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    Clinical Trial Results:
    Immunogenicity and Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 2, 3 and 4 Months of Age or 3, 4 and 5 Months of Age and followed by a Booster Dose at 18 to 20 Months, as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in infants in People’s Republic of China

    Summary
    EudraCT number
    		 2015-005353-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Jan 2009

    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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    E2I42
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00453570
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Medical Team Leader, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.vidor@sanpofipasteur.com
    Scientific contact
    Medical Team Leader, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.vidor@sanpofipasteur.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
    03 Aug 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2009
    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 seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of sanofi pasteur’s DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) administered at 2, 3 and 4 months of age or administered at 3, 4 and 5 months of age versus commercially available Wuhan’s DTacP vaccine and sanofi pasteur’s Hib tetanus conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines, one month after the three-dose primary vaccination of the combined vaccine.
    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
    16 Mar 2007
    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
    China: 792
    Worldwide total number of subjects
    792
    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)
    792
    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 16 March 2007 to 24 July 2007 at 3 clinic centers in China.

    Pre-assignment
    Screening details
    		 A total of 792 subjects who met all inclusion and none of the exclusion criteria were randomized and vaccinated in the study.

    Period 1
    Period 1 title
    Primary phase
    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
    		 Group A
    Arm description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 2, 3, and 4 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV//PRP~T combined vaccine (PENTAXIM™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral aspect of the right thigh, 1 injection each at 2, 3, and 4 months of age and a booster at 18 to 20 months of age.

    Arm title
    		 Group B
    Arm description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 3, 4, and 5 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV//PRP~T combined vaccine (PENTAXIM™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral aspect of the right thigh, 1 injection each at 3, 4, and 5 months of age and a booster at 18 to 20 months of age.

    Arm title
    		 Group C
    Arm description
    		 Subjects received the control vaccine (Wuhan's DTacP, Act-HIB™ and IMOVAX Polio™) at 3, 4, and 5 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DTacP combined vaccine (Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Absorbed)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the right deltoid, 1 injection each at 3, 4, and 5 months of age and a booster at 18 to 20 months of age.

    Investigational medicinal product name
    PRP-Tetanus conjugated 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 3, 4, and 5 months of age and a booster at 18 to 20 months of age.

    Investigational medicinal product name
    IPV vaccine (IMOVAX Polio™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral area of the right thigh, 1 injection each at 3, 4, and 5 months of age and a booster at 18 to 20 months of age.

    Number of subjects in period 1
    		Group A Group B Group C
    Started
    264
    264
    264
    Completed
    257
    237
    237
    Not completed
    7
    27
    27
         Consent withdrawn by subject
    4
    21
    24
         Adverse event, non-fatal
    2
    1
    1
         Serious adverse event
    -
    1
    -
         Lost to follow-up
    1
    1
    -
         Protocol deviation
    -
    3
    2
    Period 2
    Period 2 title
    Booster phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) booster dose at 18 to 20 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV//PRP~T combined vaccine (PENTAXIM™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral aspect of the right thigh, 1 injection each at 2, 3, and 4 months of age and a booster at 18 to 20 months of age.

    Arm title
    		 Group B
    Arm description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) booster dose at 18 to 20 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTacP-IPV//PRP~T combined vaccine (PENTAXIM™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral aspect of the right thigh, 1 injection each at 3, 4, and 5 months of age and a booster at 18 to 20 months of age.

    Arm title
    		 Group C
    Arm description
    		 Subjects received the control vaccine (Wuhan's DTacP, Act-HIB™ and IMOVAX Polio™) booster dose at 18 to 20 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DTacP combined vaccine (Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Absorbed)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the right deltoid, 1 injection each at 3, 4, and 5 months of age and a booster at 18 to 20 months of age.

    Investigational medicinal product name
    PRP-Tetanus conjugated 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 3, 4, and 5 months of age and a booster at 18 to 20 months of age.

    Investigational medicinal product name
    IPV vaccine (IMOVAX Polio™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral area of the right thigh, 1 injection each at 3, 4, and 5 months of age and a booster at 18 to 20 months of age.

    Number of subjects in period 2
    		Group A Group B Group C
    Started
    257
    237
    237
    Completed
    251
    233
    228
    Not completed
    6
    4
    9
         Consent withdrawn by subject
    5
    2
    5
         Serious adverse event
    -
    1
    -
         Lost to follow-up
    -
    -
    1
         Protocol deviation
    1
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 2, 3, and 4 months of age.

    Reporting group title
    Group B
    Reporting group description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 3, 4, and 5 months of age.

    Reporting group title
    Group C
    Reporting group description
    		 Subjects received the control vaccine (Wuhan's DTacP, Act-HIB™ and IMOVAX Polio™) at 3, 4, and 5 months of age.

    Reporting group values
    		 Group A Group B Group C Total
    Number of subjects
    		 264 264 264 792
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 264 264 264 792
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2.2 ( 0.1 ) 2.2 ( 0.1 ) 2.2 ( 0.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 116 133 127 376
        Male
    		 148 131 137 416
    Subject analysis sets

    Subject analysis set title
    Group A; Post-Booster Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received a booster dose of DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 20 months of age.

    Subject analysis set title
    Group B; Post-Booster Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received a booster dose of DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 20 months of age.

    Subject analysis set title
    Group C; Post-Booster Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received a booster dose of Wuhan's DTacP, Sanofi Pasteur's HIb tetanus conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines at 18 to 20 months of age.

    Subject analysis sets values
    		 Group A; Post-Booster Analysis Set Group B; Post-Booster Analysis Set Group C; Post-Booster Analysis Set
    Number of subjects
    250
    230
    227
    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)
    250
    230
    227
        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)
    2.2 ( 0.1 )
    2.2 ( 0.1 )
    2.2 ( 0.1 )
    Gender categorical
    Units: Subjects
        Female
    109
    118
    110
        Male
    141
    112
    117

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 2, 3, and 4 months of age.

    Reporting group title
    Group B
    Reporting group description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 3, 4, and 5 months of age.

    Reporting group title
    Group C
    Reporting group description
    		 Subjects received the control vaccine (Wuhan's DTacP, Act-HIB™ and IMOVAX Polio™) at 3, 4, and 5 months of age.
    Reporting group title
    Group A
    Reporting group description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) booster dose at 18 to 20 months of age.

    Reporting group title
    Group B
    Reporting group description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) booster dose at 18 to 20 months of age.

    Reporting group title
    Group C
    Reporting group description
    		 Subjects received the control vaccine (Wuhan's DTacP, Act-HIB™ and IMOVAX Polio™) booster dose at 18 to 20 months of age.

    Subject analysis set title
    Group A; Post-Booster Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received a booster dose of DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 20 months of age.

    Subject analysis set title
    Group B; Post-Booster Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received a booster dose of DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 18 to 20 months of age.

    Subject analysis set title
    Group C; Post-Booster Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received a booster dose of Wuhan's DTacP, Sanofi Pasteur's HIb tetanus conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines at 18 to 20 months of age.

    Primary: Percentage of Subjects with Seroprotection/Seroconversion to Vaccine Antigens One Month after a Primary Series with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines

    		 Close Top of page
    End point title
    		 Percentage of Subjects with Seroprotection/Seroconversion to Vaccine Antigens One Month after a Primary Series with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP), Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Seroprotection for Anti-Diphtheria and Anti-Tetanus was defined as antibody titers ≥ 0.1 IU/mL, ≥ 8 (dil) for Anti-Polio types 1, 2, and 3, and ≥ 0.15 µg/mL for Anti-PRP. Seroconversion for Anti-Pertussis toxoid and Anti-FHA was defined as antibody titers ≥ 4-fold increase EU/mL.
    End point type
    Primary
    End point timeframe
    1 month post-primary vaccination series
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    254
    229
    232
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria
    100
    100
    100
        Anti-Tetanus
    100
    100
    100
        Anti-Polio 1
    100
    100
    100
        Anti-Polio 2
    100
    100
    99.57
        Anti-Polio 3
    100
    99.56
    99.57
        Anti-PRP
    97.64
    99.12
    100
        Anti-Pertussis toxoid
    100
    100
    97.38
        Anti-FHA
    98.02
    99.56
    89.08
    Statistical analysis title
    		 Anti-Diphtheria; Group A-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group A minus Group C for Anti-Diphtheria.
    Comparison groups
    Group A v Group C
    Number of subjects included in analysis
    486
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference; Group A-Group C
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 1.63
    Notes
    [1] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group A was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Tetanus; Group A-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group A minus Group C for Anti-Tetanus.
    Comparison groups
    Group A v Group C
    Number of subjects included in analysis
    486
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference; Group A-Group C
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 1.63
    Notes
    [2] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group A was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Polio 1; Group A-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group A minus Group C for Anti-Polio 1.
    Comparison groups
    Group A v Group C
    Number of subjects included in analysis
    486
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference; Group A-Group C
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 1.63
    Notes
    [3] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group A was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Polio 2; Group A-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group A minus Group C for Anti-Polio 2.
    Comparison groups
    Group A v Group C
    Number of subjects included in analysis
    486
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference; Group A-Group C
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 2.4
    Notes
    [4] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group A was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Polio 3; Group A-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group A minus Group C for Anti-Polio 3.
    Comparison groups
    Group A v Group C
    Number of subjects included in analysis
    486
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference; Group A-Group C
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 2.4
    Notes
    [5] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group A was non-inferior to Group C.
    Statistical analysis title
    		 Anti-PRP; Group A-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group A minus Group C for Anti-PRP.
    Comparison groups
    Group A v Group C
    Number of subjects included in analysis
    486
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference; Group A-Group C
    Point estimate
    -2.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.06
         upper limit
    		 -0.29
    Notes
    [6] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group A was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Pertussis toxoid; Group A-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group A minus Group C for Anti-Pertussis toxoid.
    Comparison groups
    Group A v Group C
    Number of subjects included in analysis
    486
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference; Group A-Group C
    Point estimate
    2.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 5.6
    Notes
    [7] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group A was non-inferior to Group C.
    Statistical analysis title
    		 Anti-FHA; Group A-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group A minus Group C for Anti-FHA.
    Comparison groups
    Group C v Group A
    Number of subjects included in analysis
    486
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Difference; Group A-Group C
    Point estimate
    8.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.66
         upper limit
    		 13.77
    Notes
    [8] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group A was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Diphtheria; Group B-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group B minus Group C for Anti-Diphtheria.
    Comparison groups
    Group B v Group C
    Number of subjects included in analysis
    461
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Difference; Group A-Group C
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 1.63
    Notes
    [9] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group B was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Tetanus; Group B-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group B minus Group C for Anti-Tetanus.
    Comparison groups
    Group B v Group C
    Number of subjects included in analysis
    461
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Difference; Group B-Group C
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 1.63
    Notes
    [10] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group B was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Polio 1; Group B-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group B minus Group C for Anti-Polio 1.
    Comparison groups
    Group B v Group C
    Number of subjects included in analysis
    461
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 Difference; Group B-Group C
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.66
         upper limit
    		 1.63
    Notes
    [11] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group B was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Polio 2; Group B-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group B minus Group C for Anti-Diphtheria.
    Comparison groups
    Group B v Group C
    Number of subjects included in analysis
    461
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    Method
    Parameter type
    		 Difference; Group B-Group C
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 2.4
    Notes
    [12] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group B was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Polio 3; Group B-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group B minus Group C for Anti-Polio 3.
    Comparison groups
    Group B v Group C
    Number of subjects included in analysis
    461
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    Method
    Parameter type
    		 Difference; Group B-Group C
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.05
         upper limit
    		 1.99
    Notes
    [13] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group B was non-inferior to Group C.
    Statistical analysis title
    		 Anti-PRP; Group B-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group B minus Group C for Anti-PRP.
    Comparison groups
    Group B v Group C
    Number of subjects included in analysis
    461
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [14]
    Method
    Parameter type
    		 Difference; Group B-Group C
    Point estimate
    -0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.14
         upper limit
    		 0.87
    Notes
    [14] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group B was non-inferior to Group C.
    Statistical analysis title
    		 Anti-Pertussis toxoid; Group B-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group B minus Group C for Anti-Pertussis toxoid.
    Comparison groups
    Group B v Group C
    Number of subjects included in analysis
    461
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [15]
    Method
    Parameter type
    		 Difference; Group B-Group C
    Point estimate
    2.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 5.6
    Notes
    [15] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group B was non-inferior to Group C.
    Statistical analysis title
    		 Anti-FHA; Group B-Group C
    Statistical analysis description
    This non-inferiority analysis assessed the difference between Group B minus Group C for Anti-FHA.
    Comparison groups
    Group B v Group C
    Number of subjects included in analysis
    461
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [16]
    Method
    Parameter type
    		 Difference; Group B-Group C
    Point estimate
    10.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.52
         upper limit
    		 15.19
    Notes
    [16] - Non-inferiority was demonstrated if the 95% confidence interval of the difference (study vaccine minus control vaccine) lay entirely above the clinically acceptable limit for non-inferiority (> -10%). Group B was non-inferior to Group C.

    Secondary: Geometric Mean Titers of Antibodies Against Vaccine Antigens Before and Following A Three Dose Primary Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines

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    End point title
    		 Geometric Mean Titers of Antibodies Against Vaccine Antigens Before and Following A Three Dose Primary Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP), Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization.
    End point type
    Secondary
    End point timeframe
    Pre- and post-primary vaccination
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    254
    229
    232
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Pre-primary
    0.01 (0.01 to 0.012)
    0.01 (0.009 to 0.011)
    0.011 (0.01 to 0.012)
        Anti-Diphtheria; Post-primary
    0.431 (0.405 to 0.459)
    0.516 (0.489 to 0.544)
    0.41 (0.39 to 0.43)
        Anti-Tetanus; Pre-primary
    0.02 (0.02 to 0.02)
    0.02 (0.02 to 0.02)
    0.02 (0.02 to 0.02)
        Anti-Tetanus; Post-primary
    2.88 (2.79 to 2.98)
    3.02 (2.92 to 3.12)
    3.05 (2.94 to 3.16)
        Anti-PRP; Pre-primary
    0.06 (0.05 to 0.07)
    0.05 (0.05 to 0.06)
    0.06 (0.05 to 0.07)
        Anti-PRP; Post-primary
    4.31 (3.71 to 5.02)
    6.32 (5.52 to 7.23)
    12.61 (11.21 to 14.18)
        Anti-Polio 1; Pre-primary
    7.7 (6.7 to 8.8)
    8.1 (7 to 9.5)
    6.9 (6.1 to 7.8)
        Anti-Polio 1; Post-primary
    322.5 (281.1 to 369.9)
    299.2 (258.9 to 345.9)
    130.1 (116.9 to 144.8)
        Anti-Polio 2; Pre-primary
    6.1 (5.5 to 6.7)
    6.6 (5.8 to 7.6)
    5.7 (5.3 to 6.2)
        Anti-Polio 2; Post-primary
    166.3 (144.7 to 191)
    160.1 (138.2 to 185.5)
    78.8 (69.8 to 88.9)
        Anti-Polo 3; Pre-primary
    4.9 (4.5 to 5.3)
    5.1 (4.7 to 5.5)
    4.5 (4.2 to 4.7)
        Anti-Polo 3; Post-primary
    587.5 (506.8 to 681)
    525.5 (451.8 to 611.2)
    222.6 (195.7 to 253.1)
        Anti-Pertussis toxoid; Pre-primary
    1.9 (1.7 to 2)
    1.9 (1.7 to 2)
    1.8 (1.6 to 1.9)
        Anti-Pertussis toxoid; Post-primary
    98.4 (93.7 to 103.4)
    101.5 (96.3 to 107)
    37.4 (34.9 to 40.1)
        Anti-FHA; Pre-primary
    3.7 (3.4 to 4.1)
    4 (3.6 to 4.3)
    3.8 (3.5 to 4.1)
        Anti-FHA; Post-primary
    92.9 (87.8 to 98.3)
    103.6 (97.9 to 109.5)
    47.1 (44 to 50.4)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens Following A Three Dose Primary Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines

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    End point title
    		 Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens Following A Three Dose Primary Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP), Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Geometric mean titer ratios of post-primary/pre-primary are reported.
    End point type
    Secondary
    End point timeframe
    Pre- and post-primary vaccination
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    253
    228
    231
    Units: Titer ratio (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Post-primary
    41.225 (36.021 to 47.181)
    50.467 (44.933 to 56.684)
    38.033 (33.961 to 42.593)
        Anti-Tetanus; Post-primary
    147.7 (131.91 to 165.37)
    176.46 (155.05 to 200.83)
    157.76 (137.8 to 180.6)
        Anti-PRP; Post-primary
    76.54 (62.45 to 93.81)
    114.67 (93.73 to 140.29)
    206.18 (168.14 to 252.82)
        Anti-Polio 1; Post-primary
    42 (34.3 to 51.3)
    36.4 (29.3 to 45.3)
    18.8 (16 to 22.1)
        Anti-Polio 2; Post-primary
    27.7 (23 to 33.4)
    24.1 (19.5 to 29.9)
    13.7 (11.7 to 16.2)
        Anti-Polio 3; Post-primary
    122.3 (102.7 to 145.6)
    102.5 (86.5 to 121.5)
    49.6 (42.6 to 57.6)
        Anti-Pertussis toxoid
    52.8 (47.8 to 58.2)
    54.7 (49.1 to 61)
    21 (19 to 23.3)
        Anti-FHA
    24.8 (22.2 to 27.7)
    26.1 (23.5 to 29)
    12.5 (11.1 to 14.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Seroprotection/Seroconversion to Antigens Before and One Month after A Primary Series with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or A DTacP, Hib conjugate (Act-HIB) and IPV (IMOVAX Polio) Monovalent Vaccine

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    End point title
    		 Percentage of Subjects with Seroprotection/Seroconversion to Antigens Before and One Month after A Primary Series with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM) or A DTacP, Hib conjugate (Act-HIB) and IPV (IMOVAX Polio) Monovalent Vaccine
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP), Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Seroprotection for Anti-Diphtheria and Anti-Tetanus was defined as antibody titers ≥ 0.01 IU/mL, ≥ 8 (dil) for Anti-Polio types 1, 2, and 3, and ≥ 0.15 µg/mL for Anti-PRP. Seroconversion (post-primary only) for Anti-Pertussis toxoid and Anti-FHA was defined as antibody titers ≥ 4-fold increase EU/mL.
    End point type
    Secondary
    End point timeframe
    Pre- and post-primary vaccination
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    254
    229
    232
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Pre-primary
    58.9
    61.8
    63.2
        Anti-Diphtheria; Post-primary
    100
    100
    100
        Anti-Tetanus; Pre-primary
    85
    78.5
    79.7
        Anti-Tetanus; Post-primary
    100
    100
    100
        Anti-PRP; Pre-primary
    15.1
    13.3
    16.5
        Anti-PRP; Post-primary
    97.6
    99.1
    100
        Anti-Polio 1; Pre-primary
    34.5
    37.2
    34.1
        Anti-Polio 1; Post-primary
    100
    100
    100
        Anti-Polio 2; Pre-primary
    26.5
    30.1
    27.9
        Anti-Polio 2; Post-primary
    100
    100
    99.6
        Anti-Polio 3; Pre-primary
    11.6
    15
    7.9
        Anti-Polio 3; Post-primary
    100
    99.6
    99.6
        Anti-Pertussis toxoid; Pre-primary
    0
    0
    0
        Anti-Pertussis toxoid; Post-primary
    100
    100
    97.4
        Anti-FHA; Pre-primary
    0
    0
    0
        Anti-FHA; Post-primary
    98
    99.6
    89.1
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Antibodies Against Vaccine Antigens Before and Following A Booster Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or A DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines

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    End point title
    		 Geometric Mean Titers of Antibodies Against Vaccine Antigens Before and Following A Booster Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or A DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP), Anti-Pertussis toxoid (PT), Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization.
    End point type
    Secondary
    End point timeframe
    Pre- and post-booster vaccination
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    250
    230
    227
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Pre-booster
    0.122 (0.115 to 0.129)
    0.137 (0.128 to 0.147)
    0.106 (0.1 to 0.112)
        Anti-Diphtheria; Post-booster
    1.399 (1.291 to 1.516)
    1.583 (1.459 to 1.719)
    1.047 (0.97 to 1.13)
        Anti-Tetanus; Pre-booster
    0.49 (0.46 to 0.53)
    0.54 (0.5 to 0.58)
    0.64 (0.6 to 0.68)
        Anti-Tetanus; Post-booster
    6.19 (5.82 to 6.57)
    6.13 (5.79 to 6.49)
    5.63 (5.35 to 5.92)
        Anti-PRP; Pre-booster
    2.18 (1.86 to 2.55)
    2.65 (2.26 to 3.11)
    3.76 (3.18 to 4.44)
        Anti-PRP; Post-booster
    61.81 (54.35 to 70.29)
    81.86 (71.82 to 93.3)
    109.33 (94.71 to 126.22)
        Anti-Polio 1; Pre-booster
    53.2 (45.2 to 62.7)
    59 (49.7 to 70.2)
    55.6 (47.5 to 65.1)
        Anti-Polio 1; Post-booster
    2405.7 (2142.8 to 2701)
    2365.3 (2114.5 to 2645.8)
    2241.3 (1993.5 to 2519.9)
        Anti-Polio 2; Pre-booster
    52.2 (42.5 to 64.1)
    62.2 (49.2 to 78.5)
    73.4 (59.6 to 90.4)
        Anti-Polio 2; Post-booster
    1688.3 (1498.6 to 1902.1)
    1566 (1395.5 to 1757.3)
    1286 (1151.7 to 1435.9)
        Anti-Polio 3; Pre-booster
    68.3 (55.2 to 84.4)
    68 (54 to 85.7)
    62.2 (50.1 to 77.2)
        Anti-Polio 3; Post-booster
    4223.4 (3713.9 to 4802.8)
    4048.9 (3539.1 to 4632)
    3970.8 (3512.7 to 4488.7)
        Anti-Pertussis toxoid; Pre-booster
    13.6 (12.6 to 14.6)
    14.9 (13.8 to 16.1)
    7.5 (7 to 8.1)
        Anti-Pertussis toxoid; Post-booster
    194.4 (182.8 to 206.8)
    198.1 (185.4 to 211.6)
    51.9 (47.8 to 56.2)
        Anti-FHA; Pre-booster
    12 (10.7 to 13.3)
    14.2 (12.7 to 15.9)
    5.2 (4.6 to 5.8)
        Anti-FHA; Post-booster
    131.5 (124 to 139.5)
    137.9 (130 to 146.3)
    68.7 (64.1 to 73.6)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens Following A Booster Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines

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    End point title
    		 Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens Following A Booster Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP), Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Geometric mean titer ratios of post-booster/pre-booster are reported.
    End point type
    Secondary
    End point timeframe
    Pre- and post-booster vaccination
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    250
    230
    227
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Post-booster
    11.509 (10.58 to 12.52)
    11.552 (10.536 to 12.666)
    9.916 (9.19 to 10.701)
        Anti-Tetanus; Post-booster
    12.55 (11.59 to 13.6)
    11.36 (10.44 to 12.37)
    8.83 (8.21 to 9.51)
        Anti-PRP; Post-booster
    28.37 (23.69 to 33.98)
    30.87 (25.95 to 36.72)
    29.1 (24.28 to 34.89)
        Anti-Polio 1; Post-booster
    45.2 (38.2 to 53.4)
    40.2 (33.1 to 48.7)
    40.3 (33.3 to 48.8)
        Anti-Polio 2; Post-booster
    32.4 (25.9 to 40.5)
    25.3 (19.7 to 32.5)
    17.4 (13.9 to 21.9)
        Anti-Polio 3; Post-booster
    61.9 (49.9 to 76.7)
    59.8 (47.7 to 75)
    64.2 (51 to 80.9)
        Anti-Pertussis toxoid; Post-booster
    14.3 (13.2 to 15.6)
    13.3 (12.1 to 14.6)
    6.9 (6.3 to 7.5)
        Anti-FHA; Post-booster
    11 (9.9 to 12.1)
    9.7 (8.7 to 10.8)
    13.3 (11.9 to 14.8)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Seroprotection/Seroconversion to Antigens Before and One Month After A Booster Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines

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    End point title
    		 Percentage of Subjects with Seroprotection/Seroconversion to Antigens Before and One Month After A Booster Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines
    End point description
    Anti-Diphtheria, Anti-Tetanus, Anti-Polyribosyl Ribitol Phosphate conjugated to Tetanus protein (PRP), Anti-Pertussis toxoid, Anti-Filamentous hemagglutinin (FHA) were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-Polio types 1, 2, and 3 were assessed by seroneutralization. Seroprotection for Anti-Diphtheria and Anti-Tetanus was defined as antibody titers ≥ 0.01 IU/mL, ≥ 8 (dil) for Anti-Polio types 1, 2, and 3, and ≥ 0.15 µg/mL for Anti-PRP. Seroconversion (post-primary only) for Anti-Pertussis toxoid and Anti-FHA was defined as antibody titers ≥ 4-fold increase EU/mL.
    End point type
    Secondary
    End point timeframe
    Pre- and post-booster vaccination
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    250
    230
    227
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Pre-booster
    100
    100
    100
        Anti-Diphtheria; Post-booster
    100
    100
    100
        Anti-Tetanus; Pre-booster
    100
    100
    100
        Anti-Tetanus; Post-booster
    100
    100
    100
        Anti-PRP; Pre-booster
    99.6
    100
    100
        Anti-PRP; Post-booster
    100
    100
    100
        Anti-Polio 1; Pre-booster
    94
    93.9
    94.2
        Anti-Polio 1; Post-booster
    100
    100
    100
        Anti-Polio 2; Pre-booster
    88.4
    89.5
    96.5
        Anti-Polio 2; Post-booster
    100
    100
    100
        Anti-Polio 3; Pre-booster
    87.6
    89.1
    89.8
        Anti-Polio 3; Post-booster
    100
    100
    100
        Anti-Pertussis toxoid; Post-booster
    97.6
    95.2
    80.4
        Anti-FHA; Post-booster
    89.9
    85.5
    92.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Solicited Injection-site and Systemic Reactions After Any Primary Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions After Any Primary Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines
    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 (China SFDA): Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, > 3 cm. Grade 3 systemic reactions (China SFDA): Fever, > 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-any primary vaccination
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    264
    243
    244
    Units: Percentage of subjects
    number (not applicable)
        Any Inj. site Tenderness; Post-Any inj.; DTacP
    43
    41.3
    40.1
        Grade 3 Inj. site Tenderness; Post-Any inj.; DTacP
    0.4
    0
    0.8
        Any Inj. site Tenderness; Post-Any inj.; PRP~T
    0
    0
    40.1
        Grade 3 Inj. site Tenderness; Post-Any inj.; PRP~T
    0
    0
    0.8
        Any Inj. site Tenderness; Post-Any inj.; IPV
    0
    0
    44.2
        Grade 3 Inj. site Tenderness; Post-Any inj.; IPV
    0
    0
    0.8
        Any Inj. site Erythema; Post-Any inj.; DTacP
    35
    36
    18.2
        Grade 3 Inj. site Erythema; Post-Any inj.; DTacP
    1.1
    2.5
    0
        Any Inj. site Erythema; Post-Any inj.; PRP~T
    0
    0
    17.8
        Grade 3 Inj. site Erythema; Post-Any inj.; PRP~T
    0
    0
    0.8
        Any Inj. site Erythema; Post-Any inj.; IPV
    0
    0
    15.7
        Grade 3 Inj. site Erythema; Post-Any inj.; IPV
    0
    0
    0
        Any Inj. site Swelling; Post-Any injection; DTacP
    25.9
    21.5
    9.1
        Grade 3 Inj. site Swelling; Post-Any inj.; DTacP
    2.3
    0.4
    0
        Any Inj. site Swelling; Post-Any inj.; PRP~T
    0
    0
    7
        Grade 3 Inj. site Swelling; Post-Any inj.; PRP~T
    0
    0
    0.4
        Any Inj. site Swelling; Post-Any inj.; IPV
    0
    0
    6.2
        Grade 3 Inj. site Swelling; Post-Any inj.; IPV
    0
    0
    0
        Any Fever; Post-Any injection
    57.4
    62
    61.6
        Grade 3 Fever; Post-Any injection
    0.8
    1.7
    2.5
        Any Vomiting; Post-Any injection
    46
    33.1
    31.4
        Grade 3 Vomiting; Post-Any injection
    0
    0
    0
        Any Crying abnormal; Post-Any injection
    39.5
    38
    51.7
        Grade 3 Crying abnormal; Post-Any injection
    1.1
    0
    1.2
        Any Drowsiness; Post-Any injection
    30.4
    26.4
    29.3
        Grade 3 Drowsiness; Post-Any injection
    0.8
    0.4
    0.4
        Any Appetite lost; Post-Any injection
    31.2
    32.6
    31.8
        Grade 3 Appetite lost; Post-Any injection
    1.1
    0
    0.4
        Any Irritability; Post-Any injection
    30.4
    29.3
    37.6
        Grade 3 Irritability; Post-Any injection
    1.5
    0.4
    2.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Each Primary Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Each Primary Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccines
    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 (China SFDA): Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, > 3 cm. Grade 3 systemic reactions (China SFDA): Fever, > 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-each primary vaccination
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    264
    243
    244
    Units: Percentage of subjects
    number (not applicable)
        Any Inj. site Tenderness; Post-dose 1; DTacP
    31.6
    24.8
    30.6
        Grade 3 Inj. site Tenderness; Post-dose 1; DTacP
    0.4
    0
    0.8
        Any Inj. site Tenderness; Post-dose 1; PRP~T
    0
    0
    32.6
        Grade 3 Inj. site Tenderness; Post-dose 1; PRP~T
    0
    0
    0.8
        Any Inj. site Tenderness; Post-dose 1; IPV
    0
    0
    33.9
        Grade 3 Inj. site Tenderness; Post-dose 1; IPV
    0
    0
    0.8
        Any Inj. site Tenderness; Post-dose 2; DTacP
    25.3
    27.9
    24.3
        Grade 3 Inj. site Tenderness; Post-dose 2; DTacP
    0
    0
    0
        Any Inj. site Tenderness; Post-dose 2; PRP~T
    0
    0
    23
        Grade 3 Inj. site Tenderness; Post-dose 2; PRP~T
    0
    0
    0
        Any Inj. site Tenderness; Post-dose 2; IPV
    0
    0
    25.1
        Grade 3 Inj. site Tenderness; Post-dose 2; IPV
    0
    0
    0
        Any Inj. site Tenderness; Post-dose 3; DTacP
    22.2
    22.2
    22.4
        Grade 3 Inj. site Tenderness; Post-dose 3; DTacP
    0
    0
    0
        Any Inj. site Tenderness; Post-dose 3; PRP~T
    0
    0
    22.8
        Grade 3 Inj. site Tenderness; Post-dose 3; PRP~T
    0
    0
    0
        Any Inj. site Tenderness; Post-dose 3; IPV
    0
    0
    24.1
        Grade 3 Inj. site Tenderness; Post-dose 3; IPV
    0
    0
    0
        Any Inj. site Erythema; Post-dose 1; DTacP
    17.1
    15.7
    8.3
        Grade 3 Inj. site Erythema; Post-dose 1; DTacP
    0
    0
    0
        Any Inj. site Erythema; Post-dose 1; PRP~T
    0
    0
    9.5
        Grade 3 Inj. site Erythema; Post-dose 1; PRP~T
    0
    0
    0.8
        Any Inj. site Erythema; Post-dose 1; IPV
    0
    0
    7.4
        Grade 3 Inj. site Erythema; Post-dose 1; IPV
    0
    0
    0
        Any Inj. site Erythema; Post-dose 2; DTacP
    21.4
    23.8
    9.2
        Grade 3 Inj. site Erythema; Post-dose 2; DTacP
    0
    1.7
    0
        Any Inj. site Erythema; Post-dose 2; PRP~T
    0
    0
    7.9
        Grade 3 Inj. site Erythema; Post-dose 2; PRP~T
    0
    0
    0
        Any Inj. site Erythema; Post-dose 2; IPV
    0
    0
    8.4
        Grade 3 Inj. site Erythema; Post-dose 2; IPV
    0
    0
    0
        Any Inj. site Erythema; Post-dose 3; DTacP
    24.1
    20.1
    9.3
        Grade 3 Inj. site Erythema; Post-dose 3; DTacP
    1.2
    1.3
    0
        Any Inj. site Erythema; Post-dose 3; PRP~T
    0
    0
    8.4
        Grade 3 Inj. site Erythema; Post-dose 3; PRP~T
    0
    0
    0
        Any Inj. site Erythema; Post-dose 3; IPV
    0
    0
    8.9
        Grade 3 Inj. site Erythema; Post-dose 3; IPV
    0
    0
    0
        Any Inj. site Swelling; Post-dose 1; DTacP
    12.9
    8.3
    3.3
        Grade 3 Inj. site Swelling; Post-dose 1; DTacP
    0.4
    0
    0
        Any Inj. site Swelling; Post-dose 1; PRP~T
    0
    0
    2.9
        Grade 3 Inj. site Swelling; Post-dose 1; PRP~T
    0
    0
    0.4
        Any Inj. site Swelling; Post-dose 1; IPV
    0
    0
    2.9
        Grade 3 Inj. site Swelling; Post-dose 1; IPV
    0
    0
    0
        Any Inj. site Swelling; Post-dose 2; DTacP
    10.9
    13.8
    3.8
        Grade 3 Inj. site Swelling; Post-dose 2; DTacP
    1.2
    0
    0
        Any Inj. site Swelling; Post-dose 2; PRP~T
    0
    0
    2.5
        Grade 3 Inj. site Swelling; Post-dose 2; PRP~T
    0
    0
    0
        Any Inj. site Swelling; Post-dose 2; IPV
    0
    0
    3.3
        Grade 3 Inj. site Swelling; Post-dose 2; IPV
    0
    0
    0
        Any Inj. site Swelling; Post-dose 3; DTacP
    17.1
    13.8
    5.9
        Grade 3 Inj. site Swelling; Post-dose 3; DTacP
    1.2
    0.4
    0
        Any Inj. site Swelling; Post-dose 3; PRP~T
    0
    0
    5.5
        Grade 3 Inj. site Swelling; Post-dose 3; PRP~T
    0
    0
    0
        Any Inj. site Swelling; Post-dose 3; IPV
    0
    0
    4.2
        Grade 3 Inj. site Swelling; Post-dose 3; IPV
    0
    0
    0
        Any Fever; Post-dose 1
    29.3
    37.6
    38.8
        Grade 3 Fever; Post-dose 1
    0
    0.4
    0.8
        Any Fever; Post-dose 2
    33.5
    35.4
    29.7
        Grade 3 Fever; Post-dose 2
    0
    0
    1.3
        Any Fever; Post-dose 3
    23.3
    23.8
    24.1
        Grade 3 Fever; Post-dose 3
    0.8
    1.3
    0.4
        Any Vomiting; Post-dose 1
    35
    21.9
    21.9
        Grade 3 Vomiting; Post-dose 1
    0
    0
    0
        Any Vomiting; Post-dose 2
    21.8
    16.3
    15.9
        Grade 3 Vomiting; Post-dose 2
    0
    0
    0
        Any Vomiting; Post-dose 3
    14.4
    12.1
    11
        Grade 3 Vomiting; Post-dose 3
    0
    0
    0
        Any Crying abnormal; Post-dose 1
    30
    26.9
    41.3
        Grade 3 Crying abnormal; Post-dose 1
    1.1
    0
    1.2
        Any Crying abnormal; Post-dose 2
    17.9
    20
    26.4
        Grade 3 Crying abnormal; Post-dose 2
    0
    0
    0
        Any Crying abnormal; Post-dose 3
    14.8
    16.7
    15.2
        Grade 3 Crying abnormal; Post-dose 3
    0
    0
    0
        Any Drowsiness; Post-dose 1
    25.1
    22.3
    19.8
        Grade 3 Drowsiness; Post-dose 1
    0.8
    0.4
    0.4
        Any Drowsiness; Post-dose 2
    12.5
    9.6
    13.4
        Grade 3 Drowsiness; Post-dose 2
    0
    0
    0
        Any Drowsiness; Post-dose 3
    6.6
    8.8
    8
        Grade 3 Drowsiness; Post-dose 3
    0
    0
    0
        Any Appetite lost; Post-dose 1
    20.2
    21.9
    21.9
        Grade 3 Appetite lost; Post-dose 1
    1.1
    0
    0.4
        Any Appetite lost; Post-dose 2
    14
    17.1
    13
        Grade 3 Appetite lost; Post-dose 2
    0.4
    0
    0
        Any Appetite lost; Post-dose 3
    10.9
    12.6
    12.7
        Grade 3 Appetite lost; Post-dose 3
    0
    0
    0
        Any Irritability; Post-dose 1
    23.6
    21.1
    28.5
        Grade 3 Irritability; Post-dose 1
    0.8
    0.4
    1.7
        Any Irritability; Post-dose 2
    13.6
    17.5
    18
        Grade 3 Irritability; Post-dose 2
    0.4
    0
    1.3
        Any Irritability; Post-dose 3
    11.7
    10.5
    11.8
        Grade 3 Irritability; Post-dose 3
    0.4
    0
    0.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following a Booster Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or A DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccine

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    End point title
    		 Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following a Booster Vaccination with Either DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) or A DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) Monovalent Vaccine
    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 (China SFDA): Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, > 3 cm. Grade 3 systemic reactions (China SFDA): Fever, > 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-booster vaccination
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    252
    234
    228
    Units: Percentage of subjects
    number (not applicable)
        Any Inj. site Tenderness; DTacP
    33.9
    39.5
    25
        Grade 3 Inj. site Tenderness; DTacP
    0
    0
    0
        Any Inj. site Tenderness; PRP~T
    0
    0
    24.6
        Grade 3 Inj. site Tenderness; PRP~T
    0
    0
    0.9
        Any Inj. site Tenderness; IPV
    0
    0
    27.2
        Grade 3 Inj. site Tenderness; IPV
    0
    0
    0.9
        Any Inj. site Erythema; DTacP
    37.1
    36.9
    13.6
        Grade 3 Inj. site Erythema; DTacP
    8.8
    6.9
    0.4
        Any Inj. site Erythema; PRP~T
    0
    0
    10.5
        Grade 3 Inj. site Erythema; PRP~T
    0
    0
    0.4
        Any Inj. site Erythema; IPV
    0
    0
    11.8
        Grade 3 Inj. site Erythema; IPV
    0
    0
    0
        Any Inj. site Swelling; DTAcP
    27.5
    26.6
    7.5
        Grade 3 Inj. site Swelling; DTAcP
    6.8
    6
    0
        Any Inj. site Swelling; PRP~T
    0
    0
    5.7
        Grade 3 Inj. site Swelling; PRP~T
    0
    0
    0
        Any Inj. site Swelling; IPV
    0
    0
    5.3
        Grade 3 Inj. site Swelling; IPV
    0
    0
    0
        Any Fever
    32.7
    37.8
    21.5
        Grade 3 Fever
    0.8
    1.3
    1.3
        Any Vomiting
    6.4
    9.4
    3.9
        Grade 3 Vomiting
    0
    0
    0
        Any Crying abnormal
    15.1
    18.5
    15.8
        Grade 3 Crying abnormal
    0
    0.4
    0.4
        Any Drowsiness
    6.8
    11.2
    4.8
        Grade 3 Drowsiness
    0
    0
    0
        Any Appetite lost
    19.5
    24.5
    14.9
        Grade 3 Appetite lost
    0
    0
    0
        Any Irritability
    16.3
    18.9
    15.8
        Grade 3 Irritability
    0.4
    0
    0.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 post-vaccination up to 1 month post-booster vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 2, 3, and 4 months of age and a booster dose at 18 to 20 months of age.

    Reporting group title
    Group B
    Reporting group description
    		 Subjects received Sanofi Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) at 3, 4, and 5 months of age and a booster dose at 18 to 20 months of age.

    Reporting group title
    Group C
    Reporting group description
    		 Subjects received the control vaccine (Wuhan's DTacP, Act-HIB™ and IMOVAX Polio™) at 3, 4, and 5 months of age and a booster dose at 18 to 20 months of age.

    Serious adverse events
    		 Group A Group B Group C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 264 (2.27%)
    7 / 243 (2.88%)
    5 / 244 (2.05%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 264 (1.14%)
    3 / 243 (1.23%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 264 (0.38%)
    1 / 243 (0.41%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 264 (0.38%)
    3 / 243 (1.23%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 243 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infantile bronchitis
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 243 (0.41%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute enteritis
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 243 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infant pneumonia
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 243 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthmatic bronchitis
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 243 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A Group B Group C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    151 / 264 (57.20%)
    150 / 243 (61.73%)
    149 / 244 (61.07%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    80 / 264 (30.30%)
    64 / 243 (26.34%)
    71 / 244 (29.10%)
         occurrences all number
    80
    64
    71
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    113 / 264 (42.80%)
    100 / 243 (41.15%)
    107 / 244 (43.85%)
         occurrences all number
    113
    100
    107
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    92 / 264 (34.85%)
    87 / 243 (35.80%)
    44 / 244 (18.03%)
         occurrences all number
    92
    87
    44
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    68 / 264 (25.76%)
    52 / 243 (21.40%)
    22 / 244 (9.02%)
         occurrences all number
    68
    52
    22
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    151 / 264 (57.20%)
    150 / 243 (61.73%)
    149 / 244 (61.07%)
         occurrences all number
    151
    150
    149
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    121 / 264 (45.83%)
    80 / 243 (32.92%)
    76 / 244 (31.15%)
         occurrences all number
    121
    80
    76
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    104 / 264 (39.39%)
    92 / 243 (37.86%)
    125 / 244 (51.23%)
         occurrences all number
    104
    92
    125
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    80 / 264 (30.30%)
    71 / 243 (29.22%)
    91 / 244 (37.30%)
         occurrences all number
    80
    71
    91
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    82 / 264 (31.06%)
    79 / 243 (32.51%)
    77 / 244 (31.56%)
         occurrences all number
    82
    79
    77

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 May 2007
    The number of planned subjects was modified and the sample labeling and storage procedures were updated.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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