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    Clinical Trial Results:
    Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13) at 3, 5, 11 to 12 Months of Age in Healthy Infants in Europe.

    Summary
    EudraCT number
    		 2012-001054-26
    Trial protocol
    		 SE   FI  
    Global end of trial date
    10 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2016
    First version publication date
    14 Feb 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L38
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1122-2235
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43, emmanuel.feroldi@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43, emmanuel.feroldi@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001201-PIP01-11
    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
    12 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of the Hexaxim vaccine to the licensed Infanrix hexa vaccine, both co-administered with Prevenar 13, in terms of seroprotection or vaccine response rates to all antigens contained in both investigational and control vaccines, 1 month after a 2+1-dose schedule.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Prevenar 13 was co-administered with both the investigational and control vaccines in order to document the concomitant administration with the investigational vaccine as compared to its co-administration with the licensed vaccine.
    Evidence for comparator
    		 Infanrix hexa was chosen as the comparator vaccine as it was the only licensed hexavalent vaccine in Europe at the time of study start and was licensed but not used in Sweden and Finland.
    Actual start date of recruitment
    01 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 43
    Country: Number of subjects enrolled
    Finland: 511
    Worldwide total number of subjects
    554
    EEA total number of subjects
    554
    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)
    554
    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 01 November 2012 to 12 March 2014 in 11 centers in Finland and 2 centers in Sweden.

    Pre-assignment
    Screening details
    		 A total of 546 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Neither the Investigator, the subject‘s parent(s)/legally representative(s), nor the Sponsor knew the vaccine administered. The product preparation and administration, and the assessment of safety were performed by 2 different individuals in separate rooms. The Investigator or delegate included subjects and evaluated the immediate safety post- vaccination. The nurse/vaccinator prepared and administered the vaccine in a separate room and had sole access to the product accountability forms.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTaP-IPV-HB-Hib+Prevenar 13
    Arm description
    		 Subjects who received 3 doses of DTaP-IPV-HB-Hib vaccine co-administered with Prevenar 13 at 3, 5, and 11 to 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-HepB-PRP-T
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular injection into the anterolateral area of the right thigh, 3 doses at 3, 5, and 11 to 12 months of age.

    Arm title
    		 Infanrix hexa+Prevenar 13
    Arm description
    		 Subjects who received 3 doses of Infanrix hexa vaccine co-administered with Prevenar 13 at 3, 5, and 11 to 12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection, Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular injection into the anterolateral area of the right thigh, 3 doses at 3, 5, and 11 to 12 months of age.

    Number of subjects in period 1 [1]
    		DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Started
    271
    275
    Completed
    266
    267
    Not completed
    5
    8
         Consent withdrawn by subject
    4
    6
         Adverse event, non-fatal
    1
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects enrolled at baseline (N=546) represents subjects who were vaccinated at V01 and included in the Full Analysis Set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV-HB-Hib+Prevenar 13
    Reporting group description
    		 Subjects who received 3 doses of DTaP-IPV-HB-Hib vaccine co-administered with Prevenar 13 at 3, 5, and 11 to 12 months of age.

    Reporting group title
    Infanrix hexa+Prevenar 13
    Reporting group description
    		 Subjects who received 3 doses of Infanrix hexa vaccine co-administered with Prevenar 13 at 3, 5, and 11 to 12 months of age.

    Reporting group values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13 Total
    Number of subjects
    		 271 275 546
    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)
    		 271 275 546
        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)
    		 89.6 ( 3.2 ) 89 ( 3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 130 142 272
        Male
    		 141 133 274

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV-HB-Hib+Prevenar 13
    Reporting group description
    		 Subjects who received 3 doses of DTaP-IPV-HB-Hib vaccine co-administered with Prevenar 13 at 3, 5, and 11 to 12 months of age.

    Reporting group title
    Infanrix hexa+Prevenar 13
    Reporting group description
    		 Subjects who received 3 doses of Infanrix hexa vaccine co-administered with Prevenar 13 at 3, 5, and 11 to 12 months of age.

    Primary: Percentage of Subjects with Seroprotection or Vaccine Response Following Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Percentage of Subjects with Seroprotection or Vaccine Response Following Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13) [1]
    End point description
    Anti-Diphtheria antibodies (Ab) were measured by a diphtheria micrometabolic inhibition test; Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti- Filamentous Hemaglutinin (FHA) Ab were measured by enzyme-linked immunosorbent assay; Anti-Polio types were measured by neutralization assay; Anti-hepatitis B (Hep B) Ab were measured by the VITROS ECi/ECiQ Immunodiagnostic System; and Anti-polyribosyl ribitol phosphate (PRP) Ab were measured using a Farr-type radioimmunoassay. Seroprotection was defined as Anti-Diphtheria and anti-Tetanus Ab concentrations ≥ 0.1 international units (IU)/mL, Anti-poliovirus 1, 2, and 3 Ab titers ≥ 8 (1/dil), Anti-Hep B Ab concentrations ≥ 10 mIU/mL, and Anti-PRP Ab concentrations ≥ 1 μg/mL. Vaccine response for PT and FHA was defined as Post-Dose 3 Ab concentrations ≥ 4 × Lower Level Of Quantitation (LLOQ), if pre-Dose 1 Ab concentrations < 4 × LLOQ; Post-Dose 3 Ab concentrations ≥ pre-Dose 1 Ab concentrations, , if pre-Dose 1 Ab concentrations ≥ 4 × LLOQ.
    End point type
    Primary
    End point timeframe
    1 month post-Dose 3
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    249
    248
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria
    100
    99.2
        Anti-Tetanus
    100
    100
        Anti-PT
    98
    99.6
        Anti-FHA
    100
    99.6
        Anti-Polio 1
    100
    100
        Anti-Polio 2
    100
    100
        Anti-Polio 3
    99.6
    99.6
        Anti-Hep B
    96.4
    99.6
        Anti-PRP
    93.5
    85.2
    No statistical analyses for this end point

    Secondary: Summary of Vaccine Antibodies’ Titers Before and After Dose 3 Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Summary of Vaccine Antibodies’ Titers Before and After Dose 3 Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Anti-Diphtheria antibodies (Ab) were measured by a diphtheria micrometabolic inhibition test (MIT); Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti- Filamentous Hemaglutinin (FHA) Ab were measured by enzyme-linked immunosorbent assay (ELISA); Anti-hepatitis B (Hep B) Ab were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System; and Anti-polyribosyl ribitol phosphate (PRP) Ab were measured using a Farr-type radioimmunoassay. The following Ab criteria were applied: Pre-Dose 3 for Anti-Diphtheria and Anti-Tetanus (≥0.01 IU/mL), Anti-PT and Anti-FHA (≥4 EU/mL), Anti-Hep B (≥100 mIU/mL), and Anti-PRP (≥0.15 µg/mL) and Post-Dose 3 for Anti-Diphtheria and Anti-Tetanus (≥0.01 IU/mL), Anti-PT and Anti-FHA (≥4 EU/mL), Anti-Hep B (≥100 mIU/mL), and Anti-PRP (≥0.15 µg/mL).
    End point type
    Secondary
    End point timeframe
    Pre- and Post-Dose 3
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    249
    248
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Pre-Dose 3
    98.3
    97.5
        Anti-Diphtheria; Post-Dose 3
    100
    99.6
        Anti-Tetanus; Pre-Dose 3
    100
    100
        Anti-Tetanus; Post-Dose 3
    100
    100
        Anti-PT; Pre-Dose 3
    99.6
    99.2
        Anti-PT; Post-Dose 3
    100
    100
        Anti-FHA; Pre-Dose 3
    100
    100
        Anti-FHA; Post-Dose 3
    100
    100
        Anti-Hep B; Pre-Dose 3
    45.2
    80.5
        Anti-Hep B; Post-Dose 3
    91.2
    98
        Anti-PRP; Pre-Dose 3
    50.6
    40.8
        Anti-PRP; Post-Dose 3
    99.6
    98.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Seroconversion or Booster Response to Pertussis Toxoid and Filamentous Hemagglutinin Antibodies After Vaccinations with DTaP-IPV-Hep B-PRP-T Vaccine or Infanrix hexa™ Administered With 13-Valent Pneumococcal Conjugate Vaccine

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    End point title
    		 Percentage of Subjects with Seroconversion or Booster Response to Pertussis Toxoid and Filamentous Hemagglutinin Antibodies After Vaccinations with DTaP-IPV-Hep B-PRP-T Vaccine or Infanrix hexa™ Administered With 13-Valent Pneumococcal Conjugate Vaccine
    End point description
    Anti-Pertussis toxoid (PT), and Anti- Filamentous Hemaglutinin (FHA) Ab were measured by enzyme-linked immunosorbent assay (ELISA). Seroconversion for PT and FHA was defined as follows: ≥ 4-fold Ab concentrations increase from pre-Dose 1 (V01) to post-Dose 3 (V05). Booster response for PT and FHA was defined as Post-Dose 3 Ab concentrations ≥ 4-fold rise if pre-Dose 3 Ab concentrations < 4x LLOQ; Post-Dose 3 Ab concentrations ≥ 2-fold rise if pre-Dose 3 Ab concentrations ≥ 4x LLOQ.
    End point type
    Secondary
    End point timeframe
    Post-Dose 3
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    249
    248
    Units: Percentage of subjects
    number (not applicable)
        Anti-PT; Seroconversion
    94.3
    95.5
        Anti-PT; Booster response
    94
    99.2
        Anti-FHA; Seroconversion
    97.6
    94.2
        Anti-FHA; Booster response
    96.6
    95.8
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Vaccine Antigens Following Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Vaccine Antigens Following Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Anti-Diphtheria antibodies (Ab) were measured by a diphtheria micrometabolic inhibition test (MIT); Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti- Filamentous Hemaglutinin (FHA) Ab were measured by enzyme-linked immunosorbent assay (ELISA); Anti-Polio types 1, 2, and 3 were measured by neutralization assay; Anti-hepatitis B (Hep B) Ab were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System; and Anti- polyribosyl ribitol phosphate (PRP) Ab were measured using a Farr-type radioimmunoassay.
    End point type
    Secondary
    End point timeframe
    Pre- and Post-Dose 3
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    249
    248
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Pre-Dose 3
    0.08 (0.069 to 0.092)
    0.053 (0.046 to 0.06)
        Anti-Diphtheria; Post-Dose 3
    1.7 (1.54 to 1.87)
    1.2 (1.07 to 1.34)
        Anti-Tetanus; Pre-Dose 3
    0.129 (0.114 to 0.146)
    0.167 (0.149 to 0.188)
        Anti-Tetanus; Post-Dose 3
    2.23 (2.01 to 2.47)
    2.37 (2.16 to 2.6)
        Anti-PT; Pre-Dose 3
    20.5 (18.8 to 22.5)
    23.7 (21.5 to 26)
        Anti-PT; Post-Dose 3
    90.9 (84.9 to 97.4)
    129 (119 to 139)
        Anti-FHA; Pre-Dose 3
    30.6 (28.3 to 33.1)
    28.7 (26.3 to 31.4)
        Anti-FHA; Post-Dose 3
    148 (138 to 158)
    167 (155 to 179)
        Anti-Polio 1; Pre-Dose 3
    15.8 (12.8 to 19.4)
    27.3 (22.4 to 33.3)
        Anti-Polio 1; Post-Dose 3
    1749 (1494 to 2047)
    3279 (2869 to 3746)
        Anti-Polio 2; Pre-Dose 3
    14.1 (11.5 to 17.2)
    22.4 (18 to 27.8)
        Anti-Polio 2; Post-Dose 3
    1729 (1454 to 2058)
    2954 (2520 to 3462)
        Anti-Polio 3; Pre-Dose 3
    15.7 (12.8 to 19.1)
    20.9 (17.4 to 25)
        Anti-Polio 3; Post-Dose 3
    1213 (1005 to 1463)
    1906 (1594 to 2279)
        Anti-Hep B; Pre-Dose 3
    76.5 (62 to 94.4)
    260 (218 to 311)
        Anti-Hep B; Post-Dose 3
    1370 (1069 to 1757)
    5015 (4178 to 6020)
        Anti-PRP; Pre-Dose 3
    0.168 (0.137 to 0.205)
    0.115 (0.096 to 0.137)
        Anti-PRP; Post-Dose 3
    9.73 (8.12 to 11.7)
    5.64 (4.66 to 6.81)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Immune Responses to Prevenar 13 antigens Following Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Percentage of Subjects with Immune Responses to Prevenar 13 antigens Following Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Anti-pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by enzyme-linked immunosorbent assay (ELISA). Immune response was defined as subjects with antibody concentrations ≥ 0.35 µg/mL 1 month after a 2+1-dose schedule.
    End point type
    Secondary
    End point timeframe
    Post-Dose 3
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    249
    248
    Units: Percentage of subjects
    number (not applicable)
        Serotype 1
    99.4
    100
        Serotype 3
    86.3
    88
        Serotype 4
    99.4
    98.8
        Serotype 5
    95.1
    98.1
        Serotype 6A
    100
    98.8
        Serotype 6B
    100
    100
        Serotype 7F
    100
    100
        Serotype 9V
    99.4
    99.4
        Serotype 14
    100
    100
        Serotype 18C
    98.2
    100
        Serotype 19A
    100
    100
        Serotype 19F
    100
    100
        Serotype 23F
    100
    99.4
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Prevenar Vaccine Antibodies Following Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Geometric Mean Titers (GMTs) of Prevenar Vaccine Antibodies Following Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Anti-pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    Post-Dose 3
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    249
    248
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Serotype 1
    2.15 (1.95 to 2.36)
    2.47 (2.21 to 2.75)
        Serotype 3
    0.669 (0.605 to 0.74)
    0.824 (0.735 to 0.924)
        Serotype 4
    1.5 (1.36 to 1.66)
    1.95 (1.74 to 2.18)
        Serotype 5
    1.07 (0.973 to 1.19)
    1.32 (1.2 to 1.45)
        Serotype 6A
    4.01 (3.63 to 4.44)
    4.92 (4.34 to 5.58)
        Serotype 6B
    2.82 (2.51 to 3.17)
    4.29 (3.8 to 4.84)
        Serotype 7F
    3.04 (2.79 to 3.31)
    3.97 (3.6 to 4.38)
        Serotype 9V
    1.36 (1.24 to 1.5)
    1.7 (1.53 to 1.88)
        Serotype 14
    6.79 (6 to 7.69)
    7.77 (6.98 to 8.65)
        Serotype 18C
    1.27 (1.14 to 1.41)
    1.79 (1.61 to 1.99)
        Serotype 19A
    4.43 (3.88 to 5.06)
    5.78 (5.1 to 6.55)
        Serotype 19F
    4.75 (4.27 to 5.3)
    6 (5.31 to 6.78)
        Serotype 23F
    2.89 (2.6 to 3.22)
    4.24 (3.74 to 4.8)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seroprotection or Vaccine Response One Month Post-dose 2 Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Percentage of Subjects with Seroprotection or Vaccine Response One Month Post-dose 2 Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Anti-Diphtheria antibodies (Ab) were measured by a diphtheria micrometabolic inhibition test (MIT); Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti- Filamentous Hemaglutinin (FHA) Ab were measured by enzyme-linked immunosorbent assay (ELISA); Anti-poliovirus 1, 2, and 3 were measured by neutralization assay; Anti-hepatitis B (Hep B) Ab were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System; and Anti-polyribosyl ribitol phosphate (PRP) Ab were measured using a Farr-type radioimmunoassay. The following Ab criteria were applied 1 month Post-Dose 3: Anti-Diphtheria and Anti-Tetanus (≥0.01 IU/mL), Anti-Polio 1, 2, and 3 (≥8 1[dil]), Anti-Hep B (≥10 mIU/mL), and Anti-PRP (≥0.15 µg/mL). Vaccine response for Anti-PT and Anti-FHA was defined as Post-Dose 2 Ab concentrations ≥ 4 × Lower Level Of Quantitation (LLOQ), if pre-Dose 1 Ab concentrations < 4 × LLOQ; Post-Dose 2 Ab concentrations ≥ pre-Dose 1 Ab concentrations, if pre-Dose 1 Ab concentrations ≥ 4 × LLOQ.
    End point type
    Other pre-specified
    End point timeframe
    1 month Post-Dose 2
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    249
    246
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria
    99.6
    99.6
        Anti-Tetanus
    100
    100
        Anti-PT
    98.4
    99.2
        Anti-FHA
    99.6
    98.3
        Anti-Polio 1
    90.8
    95.4
        Anti-Polio 2
    95
    96.6
        Anti-Polio 3
    96.7
    98.3
        Anti-Hep B
    97.2
    98.4
        Anti-PRP
    71.5
    57.9
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers (GMTs) of Antibodies Against Vaccine Antigens One Month Post-dose 2 Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Vaccine Antigens One Month Post-dose 2 Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Anti-Diphtheria antibodies (Ab) were measured by a diphtheria micrometabolic inhibition test (MIT); Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti- Filamentous Hemaglutinin (FHA) Ab were measured by enzyme-linked immunosorbent assay (ELISA); Anti-poliovirus 1, 2, and 3 Ab were measured by neutralization assay; Anti-hepatitis B (Hep B) Ab were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System; and Anti-polyribosyl ribitol phosphate (PRP) Ab were measured using a Farr-type radioimmunoassay.
    End point type
    Other pre-specified
    End point timeframe
    1 month Post-Dose 2
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    249
    246
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    0.13 (0.112 to 0.152)
    0.118 (0.103 to 0.134)
        Anti-Tetanus
    0.491 (0.439 to 0.549)
    0.594 (0.54 to 0.652)
        Anti-PT
    105 (97.8 to 113)
    106 (97.7 to 115)
        Anti-FHA
    94.9 (88.5 to 102)
    97.7 (90.5 to 105)
        Anti-Polio 1
    60 (47.6 to 75.5)
    105 (84.5 to 129)
        Anti-Polio 2
    62.1 (49.1 to 78.5)
    89.5 (70.9 to 113)
        Anti-Polio 3
    122 (97.7 to 152)
    142 (115 to 175)
        Anti-Hep B
    401 (330 to 488)
    699 (577 to 847)
        Anti-PRP
    0.507 (0.398 to 0.647)
    0.226 (0.184 to 0.277)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Each Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Each Vaccinations with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Solicited injection site: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 7 post-each vaccination
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    271
    275
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain; Post-Injection 1
    43.9
    32.1
        Injection site Pain; Post-Injection 2
    40.1
    29.9
        Injection site Pain; Post-Injection 3
    65
    56.8
        Injection site Erythema; Post-Injection 1
    32.8
    26.6
        Injection site Erythema; Post-Injection 2
    46.5
    40.6
        Injection site Erythema; Post-Injection 3
    53.4
    51.9
        Injection site Swelling; Post-Injection 1
    24.7
    18.2
        Injection site Swelling; Post-Injection 2
    27.5
    29.5
        Injection site Swelling; Post-Injection 3
    28.2
    38.7
        Pyrexia; Post-Injection 1
    46.3
    26.3
        Pyrexia; Post-Injection 2
    61.7
    49.8
        Pyrexia; Post-Injection 3
    52.1
    48.1
        Vomiting; Post-Injection 1
    15.5
    21.9
        Vomiting; Post-Injection 2
    20.4
    22.5
        Vomiting; Post-Injection 3
    13.2
    11.7
        Crying; Post-Injection 1
    72
    65.3
        Crying; Post-Injection 2
    62.8
    64.2
        Crying; Post-Injection 3
    63.9
    64.5
        Somnolence; Post-Injection 1
    60.5
    58.8
        Somnolence; Post-Injection 2
    49.8
    49.4
        Somnolence; Post-Injection 3
    53
    52.1
        Anorexia; Post-Injection 1
    35.4
    28.5
        Anorexia; Post-Injection 2
    32
    28
        Anorexia; Post-Injection 3
    44.4
    48.9
        Irritability; Post-Injection 1
    81.9
    76.6
        Irritability; Post-Injection 2
    76.6
    74.2
        Irritability; Post-Injection 3
    75.6
    74.7
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 1 with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 1 with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Solicited injection site: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Solicited injection site reactions: Pain – Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling – ≥50 mm. Grade 3 Systemic reactions: Pyrexia – >39°C; Vomiting – ≥6 episodes per 24 hours or requiring parenteral hydration; Crying – >3 hours; Somnolence – Sleeping most of the time or difficult to wake up; Anorexia – Refuses ≥3 feeds/meals or refuses most meals; Irritability – Inconsolable.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 7 post-Dose 1
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    271
    275
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    43.9
    32.1
        Grade 3 Injection site Pain
    3.3
    2.9
        Injection site Erythema
    32.8
    26.6
        Grade 3 Injection site Erythema
    3.3
    1.8
        Injection site Swelling
    24.7
    18.2
        Grade 3 Injection site Swelling
    2.6
    1.1
        Pyrexia
    46.3
    26.3
        Grade 3 Pyrexia
    0
    0
        Vomiting
    15.5
    21.9
        Grade 3 Vomiting
    0.4
    0.7
        Crying
    72
    65.3
        Grade 3 Crying
    3.3
    0.4
        Somnolence
    60.5
    58.8
        Grade 3 Somnolence
    1.8
    0.7
        Anorexia
    35.4
    28.5
        Grade 3 Anorexia
    0.7
    0.7
        Irritability
    81.9
    76.6
        Grade 3 Irritability
    4.8
    6.2
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 2 with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 2 with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Solicited injection site: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Solicited injection site reactions: Pain – Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling – ≥50 mm. Grade 3 Systemic reactions: Pyrexia – >39°C; Vomiting – ≥6 episodes per 24 hours or requiring parenteral hydration; Crying – >3 hours; Somnolence – Sleeping most of the time or difficult to wake up; Anorexia – Refuses ≥3 feeds/meals or refuses most meals; Irritability – Inconsolable.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 7 post-Dose 2
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    269
    272
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    40.1
    29.9
        Grade 3 Injection site Pain
    0.4
    1.8
        Injection site Erythema
    46.5
    40.6
        Grade 3 Injection site Erythema
    1.1
    0.4
        Injection site Swelling
    27.5
    29.5
        Grade 3 Injection site Swelling
    1.5
    0
        Pyrexia
    61.7
    49.8
        Grade 3 Pyrexia
    0.7
    1.5
        Vomiting
    20.4
    22.5
        Grade 3 Vomiting
    1.5
    0.4
        Crying
    62.8
    64.2
        Grade 3 Crying
    3.3
    1.8
        Somnolence
    49.8
    49.4
        Grade 3 Somnolence
    0.7
    2.2
        Anorexia
    32
    28
        Grade 3 Anorexia
    1.5
    0
        Irritability
    76.6
    74.2
        Grade 3 Irritability
    4.1
    2.2
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 3 with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 3 with Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13)
    End point description
    Solicited injection site: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Solicited injection site reactions: Pain – Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling – ≥50 mm. Grade 3 Systemic reactions: Pyrexia – >39°C; Vomiting – ≥6 episodes per 24 hours or requiring parenteral hydration; Crying – >3 hours; Somnolence – Sleeping most of the time or difficult to wake up; Anorexia – Refuses ≥3 feeds/meals or refuses most meals; Irritability – Inconsolable.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 7 post-Dose 3
    End point values
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Number of subjects analysed
    267
    268
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    65
    56.8
        Grade 3 Injection site Pain
    6.8
    4.1
        Injection site Erythema
    53.4
    51.9
        Grade 3 Injection site Erythema
    2.6
    4.1
        Injection site Swelling
    28.2
    38.7
        Grade 3 Injection site Swelling
    1.5
    2.3
        Pyrexia
    52.1
    48.1
        Grade 3 Pyrexia
    2.3
    1.5
        Vomiting
    13.2
    11.7
        Grade 3 Vomiting
    0
    0
        Crying
    63.9
    64.5
        Grade 3 Crying
    5.3
    2.6
        Somnolence
    53
    52.1
        Grade 3 Somnolence
    1.1
    1.5
        Anorexia
    44.4
    48.9
        Grade 3 Anorexia
    2.6
    0.8
        Irritability
    75.6
    74.7
        Grade 3 Irritability
    3.4
    1.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-final vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    DTaP-IPV-HB-Hib+Prevenar 13
    Reporting group description
    		 Subjects who received 3 doses of DTaP-IPV-HB-Hib vaccine co-administered with Prevenar 13 at 3, 5, and 11 to 12 months of age.

    Reporting group title
    Infanrix hexa+Prevenar 13
    Reporting group description
    		 Subjects who received 3 doses of Infanrix hexa vaccine co-administered with Prevenar 13 at 3, 5, and 11 to 12 months of age.

    Serious adverse events
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 271 (5.54%)
    15 / 275 (5.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Petechiae
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Inguinal mass
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    3 / 271 (1.11%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 271 (0.74%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    3 / 271 (1.11%)
    3 / 275 (1.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 271 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 271 (0.37%)
    2 / 275 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 271 (0.37%)
    0 / 275 (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
    		 DTaP-IPV-HB-Hib+Prevenar 13 Infanrix hexa+Prevenar 13
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    222 / 271 (81.92%)
    210 / 275 (76.36%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    164 / 271 (60.52%)
    161 / 274 (58.76%)
         occurrences all number
    164
    161
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    166 / 271 (61.25%)
    135 / 274 (49.27%)
         occurrences all number
    166
    135
    Injection site induration
         subjects affected / exposed
    12 / 271 (4.43%)
    17 / 275 (6.18%)
         occurrences all number
    16
    32
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    173 / 271 (63.84%)
    151 / 274 (55.11%)
         occurrences all number
    173
    151
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    142 / 271 (52.40%)
    138 / 274 (50.36%)
         occurrences all number
    142
    138
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    75 / 271 (27.68%)
    103 / 274 (37.59%)
         occurrences all number
    75
    103
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    23 / 271 (8.49%)
    22 / 275 (8.00%)
         occurrences all number
    23
    27
    Teething
         subjects affected / exposed
    13 / 271 (4.80%)
    23 / 275 (8.36%)
         occurrences all number
    18
    31
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    55 / 271 (20.30%)
    61 / 274 (22.26%)
         occurrences all number
    55
    61
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    31 / 271 (11.44%)
    26 / 275 (9.45%)
         occurrences all number
    35
    28
    Psychiatric disorders
    Crying
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    195 / 271 (71.96%)
    179 / 274 (65.33%)
         occurrences all number
    195
    179
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    222 / 271 (81.92%)
    210 / 274 (76.64%)
         occurrences all number
    222
    210
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    62 / 271 (22.88%)
    71 / 275 (25.82%)
         occurrences all number
    77
    96
    Rhinitis
         subjects affected / exposed
    45 / 271 (16.61%)
    45 / 275 (16.36%)
         occurrences all number
    52
    53
    Otitis media
         subjects affected / exposed
    27 / 271 (9.96%)
    26 / 275 (9.45%)
         occurrences all number
    32
    31
    Nasopharyngitis
         subjects affected / exposed
    24 / 271 (8.86%)
    29 / 275 (10.55%)
         occurrences all number
    35
    33
    Metabolism and nutrition disorders
    Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    118 / 271 (43.54%)
    130 / 274 (47.45%)
         occurrences all number
    118
    130
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after each vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after each vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after each vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after each vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after each vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after each vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after each vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after each vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after each vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2012
    The scale for assessment of Extensive Limb Swelling was added and the protocol was corrrected with the new Sponsor's Responsible Medical Officer information.
    14 Jun 2013
    The Global Clinical Immunology (GCI) re-implemented the micrometabolic inhibition test using pH indicator for development (MIT-pH) assay for the DTaP-IPV-HB-Hib studies and discontinued the micrometabolic inhibition test using cell survival assessed by crystal violet staining (MIT-CV) method.

    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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