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    Clinical Trial Results:
    Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine at 2, 4, and 6 Months of Age versus Sanofi Pasteur's DTaP-IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed with Hep B at Birth

    Summary
    EudraCT number
    		 2016-002873-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A3L31
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02094833
    WHO universal trial number (UTN)
    		 U1111-1127-6896
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Medical Product Leader, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.Vidor@sanofi.com
    Scientific contact
    Medical Product Leader, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.Vidor@sanofi.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
    28 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2016
    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 (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hepatitis B) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A (DTaP-IPV-Hep B-PRP-T combined vaccine) versus Group B (DTaP-IPV//PRP~T vaccine [Pentaxim]), one month after the third dose of combined vaccines.
    Protection of trial subjects
    Only subjects that met all the study inclusion and no exclusion criteria were randomized and vaccinated in the study. In addition, 9 subjects who did not meet the eligibility criteria were also vaccinated in the study but were not included in the Per Protocol Analysis Set. 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
    		 All subjects enrolled in this study received a dose of recombinant hepatitis B vaccine at birth according to the National Immunization Program in Republic of Korea.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    19 Mar 2014
    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: 310
    Worldwide total number of subjects
    310
    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)
    310
    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 19 March 2014 to 01 October 2015 at 18 clinic centers in Republic of Korea.

    Pre-assignment
    Screening details
    		 A total of 310 subjects were included in the study. Of those subjects, 301 subjects who met all inclusion and no exclusion criteria were randomized and vaccinated; 9 subjects were vaccinated but excluded from the Per Protocol Analysis Set.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTaP-IPV-Hep B-PRP~T
    Arm description
    		 Infants received 3 injections of DTaP-IPV-Hep B-PRP~T at 2, 4, and 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTAP-IPV-Hep B-PRP~T (Hexaxim™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral area of the right thigh, 1 injection at 2, 4, and 6 months of age

    Arm title
    		 DTaP-IPV//PRP~T and Hepatitis B
    Arm description
    		 Infants received Hep B Vaccine (Euvax B®) at 1 and 6 months of age and DTaP-IPV/PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DTaP-IPV//PRP~T (Pentaxim™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral aspect of the right thigh, 1 injection each at 2, 4, and 6 months of age

    Investigational medicinal product name
    Recombinant hepatitis B monovalent vaccine (Euvax B®)
    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 aspect of the left thigh, 1 injection each at 1 and 6 months of age

    Number of subjects in period 1
    		DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B
    Started
    153
    157
    Completed
    148
    153
    Not completed
    5
    4
         Consent withdrawn by subject
    4
    2
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T
    Reporting group description
    		 Infants received 3 injections of DTaP-IPV-Hep B-PRP~T at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV//PRP~T and Hepatitis B
    Reporting group description
    		 Infants received Hep B Vaccine (Euvax B®) at 1 and 6 months of age and DTaP-IPV/PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age.

    Reporting group values
    		 DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B Total
    Number of subjects
    		 153 157 310
    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)
    		 153 157 310
        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: days
        arithmetic mean (standard deviation)
    		 33.9 ( 2.8 ) 33.8 ( 2.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 63 75 138
        Male
    		 90 82 172

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T
    Reporting group description
    		 Infants received 3 injections of DTaP-IPV-Hep B-PRP~T at 2, 4, and 6 months of age.

    Reporting group title
    DTaP-IPV//PRP~T and Hepatitis B
    Reporting group description
    		 Infants received Hep B Vaccine (Euvax B®) at 1 and 6 months of age and DTaP-IPV/PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age.

    Primary: Percentage of Subjects with Seroprotection or Seroconversion Following Vaccinations with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)

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    End point title
    		 Percentage of Subjects with Seroprotection or Seroconversion Following Vaccinations with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    End point description
    Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti-Filamentous hemagglutinin (FHA) antibodies were assessed using an enzyme-linked immunosorbent assay. Anti-PRP antibodies were assessed by a Farr-type radioimmunoassay. Anti-Hepatitis B antibodies were measured by the VITROS ECi/ECiQ Immunodiagnostic System using chemiluminesce detection technology. Anti-Poliovirus (Polio) types 1, 2, and 3 antibodies were assessed by a neutralization assay, the poliovirus Micrometabolic Inhibition Test. Seroprotection was defined as the following: Anti-Diphtheria ≥0.01 International Units (IU)/mL, Anti-Tetanus ≥0.1 IU/mL, Anti-PRP ≥0.15 µg/mL, Anti Poliovirus types 1, 2, and 3 ≥8 (1/dilution), and Anti-Hepatitis B ≥10 mIU/mL. Seroconversion for Anti-PT and Anti-FHA was defined as a ≥4-fold increase from 1 month pre-dose 1 to 1 month post-dose 3 in Anti-PT and Anti-FHA antibody concentrations (EU/mL).
    End point type
    Primary
    End point timeframe
    1 month post-dose 3
    End point values
    		 DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects analysed
    132
    131
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria
    100
    100
        Anti-Tetanus
    99.2
    100
        Anti-Polio 1
    100
    100
        Anti-Polio 2
    100
    100
        Anti-Polio 3
    100
    100
        Anti-PRP
    100
    100
        Anti-Hepatitis B
    97.7
    96.9
        Anti-PT
    94.6
    93
        Anti-FHA
    91.7
    89.3
    Statistical analysis title
    		 Non-inferiority: Diphtheria
    Statistical analysis description
    This analysis was performed to determine the non-inferiority of the DTaP-IPV-Hep B-PRP~T (Group A) vs DTaP-IPV//PRP~T and Hepatitis B (Group B) for Diphtheria.
    Comparison groups
    DTaP-IPV-Hep B-PRP~T v DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Percent observed (Group A-Group B)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.87
         upper limit
    		 2.98
    Notes
    [1] - Non-inferiority was assessed by DTaP-IPV-Hep B-PRP~T (Group A) minus DTaP-IPV//PRP~T and Hepatitis B (Group B). If the lower bound of the 95% CI was greater than -10% then the null hypothesis H0 was rejected and non-inferiority was met. For Diphtheria, non-inferiority was met.
    Statistical analysis title
    		 Non-inferiority: Tetanus
    Statistical analysis description
    This analysis was performed to determine the non-inferiority of the DTaP-IPV-Hep B-PRP~T (Group A) vs DTaP-IPV//PRP~T and Hepatitis B (Group B) for Tetanus.
    Comparison groups
    DTaP-IPV-Hep B-PRP~T v DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Percent observed (Group A-Group B)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.29
         upper limit
    		 2.29
    Notes
    [2] - Non-inferiority was assessed by DTaP-IPV-Hep B-PRP~T (Group A) minus DTaP-IPV//PRP~T and Hepatitis B (Group B). If the lower bound of the 95% CI was greater than -10% then the null hypothesis H0 was rejected and non-inferiority was met. For Tetanus, non-inferiority was met.
    Statistical analysis title
    		 Non-inferiority: Polio 1
    Statistical analysis description
    This analysis was performed to determine the non-inferiority of the DTaP-IPV-Hep B-PRP~T (Group A) vs DTaP-IPV//PRP~T and Hepatitis B (Group B) for Polio 1.
    Comparison groups
    DTaP-IPV-Hep B-PRP~T v DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Percent observed (Group A-Group B)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.87
         upper limit
    		 2.85
    Notes
    [3] - Non-inferiority was assessed by DTaP-IPV-Hep B-PRP~T (Group A) minus DTaP-IPV//PRP~T and Hepatitis B (Group B). If the lower bound of the 95% CI was greater than -10% then the null hypothesis H0 was rejected and non-inferiority was met. For Polio 1, non-inferiority was met.
    Statistical analysis title
    		 Non-inferiority: Polio 2
    Statistical analysis description
    This analysis was performed to determine the non-inferiority of the DTaP-IPV-Hep B-PRP~T (Group A) vs DTaP-IPV//PRP~T and Hepatitis B (Group B) for Polio 2.
    Comparison groups
    DTaP-IPV-Hep B-PRP~T v DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Percent observed (Group A-Group B)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.87
         upper limit
    		 2.91
    Notes
    [4] - Non-inferiority was assessed by DTaP-IPV-Hep B-PRP~T (Group A) minus DTaP-IPV//PRP~T and Hepatitis B (Group B). If the lower bound of the 95% CI was greater than -10% then the null hypothesis H0 was rejected and non-inferiority was met. For Polio 2, non-inferiority was met.
    Statistical analysis title
    		 Non-inferiority: Polio 3
    Statistical analysis description
    This analysis was performed to determine the non-inferiority of the DTaP-IPV-Hep B-PRP~T (Group A) vs DTaP-IPV//PRP~T and Hepatitis B (Group B) for Polio 3.
    Comparison groups
    DTaP-IPV-Hep B-PRP~T v DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Percent observed (Group A-Group B)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.87
         upper limit
    		 2.89
    Notes
    [5] - Non-inferiority was assessed by DTaP-IPV-Hep B-PRP~T (Group A) minus DTaP-IPV//PRP~T and Hepatitis B (Group B). If the lower bound of the 95% CI was greater than -10% then the null hypothesis H0 was rejected and non-inferiority was met. For Polio 3, non-inferiority was met.
    Statistical analysis title
    		 Non-inferiority: PRP
    Statistical analysis description
    This analysis was performed to determine the non-inferiority of the DTaP-IPV-Hep B-PRP~T (Group A) vs DTaP-IPV//PRP~T and Hepatitis B (Group B) for PRP.
    Comparison groups
    DTaP-IPV-Hep B-PRP~T v DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Percent observed (Group A-Group B)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.83
         upper limit
    		 2.85
    Notes
    [6] - Non-inferiority was assessed by DTaP-IPV-Hep B-PRP~T (Group A) minus DTaP-IPV//PRP~T and Hepatitis B (Group B). If the lower bound of the 95% CI was greater than -10% then the null hypothesis H0 was rejected and non-inferiority was met. For PRP, non-inferiority was met.
    Statistical analysis title
    		 Non-inferiority: Hepatitis B
    Statistical analysis description
    This analysis was performed to determine the non-inferiority of the DTaP-IPV-Hep B-PRP~T combined vaccine (Group A) vs DTaP-IPV//PRP~T and Hepatitis B (Group B) for Hepatitis B.
    Comparison groups
    DTaP-IPV-Hep B-PRP~T v DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Percent observed (Group A-Group B)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.81
         upper limit
    		 5.56
    Notes
    [7] - Non-inferiority was assessed by DTaP-IPV-Hep B-PRP~T combined vaccine (Group A) minus DTaP-IPV//PRP~T and Hepatitis B (Group B). If the lower bound of the 95% CI was greater than -10% then the null hypothesis H0 was rejected and non-inferiority was met. For Hepatitis B, non-inferiority was met.
    Statistical analysis title
    		 Non-inferiority: PT
    Statistical analysis description
    This analysis was performed to determine the non-inferiority of the DTaP-IPV-Hep B-PRP~T (Group A) vs DTaP-IPV//PRP~T and Hepatitis B (Group B) for PT.
    Comparison groups
    DTaP-IPV-Hep B-PRP~T v DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Percent observed (Group A-Group B)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.68
         upper limit
    		 8.03
    Notes
    [8] - Non-inferiority was assessed by DTaP-IPV-Hep B-PRP~T (Group A) minus DTaP-IPV//PRP~T and Hepatitis B (Group B). If the lower bound of the 95% CI was greater than -10% then the null hypothesis H0 was rejected and non-inferiority was met. For PT, non-inferiority was met.
    Statistical analysis title
    		 Non-inferiority: FHA
    Statistical analysis description
    This analysis was performed to determine the non-inferiority of the DTaP-IPV-Hep B-PRP~T (Group A) vs DTaP-IPV//PRP~T and Hepatitis B (Group B) for FHA.
    Comparison groups
    DTaP-IPV-Hep B-PRP~T v DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects included in analysis
    263
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Percent observed (Group A-Group B)
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.96
         upper limit
    		 9.75
    Notes
    [9] - Non-inferiority was assessed by DTaP-IPV-Hep B-PRP~T (Group A) minus DTaP-IPV//PRP~T and Hepatitis B (Group B). If the lower bound of the 95% CI was greater than -10% then the null hypothesis H0 was rejected and non-inferiority was met. For FHA, non-inferiority was met.

    Secondary: Summary of Vaccine Antibodies’ Titers Before First Dose and After Third Dose Vaccination with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)

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    End point title
    		 Summary of Vaccine Antibodies’ Titers Before First Dose and After Third Dose Vaccination with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    End point description
    Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus, Anti-PT, and Anti-FHA antibodies were assessed using an enzyme-linked immunosorbent assay. Anti-PRP antibodies were assessed by a Farr-type radioimmunoassay. Anti-Hepatitis B was measured by the VITROS ECi/ECiQ Immunodiagnostic System using chemiluminesce. Anti-Polio types 1, 2, and 3 antibodies were assessed by a neutralization assay, the poliovirus Micrometabolic Inhibition Test. Seroprotection was defined as: Anti-Diphtheria ≥0.01 IU/mL (pre- and post-doses), Anti-Tetanus ≥0.1 IU/mL (post dose), Anti-PRP ≥0.15 µg/mL (post dose), Anti Poliovirus types 1, 2, and 3 ≥8 (1/dilution; post doses), Anti-Hepatitis B ≥10 mIU/mL (pre- and post doses). Vaccine response was defined as Anti-PT or Anti-FHA antibody concentrations in ELISA units (EU)/mL ≥4X lower limit of quantitation (LLOQ) if pre-vaccination concentration <4X LLOQ or ≥pre-vaccination concentration if pre-vaccination concentration ≥4X LLOQ.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 3
    End point values
    		 DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects analysed
    132
    131
    Units: Percentage of subjects
    number (not applicable)
        Anti-Diphtheria; Pre-dose 1 (≥0.01 IU/mL)
    54.7
    48.1
        Anti-Diphtheria; Pre-dose 1 (≥0.1 IU/mL)
    5.5
    4.6
        Anti-Diphtheria; Post-dose 3 (≥0.01 IU/mL)
    100
    100
        Anti-Diphtheria; Post-dose 3 (≥0.1 IU/mL)
    98.5
    97.6
        Anti-Tetanus; Post-dose 3 (≥0.01 IU/mL)
    100
    100
        Anti-Tetanus; Post-dose 3 (≥0.1 IU/mL)
    99.2
    100
        Anti-Polio 1; Post-dose 3 (≥8 [1/dil])
    100
    100
        Anti-Polio 2; Post-dose 3 (≥8 [1/dil])
    100
    100
        Anti-Polio 3; Post-dose 3 (≥8 [1/dil])
    100
    100
        Anti-PRP; Post-dose 3 (≥0.15 µg/ml)
    100
    100
        Anti-PRP; Post-dose 3 (≥1 µg/ml)
    87.1
    96.9
        Anti-Hepatitis B; Pre-dose 1 (≥10 mIU/mL)
    74
    68.7
        Anti-Hepatitis B; Post-dose 3 (≥10 mIU/mL)
    97.7
    96.9
        Anti-PT; Vaccine response
    98.4
    98.4
        Anti-PT; 4-fold increase
    94.6
    93
        Anti-FHA; Vaccine response
    97.7
    96.2
        Anti-FHA; 4-fold increase
    91.7
    89.3
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigens Following Vaccinations with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigens Following Vaccinations with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    End point description
    Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus, Anti-Pertussis toxoid (PT), and Anti-Filamentous hemagglutinin (FHA) antibodies were assessed using an enzyme-linked immunosorbent assay. Anti-Hib capsular polyribosyl ribitol phosphate conjugated to tetanus protein (PRP) antibodies were assessed by a Farr-type radioimmunoassay. Anti-Hepatitis B was measured by the VITROS ECi/ECiQ Immunodiagnostic System using chemiluminesce detection technology. Anti-Poliovirus (Polio) types 1, 2, and 3 antibodies were assessed by a neutralization assay, the poliovirus Micrometabolic Inhibition Test.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 3
    End point values
    		 DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects analysed
    132
    131
    Units: Concentrations/titers
    geometric mean (confidence interval 95%)
        Anti-Diphtheria; Pre-Dose 1
    0.01 (0.008 to 0.013)
    0.009 (0.007 to 0.012)
        Anti-Diphtheria; Post-Dose 3
    1.01 (0.874 to 1.16)
    0.676 (0.582 to 0.786)
        Anti-Tetanus; Post-Dose 3
    3.05 (2.67 to 3.48)
    2.53 (2.3 to 2.78)
        Anti-Polio 1; Post-Dose 3
    823 (695 to 975)
    1210 (1003 to 1459)
        Anti-Polio 2; Post-Dose 3
    1380 (1126 to 1692)
    1588 (1255 to 2009)
        Anti-Polio 3; Post-Dose 3
    899 (721 to 1120)
    1280 (1000 to 1639)
        Anti-PRP; Post-Dose 3
    5.44 (4.37 to 6.77)
    9.35 (7.67 to 11.4)
        Anti-Hepatitis B; Pre-Dose 1
    37.3 (26 to 53.4)
    41.8 (29 to 60.2)
        Anti-Hepatitis B; Post-Dose 3
    1068 (805 to 1416)
    827 (601 to 1138)
        Anti-PT; Pre-Dose 1
    2.84 (2.35 to 3.43)
    2.98 (2.4 to 3.69)
        Anti-PT; Post-Dose 3
    99 (90.6 to 108)
    143 (129 to 157)
        Anti-FHA; Pre-Dose 1
    6.3 (5.2 to 7.64)
    6.84 (5.5 to 8.51)
        Anti-FHA; Post-Dose 3
    153 (141 to 166)
    163 (148 to 180)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) Ratios of Antibodies Against Vaccine Antigens Following Vaccinations with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)

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    End point title
    		 Geometric Mean Concentration (GMC) Ratios of Antibodies Against Vaccine Antigens Following Vaccinations with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    End point description
    Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Hepatitis B was measured by the VITROS ECi/ECiQ Immunodiagnostic System using chemiluminesce detection technology. Anti-PT and Anti-FHA antibodies were assessed using an enzyme-linked immunosorbent assay.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 3
    End point values
    		 DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects analysed
    132
    131
    Units: Concentration ratio
    geometric mean (confidence interval 95%)
        Anti-Diphtheria
    99.4 (71.3 to 139)
    80.3 (58.2 to 111)
        Anti-Hepatitis B
    28.7 (17.9 to 46.1)
    19.8 (12 to 32.7)
        Anti-PT
    34.4 (27.4 to 43.2)
    48 (37.3 to 61.9)
        Anti-FHA
    24.2 (19.4 to 30.2)
    23.9 (18.3 to 31)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Any Vaccination with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Any Vaccination with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, Irritability. Grade 3 Injection site reactions: Pain, Cries when injected limb is moved, or the movement of the limb is reduced; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Pyrexia, >39.5°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-any vaccination
    End point values
    		 DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects analysed
    149
    155
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Pain
    61.7
    58.1
        Grade 3 Injection site Pain
    2
    1.3
        Any Injection site Erythema
    53.7
    44.5
        Grade 3 Injection site Erythema
    2.7
    2.6
        Any Injection site Swelling
    47.7
    43.2
        Grade 3 Injection site Swelling
    1.3
    0.6
        Any Pyrexia
    20.1
    7.7
        Grade 3 Pyrexia
    0
    0
        Any Vomiting
    26.8
    24.5
        Grade 3 Vomiting
    0.7
    1.3
        Any Crying abnormal
    48.3
    33.5
        Grade 3 Crying abnormal
    4
    2.6
        Any Somnolence
    51
    45.2
        Grade 3 Somnolence
    2
    1.9
        Any Decreased appetite
    34.9
    35.5
        Grade 3 Decreased appetite
    0.7
    0.6
        Any Irritability
    53.7
    49
        Grade 3 Irritability
    3.4
    1.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 1 with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 1 with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, Irritability. Grade 3 Injection site reactions: Pain, Cries when injected limb is moved, or the movement of the limb is reduced; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Pyrexia, >39.5°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination 1
    End point values
    		 DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects analysed
    149
    155
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Pain
    47.7
    41.9
        Grade 3 Injection site Pain
    1.3
    1.3
        Any Injection site Erythema
    33.6
    20.6
        Grade 3 Injection site Erythema
    1.3
    1.3
        Any Injection site Swelling
    26.8
    22.6
        Grade 3 Injection site Swelling
    0.7
    0.6
        Any Pyrexia
    8.1
    1.3
        Grade 3 Pyrexia
    0
    0
        Any Vomiting
    18.1
    15.5
        Grade 3 Vomiting
    0
    0.6
        Any Crying abnormal
    36.9
    25.2
        Grade 3 Crying abnormal
    2
    1.9
        Any Somnolence
    41.6
    35.5
        Grade 3 Somnolence
    0.7
    1.9
        Any Decreased appetite
    27.5
    27.1
        Grade 3 Decreased appetite
    0.7
    0.6
        Any Irritability
    42.3
    38.1
        Grade 3 Irritability
    2
    1.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 2 with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 2 with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying, Somnolence, Decreased appetite, Irritability. Grade 3 Injection site reactions: Pain, Cries when injected limb is moved, or the movement of the limb is reduced; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Pyrexia, >39.5°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination 2
    End point values
    		 DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects analysed
    149
    154
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Pain
    41.6
    26.6
        Grade 3 Injection site Pain
    1.3
    0
        Any Injection site Erythema
    38.9
    22.7
        Grade 3 Injection site Erythema
    0
    0
        Any Injection site Swelling
    28.9
    22.1
        Grade 3 Injection site Swelling
    0
    0
        Any Pyrexia
    9.4
    2.6
        Grade 3 Pyrexia
    0
    0
        Any Vomiting
    13.4
    10.4
        Grade 3 Vomiting
    0
    0.6
        Any Crying abnormal
    23.5
    15.6
        Grade 3 Crying abnormal
    1.3
    0
        Any Somnolence
    20.8
    20.1
        Grade 3 Somnolence
    1.3
    0
        Any Decreased appetite
    16.1
    12.3
        Grade 3 Decreased appetite
    0
    0
        Any Irritability
    28.9
    20.8
        Grade 3 Irritability
    1.3
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 3 with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination 3 with DTaP-IPV-Hep B-PRP~T (Hexaxim™) or DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying, Somnolence, Decreased appetite, Irritability. Grade 3 Injection site reactions: Pain, Cries when injected limb is moved, or the movement of the limb is reduced; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Pyrexia, >39.5°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable. Solicited injection site reactions are reported at the Hexaxim and Pentaxim injection sites for each group, respectively, and solicited systemic reactions are reported at the Hexaxim and Pentxim+Euvax injection sites for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination 3
    End point values
    		 DTaP-IPV-Hep B-PRP~T DTaP-IPV//PRP~T and Hepatitis B
    Number of subjects analysed
    148
    154
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Pain
    31.8
    37.3
        Grade 3 Injection site Pain
    0
    0
        Any Injection site Erythema
    33.1
    30.7
        Grade 3 Injection site Erythema
    1.4
    0.7
        Any Injection site Swelling
    29.7
    26.8
        Grade 3 Injection site Swelling
    0.7
    0
        Any Pyrexia
    4.1
    3.9
        Grade 3 Pyrexia
    0
    0
        Any Vomiting
    4.7
    7.8
        Grade 3 Vomiting
    0.7
    0
        Any Crying abnormal
    14.2
    12.4
        Grade 3 Crying abnormal
    1.4
    0.7
        Any Somnolence
    16.2
    17
        Grade 3 Somnolence
    0
    0
        Any Decreased appetite
    8.8
    14.4
        Grade 3 Decreased appetite
    0
    0
        Any Irritability
    20.3
    22.9
        Grade 3 Irritability
    0.7
    0.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 up to Day 30 post-vaccination 3 and SAEs were collected throughout the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP-T (Hexaxim™)
    Reporting group description
    		 -

    Reporting group title
    DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    Reporting group description
    		 -

    Serious adverse events
    		 DTaP-IPV-Hep B-PRP-T (Hexaxim™) DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 149 (12.75%)
    19 / 155 (12.26%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intussusception
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 155 (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 / 149 (4.70%)
    4 / 155 (2.58%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis enteroviral
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 155 (0.65%)
         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 / 149 (0.67%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 149 (0.00%)
    2 / 155 (1.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 149 (0.67%)
    5 / 155 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 149 (0.67%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    4 / 149 (2.68%)
    4 / 155 (2.58%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DTaP-IPV-Hep B-PRP-T (Hexaxim™) DTAP-IPV//PRP~T (Pentaxim™) and Hepatitis B Vaccine (Euvax B®)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 149 (61.74%)
    90 / 155 (58.06%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    76 / 149 (51.01%)
    70 / 155 (45.16%)
         occurrences all number
    76
    70
    General disorders and administration site conditions
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    92 / 149 (61.74%)
    90 / 155 (58.06%)
         occurrences all number
    92
    90
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    80 / 149 (53.69%)
    69 / 155 (44.52%)
         occurrences all number
    80
    69
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    71 / 149 (47.65%)
    67 / 155 (43.23%)
         occurrences all number
    71
    67
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    30 / 149 (20.13%)
    12 / 155 (7.74%)
         occurrences all number
    30
    12
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 149 (3.36%)
    10 / 155 (6.45%)
         occurrences all number
    5
    12
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    40 / 149 (26.85%)
    38 / 155 (24.52%)
         occurrences all number
    40
    38
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 149 (7.38%)
    8 / 155 (5.16%)
         occurrences all number
    12
    9
    Rhinorrhoea
         subjects affected / exposed
    16 / 149 (10.74%)
    19 / 155 (12.26%)
         occurrences all number
    18
    25
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    72 / 149 (48.32%)
    52 / 155 (33.55%)
         occurrences all number
    72
    52
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    80 / 149 (53.69%)
    76 / 155 (49.03%)
         occurrences all number
    80
    76
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    9 / 149 (6.04%)
    11 / 155 (7.10%)
         occurrences all number
    10
    16
    Bronchitis
         subjects affected / exposed
    8 / 149 (5.37%)
    11 / 155 (7.10%)
         occurrences all number
    9
    21
    Nasopharyngitis
         subjects affected / exposed
    32 / 149 (21.48%)
    35 / 155 (22.58%)
         occurrences all number
    43
    50
    Otitis media
         subjects affected / exposed
    8 / 149 (5.37%)
    7 / 155 (4.52%)
         occurrences all number
    8
    11
    Rhinitis
         subjects affected / exposed
    9 / 149 (6.04%)
    6 / 155 (3.87%)
         occurrences all number
    10
    7
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 149 (8.05%)
    15 / 155 (9.68%)
         occurrences all number
    22
    22
    Metabolism and nutrition disorders
    Decreased appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    52 / 149 (34.90%)
    55 / 155 (35.48%)
         occurrences all number
    52
    55

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Dec 2013
    Secondary endpoints (4-fold elevation of pre-vaccination titers after vaccination for PT and FHA) were moved to primary endpoints while vaccine response (identified as ≥4-fold increase of the LLOQ) was moved to the secondary endpoints; sample size section was updated; specifications to the administration of the vaccine were added; correspondence details of the laboratory for serology tests were added; and the planned trial calendar was updated.
    31 Jul 2014
    Inclusion criteria regarding hepatitis B surface antigen (HBsAg) negative status was updated to include documented HBsAg negative status during the last trimester of pregnancy (or post-birth) or documented HBsAg negative and HBsAb positive status before last trimester of pregnancy
    12 Dec 2014
    Sample size was increased and the number of centers involved in the study was increased to facilitate the achievement of the enrollment in an acceptable timing; the planned trial calendar was also updated.
    19 May 2015
    Clarified the parameters used to calculate the minimal acceptable power for the primary analysis.

    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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