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    Clinical Trial Results:
    An open, phase IIIb, randomized, multicentric clinical trial to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ DTPa-IPV vaccine versus co-administration of GSK Biologicals’ DTPa vaccine and Sanofi-Pasteurs’ IPV vaccine at different injection sites, to healthy children at 2, 4 and 6 months of age.

    Summary
    EudraCT number
    		 2015-001508-71
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Jan 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Apr 2023
    First version publication date
    10 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    104871
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00290342
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.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
    16 Nov 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jan 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of the DTPa-IPV vaccine to DTPa and IPV vaccines administered separately, in terms of antibody response against all vaccine antigens, one month after the three-dose primary vaccination course.
    Protection of trial subjects
    The vaccinees were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jan 2006
    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: 458
    Worldwide total number of subjects
    458
    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)
    458
    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
    		 -

    Pre-assignment
    Screening details
    		 Of the 458 subjects enrolled in the study, 6 subjects (5 from Infanrix-IPV Group and 1 from Infanrix + IMOVAX Polio Group) were not administered the study vaccine due to consent withdrawal from parents/guardians and received an elimination code.

    Pre-assignment period milestones
    Number of subjects started
    		 458
    Number of subjects completed
    		 452

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 6
    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infanrix-IPV Group
    Arm description
    		 Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the anterolateral thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix-IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of Infanrix-IPV at 2, 4 and 6 months of age as an intramuscular injection into the anterolateral thigh.

    Arm title
    		 Infanrix + IMOVAX Polio Group
    Arm description
    		 Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the anterolateral sides of opposite thighs.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of Infanrix co-administered with IMOVAX Polio at 2, 4 and 6 months of age as an intramuscular injection into the anterolateral sides of opposite thighs.

    Investigational medicinal product name
    IMOVAX Polio
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of Infanrix co-administered with IMOVAX Polio at 2, 4 and 6 months of age as an intramuscular injection into the anterolateral sides of opposite thighs.

    Number of subjects in period 1 [1]
    		Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Started
    224
    228
    Completed
    217
    223
    Not completed
    7
    5
         Consent withdrawn by subject
    6
    4
         Unspecified
    -
    1
         Lost to follow-up
    1
    -
    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: Of the 458 subjects enrolled in the study, 6 subjects (5 from Infanrix-IPV Group and 1 from Infanrix + IMOVAX Polio Group) were not administered the study vaccine due to consent withdrawal from parents/guardians and received an elimination code.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix-IPV Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the anterolateral thigh.

    Reporting group title
    Infanrix + IMOVAX Polio Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the anterolateral sides of opposite thighs.

    Reporting group values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group Total
    Number of subjects
    		 224 228 452
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 8.8 ( 0.9 ) 8.8 ( 0.91 ) -
    Gender categorical
    Units: Subjects
        Female
    		 112 110 222
        Male
    		 112 118 230

    End points

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    End points reporting groups
    Reporting group title
    Infanrix-IPV Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the anterolateral thigh.

    Reporting group title
    Infanrix + IMOVAX Polio Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the anterolateral sides of opposite thighs.

    Primary: Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)

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    End point title
    		 Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
    End point description
    A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).
    End point type
    Primary
    End point timeframe
    One month (Month 5) post-primary vaccination course
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    204
    211
    Units: Subjects
        Anti-D ≥ 0.1 IU/mL (N=204; 211)
    204
    211
        Anti-T≥ 0.1 IU/mL (N=204; 211)
    204
    211
    Statistical analysis title
    		 Non-inferiority in terms of vaccine response to D
    Comparison groups
    Infanrix + IMOVAX Polio Group v Infanrix-IPV Group
    Number of subjects included in analysis
    415
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.85
         upper limit
    		 1.79
    Notes
    [1] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups’difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.
    Statistical analysis title
    		 Non-inferiority in terms of vaccine response to T
    Comparison groups
    Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
    Number of subjects included in analysis
    415
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.85
         upper limit
    		 1.79
    Notes
    [2] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to tetanus, standardized asymptotic 95% CI for the groups’difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.

    Primary: Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3

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    End point title
    		 Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3
    End point description
    A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.
    End point type
    Primary
    End point timeframe
    One month (Month 5) post-primary vaccination course
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    204
    207
    Units: Subjects
        Anti-polio 1 ≥ 8 (N=204; 207)
    204
    207
        Anti-polio 2 ≥ 8 (N=204; 205)
    204
    204
        Anti-polio 3 ≥ 8 (N=204; 207)
    203
    206
    Statistical analysis title
    		 Immune response non-inferiority - Anti-Polio 1
    Comparison groups
    Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
    Number of subjects included in analysis
    411
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.85
         upper limit
    		 1.82
    Notes
    [3] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 1, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.
    Statistical analysis title
    		 Immune response non-inferiority - Anti-Polio 2
    Comparison groups
    Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
    Number of subjects included in analysis
    411
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.36
         upper limit
    		 2.71
    Notes
    [4] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 2, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.
    Statistical analysis title
    		 Immune response non-inferiority - Anti-Polio 3
    Comparison groups
    Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
    Number of subjects included in analysis
    411
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.28
         upper limit
    		 2.24
    Notes
    [5] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 3, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.

    Primary: Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)

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    End point title
    		 Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)
    End point description
    Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.
    End point type
    Primary
    End point timeframe
    One month (Month 5) post-primary vaccination course
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    202
    211
    Units: Subjects
        Anti-PT (N=200; 209)
    200
    206
        Anti-FHA (N=202; 211)
    201
    209
        Anti-PRN (N=202; 211)
    202
    210
    Statistical analysis title
    		 Immune response non-inferiority - Anti-PT
    Comparison groups
    Infanrix + IMOVAX Polio Group v Infanrix-IPV Group
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 4.13
    Notes
    [6] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertussis toxoid, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.
    Statistical analysis title
    		 Immune response non-inferiority - Anti-FHA
    Comparison groups
    Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.88
         upper limit
    		 2.95
    Notes
    [7] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to filamentous haemagglutinin, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.
    Statistical analysis title
    		 Immune response non-inferiority - Anti-PRN
    Comparison groups
    Infanrix + IMOVAX Polio Group v Infanrix-IPV Group
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 2.64
    Notes
    [8] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertactin, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.

    Primary: Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens

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    End point title
    		 Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens [9]
    End point description
    Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations < 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).
    End point type
    Primary
    End point timeframe
    One month (Month 5) post-primary vaccination course
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    202
    211
    Units: Subjects
        Anti-PT (N=200; 209)
    200
    206
        Anti-FHA (N=202; 211)
    201
    209
        Anti-PRN (N=202; 211)
    202
    210
    No statistical analyses for this end point

    Secondary: Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)

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    End point title
    		 Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
    End point description
    A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 1 international units/milliliter (IU//mL).
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the primary vaccination course
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    204
    212
    Units: Subjects
        Anti-D, PRE, ≥ 1 IU/mL (N=202; 212)
    0
    0
        Anti-D, POST, ≥ 1 IU/mL (N=204; 211)
    194
    187
        Anti-T, PRE, ≥ 1 IU/mL (N=202; 212)
    1
    1
        Anti-T, POST, ≥ 1 IU/mL (N=204; 211)
    204
    208
    No statistical analyses for this end point

    Secondary: Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)

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    End point title
    		 Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)
    End point description
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the primary vaccination course
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    204
    212
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D, PRE (N=202; 212)
    0.052 (0.051 to 0.054)
    0.053 (0.05 to 0.055)
        Anti-D, POST (N=204; 211)
    4.333 (3.902 to 4.813)
    2.63 (2.36 to 2.932)
        Anti-T, PRE (N=202; 212)
    0.059 (0.055 to 0.064)
    0.06 (0.056 to 0.065)
        Anti-T, POST (N=204; 211)
    10.306 (9.5 to 11.18)
    7.139 (6.512 to 7.826)
    No statistical analyses for this end point

    Secondary: Titers for Poliovirus Type 1, 2 and 3 Antibodies

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    End point title
    		 Titers for Poliovirus Type 1, 2 and 3 Antibodies
    End point description
    Titers for anti-polio 1, 2 and 3 are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was greater than or equal to (≥) 8.
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the primary vaccination course
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    204
    212
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1, PRE (N=199; 212)
    6.3 (5.5 to 7.1)
    6.1 (5.4 to 6.9)
        Anti-polio 1, POST (N=204; 207)
    755.5 (643.5 to 887.4)
    263 (232.1 to 298)
        Anti-polio 2, PRE (N=202; 211)
    5.8 (5.2 to 6.5)
    6.5 (5.8 to 7.3)
        Anti-polio 2, POST (N=204; 205)
    704.7 (599.5 to 828.4)
    267.6 (233.4 to 306.8)
        Anti-polio 3, PRE (N=202; 212)
    5 (4.5 to 5.4)
    4.9 (4.5 to 5.3)
        Anti-polio 3, POST (N=204; 207)
    1209.5 (1040.1 to 1406.5)
    438.3 (383.1 to 501.3)
    No statistical analyses for this end point

    Secondary: Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)

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    End point title
    		 Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)
    End point description
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Before (Pre) and one month after (Post) the primary vaccination course
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    204
    212
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, PRE (N=200; 210)
    3 (2.8 to 3.2)
    3.2 (3 to 3.5)
        Anti-PT, POST (N=204; 211)
    63.3 (58.7 to 68.2)
    55.6 (50.9 to 60.7)
        Anti-FHA, PRE (N=202; 212)
    7.4 (6.5 to 8.4)
    8.5 (7.4 to 9.7)
        Anti-FHA, POST (N=204; 211)
    294.3 (269.5 to 321.4)
    259.6 (235.1 to 286.6)
        Anti-PRN, PRE (N=202; 212)
    2.7 (2.5 to 2.8)
    2.7 (2.6 to 2.9)
        Anti-PRN, POST (N=204; 211)
    205 (187.7 to 223.9)
    155.6 (140.7 to 172.1)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Local Symptoms

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    End point title
    		 Number of Subjects Reporting Solicited Local Symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period, across doses
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    220
    226
    Units: Subjects
        Any Pain
    92
    96
        Grade 3 Pain
    5
    8
        Any Redness
    115
    116
        Grade 3 Redness
    22
    26
        Any Swelling
    74
    79
        Grade 3 Swelling
    17
    20
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited General Symptoms

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    End point title
    		 Number of Subjects Reporting Solicited General Symptoms
    End point description
    Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = symptom symptoms considered by the investigator to have a causal relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period, across doses
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    221
    226
    Units: Subjects
        Any Drowsiness
    95
    99
        Grade 3 Drowsiness
    4
    2
        Related Drowsiness
    54
    53
        Any Fever (axillary)
    63
    38
        Grade 3 Fever (axillary)
    4
    1
        Related Fever (axillary)
    45
    22
        Any Irritability
    140
    139
        Grade 3 Irritability
    14
    10
        Related Irritability
    85
    91
        Any Loss of appetite
    84
    78
        Grade 3 Loss of appetite
    1
    0
        Related Loss of appetite
    50
    46
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)

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    End point title
    		 Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post-vaccination period
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    224
    228
    Units: Subjects
        Any AE(s)
    135
    138
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Any Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects Reporting Any Serious Adverse Events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Month 0 up to Month 5)
    End point values
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Number of subjects analysed
    224
    228
    Units: Subjects
        Any SAE(s)
    15
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs during the 31-day (Days 0-30) post-vaccination period and SAEs during the entire study period (from Month 0 up to Month 5)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Infanrix-IPV Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the anterolateral thigh.

    Reporting group title
    Infanrix + IMOVAX Polio Group
    Reporting group description
    		 Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the anterolateral sides of opposite thighs.

    Serious adverse events
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 224 (6.70%)
    17 / 228 (7.46%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Congenital, familial and genetic disorders
    Patent ductus arteriosus
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 224 (0.89%)
    1 / 228 (0.44%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 224 (0.00%)
    2 / 228 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 228 (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
    7 / 224 (3.13%)
    3 / 228 (1.32%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 224 (1.79%)
    5 / 228 (2.19%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 224 (1.34%)
    5 / 228 (2.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 224 (0.89%)
    2 / 228 (0.88%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kawasaki’s disease
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix-IPV Group Infanrix + IMOVAX Polio Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    200 / 224 (89.29%)
    196 / 228 (85.96%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    95 / 224 (42.41%)
    99 / 228 (43.42%)
         occurrences all number
    152
    161
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    92 / 224 (41.07%)
    96 / 228 (42.11%)
         occurrences all number
    164
    161
    Swelling
         subjects affected / exposed
    74 / 224 (33.04%)
    79 / 228 (34.65%)
         occurrences all number
    114
    129
    Pyrexia
         subjects affected / exposed
    74 / 224 (33.04%)
    40 / 228 (17.54%)
         occurrences all number
    91
    48
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 224 (5.36%)
    8 / 228 (3.51%)
         occurrences all number
    16
    8
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    115 / 224 (51.34%)
    116 / 228 (50.88%)
         occurrences all number
    212
    209
    Dermatitis atopic
         subjects affected / exposed
    16 / 224 (7.14%)
    17 / 228 (7.46%)
         occurrences all number
    18
    20
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    140 / 224 (62.50%)
    139 / 228 (60.96%)
         occurrences all number
    238
    241
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    72 / 224 (32.14%)
    61 / 228 (26.75%)
         occurrences all number
    98
    88
    Gastroenteritis
         subjects affected / exposed
    10 / 224 (4.46%)
    13 / 228 (5.70%)
         occurrences all number
    11
    14
    Bronchiolitis
         subjects affected / exposed
    14 / 224 (6.25%)
    7 / 228 (3.07%)
         occurrences all number
    14
    11
    Bronchitis
         subjects affected / exposed
    7 / 224 (3.13%)
    12 / 228 (5.26%)
         occurrences all number
    8
    12
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    84 / 224 (37.50%)
    78 / 228 (34.21%)
         occurrences all number
    130
    115

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2005
    This amendment was written to reflect the changes in study design following discussions with KFDA, ad to clarify some study aspects. Major changes in study design being: - Usage of IMOVAX Polio instead of IPOL in the study. Both vaccines are manufactured by Sanofi-Pasteur and both have the same content. IMOVAX Polio will be used instead of IPOL in order to source the vaccine supply directly from Belgium instead of the United States. - Perform Hib vaccine administration out of the study context. - Inclusion of vaccine response to pertussis antigens as a primary endpoint and recalculation of sample size accordingly.

    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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