    Upper respiratory tract infection
         subjects affected / exposed
    25 / 174 (14.37%)
    27 / 176 (15.34%)
         occurrences all number
    29
    27

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2013
    Amendment 1 to Protocol (leading to Version 2.0) was produced to provide details regarding the booster vaccination at 12 to 13 months of age with hexavalent vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine and meningococcal C containing 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.
    None reported
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