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    Clinical Trial Results:
    Immunogenicity and Safety of the sanofi pasteur’s DTacP-IPV Combined Vaccine (TETRAXIM™) given as a booster dose at 4 to 6 years of life in children previously vaccinated with PENTAXIM™ in the study E2I34

    Summary
    EudraCT number
    		 2015-005403-87
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    31 May 2010

    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
    E2I57
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01031303
    WHO universal trial number (UTN)
    		 U1111-1112-2680
    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?
    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
    16 Sep 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur’s DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years 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 kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were available on site in case of any immediate allergic reactions.
    Background therapy
    		 Subjects were vaccinated with PENTAXIM™ in a previous Study, 2015-005352-10 .
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    19 Dec 2009
    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
    Thailand: 123
    Worldwide total number of subjects
    123
    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)
    123
    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 19 December 2009 to 31 March 2010 at 2 clinical centers in Thailand.

    Pre-assignment
    Screening details
    		 Subjects who received Sanofi Pasteur's DTacP-IPV//PRP~T vaccine (Pentaxim™) as a 3-dose primary vaccination (at 2, 4, and 6 months of age) in parallel with a recombinant hepatitis B vaccination received at birth, 2 and 6 months of age in the study E2I34 are eligible for the booster dose study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    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 a booster dose of study vaccine DTacP-IPV vaccine (TETRAXIM™) at 4 to 6 years of age (at visit 1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV combined vaccine
    Investigational medicinal product code
    Other name
    TETRAXIM™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, Intramuscular into the right deltoid region

    Number of subjects in period 1
    		Study Group
    Started
    123
    Completed
    123

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 123 123
    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)
    		 0 0
        Children (2-11 years)
    		 123 123
        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
    Units: years
        arithmetic mean (standard deviation)
    		 4.2 ( 0.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 50 50
        Male
    		 73 73

    End points

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    End points reporting groups
    Reporting group title
    Study Group
    Reporting group description
    		 Subjects received a booster dose of study vaccine DTacP-IPV vaccine (TETRAXIM™) at 4 to 6 years of age (at visit 1).

    Primary: Percentage of Subjects with Seroprotection, Seroconversion/Vaccine Response After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10).

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    End point title
    		 Percentage of Subjects with Seroprotection, Seroconversion/Vaccine Response After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10). [1]
    End point description
    Anti-diphtheria (D) and Anti-poliovirus (IPV) types 1, 2, and 3 antibodies were measured by a toxin neutralization test. Anti-Tetanus (T), anti-Pertussis toxoid (PT) and anti-Filamentous Haemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
    End point type
    Primary
    End point timeframe
    Day 30 post-booster 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 booster vaccine administered in the study.
    End point values
    		 Study Group
    Number of subjects analysed
    123
    Units: Percentage of Subjects
    number (not applicable)
        Anti-Diphteria
    100
        Anti-Tetanus
    100
        Anti-Polio 1
    100
        Anti-Polio 1 (subjects got OPV, N = 11)
    100
        Anti-Polio 1 (subjects did not get OPV, N = 112)
    100
        Anti-Polio 2
    100
        Anti-Polio 2 (subjects got OPV, N = 11)
    100
        Anti-Polio 2 (subjects did not get OPV, N = 112)
    100
        Anti-Polio 3
    100
        Anti-Polio 3 (subjects got OPV, N = 11)
    100
        Anti-Polio 3 (subjects did not get OPV, N = 112)
    100
        Anti-Pertussis toxoid
    97.6
        Anti-Filamentous Haemagglutinin
    92.6
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Antibodies Against Vaccine Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10).

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    End point title
    		 Geometric Mean Titers of Antibodies Against Vaccine Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10).
    End point description
    Anti-diphtheria (D) and Anti-poliovirus (IPV) types 1, 2, and 3 antibodies were measured by a toxin neutralization test. Anti-Tetanus (T), anti-Pertussis toxoid (PT) and anti-Filamentous Haemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
    End point type
    Secondary
    End point timeframe
    Day 0 Pre-vaccination and Day 30 Post-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    123
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Diphtheria Antibody (Day 0 Pre-vaccination)
    0.149 (0.109 to 0.204)
        Anti-Diphtheria Antibody (Day 30 Post-vaccination)
    7.81 (6.47 to 9.43)
        Anti-Tetanus Antibody (Day 0 Pre-vaccination)
    0.654 (0.556 to 0.769)
        Anti-Tetanus Antibody (Day 30 Post-vaccination)
    7.72 (6.83 to 8.72)
        Anti-Polio 1 Antibody (Day 0 Pre-vaccination)
    583 (467 to 729)
        Anti-Polio 1 Antibody (Day 30 Post-vaccination)
    3013 (2631 to 3450)
        Anti-Polio 2 Antibody (Day 0 Pre-vaccination)
    714 (566 to 900)
        Anti-Polio 2 Antibody (Day 30 Post-vaccination)
    3430 (2969 to 3963)
        Anti-Polio 3 Antibody (Day 0 Pre-vaccination)
    481 (374 to 619)
        Anti-Polio 3 Antibody (Day 30 Post-vaccination)
    3837 (3261 to 4515)
        Anti-Pertussis Antibody (Day 0 Pre-vaccination)
    10.9 (9.11 to 13.1)
        Anti-Pertussis Antibody (Day 30 Post-vaccination)
    190 (168 to 216)
        Anti-FHA Antibody (Day 0 Pre-vaccination)
    24.3 (19.7 to 29.9)
        Anti-FHA Antibody (Day 30 Post-vaccination)
    356 (314 to 405)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10).

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    End point title
    		 Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10).
    End point description
    Anti-diphtheria (D) and Anti-poliovirus (IPV) types 1, 2, and 3 antibodies were measured by a toxin neutralization test. Anti-Tetanus (T), anti-Pertussis toxoid (PT) and anti-Filamentous Haemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 Post-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    123
    Units: Titer Ratios
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    52.5 (42.5 to 64.9)
        Anti-Tetanus
    11.6 (10 to 13.5)
        Anti-Polio 1
    5.14 (4.08 to 6.46)
        Anti-Polio 2
    4.77 (3.82 to 5.96)
        Anti-Polio 3
    8.26 (6.33 to 10.8)
        Anti-Pertussis toxoid
    17.4 (15.1 to 20)
        Anti-Filamentous Haemagglutinin
    14.6 (12.3 to 17.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Solicited Injection-site and Systemic Reactions After A Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10)

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions After A Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10)
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia Grade 3 injection-site Pain, Incapacitating, preventing the performance of usual activities; Erythema and Swelling, ≥5 cm; Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 Study Group
    Number of subjects analysed
    123
    Units: Percentage of Subjects
    number (not applicable)
        Injection-site Pain
    75.6
        Grade 3 Injection-site Pain
    0.8
        Injection-site Erythema
    48.8
        Grade 3 Injection-site Erythema
    4.1
        Injection-site Swelling
    36.6
        Grade 3 Injection-site Swelling
    2.4
        Fever
    10.6
        Grade 3 Fever
    0.8
        Headache
    24.4
        Grade 3 Headache
    0
        Malaise
    32.5
        Grade 3 Malaise
    0
        Myalgia
    43.9
        Grade 3 Myalgia
    0
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers of Antibodies Against Poliovirus Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in OPV and non-OPV Recipients in a Previous Study.

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    End point title
    		 Geometric Mean Titers of Antibodies Against Poliovirus Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in OPV and non-OPV Recipients in a Previous Study.
    End point description
    Geometric Mean Titers were determined in subjects who received Oral Polio Vaccine (OPV), and those who did not received Oral Polio Vaccine (N/A) Anti-poliovirus (IPV) types 1, 2, and 3 antibodies was measured by a toxin neutralization test.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 Post-vaccination.
    End point values
    		 Study Group
    Number of subjects analysed
    123 [2]
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1 (Day 0, + OPV)
    563 (296 to 1070)
        Anti-Polio 1 (Day 30, + OPV)
    2719 (1752 to 4221)
        Anti-Polio 1 (Day 0, N/A)
    586 (461 to 744)
        Anti-Polio 1 (Day 30, N/A)
    3043 (2634 to 3516)
        Anti-Polio 2 (Day 0, + OPV)
    875 (406 to 1885)
        Anti-Polio 2 (Day 30, + OPV)
    3285 (1835 to 5881)
        Anti-Polio 2 (Day 0, N/A)
    700 (547 to 895)
        Anti-Polio 2 (Day 30, N/A)
    3444 (2961 to 4006)
        Anti-Polio 3 (Day 0, + OPV)
    724 (315 to 1666)
        Anti-Polio 3 (Day 30, + OPV)
    2896 (1758 to 4772)
        Anti-Polio 3 (Day 0, N/A)
    462 (354 to 603)
        Anti-Polio 3 (Day 30, N/A)
    3945 (3318 to 4692)
    Notes
    [2] - N = 11 for subject who received OPV (+ OPV) N = 112 for subject who did not receive OPV (N/A)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titer Ratios of Antibodies Against Poliovirus Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in OPV and non-OPV Recipients in a Previous Study.

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    End point title
    		 Geometric Mean Titer Ratios of Antibodies Against Poliovirus Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in OPV and non-OPV Recipients in a Previous Study.
    End point description
    Geometric Mean Titers were determined in subjects who received Oral Polio Vaccine (OPV), and those who did not received Oral Polio Vaccine (N/A) Anti-poliovirus (IPV) types 1, 2, and 3 antibodies were measured by a toxin neutralization test.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-vaccination.
    End point values
    		 Study Group
    Number of subjects analysed
    123 [3]
    Units: Titer Ratios
    geometric mean (confidence interval 95%)
        Anti-polio 1 (Day 30 + OPV)
    4.83 (1.91 to 12.2)
        Anti-polio 1 (Day 30, N/A)
    5.17 (4.07 to 6.57)
        Anti-polio 2 (Day 30 + OPV)
    3.76 (1.79 to 7.89)
        Anti-polio 2 (Day 30 , N/A)
    4.88 (3.85 to 6.19)
        Anti-polio 3 (Day 30 + OPV)
    4 (1.55 to 10.3)
        Anti-polio 2 (Day 30, N/A)
    8.88 (6.72 to 11.7)
    Notes
    [3] - N = 11 for subject who received OPV (+ OPV) N = 112 for subject who did not receive OPV (N/A)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from Day 0 up to Day 30 post-vaccination
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Study Group
    Reporting group description
    		 Subjects received a booster dose of study vaccine DTacP-IPV vaccine (TETRAXIM™) at 4 to 6 years of age (at visit 1).

    Serious adverse events
    		 Study Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 123 (0.81%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 123 (0.81%)
         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
    93 / 123 (75.61%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    30 / 123 (24.39%)
         occurrences all number
    30
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    93 / 123 (75.61%)
         occurrences all number
    93
    Injection-site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    60 / 123 (48.78%)
         occurrences all number
    60
    Injection-site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    45 / 123 (36.59%)
         occurrences all number
    45
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 123 (10.57%)
         occurrences all number
    13
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    40 / 123 (32.52%)
         occurrences all number
    40
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    54 / 123 (43.90%)
         occurrences all number
    54
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    28 / 123 (22.76%)
         occurrences all number
    30

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Oct 2009
    This amendment was issued before the commencement of the trial to change the site of the intramuscular injection of the vaccine from anterolateral aspect of the right thigh to the right deltoid region.
    13 Jan 2010
    Protocol updated to allow inclusion of subjects that received or were to receive Oral Polio Vaccine (OPV) as part of the National Immunization Days (that occurred at the same time as study period in Thailand) In the section on "Population used in the Analyses" the following text was added "In addition, anti polio 1, 2, and 3 antibody titers will be analyzed on the subset of subjects who did not receive OPV as part of the National Immunization Days campaign, as well as on the subset of subjects who received OPV as part of the National Immunization Days campaign."

    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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