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    Clinical Trial Results:
    Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination with Investigational (DTaP-IPV-HB-Hib) or Infanrix™ hexa vaccines in Latin America

    Summary
    EudraCT number
    		 2011-004451-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 May 2016
    First version publication date
    21 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A3L28
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01983540
    WHO universal trial number (UTN)
    		 U1111-1122-2457
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    1 Discovery Drive, Swiftwater, United States, 18370
    Public contact
    Central Clinical Team Leader, Sanofi Pasteur Inc., 33 4 37 37 58 43 , Emmanuel.feroldi@sanofipasteur.com
    Scientific contact
    Central Clinical Team Leader, Sanofi Pasteur Inc., 33 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 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a 3-dose primary series vaccination of either DTaP-IPV-HB-Hib+Prevenar™ (PCV7)+Rotarix™ or Infanrix™ hexa+Prevenar™ (PCV7)+Rotarix™ vaccination at 2, 4, 6 months of age and a booster vaccination of DTaP-IPV-HB-Hib+Prevenar™ (PCV7) or Infanrix™ hexa+Prevenar™ (PCV7) at 12 to 24 months of age. Only 2 doses of Rotarix™ were administered in the primary series at 2 and 4 months of age.
    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
    		 Subjects included in the A3L28 study had previously completed a 3-dose primary series (DTaP-IPV-HB-Hib) or Infanrix hexa, concomitantly administered with Prevenar (PCV7) (3 doses) and Rotarix (2 doses) in study A3L24, and the booster vaccination (DTaP-IPV-HB-Hib) or Infanrix hexa, concomitantly administered with PCV7 in study A3L27. All subjects also received Hepatitis B vaccination at birth. No investigational vaccine administration was planned in the current study.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    18 Oct 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
    Colombia: 558
    Worldwide total number of subjects
    558
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    558
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study subjects were enrolled from 18 October 2013 to 21 May 2014 for follow-up 1 (3.5 years) and from 19 November 2014 to 15 April 2015 for follow-up 2 (4.5 years).

    Pre-assignment
    Screening details
    		 A total of 558 subjects who met all inclusion and none of the exclusion criteria were enrolled in this follow-up study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster)
    Arm description
    		 Subjects previously primed with DTaP-IPV-HB-Hib vaccine concomitantly with PCV7 and Rotarix™, received DTaP-IPV-HB-Hib vaccine concomitantly with Prevenar™ (PCV7) as booster.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTaP-IPV-Hep B PRP~T combined vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the right thigh, 1 injection each at 2, 4, and 6 months of age and then as a booster.

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the left thigh, 1 injection each at 2, 4, and 6 months of age and as a booster.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    1mL, oral, 1 dose each at 2 and 4 months of age.

    Arm title
    		 Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster)
    Arm description
    		 Subjects previously primed with DTaP-IPV-HB-Hib vaccine concomitantly with PCV7 and Rotarix™, received Infanrix™ hexa vaccine concomitantly with PCV7 as booster.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the right thigh, booster dose.

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the left thigh, 1 injection each at 2, 4, and 6 months of age and as a booster.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    1mL, oral, 1 dose each at 2 and 4 months of age.

    Investigational medicinal product name
    DTaP-IPV-Hep B PRP~T combined vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the right thigh, 1 injection each at 2, 4, and 6 months of age.

    Arm title
    		 Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Arm description
    		 Subject previously primed with Infanrix™ hexa vaccine concomitantly with PCV7 and Rotarix™, received DTaP-IPV-HB-Hib vaccine concomitantly with PCV7 as booster.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DTaP-IPV-Hep B PRP~T combined vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the right thigh, booster dose.

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the left thigh, 1 injection each at 2, 4, and 6 months of age and as a booster.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular injection into the anterolateral area of the right thigh, 1 injection each at 2, 4, and 6 months of age.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    1mL, oral, 1 dose each at 2 and 4 months of age.

    Number of subjects in period 1
    		Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Started
    220
    208
    130
    Completed
    213
    200
    125
    Not completed
    7
    8
    5
         Consent withdrawn by subject
    5
    7
    4
         Lost to follow-up
    2
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: DTaP-IPV-HB-Hib (Primary and Booster)
    Reporting group description
    		 Subjects previously primed with DTaP-IPV-HB-Hib vaccine concomitantly with PCV7 and Rotarix™, received DTaP-IPV-HB-Hib vaccine concomitantly with Prevenar™ (PCV7) as booster.

    Reporting group title
    Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster)
    Reporting group description
    		 Subjects previously primed with DTaP-IPV-HB-Hib vaccine concomitantly with PCV7 and Rotarix™, received Infanrix™ hexa vaccine concomitantly with PCV7 as booster.

    Reporting group title
    Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Reporting group description
    		 Subject previously primed with Infanrix™ hexa vaccine concomitantly with PCV7 and Rotarix™, received DTaP-IPV-HB-Hib vaccine concomitantly with PCV7 as booster.

    Reporting group values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster) Total
    Number of subjects
    		 220 208 130 558
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 220 208 130 558
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 41.9 ( 0.9 ) 41.8 ( 0.9 ) 41.8 ( 0.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 110 90 59 259
        Male
    		 110 118 71 299

    End points

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    End points reporting groups
    Reporting group title
    Group 1: DTaP-IPV-HB-Hib (Primary and Booster)
    Reporting group description
    		 Subjects previously primed with DTaP-IPV-HB-Hib vaccine concomitantly with PCV7 and Rotarix™, received DTaP-IPV-HB-Hib vaccine concomitantly with Prevenar™ (PCV7) as booster.

    Reporting group title
    Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster)
    Reporting group description
    		 Subjects previously primed with DTaP-IPV-HB-Hib vaccine concomitantly with PCV7 and Rotarix™, received Infanrix™ hexa vaccine concomitantly with PCV7 as booster.

    Reporting group title
    Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Reporting group description
    		 Subject previously primed with Infanrix™ hexa vaccine concomitantly with PCV7 and Rotarix™, received DTaP-IPV-HB-Hib vaccine concomitantly with PCV7 as booster.

    Primary: Vaccine Antibodies’ Titers at Year 1 and Year 2 After A Primary Series with Either DTaP-IPV-HB-Hib With Prevenar™ and Rotarix™ or Infanrix™ hexa With Prevenar™ and Rotarix™ and a Booster with DTaP-IPV-HB-Hib With Prevenar™ or Infanrix™ hexa With Prevenar™

    		 Close Top of page
    End point title
    		 Vaccine Antibodies’ Titers at Year 1 and Year 2 After A Primary Series with Either DTaP-IPV-HB-Hib With Prevenar™ and Rotarix™ or Infanrix™ hexa With Prevenar™ and Rotarix™ and a Booster with DTaP-IPV-HB-Hib With Prevenar™ or Infanrix™ hexa With Prevenar™ [1]
    End point description
    Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti-Filamentous hemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate conjugated to tetanus toxoid (PRP) antibodies were measured using a Farr-type radioimmunoassay. Vaccine responses were defined as Anti-Diphtheria and Anti-Tetanus ≥ 0.01 IU/mL, ≥ 0.1 IU/mL, and ≥ 1.0 IU/mL, Anti-Hepatitis B ≥ 10 mIU/mL and ≥ 100 mIU/mL, Anti-PRP ≥ 0.15 µg/mL and ≥ 1.0 µg/mL, Anti-PT and FHA ≥ lower limit of quantitation (LLOQ), ≥ 2XLLOQ, and ≥ 4XLLOQ, and Anti-Poliovirus types 1, 2, and 3 ≥ 8 (1/dil).
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2
    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 study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Year 1; ≥0.01 IU/mL
    100
    99.5
    100
        Anti-Diphtheria; Year 1; ≥0.1 IU/mL
    72.8
    67
    73.1
        Anti-Diphtheria; Year 1; ≥1.0 IU/mL
    12.9
    8.3
    12.3
        Anti-Diphtheria; Year 2; ≥0.01 IU/mL
    100
    98
    99.2
        Anti-Diphtheria; Year 2; ≥0.1 IU/mL
    57.2
    48.2
    59.2
        Anti-Diphtheria; Year 2; ≥1.0 IU/mL
    10.1
    7
    10.4
        Anti-Tetanus; Year 1; ≥0.01 IU/mL
    100
    100
    100
        Anti-Tetanus; Year 1; ≥0.1 IU/mL
    88.5
    86.8
    88.5
        Anti-Tetanus; Year 1; ≥1.0 IU/mL
    22.6
    14.1
    33.8
        Anti-Tetanus; Year 2; ≥0.01 IU/mL
    100
    99
    100
        Anti-Tetanus; Year 2; ≥0.1 IU/mL
    80.8
    76.8
    81.6
        Anti-Tetanus; Year 2; ≥1.0 IU/mL
    17.3
    6.1
    21.6
        Anti-PT; Year 1; ≥LLOQ
    79.2
    82
    80.5
        Anti-PT; Year 1; ≥2XLLOQ
    64.4
    64.5
    62.5
        Anti-PT; Year 1; ≥4XLLOQ
    32.4
    34.5
    29.7
        Anti-PT; Year 2; ≥LLOQ
    65.7
    62.2
    57.3
        Anti-PT; Year 2; ≥2XLLOQ
    43
    45.4
    43.5
        Anti-PT; Year 2; ≥4XLLOQ
    22.2
    25
    20.2
        Anti-FHA; Year 1; ≥LLOQ
    99.5
    100
    98.4
        Anti-FHA; Year 1; ≥2XLLOQ
    95
    97.5
    93
        Anti-FHA; Year 1; ≥4XLLOQ
    84.9
    84.8
    81.4
        Anti-FHA; Year 2; ≥LLOQ
    99.5
    100
    98.4
        Anti-FHA; Year 2; ≥2XLLOQ
    95.7
    96.5
    93.6
        Anti-FHA; Year 2; ≥4XLLOQ
    85.6
    84.4
    79.2
        Anti-Polio 1; Year 1; ≥8 (1/dil)
    100
    100
    100
        Anti-Polio 1; Year 2; ≥8 (1/dil)
    99.5
    99.5
    100
        Anti-Polio 2; Year 1; ≥8 (1/dil)
    100
    100
    100
        Anti-Polio 2; Year 2; ≥8 (1/dil)
    100
    100
    100
        Anti-Polio 3; Year 1; ≥8 (1/dil)
    100
    98.5
    100
        Anti-Polio 3; Year 2; ≥8 (1/dil)
    100
    99
    100
        Anti-Hepatitis B; Year 1; ≥10 mIU/mL
    95.4
    95.1
    96.2
        Anti-Hepatitis B; Year 1; ≥100 mIU/mL
    80.4
    83.5
    82.3
        Anti-Hepatitis B; Year 2; ≥10 mIU/mL
    92.3
    93
    94.4
        Anti-Hepatitis B; Year 2; ≥100 mIU/mL
    74
    71.9
    75
        Anti-PRP; Year 1; ≥0.15 µg/mL
    100
    100
    99.2
        Anti-PRP; Year 1; ≥1.0 µg/mL
    86.8
    89.8
    90.8
        Anti-PRP; Year 2; ≥0.15 µg/mL
    100
    100
    100
        Anti-PRP; Year 2; ≥1.0 µg/mL
    85.6
    84.4
    90.4
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations/Titers of Antibodies at Year 1 and Year 2 After A Primary Series with Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar

    		 Close Top of page
    End point title
    		 Geometric Mean Concentrations/Titers of Antibodies at Year 1 and Year 2 After A Primary Series with Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar [2]
    End point description
    Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti-Filamentous hemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate conjugated to tetanus toxoid (PRP) antibodies were measured using a Farr-type radioimmunoassay.
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2
    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: Descriptive analyses were performed based on the study groups and study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Concentrations/Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Year 1
    0.256 (0.216 to 0.303)
    0.187 (0.159 to 0.22)
    0.231 (0.188 to 0.284)
        Anti-Diphtheria; Year 2
    0.164 (0.136 to 0.197)
    0.119 (0.098 to 0.145)
    0.143 (0.112 to 0.183)
        Anti-Tetanus; Year 1
    0.433 (0.372 to 0.503)
    0.323 (0.281 to 0.372)
    0.579 (0.465 to 0.722)
        Anti-Tetanus; Year 2
    0.297 (0.252 to 0.35)
    0.221 (0.189 to 0.26)
    0.381 (0.302 to 0.481)
        Anti-PT; Year 1
    4.75 (4.07 to 5.56)
    5.09 (4.32 to 5.98)
    4.62 (3.78 to 5.65)
        Anti-PT; Year 2
    3.16 (2.71 to 3.69)
    3.13 (2.67 to 3.68)
    3.06 (2.45 to 3.82)
        Anti-FHA; Year 1
    26.1 (21.8 to 31.1)
    26.3 (22.2 to 31.1)
    19.9 (15.9 to 24.9)
        Anti-FHA; Year 2
    33.8 (28.5 to 40.1)
    35.1 (29.2 to 42.1)
    27.3 (21.3 to 34.9)
        Anti-Polio 1; Year 1
    285 (245 to 332)
    294 (250 to 345)
    508 (410 to 630)
        Anti-Polio 1; Year 2
    211 (180 to 249)
    207 (173 to 247)
    417 (331 to 525)
        Anti-Polio 2; Year 1
    694 (587 to 822)
    553 (470 to 652)
    997 (788 to 1261)
        Anti-Polio 2; Year 2
    543 (455 to 647)
    403 (332 to 490)
    700 (555 to 883)
        Anti-Polio 3; Year 1
    691 (570 to 838)
    508 (414 to 622)
    1213 (962 to 1530)
        Anti-Polio 3; Year 2
    408 (338 to 493)
    307 (254 to 372)
    696 (554 to 875)
        Anti-Hepatitis B; Year 1
    500 (379 to 658)
    475 (364 to 619)
    671 (463 to 971)
        Anti-Hepatitis B; Year 2
    299 (223 to 401)
    277 (210 to 365)
    399 (271 to 589)
        Anti-PRP; Year 1
    4.55 (3.84 to 5.4)
    5.22 (4.37 to 6.23)
    5.37 (4.32 to 6.69)
        Anti-PRP; Year 2
    4.02 (3.39 to 4.78)
    4.34 (3.59 to 5.26)
    4.87 (3.83 to 6.19)
    No statistical analyses for this end point

    Primary: Diphtheria and Tetanus Antibodies’ Titers Post-Primary Series, Booster, Year 1, and Year 2 After Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar

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    End point title
    		 Diphtheria and Tetanus Antibodies’ Titers Post-Primary Series, Booster, Year 1, and Year 2 After Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar [3]
    End point description
    Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Vaccine responses were defined as Anti-Diphtheria and Anti-Tetanus ≥ 0.01 IU/mL, ≥ 0.1 IU/mL, and ≥ 1.0 IU/mL.
    End point type
    Primary
    End point timeframe
    Post-dose 3, Pre- and post-booster, Year 1, and Year 2
    Notes
    [3] - 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 study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Post-dose 3; ≥ 0.01 IU/mL
    100
    100
    100
        Anti-Diphtheria; Post-dose 3; ≥ 0.1 IU/mL
    79.3
    72.2
    72.3
        Anti-Diphtheria; Post-dose 3; ≥ 1.0 IU/mL
    12.9
    7.3
    5.4
        Anti-Diphtheria; Pre-booster; ≥ 0.01 IU/mL
    97.7
    95.6
    96.9
        Anti-Diphtheria; Pre-booster; ≥ 0.1 IU/mL
    42.7
    40.3
    23.8
        Anti-Diphtheria; Post-booster; ≥ 0.01 IU/mL
    100
    100
    100
        Anti-Diphtheria; Post-booster; ≥ 0.1 IU/mL
    100
    100
    100
        Anti-Diphtheria; Post-booster; ≥ 1.0 IU/mL
    96.8
    95.6
    98.4
        Anti-Diphtheria; Year 1; ≥ 0.01 IU/mL
    100
    99.5
    100
        Anti-Diphtheria; Year 1; ≥ 0.1 IU/mL
    72.8
    67
    73.1
        Anti-Diphtheria; Year 1; ≥ 1.0 IU/mL
    12.9
    8.3
    12.3
        Anti-Diphtheria; Year 2; ≥ 0.01 IU/mL
    100
    98
    99.2
        Anti-Diphtheria; Year 2; ≥ 0.1 IU/mL
    57.2
    48.2
    59.2
        Anti-Diphtheria; Year 2; ≥ 1.0 IU/mL
    10.1
    7
    10.4
        Anti-Tetanus; Post-dose 3; ≥ 0.01 IU/mL
    100
    100
    100
        Anti-Tetanus; Post-dose 3; ≥ 0.1 IU/mL
    100
    99.5
    100
        Anti-Tetanus; Post-dose 3; ≥ 1.0 IU/mL
    72.8
    73.7
    83.8
        Anti-Tetanus; Pre-booster; ≥ 0.01 IU/mL
    100
    100
    100
        Anti-Tetanus; Pre-booster; ≥ 0.1 IU/mL
    72.9
    73.3
    76.2
        Anti-Tetanus; Post-booster; ≥ 0.01 IU/mL
    100
    100
    100
        Anti-Tetanus; Post-booster; ≥ 0.1 IU/mL
    99.5
    100
    100
        Anti-Tetanus; Post-booster; ≥ 1.0 IU/mL
    98.2
    96.6
    96.9
        Anti-Tetanus; Year 1; ≥ 0.01 IU/mL
    100
    100
    100
        Anti-Tetanus; Year 1; ≥ 0.1 IU/mL
    88.5
    86.8
    88.5
        Anti-Tetanus; Year 1; ≥ 1.0 IU/mL
    22.6
    14.1
    33.8
        Anti-Tetanus; Year 2; ≥ 0.01 IU/mL
    100
    99
    100
        Anti-Tetanus; Year 2; ≥ 0.1 IU/mL
    80.8
    76.8
    81.6
        Anti-Tetanus; Year 2; ≥ 1.0 IU/mL
    17.3
    6.1
    21.6
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Diphtheria and Tetanus Antibodies’ Titers Post-Primary, Booster, and Year 1 and 2 After DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar

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    End point title
    		 Geometric Mean Concentrations of Diphtheria and Tetanus Antibodies’ Titers Post-Primary, Booster, and Year 1 and 2 After DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar [4]
    End point description
    Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Post-dose 3, Pre- and post-booster, Year 1, and Year 2
    Notes
    [4] - 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 study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Concentrations (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Post-dose 3
    0.272 (0.234 to 0.316)
    0.226 (0.195 to 0.262)
    0.199 (0.171 to 0.232)
        Anti-Diphtheria; Pre-booster
    0.083 (0.071 to 0.096)
    0.076 (0.065 to 0.089)
    0.059 (0.049 to 0.071)
        Anti-Diphtheria; Post-booster
    6.14 (5.4 to 6.98)
    4.4 (3.86 to 5.02)
    6.18 (5.28 to 7.23)
        Anti-Diphtheria; Year 1
    0.256 (0.216 to 0.303)
    0.187 (0.159 to 0.22)
    0.231 (0.188 to 0.284)
        Anti-Diphtheria; Year 2
    0.164 (0.136 to 0.197)
    0.119 (0.098 to 0.145)
    0.143 (0.112 to 0.183)
        Anti-Tetanus; Post-dose 3
    1.55 (1.4 to 1.71)
    1.6 (1.44 to 1.78)
    1.79 (1.63 to 1.98)
        Anti-Tetanus; Pre-booster
    0.204 (0.177 to 0.234)
    0.247 (0.208 to 0.293)
    0.206 (0.176 to 0.24)
        Anti-Tetanus; Post-booster
    5.94 (5.26 to 6.7)
    5.17 (4.6 to 5.81)
    8.28 (6.94 to 9.89)
        Anti-Tetanus; Year 1
    0.433 (0.372 to 0.503)
    0.323 (0.281 to 0.372)
    0.579 (0.465 to 0.722)
        Anti-Tetanus; Year 2
    0.297 (0.252 to 0.35)
    0.221 (0.189 to 0.26)
    0.381 (0.302 to 0.481)
    No statistical analyses for this end point

    Primary: Pertussis Toxoid and Filamentous Hemagglutinin Antibodies’ Titers Post-Primary, Booster, and Year 1 and 2 After DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar

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    End point title
    		 Pertussis Toxoid and Filamentous Hemagglutinin Antibodies’ Titers Post-Primary, Booster, and Year 1 and 2 After DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar [5]
    End point description
    Anti-Pertussis toxoid (PT) and Anti-Filamentous hemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Vaccine responses for Anti-PT and Anti-FHA were defined as ≥ lower limit of quantitation (LLOQ), ≥ 2XLLOQ, and ≥ 4XLLOQ.
    End point type
    Primary
    End point timeframe
    Post-dose 3, Pre- and post-booster, Year 1, and Year 2
    Notes
    [5] - 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 study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Percentage of subjects
    number (not applicable)
        Anti-PT; Post-dose 3; ≥ LLOQ
    100
    100
    100
        Anti-PT; Post-dose 3; ≥ 2XLLOQ
    99.1
    100
    100
        Anti-PT; Post-dose 3; ≥ 4XLLOQ
    98.6
    100
    100
        Anti-PT; Pre-booster; ≥ LLOQ
    91.5
    91.2
    89.1
        Anti-PT; Pre-booster; ≥ 2XLLOQ
    81.1
    81.4
    80.6
        Anti-PT; Pre-booster; ≥ 4XLLOQ
    50.5
    47.5
    42.6
        Anti-PT; Post-booster; ≥ LLOQ
    100
    100
    100
        Anti-PT; Post-booster; ≥ 2XLLOQ
    100
    100
    100
        Anti-PT; Post-booster; ≥ 4XLLOQ
    100
    100
    100
        Anti-PT; Year 1; ≥ LLOQ
    79.2
    82
    80.5
        Anti-PT; Year 1; ≥ 2XLLOQ
    64.4
    64.5
    62.5
        Anti-PT; Year 1; ≥ 4XLLOQ
    32.4
    34.5
    29.7
        Anti-PT; Year 2; ≥ LLOQ
    65.7
    62.2
    57.3
        Anti-PT; Year 2; ≥ 2XLLOQ
    43
    45.4
    43.5
        Anti-PT; Year 2; ≥ 4XLLOQ
    22.2
    25
    20.2
        Anti-FHA; Post-dose 3; ≥ LLOQ
    100
    100
    100
        Anti-FHA; Post-dose 3; ≥ 2XLLOQ
    100
    100
    100
        Anti-FHA; Post-dose 3; ≥ 4XLLOQ
    100
    100
    100
        Anti-FHA; Pre-booster; ≥ LLOQ
    100
    100
    99.2
        Anti-FHA; Pre-booster; ≥ 2XLLOQ
    98.6
    97.5
    89.9
        Anti-FHA; Pre-booster; ≥ 4XLLOQ
    81.7
    89.7
    68.2
        Anti-FHA; Post-booster; ≥ LLOQ
    100
    100
    100
        Anti-FHA; Post-booster; ≥ 2XLLOQ
    100
    100
    100
        Anti-FHA; Post-booster; ≥ 4XLLOQ
    100
    100
    100
        Anti-FHA; Year 1; ≥ LLOQ
    99.5
    100
    98.4
        Anti-FHA; Year 1; ≥ 2XLLOQ
    95
    97.5
    93
        Anti-FHA; Year 1; ≥ 4XLLOQ
    84.9
    84.8
    81.4
        Anti-FHA; Year 2; ≥ LLOQ
    99.5
    100
    98.4
        Anti-FHA; Year 2; ≥ 2XLLOQ
    95.7
    96.5
    93.6
        Anti-FHA; Year 2; ≥ 4XLLOQ
    85.6
    84.4
    79.2
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration of Pertussis Toxoid and Filamentous Hemagglutinin Post-Primary, Booster, Year 1 and 2 After DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar

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    End point title
    		 Geometric Mean Concentration of Pertussis Toxoid and Filamentous Hemagglutinin Post-Primary, Booster, Year 1 and 2 After DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar [6]
    End point description
    Anti-Pertussis toxoid (PT) and Anti-Filamentous hemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Post-dose 3, Pre- and post-booster, Year 1, and Year 2
    Notes
    [6] - 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 study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Concentrations (1/dil)
    geometric mean (confidence interval 95%)
        Anti-PT; Post-dose 3
    96.4 (88 to 106)
    97.5 (90 to 106)
    94.4 (84.9 to 105)
        Anti-PT; Pre-booster
    7.35 (6.37 to 8.49)
    8.54 (7.2 to 10.1)
    7.2 (5.82 to 8.89)
        Anti-PT; Post-booster
    158 (142 to 174)
    180 (161 to 200)
    139 (121 to 159)
        Anti-PT; Year 1
    4.75 (4.07 to 5.56)
    5.09 (4.32 to 5.98)
    4.62 (3.78 to 5.65)
        Anti-PT; Year 2
    3.16 (2.71 to 3.69)
    3.13 (2.67 to 3.68)
    3.06 (2.45 to 3.82)
        Anti-FHA; Post-dose 3
    166 (153 to 180)
    181 (167 to 197)
    104 (94.6 to 115)
        Anti-FHA; Pre-booster
    20.6 (17.8 to 23.9)
    25.3 (21.6 to 29.7)
    13.9 (11 to 17.4)
        Anti-FHA; Post-booster
    281 (253 to 312)
    418 (371 to 472)
    234 (197 to 277)
        Anti-FHA; Year 1
    26.1 (21.8 to 31.1)
    26.3 (22.2 to 31.1)
    19.9 (15.9 to 24.9)
        Anti-FHA; Year 2
    33.8 (28.5 to 40.1)
    35.1 (29.2 to 42.1)
    27.3 (21.3 to 34.9)
    No statistical analyses for this end point

    Primary: Poliovirus 1, 2, and 3 Antibodies’ Titers Post-Primary Series, Booster, Year 1 and Year 2 After Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar

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    End point title
    		 Poliovirus 1, 2, and 3 Antibodies’ Titers Post-Primary Series, Booster, Year 1 and Year 2 After Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar [7]
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Vaccine responses for Anti-Poliovirus types 1, 2, and 3 were defined as titers ≥ 8 (1/dil).
    End point type
    Primary
    End point timeframe
    Post-dose 3, Pre- and post-booster, Year 1, and Year 2
    Notes
    [7] - 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 study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Percentage of subjects
    number (not applicable)
        Anti-Polio 1; Post-dose 3
    100
    100
    100
        Anti-Polio 1; Pre-booster
    99.1
    98.5
    98.5
        Anti-Polio 1; Post-booster
    100
    100
    100
        Anti-Polio 1; Year 1
    100
    100
    100
        Anti-Polio 1; Year 2
    99.5
    99.5
    100
        Anti-Polio 2; Post-dose 3
    100
    100
    100
        Anti-Polio 2; Pre-booster
    99.5
    100
    100
        Anti-Polio 2; Post-booster
    100
    100
    100
        Anti-Polio 2; Year 1
    100
    100
    100
        Anti-Polio 2; Year 2
    100
    100
    100
        Anti-Polio 3; Post-dose 3
    100
    100
    100
        Anti-Polio 3; Pre-booster
    95.9
    93.7
    100
        Anti-Polio 3; Post-booster
    100
    100
    100
        Anti-Polio 3; Year 1
    100
    98.5
    100
        Anti-Polio 3; Year 2
    100
    99
    100
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Poliovirus 1, 2, and 3 Antibodies’ Post-Primary Series, Booster, and Year 1 and 2 After Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar

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    End point title
    		 Geometric Mean Titers of Poliovirus 1, 2, and 3 Antibodies’ Post-Primary Series, Booster, and Year 1 and 2 After Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar [8]
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay.
    End point type
    Primary
    End point timeframe
    Post-dose 3, Pre- and post-booster, Year 1, and Year 2
    Notes
    [8] - 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 study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Polio 1; Post-dose 3
    662 (579 to 757)
    682 (587 to 792)
    1340 (1110 to 1619)
        Anti-Polio 1; Pre-booster
    129 (110 to 151)
    124 (105 to 147)
    217 (175 to 269)
        Anti-Polio 1; Post-booster
    2276 (2016 to 2569)
    2562 (2233 to 2940)
    3156 (2629 to 3790)
        Anti-Polio 1; Year 1
    285 (245 to 332)
    294 (250 to 345)
    508 (410 to 630)
        Anti-Polio 1; Year 2
    211 (180 to 249)
    207 (173 to 247)
    417 (331 to 525)
        Anti-Polio 2; Post-dose 3
    1210 (1060 to 1382)
    1289 (1111 to 1496)
    2043 (1699 to 2456)
        Anti-Polio 2; Pre-booster
    233 (192 to 283)
    276 (225 to 339)
    342 (268 to 438)
        Anti-Polio 2; Post-booster
    4515 (3993 to 5106)
    4707 (4067 to 5447)
    6519 (5472 to 7767)
        Anti-Polio 2; Year 1
    694 (587 to 822)
    553 (470 to 652)
    997 (788 to 1261)
        Anti-Polio 2; Year 2
    543 (455 to 647)
    403 (332 to 490)
    700 (555 to 883)
        Anti-Polio 3; Post-dose 3
    1280 (1080 to 1517)
    1199 (1038 to 1386)
    2092 (1704 to 2569)
        Anti-Polio 3; Pre-booster
    122 (99.9 to 150)
    117 (94.6 to 145)
    192 (158 to 234)
        Anti-Polio 3; Post-booster
    3830 (3283 to 4469)
    3094 (2645 to 3619)
    5871 (4936 to 6983)
        Anti-Polio 3; Year 1
    691 (570 to 838)
    508 (414 to 622)
    1213 (962 to 1530)
        Anti-Polio 3; Year 2
    408 (338 to 493)
    307 (254 to 372)
    696 (554 to 875)
    No statistical analyses for this end point

    Primary: Hepatitis B and PRP Antibodies’ Titers Post-Primary Series, Booster, and Year 1 and 2 After Vaccinations with Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar

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    End point title
    		 Hepatitis B and PRP Antibodies’ Titers Post-Primary Series, Booster, and Year 1 and 2 After Vaccinations with Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar [9]
    End point description
    Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate conjugated to tetanus toxoid (PRP) antibodies were measured using a Farr-type radioimmunoassay. Vaccine responses for Anti-Hepatitis B were defined as ≥ 10 mIU/mL and ≥ 100 mIU/mL and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for Anti-PRP.
    End point type
    Primary
    End point timeframe
    Post-dose 3, Pre- and post-booster, Year 1, and Year 2
    Notes
    [9] - 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 study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Percentage of subjects
    number (not applicable)
        Anti-Hepatitis B; Post-dose 3; ≥ 10 mIU/mL
    99.5
    100
    100
        Anti-Hepatitis B; Post-dose 3; ≥ 100 mIU/mL
    98.2
    98.5
    99.2
        Anti-Hepatitis B; Pre-booster; ≥ 10 mIU/mL
    98.6
    97.1
    99.2
        Anti-Hepatitis B; Pre-booster; ≥ 100 mIU/mL
    82.6
    83
    80.8
        Anti-Hepatitis B; Post-booster; ≥ 10 mIU/mL
    100
    100
    100
        Anti-Hepatitis B; Post-booster; ≥ 100 mIU/mL
    98.2
    97.1
    99.2
        Anti-Hepatitis B; Year 1; ≥ 10 mIU/mL
    95.4
    95.1
    96.2
        Anti-Hepatitis B; Year 1; ≥ 100 mIU/mL
    80.4
    83.5
    82.3
        Anti-Hepatitis B; Year 2; ≥ 10 mIU/mL
    92.3
    93
    94.4
        Anti-Hepatitis B; Year 2; ≥ 100 mIU/mL
    74
    71.9
    75
        Anti-PRP; Post-dose 3; ≥ 0.15 µg/mL
    91.7
    96.1
    95.4
        Anti-PRP; Post-dose 3; ≥ 1.0 µg/mL
    78.3
    79
    71.5
        Anti-PRP; Pre-booster; ≥ 0.15 µg/mL
    74.4
    80.1
    73.8
        Anti-PRP; Pre-booster; ≥ 1.0 µg/mL
    30.6
    37.4
    27.7
        Anti-PRP; Post-booster; ≥ 0.15 µg/mL
    100
    100
    100
        Anti-PRP; Post-booster; ≥ 1.0 µg/mL
    99.5
    99
    100
        Anti-PRP; Year 1; ≥ 0.15 µg/mL
    100
    100
    99.2
        Anti-PRP; Year 1; ≥ 1.0 µg/mL
    86.8
    89.8
    90.8
        Anti-PRP; Year 2; ≥ 0.15 µg/mL
    100
    100
    100
        Anti-PRP; Year 2; ≥ 1.0 µg/mL
    85.6
    84.4
    90.4
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of Hepatitis B and PRP Antibodies’ Post-Primary, Booster, Year 1 and 2 After Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar

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    End point title
    		 Geometric Mean Concentrations of Hepatitis B and PRP Antibodies’ Post-Primary, Booster, Year 1 and 2 After Either DTaP-IPV-HB-Hib/Prevenar/Rotarix or Infanrix hexa/Prevenar/Rotarix and a Booster with DTaP-IPV-HB-Hib/Prevenar or Infanrix hexa/Prevenar [10]
    End point description
    Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate conjugated to tetanus toxoid (PRP) antibodies were measured using a Farr-type radioimmunoassay.
    End point type
    Primary
    End point timeframe
    Post-dose 3, Pre- and post-booster, Year 1, and Year 2
    Notes
    [10] - 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 study vaccines administered for this outcome.
    End point values
    		 Group 1: DTaP-IPV-HB-Hib (Primary and Booster) Group 2: DTaP-IPV-HB-Hib (Primary) Infanrix hexa (Booster) Group 3: Infanrix™ hexa (Primary) DTaP-IPV-HB-Hib (Booster)
    Number of subjects analysed
    220
    208
    130
    Units: Concentrations (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Hepatitis B; Post-dose 3
    2663 (2276 to 3117)
    2822 (2403 to 3314)
    2543 (2150 to 3007)
        Anti-Hepatitis B; Pre-booster
    351 (292 to 422)
    344 (278 to 425)
    275 (219 to 344)
        Anti-Hepatitis B; Post-booster
    7698 (6223 to 9522)
    8370 (6637 to 10556)
    8597 (6472 to 11420)
        Anti-Hepatitis B; Year 1
    500 (379 to 658)
    475 (364 to 619)
    671 (463 to 971)
        Anti-Hepatitis B; Year 2
    299 (223 to 401)
    277 (210 to 365)
    399 (271 to 589)
        Anti-PRP; Post-dose 3
    3.41 (2.68 to 4.35)
    4.15 (3.3 to 5.22)
    2.08 (1.63 to 2.67)
        Anti-PRP; Pre-booster
    0.512 (0.407 to 0.645)
    0.651 (0.518 to 0.819)
    0.408 (0.312 to 0.533)
        Anti-PRP; Post-booster
    49.1 (41.3 to 58.3)
    44.2 (37.1 to 52.8)
    56.7 (44.8 to 71.7)
        Anti-PRP; Year 1
    4.55 (3.84 to 5.4)
    5.22 (4.37 to 6.23)
    5.37 (4.32 to 6.69)
        Anti-PRP; Year 2
    4.02 (3.39 to 4.78)
    4.34 (3.59 to 5.26)
    4.87 (3.83 to 6.19)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No safety data were collected for this study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The aim of this study is to describe the long-term antibody persistence following vaccination in a previous study. There were no safety objectives and no safety data were collected in this study.

    More information

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

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

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