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    Clinical Trial Results:
    Immunogenicity and Safety of the sanofi pasteur’s DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) versus sanofi pasteur’s DTacP-IPV Combined Vaccine (TETRAXIM™) given simultaneously at separate sites with PRP~T conjugate Vaccine (ActHIB™) as a three-dose primary vaccination at 2, 4 and 6 Months of Age in South Korean Infants

    Summary
    EudraCT number
    		 2015-005293-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    02 Mar 2012

    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
    E2I49
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01214889
    WHO universal trial number (UTN)
    		 U1111-1115-6381
    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
    31 Jul 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, PRP) and vaccine response rates to acellular Pertussis antigens (PT, FHA) of Sanofi Pasteur’s DTacP-IPV//PRP~T combined vaccine versus sanofi pasteur’s DTacP-IPV (TETRAXIM™) and PRP~T (Act-HIB™) vaccines, one month after the three-dose primary vaccination.
    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
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    28 Sep 2010
    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
    Korea, Republic of: 418
    Worldwide total number of subjects
    418
    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)
    418
    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 28 September 2010 to 26 September 2011 at 13 clinic centers in South Korea.

    Pre-assignment
    Screening details
    		 A total of 418 infants who met all inclusion and none of the exclusion criteria were enrolled in the study; 414 were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTaP-IPV//PRP-T
    Arm description
    		 Healthy infants received the investigational vaccine (DTaP-IPV//PRP-T) at 2, 4, and 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTaP-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 anterolateral aspect of the right thigh, 1 injection each at 2, 4, and 6 months of age.

    Arm title
    		 DTaP-IPV+PRP-T
    Arm description
    		 Healthy infants received a control vaccine DTaP-IPV combined vaccine (TETRAXIM™) and PRP-T (Act-HIB™) at 2, 4, and 6 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DTaP-IPV combined vaccine (TETRAXIM™)
    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 aspect of the right thigh, 1 injection each at 2, 4, and 6 months of age.

    Investigational medicinal product name
    PRP-Tetanus conjugate vaccine (Act-HIB™)
    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 anterolateral aspect of the left thigh, 1 injection each at 2, 4, and 6 months of age.

    Number of subjects in period 1 [1]
    		DTaP-IPV//PRP-T DTaP-IPV+PRP-T
    Started
    208
    206
    Completed
    207
    202
    Not completed
    1
    4
         Serious adverse event
    -
    1
         Protocol deviation
    1
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 418 subjects were enrolled in the study; 414 were randomized.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV//PRP-T
    Reporting group description
    		 Healthy infants received the investigational vaccine (DTaP-IPV//PRP-T) at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV+PRP-T
    Reporting group description
    		 Healthy infants received a control vaccine DTaP-IPV combined vaccine (TETRAXIM™) and PRP-T (Act-HIB™) at 2, 4, and 6 months of age.

    Reporting group values
    		 DTaP-IPV//PRP-T DTaP-IPV+PRP-T Total
    Number of subjects
    		 208 206 414
    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)
    		 208 206 414
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2.04 ± 0.112 2.06 ± 0.12 -
    Gender categorical
    Units: Subjects
        Female
    		 90 95 185
        Male
    		 118 111 229

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV//PRP-T
    Reporting group description
    		 Healthy infants received the investigational vaccine (DTaP-IPV//PRP-T) at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV+PRP-T
    Reporting group description
    		 Healthy infants received a control vaccine DTaP-IPV combined vaccine (TETRAXIM™) and PRP-T (Act-HIB™) at 2, 4, and 6 months of age.

    Primary: Percentage of Subjects with Seroprotection/Vaccine Response One Month after Primary Vaccination Series with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or DTaP-IPV Combined Vaccine (TETRAXIM) Given at Separate Sites with PRP~T Conjugate Vaccine (ActHIB)

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    End point title
    		 Percentage of Subjects with Seroprotection/Vaccine Response One Month after Primary Vaccination Series with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or DTaP-IPV Combined Vaccine (TETRAXIM) Given at Separate Sites with PRP~T Conjugate Vaccine (ActHIB)
    End point description
    Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti-Filamentous hemagglutinin (FHA) antibody titers were measured using an enzyme-linked immunosorbent assay (ELISA), Anti-Diphtheria and Anti-Poliovirus types 1, 2, 3 antibody titers were measured using seroneutralization. Anti-Polyribosyl Ribitol Phosphate (PRP) was measured using a radioimmunology assay. Seroprotection for Anti-Diptheria was defined as antibody titers ≥ 0.01 IU/mL, for Anti-Tetanus ≥ 0.1 IU/mL, for Anti-Poliovirus types 1, 2, and 3 antibody titers ≥ 8 (1/dil). Vaccine response for Anti-PT and Anti-FHA was defined as ≥ 4-fold increase.
    End point type
    Primary
    End point timeframe
    1 month post-primary vaccination
    End point values
    		 DTaP-IPV//PRP-T DTaP-IPV+PRP-T
    Number of subjects analysed
    197
    181
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria
    100
    100
        Anti-Tetanus
    100
    100
        Anti-Polio 1
    100
    100
        Anti-Polio 2
    100
    100
        Anti-Polio 3
    100
    100
        Anti-PRP
    100
    100
        Anti-PT
    99
    98.9
        Anti-FHA
    97.5
    98.9
    Statistical analysis title
    		 Non-inferiority; Anti-Diphtheria
    Statistical analysis description
    Non-inferiority analysis of Anti-Diphtheria in DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T.
    Comparison groups
    DTaP-IPV//PRP-T v DTaP-IPV+PRP-T
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 2.08
    Notes
    [1] - The non-inferiority was demonstrated if the lower limit of all the 95% confidence intervals of the difference was greater than -10%. DTaP-IPV//PRP-T was non-inferior to DTaP-IPV+PRP-T.
    Statistical analysis title
    		 Non-inferiority; Anti-Tetanus
    Statistical analysis description
    Non-inferiority analysis of Anti-Tetanus in DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T.
    Comparison groups
    DTaP-IPV//PRP-T v DTaP-IPV+PRP-T
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 2.08
    Notes
    [2] - The non-inferiority was demonstrated if the lower limit of all the 95% confidence intervals of the difference was greater than -10%. DTaP-IPV//PRP-T was non-inferior to DTaP-IPV+PRP-T.
    Statistical analysis title
    		 Non-inferiority; Anti-Polio 1
    Statistical analysis description
    Non-inferiority analysis of Anti-Polio 1 in DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T.
    Comparison groups
    DTaP-IPV//PRP-T v DTaP-IPV+PRP-T
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 2.08
    Notes
    [3] - The non-inferiority was demonstrated if the lower limit of all the 95% confidence intervals of the difference was greater than -10%. DTaP-IPV//PRP-T was non-inferior to DTaP-IPV+PRP-T.
    Statistical analysis title
    		 Non-inferiority; Anti-Polio 2
    Statistical analysis description
    Non-inferiority analysis of Anti-Polio 2 in DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T.
    Comparison groups
    DTaP-IPV//PRP-T v DTaP-IPV+PRP-T
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 2.08
    Notes
    [4] - The non-inferiority was demonstrated if the lower limit of all the 95% confidence intervals of the difference was greater than -10%. DTaP-IPV//PRP-T was non-inferior to DTaP-IPV+PRP-T.
    Statistical analysis title
    		 Non-inferiority; Anti-Polio 3
    Statistical analysis description
    Non-inferiority analysis of Anti-Polio 3 in DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T.
    Comparison groups
    DTaP-IPV//PRP-T v DTaP-IPV+PRP-T
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 2.08
    Notes
    [5] - The non-inferiority was demonstrated if the lower limit of all the 95% confidence intervals of the difference was greater than -10%. DTaP-IPV//PRP-T was non-inferior to DTaP-IPV+PRP-T.
    Statistical analysis title
    		 Non-inferiority; Anti-PRP
    Statistical analysis description
    Non-inferiority analysis of Anti-PRP in DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T.
    Comparison groups
    DTaP-IPV//PRP-T v DTaP-IPV+PRP-T
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 2.08
    Notes
    [6] - The non-inferiority was demonstrated if the lower limit of all the 95% confidence intervals of the difference was greater than -10%. DTaP-IPV//PRP-T was non-inferior to DTaP-IPV+PRP-T.
    Statistical analysis title
    		 Non-inferiority; Anti-PT
    Statistical analysis description
    Non-inferiority analysis of Anti-PT in DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T.
    Comparison groups
    DTaP-IPV+PRP-T v DTaP-IPV//PRP-T
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.68
         upper limit
    		 3.01
    Notes
    [7] - The non-inferiority was demonstrated if the lower limit of all the 95% confidence intervals of the difference was greater than -10%. DTaP-IPV//PRP-T was non-inferior to DTaP-IPV+PRP-T.
    Statistical analysis title
    		 Non-inferiority; Anti-FHA
    Statistical analysis description
    Non-inferiority analysis of Anti-FHA in DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T.
    Comparison groups
    DTaP-IPV//PRP-T v DTaP-IPV+PRP-T
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 DTaP-IPV//PRP-T minus DTaP-IPV+PRP-T
    Point estimate
    -1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.79
         upper limit
    		 1.75
    Notes
    [8] - The non-inferiority was demonstrated if the lower limit of all the 95% confidence intervals of the difference was greater than -10%. DTaP-IPV//PRP-T was non-inferior to DTaP-IPV+PRP-T.

    Primary: Geometric Mean Titers of Antibodies Against Vaccine Antigens Before and After A Primary Vaccination Series with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or DTaP-IPV Combined Vaccine (TETRAXIM) Given at Separate Sites with PRP~T Vaccine (ActHIB)

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    End point title
    		 Geometric Mean Titers of Antibodies Against Vaccine Antigens Before and After A Primary Vaccination Series with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or DTaP-IPV Combined Vaccine (TETRAXIM) Given at Separate Sites with PRP~T Vaccine (ActHIB) [9]
    End point description
    Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti-Filamentous hemagglutinin (FHA) antibody titers were measured using an enzyme-linked immunosorbent assay (ELISA), Anti-Diphtheria and Anti-Poliovirus types 1, 2, 3 antibody titers were measured using seroneutralization. Anti-Polyribosyl Ribitol Phosphate (PRP) was measured using a radioimmunology assay.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 150 post-primary vaccination
    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 the study vaccine administered for this outcome.
    End point values
    		 DTaP-IPV//PRP-T DTaP-IPV+PRP-T
    Number of subjects analysed
    197
    181
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Pre-vaccination
    0.008 (0.007 to 0.01)
    0.008 (0.007 to 0.01)
        Anti-Diphtheria; Post-vaccination
    1.38 (1.21 to 1.58)
    1.2 (1.06 to 1.37)
        Anti-Tetanus; Pre-vaccination
    0.029 (0.024 to 0.036)
    0.03 (0.024 to 0.038)
        Anti-Tetanus; Post-vaccination
    2.87 (2.66 to 3.1)
    3.55 (3.18 to 3.95)
        Anti-Polio 1; Pre-vaccination
    4.26 (3.74 to 4.87)
    4.8 (4.14 to 5.56)
        Anti-Polio 1; Post-vaccination
    1237 (1072 to 1428)
    1042 (908 to 1196)
        Anti-Polio 2; Pre-vaccination
    7.77 (6.65 to 9.09)
    8.9 (7.47 to 10.6)
        Anti-Polio 2; Post-vaccination
    2081 (1776 to 2439)
    1781 (1525 to 2080)
        Anti-Polio 3; Pre-vaccination
    4.34 (3.85 to 4.88)
    4.48 (3.93 to 5.1)
        Anti-Polio 3; Post-vaccination
    1868 (1587 to 2199)
    1557 (1313 to 1848)
        Anti-PRP; Pre-vaccination
    0.083 (0.069 to 0.1)
    0.087 (0.071 to 0.105)
        Anti-PRP; Post-vaccination
    11 (9.42 to 12.8)
    23.9 (20.4 to 27.9)
        Anti-PT; Pre-vaccination
    2.23 (1.94 to 2.56)
    2.15 (1.87 to 2.47)
        Anti-PT; Post-vaccination
    223 (205 to 241)
    247 (228 to 269)
        Anti-FHA; Pre-vaccination
    3.7 (3.25 to 4.21)
    3.54 (3.1 to 4.04)
        Anti-FHA; Post-vaccination
    225 (206 to 246)
    259 (238 to 282)
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After A Primary Vaccination Series with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or DTaP-IPV Combined Vaccine (TETRAXIM) Given at Separate Sites with PRP-T Conjugate Vaccine (ActHIB)

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    End point title
    		 Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After A Primary Vaccination Series with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or DTaP-IPV Combined Vaccine (TETRAXIM) Given at Separate Sites with PRP-T Conjugate Vaccine (ActHIB) [10]
    End point description
    Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti-Filamentous hemagglutinin (FHA) antibody titers were measured using an enzyme-linked immunosorbent assay (ELISA), Anti-Diphtheria and Anti-Poliovirus types 1, 2, 3 antibody titers were measured using seroneutralization. Anti-Polyribosyl Ribitol Phosphate (PRP) was measured using a radioimmunology assay. The geometric mean titer ratios of post-dose 3 (Day 150)/pre-dose 1 (Day 0) are reported.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 150 post-primary vaccination
    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 the study vaccine administered for this outcome.
    End point values
    		 DTaP-IPV//PRP-T DTaP-IPV+PRP-T
    Number of subjects analysed
    196
    181
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    170 (135 to 214)
    145 (113 to 187)
        Anti-Tetanus
    98.5 (76.7 to 127)
    118 (87.9 to 160)
        Anti-Polio 1
    289 (235 to 356)
    217 (175 to 269)
        Anti-Polio 2
    268 (211 to 342)
    200 (156 to 257)
        Anti-Polio 3
    429 (355 to 518)
    348 (277 to 437)
        Anti-PRP
    136 (107 to 173)
    276 (210 to 363)
        Anti-PT
    99.9 (83.8 to 119)
    115 (96 to 138)
        Anti-FHA
    60.9 (51.2 to 72.5)
    73.1 (62 to 86.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Solicited Injection-site and Systemic Reactions After Any and Each Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or DTaP-IPV Combined Vaccine (TETRAXIM) Given at Separate Sites with PRP-T Vaccine (ActHIB)

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions After Any and Each Vaccination with DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or DTaP-IPV Combined Vaccine (TETRAXIM) Given at Separate Sites with PRP-T Vaccine (ActHIB) [11]
    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. Fever, > 39.5°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/meals or refuses most feeds/meals; Irritability, Inconsolable. Solicited injection site and systemic reactions are reported for each arm. In the DTaP-IPV+PRP-T arm, solicited injection site reactions post-each arm are also reported by separate vaccines DTaP-IPV, and PRP-T.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-any and each primary vaccination
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 DTaP-IPV//PRP-T DTaP-IPV+PRP-T
    Number of subjects analysed
    207 [12]
    203
    Units: Percentage of subjects
    number (not applicable)
        Injection site Tenderness; Post-Any injection
    61.2
    58.2
        Grade 3 Injection site Tenderness; Post-Any inj.
    1.4
    1
        Injection site Erythema; Post-Any injection
    56.9
    48.8
        Grade 3 Injection site Erythema; Post-Any inj.
    2.9
    1
        Injection site Swelling; Post-Any injection
    35.9
    33.5
        Grade 3 Injection site Swelling; Post-Any inj.
    1.9
    1.5
        Injection site Tenderness; Post-injection 1
    44
    44.8
        Grade 3 Injection site Tenderness; Post-inj. 1
    1
    0
        Injection site Tenderness; Post-inj. 1; DTaP-IPV
    0
    36.3
        Grade 3 Inj. site Tenderness; Post-inj. 1;DTaP-IPV
    0
    0
        Injection site Tenderness; Post-injection 1; PRP-T
    0
    40.3
        Grade 3 Inj. site Tenderness; Post-inj. 1; PRP-T
    0
    0
        Injection site Erythema; Post-injection 1
    38.3
    20.9
        Grade 3 Injection site Erythema; Post-injection 1
    0.5
    0.5
        Injection site Erythema; Post-inj. 1; DTaP-IPV
    0
    17.9
        Grade 3 Inj. site Erythema; Post-inj. 1; DTaP-IPV
    0
    0
        Injection site Erythema; Post-inj. 1; PRP-T
    0
    11.9
        Grade 3 Inj. site Erythema; Post-inj. 1; PRP-T
    0
    0.5
        Injection site Swelling; Post-injection 1
    12.9
    11
        Grade 3 Injection site Swelling; Post-injection 1
    0
    0
        Injection site Swelling; Post-inj. 1; DTaP-IPV
    0
    10
        Grade 3 Inj. site Swelling; Post-inj. 1; DTaP-IPV
    0
    0
        Injection site Swelling; Post-inj. 1; PRP-T
    0
    5
        Grade 3 Inj. site Swelling; Post-inj. 1; PRP-T
    0
    0
        Injection site Tenderness; Post-injection 2
    36.7
    36.1
        Grade 3 Injection site Tenderness; Post-inj. 2
    0.5
    0.5
        Injection site Tenderness; Post-inj. 2; DTaP-IPV
    0
    34.2
        Grade 3 Inj. site Tenderness; Post-inj. 2;DTaP-IPV
    0
    0.5
        Injection site Tenderness; Post-inj. 2; PRP-T
    0
    29.7
        Grade 3 Inj. site Tenderness; Post-inj. 2; PRP-T
    0
    0.5
        Injection site Erythema; Post-injection 2
    40.6
    29.2
        Grade 3 Injection site Erythema; Post-injection 2
    1
    0.5
        Injection site Erythema; Post-inj. 2; DTaP-IPV
    0
    27.7
        Grade 3 Inj. site Erythema; Post-inj. 2; DTaP-IPV
    0
    0
        Injection site Erythema; Post-inj. 2; PRP-T
    0
    14.9
        Grade 3 Inj. site Erythema; Post-inj. 2; PRP-T
    0
    0.5
        Injection site Swelling; Post-injection 2
    22.7
    19.8
        Grade 3 Injection site Swelling; Post-injection 2
    1
    0.5
        Injection site Swelling; Post-inj. 2; DTaP-IPV
    0
    18.8
        Grade 3 Inj. site Swelling; Post-inj. 2; DTaP-IPV
    0
    0
        Injection site Swelling; Post-inj. 2; PRP-T
    0
    8.9
        Grade 3 Inj. site Swelling; Post-inj. 2; PRP-T
    0
    0.5
        Injection site Tenderness; Post-injection 3
    31.4
    32.7
        Grade 3 Injection site Tenderness; Post-inj. 3
    0
    0.5
        Injection site Tenderness; Post-inj. 3; DTaP-IPV
    0
    31.7
        Grade 3 Inj. site Tenderness; Post-inj. 3;DTaP-IPV
    0
    0.5
        Injection site Tenderness; Post-inj. 3; PRP-T
    0
    25.2
        Grade 3 Inj. site Tenderness; Post-inj. 3; PRP-T
    0
    0
        Injection site Erythema; Post-injection 3
    39.1
    34.2
        Grade 3 Injection site Erythema; Post-injection 3
    1.9
    0.5
        Injection site Erythema; Post-inj. 3; DTaP-IPV
    0
    32.7
        Grade 3 Inj. site Erythema; Post-inj. 3; DTaP-IPV
    0
    0.5
        Injection site Erythema; Post-inj. 3; PRP-T
    0
    18.3
        Grade 3 Inj. site Erythema; Post-inj. 3; PRP-T
    0
    0
        Injection site Swelling; Post-injection 3
    24.6
    23.3
        Grade 3 Injection site Swelling; Post-injection 3
    1
    1
        Injection site Swelling; Post-inj. 3; DTaP-IPV
    0
    22.3
        Grade 3 Inj. site Swelling; Post-inj. 3; DTaP-IPV
    0
    1
        Injection site Swelling; Post-inj. 3; PRP-T
    0
    11.4
        Grade 3 Inj. site Swelling; Post-inj. 3; PRP-T
    0
    0
        Fever; Post-Any injection
    15.9
    11.4
        Grade 3 Fever; Post-Any injection
    0
    0
        Vomiting; Post-Any injection
    34.9
    38.3
        Grade 3 Vomiting; Post-Any injection
    1.4
    0.5
        Crying abnormal; Post-Any injection
    48.3
    54.7
        Grade 3 Crying abnormal; Post-Any injection
    4.3
    1
        Drowsiness; Post-Any injection
    49.3
    50.7
        Grade 3 Drowsiness; Post-Any injection
    1.9
    2
        Appetite lost; Post-Any injection
    41.1
    44.8
        Grade 3 Appetite lost; Post-Any injection
    1
    2
        Irritability; Post-Any injection
    51.2
    53.7
        Grade 3 Irritability; Post-Any injection
    4.8
    4
        Fever; Post-injection 1
    6.3
    2.5
        Grade 3 Fever; Post-injection 1
    0
    0
        Vomiting; Post-injection 1
    26.8
    26.9
        Grade 3 Vomiting; Post-injection 1
    0.5
    0.5
        Crying abnormal; Post-injection 1
    30.1
    38.3
        Grade 3 Crying abnormal; Post-injection 1
    1.4
    0.5
        Drowsiness; Post-injection 1
    37.3
    39.3
        Grade 3 Drowsiness; Post-injection 1
    1.4
    2
        Appetite lost; Post-injection 1
    25.4
    26.9
        Grade 3 Appetite lost; Post-injection 1
    0.5
    0.5
        Irritability; Post-injection 1
    33.5
    39.8
        Grade 3 Irritability; Post-injection 1
    2.9
    2
        Fever; Post-injection 2
    3.9
    5
        Grade 3 Fever; Post-injection 2
    0
    0
        Vomiting; Post-injection 2
    16.4
    19.8
        Grade 3 Vomiting; Post-injection 2
    0
    0
        Crying abnormal; Post-injection 2
    25.6
    26.2
        Grade 3 Crying abnormal; Post-injection 2
    1.9
    0.5
        Drowsiness; Post-injection 2
    21.7
    27.7
        Grade 3 Drowsiness; Post-injection 2
    0.5
    0
        Appetite lost; Post-injection 2
    18.4
    20.8
        Grade 3 Appetite lost; Post-injection 2
    0.5
    0.5
        Irritability; Post-injection 2
    30
    30.7
        Grade 3 Irritability; Post-injection 2
    2.4
    2
        Fever; Post-injection 3
    7.3
    7
        Grade 3 Fever; Post-injection 3
    0
    0
        Vomiting; Post-injection 3
    12.6
    13.9
        Grade 3 Vomiting; Post-injection 3
    1
    0
        Crying abnormal; Post-injection 3
    21.3
    18.3
        Grade 3 Crying abnormal; Post-injection 3
    1.4
    0
        Drowsiness; Post-injection 3
    16.9
    17.8
        Grade 3 Drowsiness; Post-injection 3
    0
    0
        Appetite lost; Post-injection 3
    13.5
    19.3
        Grade 3 Appetite lost; Post-injection 3
    0
    1
        Irritability; Post-injection 3
    19.3
    23.3
        Grade 3 Irritability; Post-injection 3
    0
    0
    Notes
    [12] - 2 subjects in the DTaP-IPV+PRP-T arm received DTaP-IPV//PRP-T and were included for a total of N=209
    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 up to Day 150 of the primary vaccination series.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    DTaP-IPV//PRP-T
    Reporting group description
    		 Healthy infants received the investigational vaccine (DTaP-IPV//PRP-T) at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV+PRP-T
    Reporting group description
    		 Healthy infants received a control vaccine DTaP-IPV combined vaccine (TETRAXIM™) and PRP-T (Act-HIB™) at 2, 4, and 6 months of age.

    Serious adverse events
    		 DTaP-IPV//PRP-T DTaP-IPV+PRP-T
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 209 (7.18%)
    8 / 203 (3.94%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Hypotonia
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 203 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hypothermia
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 203 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 203 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastro-esophageal reflux disease
         subjects affected / exposed
    1 / 209 (0.48%)
    0 / 203 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    5 / 209 (2.39%)
    2 / 203 (0.99%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 209 (0.48%)
    0 / 203 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 203 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 209 (0.48%)
    0 / 203 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 209 (0.96%)
    1 / 203 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kawasaki's disease
         subjects affected / exposed
    0 / 209 (0.00%)
    1 / 203 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 209 (0.48%)
    0 / 203 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 209 (0.48%)
    0 / 203 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 209 (1.44%)
    0 / 203 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    3 / 209 (1.44%)
    1 / 203 (0.49%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DTaP-IPV//PRP-T DTaP-IPV+PRP-T
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    128 / 209 (61.24%)
    117 / 203 (57.64%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    103 / 209 (49.28%)
    102 / 203 (50.25%)
         occurrences all number
    103
    102
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    128 / 209 (61.24%)
    117 / 203 (57.64%)
         occurrences all number
    128
    117
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    119 / 209 (56.94%)
    98 / 203 (48.28%)
         occurrences all number
    119
    98
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    75 / 209 (35.89%)
    67 / 203 (33.00%)
         occurrences all number
    75
    67
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    33 / 209 (15.79%)
    23 / 203 (11.33%)
         occurrences all number
    33
    23
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    73 / 209 (34.93%)
    77 / 203 (37.93%)
         occurrences all number
    73
    77
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    101 / 209 (48.33%)
    110 / 203 (54.19%)
         occurrences all number
    101
    110
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    107 / 209 (51.20%)
    108 / 203 (53.20%)
         occurrences all number
    107
    108
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    86 / 209 (41.15%)
    90 / 203 (44.33%)
         occurrences all number
    86
    90

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2011
    Included administrative changes and details on the recruitment procedures, vaccine batches used for the study, and on the recording of adverse events occurring after Day 30.

    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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