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    Clinical Trial Results:
    Immunogenicity and Safety of the Aventis Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™), Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18 to 19 Months of Age in Healthy Infants in South Africa. All Infants Receiving Hepatitis B Monovalent Vaccine at 6, 10 and 14 Weeks of Age.

    Summary
    EudraCT number
    		 2015-005354-35
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Feb 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2016
    First version publication date
    09 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E2I43
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00254969
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Medical Team Leader, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.vidor@sanofipasteur.com
    Scientific contact
    Medical Team Leader, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.vidor@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Feb 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity: -To assess the seroprotection rates (Diphtheria, Tetanus, polio types 1, 2 and 3, and Polyribosyl Ribitol Phosphate conjugated to Tetanus protein [PRP]) and seroconversion rates (Pertussis toxoid, Filamentous Hemagglutinin [FHA]) of Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine, one month after the three-dose primary vaccination. -To describe the immunogenicity of the study combined vaccine (PENTAXIM™) one month after the three-dose primary vaccination (Visit 5), prior to the booster dose (at Visit 6) and one month after the booster dose (Visit 7). -To describe the immunogenicity of the recombinant hepatitis B vaccine antigen one month after the three-dose primary vaccination (Visit 5) and approximately 14 to 15 months later (Visit 6). Safety: -To describe the safety after each dose of the study combined vaccine (PENTAXIM™). -To describe the safety after each dose of recombinant hepatitis B vaccine.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were 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
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    18 Oct 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 212
    Worldwide total number of subjects
    212
    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)
    212
    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 18 October 2005 to 01 July 2006 at 1 clinic center in South Africa.

    Pre-assignment
    Screening details
    		 A total of 212 subjects who met all inclusion and none of the exclusion criteria were enrolled and vaccinated in the study.

    Period 1
    Period 1 title
    Primary Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Study group
    Arm description
    		 Subjects received DTacP-IPV//PRP-T vaccine (PENTAXIM™) at 6, 10, and 14 weeks of age and hepatitis B vaccine (HEBERBIOVAC®) at 6, 10, and 14 weeks of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV//PRP~T combined vaccine (PENTAXIM™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the right anterolateral external aspect of the upper thigh, 1 injection each at 6, 10, and 14 weeks of age.

    Investigational medicinal product name
    Hepatitis B vaccine (HEBERBIOVAC HB®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the left anterolateral external aspect of the upper thigh, 1 injection each at 6, 10, and 14 weeks of age.

    Number of subjects in period 1
    		Study group
    Started
    212
    Completed
    207
    Not completed
    5
         Serious adverse events
    1
         Lost to follow-up
    1
         Protocol deviation
    3
    Period 2
    Period 2 title
    Booster Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Study group
    Arm description
    		 Subjects received a booster dose of DTacP-IPV//PRP~T vaccine at 18 to 19 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV//PRP~T combined vaccine (PENTAXIM™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the right anterolateral external aspect of the upper thigh, 1 injection each at 6, 10, and 14 weeks of age.

    Number of subjects in period 2
    		Study group
    Started
    207
    Completed
    179
    Not completed
    29
         Consent withdrawn by subject
    9
         Serious adverse events
    2
         Lost to follow-up
    15
         Protocol deviation
    3
    Joined
    1
         Withdrawn from study and re-included for booster
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study group
    Reporting group description
    		 Subjects received DTacP-IPV//PRP-T vaccine (PENTAXIM™) at 6, 10, and 14 weeks of age and hepatitis B vaccine (HEBERBIOVAC®) at 6, 10, and 14 weeks of age.

    Reporting group values
    		 Study group Total
    Number of subjects
    		 212 212
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 212 212
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    The Study group and Immunogenicity Analysis Set age is reported in days (standard deviation) whereas the Immunogenicity Analysis Set Pre-Booster and Immunogenicity Analysis Set Post-Booster age is reported in months (standard deviation).
    Units: days
        arithmetic mean (standard deviation)
    		 43.2 ( 1.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 105 105
        Male
    		 107 107
    Subject analysis sets

    Subject analysis set title
    Immunogenicity Analysis Set Post-dose 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Analysis Set was defined as all infants who received DTacP-IPV//PRP~T at Visit 02 (Day 42), Visit 03 (Day 70), and Visit 04 (Day 98) without any delays, had a blood sample performed at Visit 05 (Day 126; blood sample 02) without any delays, and had an antibody titration available in blood sample 02.

    Subject analysis set title
    Immunogenicity Analysis Set Pre-Booster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Pre-Booster was defined as all subjects who had received the DTacP-IPV//PRP-T combined vaccine on Visit 02 (Day 42), Visit 03 (Day 70), and Visit 04 (Day 98), had a blood sample performed on Visit 06 (Visit 05 + 14-15 months; blood sample 03), age at blood sample on Visit 06 (blood sample 03) less than 17 months (no older than 20 months), and had an antibody titer available for blood sample 03.

    Subject analysis set title
    Immunogenicity Analysis Set Post-Booster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Post-Booster was defined as all subjects who received the vaccination with DTacP-IPV//PRP~T combined vaccine on Visit 02 (Day 42), Visit 03 (Day 70), Visit 04 (Day 98) or Visit 06 (Visit 05 + 14-15 months) who were < 17 months (no older than 20 months) on Visit 06, had a blood sample performed on Visit 07 (Visit 06 + 28-42 days) without any delays, and had an antibody titer available for blood sample 04.

    Subject analysis sets values
    		 Immunogenicity Analysis Set Post-dose 3 Immunogenicity Analysis Set Pre-Booster Immunogenicity Analysis Set Post-Booster
    Number of subjects
    206
    180
    176
    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)
    206
    180
    176
        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
    The Study group and Immunogenicity Analysis Set age is reported in days (standard deviation) whereas the Immunogenicity Analysis Set Pre-Booster and Immunogenicity Analysis Set Post-Booster age is reported in months (standard deviation).
    Units: days
        arithmetic mean (standard deviation)
    43.2 ( 1.6 )
    18.3 ( 0.4 )
    18.3 ( 0.4 )
    Gender categorical
    Units: Subjects
        Female
    99
    86
    83
        Male
    107
    94
    93

    End points

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    End points reporting groups
    Reporting group title
    Study group
    Reporting group description
    		 Subjects received DTacP-IPV//PRP-T vaccine (PENTAXIM™) at 6, 10, and 14 weeks of age and hepatitis B vaccine (HEBERBIOVAC®) at 6, 10, and 14 weeks of age.
    Reporting group title
    Study group
    Reporting group description
    		 Subjects received a booster dose of DTacP-IPV//PRP~T vaccine at 18 to 19 months of age.

    Subject analysis set title
    Immunogenicity Analysis Set Post-dose 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Analysis Set was defined as all infants who received DTacP-IPV//PRP~T at Visit 02 (Day 42), Visit 03 (Day 70), and Visit 04 (Day 98) without any delays, had a blood sample performed at Visit 05 (Day 126; blood sample 02) without any delays, and had an antibody titration available in blood sample 02.

    Subject analysis set title
    Immunogenicity Analysis Set Pre-Booster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Pre-Booster was defined as all subjects who had received the DTacP-IPV//PRP-T combined vaccine on Visit 02 (Day 42), Visit 03 (Day 70), and Visit 04 (Day 98), had a blood sample performed on Visit 06 (Visit 05 + 14-15 months; blood sample 03), age at blood sample on Visit 06 (blood sample 03) less than 17 months (no older than 20 months), and had an antibody titer available for blood sample 03.

    Subject analysis set title
    Immunogenicity Analysis Set Post-Booster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Immunogenicity Analysis Set Post-Booster was defined as all subjects who received the vaccination with DTacP-IPV//PRP~T combined vaccine on Visit 02 (Day 42), Visit 03 (Day 70), Visit 04 (Day 98) or Visit 06 (Visit 05 + 14-15 months) who were < 17 months (no older than 20 months) on Visit 06, had a blood sample performed on Visit 07 (Visit 06 + 28-42 days) without any delays, and had an antibody titer available for blood sample 04.

    Primary: Percentage of Subjects with Seroprotection/Seroconversion to Vaccine Antigens One Month After A Three Dose Primary Vaccination with DTacP-IPV// PRP~T Combined Vaccine (PENTAXIM™) Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™)

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    End point title
    		 Percentage of Subjects with Seroprotection/Seroconversion to Vaccine Antigens One Month After A Three Dose Primary Vaccination with DTacP-IPV// PRP~T Combined Vaccine (PENTAXIM™) Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™) [1]
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP) was assessed by Farr type radioimmunoassay and Anti-Hepatitis B surface antigen were assessed by radioimmunoassay. Seroprotection for Anti-Diphtheria and Anti-Tetanus was defined as antibody titers ≥ 0.1 IU/mL, ≥ 8 (dil) for Anti-Polio types 1, 2, and 3, ≥ 0.15 µg/mL for Anti-PRP, and ≥ 10 mIU/mL for Hepatitis B. Seroconversion for Anti-Pertussis toxoid and Anti-FHA was defined as antibody titers ≥ 2-fold and ≥ 4-fold increase EU/mL.
    End point type
    Primary
    End point timeframe
    1 month post-dose 3 of primary vaccination
    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 group and the study vaccine administered for this outcome.
    End point values
    		 Study group
    Number of subjects analysed
    206
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria
    100
        Anti-Tetanus
    100
        Anti-Polio 1
    100
        Anti-Polio 2
    100
        Anti-Polio 3
    100
        Anti-PRP
    94.6
        Anti-Pertussis toxoid; ≥ 2-fold increase
    99
        Anti-Pertussis toxoid; ≥ 4-fold increase
    97.5
        Anti-FHA; ≥ 2-fold increase
    94.6
        Anti-FHA; ≥ 4-fold increase
    83.9
        Anti-Hepatitis B
    100
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers of Antibodies Against Vaccine Antigens One Month After A Three Dose Primary Vaccination with DTacP-IPV// PRP~T Combined Vaccine (PENTAXIM™) Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™)

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    End point title
    		 Geometric Mean Titers of Antibodies Against Vaccine Antigens One Month After A Three Dose Primary Vaccination with DTacP-IPV// PRP~T Combined Vaccine (PENTAXIM™) Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™)
    End point description
    Anti-Diphtheria was assessed by ELISA and seroneutralization. Anti-Tetanus, Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP) was assessed by Farr type radioimmunoassay and Anti-Hepatitis B surface antigen were assessed by radioimmunoassay.
    End point type
    Other pre-specified
    End point timeframe
    1 month post-dose 3 of primary vaccination
    End point values
    		 Immunogenicity Analysis Set Post-dose 3
    Number of subjects analysed
    206
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria (ELISA)
    0.9 (0.82 to 0.99)
        Anti-Diphtheria (seroneutralization)
    0.05 (0.04 to 0.06)
        Anti-Tetanus
    0.78 (0.71 to 0.85)
        Anti-Pertussis toxoid
    382.61 (353.13 to 414.55)
        Anti-FHA
    161 (145.94 to 177.61)
        Anti-Polio 1
    1453.05 (1235.9 to 1708.35)
        Anti-Polio 2
    1699.14 (1410.88 to 2046.29)
        Anti-Polio 3
    2398.17 (1979.8 to 2904.96)
        Anti-PRP
    1.97 (1.55 to 2.51)
        Anti-Hepatitis B
    929.21 (786.39 to 1097.97)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seroprotection/Seroconversion to Vaccine Antigens Post-Booster Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) After a Primary Series with DTacP-IPV//PRP~T Vaccine Concomitantly with Hepatitis B (HEBERBIOVAC™)

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    End point title
    		 Percentage of Subjects with Seroprotection/Seroconversion to Vaccine Antigens Post-Booster Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) After a Primary Series with DTacP-IPV//PRP~T Vaccine Concomitantly with Hepatitis B (HEBERBIOVAC™)
    End point description
    Anti-Diphtheria was assessed by ELISA and seroneutralization. Anti-Tetanus, Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP) was assessed by Farr type radioimmunoassay and Anti-Hepatitis B surface antigen were assessed by radioimmunoassay. Seroprotection for Anti-Diphtheria and Anti-Tetanus was defined as antibody titers ≥ 0.1 IU/mL, ≥ 8 (dil) for Anti-Polio types 1, 2, and 3, ≥ 0.15 µg/mL for Anti-PRP, and ≥ 10 mIU/mL for Hepatitis B. Seroconversion for Anti-Pertussis toxoid and Anti-FHA was defined as antibody titers ≥ 2-fold and ≥ 4-fold increase EU/mL.
    End point type
    Other pre-specified
    End point timeframe
    Post-booster vaccination
    End point values
    		 Immunogenicity Analysis Set Post-Booster
    Number of subjects analysed
    176
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria (ELISA)
    100
        Anti-Diphtheria (Seroneutralization)
    100
        Anti-Tetanus
    100
        Anti-Polio 1
    100
        Anti-Polio 2
    100
        Anti-Polio 3
    100
        Anti-PRP
    100
        Anti-Pertussis toxoid; ≥ 2-fold increase
    100
        Anti-Pertussis toxoid; ≥ 4-fold increase
    98.4
        Anti-FHA; ≥ 2-fold increase
    98.6
        Anti-FHA; ≥ 4-fold increase
    95.7
        Anti-Hepatitis (Pre-booster)
    99.4
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers of Antibodies Against Vaccine Antigens Post-Booster Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) After a Primary Series with DTacP-IPV//PRP~T Combined Vaccine Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™)

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    End point title
    		 Geometric Mean Titers of Antibodies Against Vaccine Antigens Post-Booster Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) After a Primary Series with DTacP-IPV//PRP~T Combined Vaccine Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™)
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP) was assessed by Farr type radioimmunoassay.
    End point type
    Other pre-specified
    End point timeframe
    1 month post-booster vaccination
    End point values
    		 Immunogenicity Analysis Set Post-dose 3 Immunogenicity Analysis Set Pre-Booster Immunogenicity Analysis Set Post-Booster
    Number of subjects analysed
    176
    175
    176
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    0.9 (0.82 to 1)
    0.04 (0.03 to 0.05)
    3.72 (3.18 to 4.35)
        Anti-Tetanus
    0.79 (0.72 to 0.86)
    0.17 (0.15 to 0.2)
    9.23 (8.1 to 10.51)
        Anti-Pertussis toxoid
    390.62 (359.03 to 424.97)
    11.21 (9.64 to 13.05)
    465.51 (419.47 to 516.61)
        Anti-FHA
    160.18 (143.55 to 178.74)
    12.89 (10.41 to 15.96)
    520.35 (465.28 to 581.95)
        Anti-Polio 1
    1459.62 (1219.02 to 1747.7)
    233.85 (166.86 to 327.73)
    8928.86 (7639.93 to 10435.25)
        Anti-Polio 2
    1634.12 (1343.97 to 1986.91)
    302.95 (217.92 to 421.16)
    6608.29 (5633.61 to 7751.59)
        Anti-Polio 3
    2328.15 (1882.84 to 2878.77)
    360.1 (254.69 to 509.15)
    12119.89 (10247.37 to 14334.58)
        Anti-PRP
    2.26 (1.79 to 2.86)
    0.35 (0.26 to 0.46)
    47.01 (37.7 to 58.62)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens Post-Booster Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) After a Primary Series with DTacP-IPV//PRP~T Combined Vaccine Concomitantly with Hepatitis B (HEBERBIOVAC™)

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    End point title
    		 Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens Post-Booster Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) After a Primary Series with DTacP-IPV//PRP~T Combined Vaccine Concomitantly with Hepatitis B (HEBERBIOVAC™)
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP) was assessed by Farr type radioimmunoassay. Geometric mean titer ratios are only reported for Anti-Pertussis toxoid and Anti-FHA for the Immunogenicity Analysis Set Post-dose 3.
    End point type
    Other pre-specified
    End point timeframe
    Visit 06 (Visit 05 + 14-15 months, where Visit 05 is Day 126) and Visit 07 (Visit 06 + 28-42 days)
    End point values
    		 Immunogenicity Analysis Set Post-dose 3 Immunogenicity Analysis Set Post-Booster
    Number of subjects analysed
    175
    175
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    0 (0 to 0)
    101.1 (85.58 to 119.45)
        Anti-Tetanus
    0 (0 to 0)
    56.16 (47.92 to 65.8)
        Anti-Pertussis toxoid
    53 (42.65 to 65.85)
    39.4 (33.18 to 46.77)
        Anti-FHA
    16.17 (13.04 to 20.04)
    40.74 (33.88 to 48.98)
        Anti-Polio 1
    0 (0 to 0)
    35.34 (24.13 to 51.78)
        Anti-Polio 2
    0 (0 to 0)
    22.24 (15.25 to 32.42)
        Anti-Polio 3
    0 (0 to 0)
    33.07 (22.27 to 49.12)
        Anti-PRP
    0 (0 to 0)
    134.12 (100.66 to 178.7)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any Primary Vaccination with DTacP-IPV// PRP~T Combined Vaccine (PENTAXIM™) Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™)

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any Primary Vaccination with DTacP-IPV// PRP~T Combined Vaccine (PENTAXIM™) Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™)
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
    End point type
    Other pre-specified
    End point timeframe
    Post-any primary vaccination
    End point values
    		 Study group
    Number of subjects analysed
    212
    Units: Percentage of subjects
    number (not applicable)
        Injection site Tenderness
    70.3
        Injection site Erythema
    47.2
        Injection site Swelling
    45.3
        Fever
    35.8
        Vomiting
    42.9
        Crying abnormal
    64.6
        Drowsiness
    48.1
        Appetite lost
    35.8
        Irritability
    55.7
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any Primary Vaccination with DTacP-IPV// PRP~T Combined Vaccine (PENTAXIM™) Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™)

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any Primary Vaccination with DTacP-IPV// PRP~T Combined Vaccine (PENTAXIM™) Concomitantly with Hepatitis B Vaccine (HEBERBIOVAC™)
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥ 5 cm. Grade 3 systemic reactions: Fever, ≥ 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 up to Day 8 post-any and each vaccination and per injected dose
    End point values
    		 Study group
    Number of subjects analysed
    212
    Units: Percentage of subjects
    number (not applicable)
        Any Inj. site Tenderness; Post-Any; PENTAXIM
    68.4
        Grade 3 Inj. site Tenderness; Post-Any; PENTAXIM
    0
        Any Inj. site Tenderness; Post-Any; HEBERBIOVAC
    65.6
        Grade 3 Inj. site Tenderness; Post-Any;HEBERBIOVAC
    0
        Any Inj. site Tenderness; Post-dose 1; PENTAXIM
    54
        Grade 3 Inj. site Tenderness; Post-dose 1;PENTAXIM
    0
        Any Inj. site Tenderness; Post-dose 1; HEBERBIOVAC
    49.3
        Gr 3 Inj. site Tenderness;Post-dose 1;HEBERBIOVAC
    0.5
        Any Inj. site Tenderness; Post-dose 2; PENTAXIM
    49
        Grade 3 Inj. site Tenderness; Post-dose 2;PENTAXIM
    1.4
        Any Inj. site Tenderness; Post-dose 2; HEBERBIOVAC
    44.8
        Gr 3 Inj. site Tenderness;Post-dose 2;HEBERBIOVAC
    1.4
        Any Inj. site Tenderness; Post-dose 3; PENTAXIM
    41.5
        Grade 3 Inj. site Tenderness; Post-dose 3;PENTAXIM
    0.5
        Any Inj. site Tenderness; Post-dose 3; HEBERBIOVAC
    36.7
        Gr 3 Inj. site Tenderness;Post-dose 3;HEBERBIOVAC
    0
        Any Inj. site Erythema; Post-Any; PENTAXIM
    45.3
        Grade 3 Inj. site Erythema; Post-Any; PENTAXIM
    0
        Any Inj. site Erythema; Post-Any; HEBERBIOVAC
    36.8
        Grade 3 Inj. site Erythema; Post-Any; HEBERBIOVAC
    0
        Any Inj. site Erythema; Post-dose 1; PENTAXIM
    30.3
        Grade 3 Inj. site Erythema; Post-dose 1; PENTAXIM
    0
        Any Inj. site Erythema; Post-dose 1; HEBERBIOVAC
    25.6
        Grade 3 Inj. site Erythema;Post-dose 1;HEBERBIOVAC
    0
        Any Inj. site Erythema; Post-dose 2; PENTAXIM
    26.2
        Grade 3 Inj. site Erythema; Post-dose 2; PENTAXIM
    0
        Any Inj. site Erythema; Post-dose 2; HEBERBIOVAC
    20
        Grade 3 Inj. site Erythema;Post-dose 2;HEBERBIOVAC
    0
        Any Inj. site Erythema; Post-dose 3; PENTAXIM
    26.1
        Grade 3 Inj. site Erythema; Post-dose 3; PENTAXIM
    0
        Any Inj. site Erythema; Post-dose 3; HEBERBIOVAC
    18.8
        Grade 3 Inj. site Erythema;Post-dose 3;HEBERBIOVAC
    0
        Any Inj. site Swelling; Post-Any; PENTAXIM
    42
        Grade 3 Inj. site Swelling; Post-Any; PENTAXIM
    0
        Any Inj. site Swelling; Post-Any; HEBERBIOVAC
    37.7
        Grade 3 Inj. site Swelling; Post-Any; HEBERBIOVAC
    0
        Any Inj. site Swelling; Post-dose 1; PENTAXIM
    23.7
        Grade 3 Inj. site Swelling; Post-dose 1; PENTAXIM
    0
        Any Inj. site Swelling; Post-dose 1; HEBERBIOVAC
    20.4
        Grade 3 Inj. site Swelling;Post-dose 1;HEBERBIOVAC
    0
        Any Inj. site Swelling; Post-dose 2; PENTAXIM
    25.2
        Grade 3 Inj. site Swelling; Post-dose 2; PENTAXIM
    0
        Any Inj. site Swelling; Post-dose 2; HEBERBIOVAC
    19
        Grade 3 Inj. site Swelling;Post-dose 2;HEBERBIOVAC
    0
        Any Inj. site Swelling; Post-dose 3; PENTAXIM
    28.5
        Grade 3 Inj. site Swelling; Post-dose 3; PENTAXIM
    0
        Any Inj. site Swelling; Post-dose 3; HEBERBIOVAC
    23.7
        Grade 3 Inj. site Swelling;Post-dose 3;HEBERBIOVAC
    0
        Any Fever; Post-Any injection
    35.8
        Grade 3 Fever; Post-Any injection
    0
        Any Fever; Post-dose 1
    17.6
        Grade 3 Fever; Post-dose 1
    1.4
        Any Fever; Post-dose 2
    12.4
        Grade 3 Fever; Post-dose 2
    0.5
        Any Fever; Post-dose 3
    14
        Grade 3 Fever; Post-dose 3
    0
        Any Vomiting; Post-Any injection
    42.9
        Grade 3 Vomiting; Post-Any injection
    0
        Any Vomiting; Post-dose 1
    29.4
        Grade 3 Vomiting; Post-dose 1
    0.5
        Any Vomiting; Post-dose 2
    18.1
        Grade 3 Vomiting; Post-dose 2
    0.5
        Any Vomiting; Post-dose 3
    17.9
        Grade 3 Vomiting; Post-dose 3
    0.5
        Any Crying abnormal; Post-Any injection
    64.6
        Grade 3 Crying abnormal; Post-Any injection
    0
        Any Crying abnormal; Post-dose 1
    48.3
        Grade 3 Crying abnormal; Post-dose 1
    1.4
        Any Crying abnormal; Post-dose 2
    36.7
        Grade 3 Crying abnormal; Post-dose 2
    1.4
        Any Crying abnormal; Post-dose 3
    29
        Grade 3 Crying abnormal; Post-dose 3
    1
        Any Drowsiness; Post-Any injection
    48.1
        Grade 3 Drowsiness; Post-Any injection
    0
        Any Drowsiness; Post-dose 1
    33.2
        Grade 3 Drowsiness; Post-dose 1
    0.5
        Any Drowsiness; Post-dose 2
    25.2
        Grade 3 Drowsiness; Post-dose 2
    0.5
        Any Drowsiness; Post-dose 3
    18.4
        Grade 3 Drowsiness; Post-dose 3
    0.5
        Any Appetite lost; Post-Any injection
    35.8
        Grade 3 Appetite lost; Post-Any injection
    0
        Any Appetite lost; Post-dose 1
    20.9
        Grade 3 Appetite lost; Post-dose 1
    0.5
        Any Appetite lost; Post-dose 2
    17.1
        Grade 3 Appetite lost; Post-dose 2
    0.5
        Any Appetite lost; Post-dose 3
    19.3
        Grade 3 Appetite lost; Post-dose 3
    1
        Any Irritability; Post-Any injection
    55.7
        Grade 3 Irritability; Post-Any injection
    0
        Any Irritability; Post-dose 1
    46
        Grade 3 Irritability; Post-dose 1
    0.5
        Any Irritability; Post-dose 2
    30.5
        Grade 3 Irritability; Post-dose 2
    1
        Any Irritability; Post-dose 3
    26.1
        Grade 3 Irritability; Post-dose 3
    1.4
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Solicited Injection-site and Systemic Reactions After A Booster with DTacP-IPV//PRP~T Vaccine (PENTAXIM) After a Primary Series with DTacP-IPV//PRP~T Vaccine (PENTAXIM) Concomitantly with Hepatitis B (HEBERBIOVAC)

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions After A Booster with DTacP-IPV//PRP~T Vaccine (PENTAXIM) After a Primary Series with DTacP-IPV//PRP~T Vaccine (PENTAXIM) Concomitantly with Hepatitis B (HEBERBIOVAC)
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥ 5 cm. Grade 3 systemic reactions: Fever, ≥ 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable.
    End point type
    Other pre-specified
    End point timeframe
    Post-booster vaccination
    End point values
    		 Study group
    Number of subjects analysed
    180
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    60.6
        Grade 3 Injection site Tenderness
    7.2
        Any Injection site Erythema
    39.4
        Grade 3 Injection site Erythema
    3.3
        Any Injection site Swelling
    39.4
        Grade 3 Injection site Swelling
    3.9
        Any Fever
    29.4
        Grade 3 Fever
    1.7
        Any Vomiting
    11.7
        Grade 3 Vomiting
    1.1
        Any Crying abnormal
    36.1
        Grade 3 Crying abnormal
    1.7
        Any Drowsiness
    26.1
        Grade 3 Drowsiness
    1.1
        Any Appetite lost
    32.8
        Grade 3 Appetite lost
    3.3
        Any Irritability
    31.7
        Grade 3 Irritability
    1.1
    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 1 month post-booster vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9
    Reporting groups
    Reporting group title
    Study group
    Reporting group description
    		 Subjects received DTacP-IPV//PRP-T vaccine (PENTAXIM™) at 6, 10, and 14 weeks of age and hepatitis B vaccine (HEBERBIOVAC®) at 6, 10, and 14 weeks of age.

    Serious adverse events
    		 Study group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 212 (11.79%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Dehydration with acidosis herbal intoxication
         subjects affected / exposed
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux
         subjects affected / exposed
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    6 / 212 (2.83%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    Bronchopneumonia
         subjects affected / exposed
    7 / 212 (3.30%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Viral bronchiolitis
         subjects affected / exposed
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    7 / 212 (3.30%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 212 (1.42%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Acute gastroenteritis
         subjects affected / exposed
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bilateral bronchopneumonia
         subjects affected / exposed
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Streptococcus viridans septicamia
         subjects affected / exposed
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Study group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    145 / 212 (68.40%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    102 / 212 (48.11%)
         occurrences all number
    102
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    145 / 212 (68.40%)
         occurrences all number
    145
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    96 / 212 (45.28%)
         occurrences all number
    96
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    89 / 212 (41.98%)
         occurrences all number
    89
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    76 / 212 (35.85%)
         occurrences all number
    76
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    14 / 212 (6.60%)
         occurrences all number
    14
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    91 / 212 (42.92%)
         occurrences all number
    91
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    21 / 212 (9.91%)
         occurrences all number
    21
    Nasal congestion
         subjects affected / exposed
    13 / 212 (6.13%)
         occurrences all number
    13
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    15 / 212 (7.08%)
         occurrences all number
    15
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    137 / 212 (64.62%)
         occurrences all number
    137
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    118 / 212 (55.66%)
         occurrences all number
    118
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    19 / 212 (8.96%)
         occurrences all number
    19
    Rhinitis
         subjects affected / exposed
    27 / 212 (12.74%)
         occurrences all number
    27
    Upper respiratory tract infection
         subjects affected / exposed
    81 / 212 (38.21%)
         occurrences all number
    81
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    76 / 212 (35.85%)
         occurrences all number
    76

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jan 2006
    Informed investigators of the protocol to replace screening failures

    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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