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    Clinical Trial Results:
    An Open-label, randomised, controlled, multi-centre study of the immunogenicity and safety of a booster dose of two different Hepatitis B vaccines to explore the anamnestic immune response in healthy 4 to 7 year-old children previously vaccinated at about 3, 5 and 11 to 13 months of age with either HEXAVAC or INFANRIX-HEXA

    Summary
    EudraCT number
    		 2007-005168-29
    Trial protocol
    		 IT  
    Global end of trial date
    04 Jan 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HXV01C
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00693186
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur MSD S.N.C.
    Sponsor organisation address
    162 avenue Jean Jaurès - CS 50712, Lyon Cedex 07, France, 69367
    Public contact
    Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.com
    Scientific contact
    Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.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
    04 Jan 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jan 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity: To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX-HEXA® during the first 2 years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL (i.e. seroprotection rate) 1 month after a booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO® 5 µg (modified process) or ENGERIX-B® 10 µg. Note: "HBVaxPRO® 5 µg (modified process)" was referred to "HBVaxPRO" and "ENGERIX-B® 10 µg" was referred to "ENGERIX-B" to facilitate reading.
    Protection of trial subjects
    Healthy subjects with known sensitivity and/or allergy to any component of the study vaccine were not vaccinated. Vaccines were administered by qualified study personnel. After each vaccination, subjects were kept under observation for at least 20 minutes to ensure their safety.
    Background therapy
    		 Subjects were previously vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX-HEXA during their first 2 years of life (at about 3, 5, and 11 to 13 months of age).
    Evidence for comparator
    		 This study was designed to explore the immune memory against Hepatitis B in healthy 4 to 7 year-old children previously vaccinated with HEXAVAC or INFANRIX-HEXA as part as the routine immunisation program. Two different Hepatitis B vaccines were used for this purpose: HBVaxPRO (namely study product) and ENGERIX-B (namely study comparator). ENGERIX-B was used as it was the one licensed for children and adolescents from birth to 15 years of age at the time the study started. Note: The lot of HBVaxPRO used in the study expired on 14 March 2009. Consequently, the study was continued with ENGERIX-B only for all subjects from 11 March 2009.
    Actual start date of recruitment
    27 Oct 2008
    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
    Italy: 410
    Worldwide total number of subjects
    410
    EEA total number of subjects
    410
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    410
    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 in 5 active centres in Italy.

    Pre-assignment
    Screening details
    		 410 subjects were included and vaccinated during Part I of the study (period 1: booster dose). 405 subjects completed period 1. 15 subjects were vaccinated during Part II of the study: all received 1 extra-dose of Hepatitis B vaccine and 3 of them also received a 2nd extra-dose (period 2: extra-doses).

    Period 1
    Period 1 title
    Booster dose
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable as this study was open-label. For immunogenicity data, serology tests were performed by laboratory staffs which were blinded to the previous hexavalent vaccine history and to which study vaccine each subject received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HEXAVAC / HBVaxPRO (period 1)
    Arm description
    		 # Subjects previously vaccinated with 3 doses of HEXAVAC (at 3, 5, and 11 to 13 months of age) received 1 booster dose of HBVaxPRO (Hepatitis B virus surface antigen, recombinant 5 µg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HBVaxPRO® 5 μg (modified process)
    Investigational medicinal product code
    Other name
    HBVaxPRO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route (deltoid muscle), 1 dose at 4 to 7 years of age.

    Arm title
    		 HEXAVAC / ENGERIX-B (period 1)
    Arm description
    		 # Subjects previously vaccinated with 3 doses of HEXAVAC (at 3, 5, and 11 to 13 months of age) received 1 booster dose of ENGERIX-B (Hepatitis B virus surface antigen (rDNA) 10 µg, adsorbed on amorphous aluminium oxide hydrated 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ENGERIX-B® 10 μg
    Investigational medicinal product code
    Other name
    ENGERIX-B
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route (deltoid muscle), 1 dose at 4 to 7 years of age.

    Arm title
    		 INFANRIX-HEXA / HBVaxPRO (period 1)
    Arm description
    		 # Subjects previously vaccinated with 3 doses of INFANRIX-HEXA (at 3, 5, and 11 to 13 months of age) received 1 booster dose of HBVaxPRO (Hepatitis B virus surface antigen, recombinant 5 µg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HBVaxPRO® 5 μg (modified process)
    Investigational medicinal product code
    Other name
    HBVaxPRO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route (deltoid muscle), 1 dose at 4 to 7 years of age.

    Arm title
    		 INFANRIX-HEXA / ENGERIX-B (period 1)
    Arm description
    		 # Subjects previously vaccinated with 3 doses of INFANRIX-HEXA (at 3, 5, and 11 to 13 months of age) received 1 booster dose of ENGERIX-B (Hepatitis B virus surface antigen (rDNA) 10 µg, adsorbed on amorphous aluminium oxide hydrated 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ENGERIX-B® 10 μg
    Investigational medicinal product code
    Other name
    ENGERIX-B
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route (deltoid muscle), 1 dose at 4 to 7 years of age.

    Number of subjects in period 1
    		HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1)
    Started
    34
    167
    28
    181
    Completed
    33
    164
    28
    180
    Not completed
    1
    3
    0
    1
         Consent withdrawn by subject
    1
    -
    -
    1
         Lost to follow-up
    -
    3
    -
    -
    Period 2
    Period 2 title
    Extra-doses
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable as this study was open-label. For immunogenicity data, serology tests were performed by laboratory staffs which were blinded to the previous hexavalent vaccine history and to which study vaccine each subject received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HEXAVAC / HBVaxPRO (period 2)
    Arm description
    		 # Subject previously vaccinated as planned during period 1 with post-booster anti-HBs Ab titre <10 mIU/mL (N=1, Local Italian Laboratory) received 1 extra-dose of HBVaxPRO by intramuscular route 2 months after the booster dose. # Blood sample was collected 1 month (D28 to D42) after the extra-dose. Note: Local Italian laboratory (Laboratorio Epatite, Università degli Studi di Milano) was used to obtain results on an ongoing basis in order to invite children to continue in part II of the study to receive 1 or 2 additional doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HBVaxPRO® 5 μg (modified process)
    Investigational medicinal product code
    Other name
    HBVaxPRO
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route (deltoid muscle), 1 extra-dose 2 months after the booster dose.

    Arm title
    		 HEXAVAC / ENGERIX-B (period 2)
    Arm description
    		 # Subjects previously vaccinated as planned during period 1 with post-booster anti-HBs Ab titre <10 mIU/mL (N=13, Local Italian laboratory) received 1 extra-dose of ENGERIX-B by intramuscular route 2 months after the booster dose. Out of these 13 subjects, 3 with post-extra-dose 1 anti-HBs Ab titre <10 mIU/mL (local Italian laboratory) received a 2nd extra-dose of ENGERIX-B 6 months after the booster dose. # Blood samples were collected 1 month (D28 to D42) after each extra-dose. Note: Local Italian laboratory (Laboratorio Epatite, Università degli Studi di Milano) was used to obtain results on an ongoing basis in order to invite children to continue in part II of the study to receive 1 or 2 additional doses.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ENGERIX-B® 10 μg
    Investigational medicinal product code
    Other name
    ENGERIX-B
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route (deltoid muscle), 1st extra-dose 2 months after the booster dose, 2nd extra-dose 6 months after the booster dose.

    Arm title
    		 INFANRIX-HEXA / ENGERIX-B (period 2)
    Arm description
    		 # Subject previously vaccinated as planned during period 1 with post-booster anti-HBs Ab titre <10 mIU/mL (N=1, Local Italian Laboratory) received 1 extra-dose of ENGERIX-B by intramuscular route 2 months after the booster dose. # Blood sample was collected 1 month (D28 to D42) after the extra-dose. Note: Local Italian laboratory (Laboratorio Epatite, Università degli Studi di Milano) was used to obtain results on an ongoing basis in order to invite children to continue in part II of the study to receive 1 or 2 additional doses.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ENGERIX-B® 10 μg
    Investigational medicinal product code
    Other name
    ENGERIX-B
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular route (deltoid muscle), 1 extra-dose 2 months after the booster dose.

    Number of subjects in period 2 [1]
    		HEXAVAC / HBVaxPRO (period 2) HEXAVAC / ENGERIX-B (period 2) INFANRIX-HEXA / ENGERIX-B (period 2)
    Started
    1
    13
    1
    Completed
    1
    13
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: For subjects' follow-up, only subjects of period 1 with post-booster anti-HBs antibody titre <10 mIU/mL and anti-HBc antibody titre test negative as measured at the local Italian laboratory were proposed 1 or 2 extra-doses of a Hepatitis B vaccine respectively 2 and 6 months after the booster dose of either HBVaxPRO or ENGERIX-B. Thus, only 15 subjects continued in period 2 of the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HEXAVAC / HBVaxPRO (period 1)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of HEXAVAC (at 3, 5, and 11 to 13 months of age) received 1 booster dose of HBVaxPRO (Hepatitis B virus surface antigen, recombinant 5 µg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.

    Reporting group title
    HEXAVAC / ENGERIX-B (period 1)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of HEXAVAC (at 3, 5, and 11 to 13 months of age) received 1 booster dose of ENGERIX-B (Hepatitis B virus surface antigen (rDNA) 10 µg, adsorbed on amorphous aluminium oxide hydrated 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.

    Reporting group title
    INFANRIX-HEXA / HBVaxPRO (period 1)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of INFANRIX-HEXA (at 3, 5, and 11 to 13 months of age) received 1 booster dose of HBVaxPRO (Hepatitis B virus surface antigen, recombinant 5 µg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.

    Reporting group title
    INFANRIX-HEXA / ENGERIX-B (period 1)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of INFANRIX-HEXA (at 3, 5, and 11 to 13 months of age) received 1 booster dose of ENGERIX-B (Hepatitis B virus surface antigen (rDNA) 10 µg, adsorbed on amorphous aluminium oxide hydrated 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.

    Reporting group values
    		 HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1) Total
    Number of subjects
    		 34 167 28 181 410
    Age categorical
    Age (years) at booster dose.
    Units: Subjects
        Children (2-11 years)
    		 34 167 28 181 410
    Age continuous
    Age at booster dose, Per Protocol Set (PPS), i.e. all randomised subjects without protocol violation which may interfere with the immunogenicity evaluation.
    Units: years
        arithmetic mean (standard deviation)
    		 6.6 ( 0.9 ) 5.7 ( 0.9 ) 5.9 ( 0.7 ) 5.7 ( 0.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 88 15 89 204
        Male
    		 22 79 13 92 206

    End points

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    End points reporting groups
    Reporting group title
    HEXAVAC / HBVaxPRO (period 1)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of HEXAVAC (at 3, 5, and 11 to 13 months of age) received 1 booster dose of HBVaxPRO (Hepatitis B virus surface antigen, recombinant 5 µg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.

    Reporting group title
    HEXAVAC / ENGERIX-B (period 1)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of HEXAVAC (at 3, 5, and 11 to 13 months of age) received 1 booster dose of ENGERIX-B (Hepatitis B virus surface antigen (rDNA) 10 µg, adsorbed on amorphous aluminium oxide hydrated 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.

    Reporting group title
    INFANRIX-HEXA / HBVaxPRO (period 1)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of INFANRIX-HEXA (at 3, 5, and 11 to 13 months of age) received 1 booster dose of HBVaxPRO (Hepatitis B virus surface antigen, recombinant 5 µg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.

    Reporting group title
    INFANRIX-HEXA / ENGERIX-B (period 1)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of INFANRIX-HEXA (at 3, 5, and 11 to 13 months of age) received 1 booster dose of ENGERIX-B (Hepatitis B virus surface antigen (rDNA) 10 µg, adsorbed on amorphous aluminium oxide hydrated 0.25 mg) by intramuscular route at 4 to 7 years of age. # Blood samples were collected on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose.
    Reporting group title
    HEXAVAC / HBVaxPRO (period 2)
    Reporting group description
    		 # Subject previously vaccinated as planned during period 1 with post-booster anti-HBs Ab titre <10 mIU/mL (N=1, Local Italian Laboratory) received 1 extra-dose of HBVaxPRO by intramuscular route 2 months after the booster dose. # Blood sample was collected 1 month (D28 to D42) after the extra-dose. Note: Local Italian laboratory (Laboratorio Epatite, Università degli Studi di Milano) was used to obtain results on an ongoing basis in order to invite children to continue in part II of the study to receive 1 or 2 additional doses.

    Reporting group title
    HEXAVAC / ENGERIX-B (period 2)
    Reporting group description
    		 # Subjects previously vaccinated as planned during period 1 with post-booster anti-HBs Ab titre <10 mIU/mL (N=13, Local Italian laboratory) received 1 extra-dose of ENGERIX-B by intramuscular route 2 months after the booster dose. Out of these 13 subjects, 3 with post-extra-dose 1 anti-HBs Ab titre <10 mIU/mL (local Italian laboratory) received a 2nd extra-dose of ENGERIX-B 6 months after the booster dose. # Blood samples were collected 1 month (D28 to D42) after each extra-dose. Note: Local Italian laboratory (Laboratorio Epatite, Università degli Studi di Milano) was used to obtain results on an ongoing basis in order to invite children to continue in part II of the study to receive 1 or 2 additional doses.

    Reporting group title
    INFANRIX-HEXA / ENGERIX-B (period 2)
    Reporting group description
    		 # Subject previously vaccinated as planned during period 1 with post-booster anti-HBs Ab titre <10 mIU/mL (N=1, Local Italian Laboratory) received 1 extra-dose of ENGERIX-B by intramuscular route 2 months after the booster dose. # Blood sample was collected 1 month (D28 to D42) after the extra-dose. Note: Local Italian laboratory (Laboratorio Epatite, Università degli Studi di Milano) was used to obtain results on an ongoing basis in order to invite children to continue in part II of the study to receive 1 or 2 additional doses.

    Primary: Seroprotection rate: percentage of subjects with an anti-Hepatitis B surface (anti-HBs) antibody titre ≥10 mIU/mL 1 month after the booster dose of either HBVaxPRO or ENGERIX-B

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    End point title
    		 Seroprotection rate: percentage of subjects with an anti-Hepatitis B surface (anti-HBs) antibody titre ≥10 mIU/mL 1 month after the booster dose of either HBVaxPRO or ENGERIX-B [1]
    End point description
    Percentage of subjects with an anti-HBs titre ≥10 mIU/mL measured by the Ortho enhanced chemiluminescence (ECi) assay at PPD Vaccines and Biologics LLC, USA, 1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B. Analysis was done on the Per Protocol Set (PPS), i.e. all randomised subjects without protocol violation which may interfere with the immunogenicity evaluation.
    End point type
    Primary
    End point timeframe
    1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Objectives were only descriptive. Thus no formal statistical hypothesis was tested in this study.
    End point values
    		 HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1)
    Number of subjects analysed
    33
    160
    27
    171
    Units: Percentage of subjects
    number (confidence interval 95%)
        Anti-HBs ≥10 mIU/mL
    90.9 (75.7 to 98.1)
    91.3 (85.8 to 95.1)
    100 (87.2 to 100)
    97.7 (94.1 to 99.4)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with an anti-Hepatitis B surface (anti-HBs) antibody titre # ≥5 mIU/mL, # ≥10 mIU/mL, and # ≥100 mIU/mL pre-booster and 1 month after the booster dose of either HBVaxPRO or ENGERIX-B

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    End point title
    		 Percentage of subjects with an anti-Hepatitis B surface (anti-HBs) antibody titre # ≥5 mIU/mL, # ≥10 mIU/mL, and # ≥100 mIU/mL pre-booster and 1 month after the booster dose of either HBVaxPRO or ENGERIX-B
    End point description
    Percentage of subjects with an anti-HBs titre # ≥5 mIU/mL, # ≥10 mIU/mL, and # ≥100 mIU/mL measured by the Ortho enhanced chemiluminescence (ECi) assay at PPD Vaccines and Biologics LLC, USA, on Day 0 (D0) before booster dose (pre-booster) and 1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B (post-booster). Analysis was done on the Per Protocol Set (PPS), i.e. all randomised subjects without protocol violation which may interfere with the immunogenicity evaluation.
    End point type
    Secondary
    End point timeframe
    # Pre-booster: Day 0 (D0) before booster dose. # Post-booster: 1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B.
    End point values
    		 HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1)
    Number of subjects analysed
    33
    160
    27
    171
    Units: Percentage of subjects
    number (confidence interval 95%)
        Pre-booster anti-HBs ≥5 mIU/mL
    63.6 (45.1 to 79.6)
    44.7 (36.8 to 52.7)
    77.8 (57.7 to 91.4)
    84.8 (78.5 to 89.8)
        Post-booster anti-HBs ≥5 mIU/mL
    97 (84.2 to 99.9)
    91.3 (85.8 to 95.1)
    100 (87.2 to 100)
    98.2 (95 to 99.6)
        Pre-booster anti-HBs ≥10 mIU/mL
    57.6 (39.2 to 74.5)
    35.8 (28.4 to 43.8)
    77.8 (57.7 to 91.4)
    81.9 (75.3 to 87.3)
        Post-booster anti-HBs ≥10 mIU/mL
    90.9 (75.7 to 98.1)
    91.3 (85.8 to 95.1)
    100 (87.2 to 100)
    97.7 (94.1 to 99.4)
        Pre-booster anti-HBs ≥100 mIU/mL
    9.1 (1.9 to 24.3)
    5.7 (2.6 to 10.5)
    40.7 (22.4 to 61.2)
    43.3 (35.7 to 51.1)
        Post-booster anti-HBs ≥100 mIU/mL
    90.9 (75.7 to 98.1)
    81.3 (74.3 to 87)
    96.3 (81 to 99.9)
    95.3 (91 to 98)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titres (GMT) of anti-HBs antibodies pre-booster and 1 month after the booster dose of either HBVaxPRO or ENGERIX-B

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    End point title
    		 Geometric Mean Titres (GMT) of anti-HBs antibodies pre-booster and 1 month after the booster dose of either HBVaxPRO or ENGERIX-B
    End point description
    Study participants were blood sampled on Day 0 (D0) before booster dose (pre-booster) and 1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B (post-booster). Anti-HBs antibody titres expressed in mIU/mL were measured by the Ortho enhanced chemiluminescence (ECi) assay at PPD Vaccines and Biologics LLC, USA. Analysis was done on the Per Protocol Set (PPS), i.e. all randomised subjects without protocol violation which may interfere with the immunogenicity evaluation.
    End point type
    Secondary
    End point timeframe
    # Pre-booster: Day 0 (D0) before booster dose. # Post-booster: 1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B.
    End point values
    		 HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1)
    Number of subjects analysed
    33
    160
    27
    171
    Units: Titres
    geometric mean (confidence interval 95%)
        Pre-booster anti-HBs GMT
    13 (7 to 22)
    8 (6 to 10)
    50 (23 to 109)
    61 (45 to 82)
        Post-booster anti-HBs GMT
    1255 (554 to 2846)
    878 (581 to 1327)
    6564 (2917 to 14772)
    7420 (5227 to 10531)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titres Ratios (GMTR) of individual post-/pre-booster anti-HBs antibody titres 1 month after the booster dose of either HBVaxPRO or ENGERIX-B

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    End point title
    		 Geometric Mean Titres Ratios (GMTR) of individual post-/pre-booster anti-HBs antibody titres 1 month after the booster dose of either HBVaxPRO or ENGERIX-B
    End point description
    Study participants were blood sampled on Day 0 (D0) before booster dose (pre-booster) and 1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B (post-booster). Anti-HBs antibody titres were measured by the Ortho enhanced chemiluminescence (ECi) assay at PPD Vaccines and Biologics LLC, USA. Individual post- (1 month) / pre-booster (D0) anti-HBs titres ratios were measured. Analysis was done on the Per Protocol Set (PPS), i.e. all randomised subjects without protocol violation which may interfere with the immunogenicity evaluation.
    End point type
    Secondary
    End point timeframe
    1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B.
    End point values
    		 HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1)
    Number of subjects analysed
    33
    160
    27
    171
    Units: Not applicable
    geometric mean (confidence interval 95%)
        Anti-HBs GMTR
    100 (57 to 175)
    111 (80 to 154)
    131 (83 to 205)
    122 (96 to 155)
    No statistical analyses for this end point

    Secondary: Global summary of safety from D0 to D14 after the booster dose of either HBVaxPRO or ENGERIX-B

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    End point title
    		 Global summary of safety from D0 to D14 after the booster dose of either HBVaxPRO or ENGERIX-B
    End point description
    Adverse events (AEs) occurring after injection of the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B were recorded as follows. 1/ From D0 to D4: # solicited injection-site adverse reactions (ISRs) (erythema, pain, and swelling), and # solicited systemic AE (pyrexia), 2/ From D0 to D14: # unsolicited ISRs, and # unsolicited systemic AEs. AEs at injection sites were always considered as related to vaccine (ISRs). The investigator had to assess whether systemic AEs were vaccine-related systemic AEs or not. Analysis was done on the Safety Analysis Set (N=407), i.e. all subjects who received at least 1 of the booster study vaccines and who had safety follow-up data.
    End point type
    Secondary
    End point timeframe
    Day 0 (D0) to D14 after injection of the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B.
    End point values
    		 HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1)
    Number of subjects analysed
    34
    164
    28
    181
    Units: Percentage of subjects
    number (confidence interval 95%)
        At least 1 ISR or systemic AE (D0-D14)
    47.1 (29.8 to 64.9)
    38.4 (30.9 to 46.3)
    35.7 (18.6 to 55.9)
    45.9 (38.4 to 53.4)
        At least 1 ISR (D0-D14)
    20.6 (8.7 to 37.9)
    24.4 (18 to 31.7)
    28.6 (13.2 to 48.7)
    38.1 (31 to 45.6)
        At least 1 solicited ISR (D0-D4)
    20.6 (8.7 to 37.9)
    24.4 (18 to 31.7)
    28.6 (13.2 to 48.7)
    37.6 (30.5 to 45.1)
        Injection-site erythema (D0-D4)
    0 (0 to 10.3)
    1.2 (0.1 to 4.3)
    3.6 (0.1 to 18.3)
    8.8 (5.1 to 14)
        Injection-site pain (D0-D4)
    20.6 (8.7 to 37.9)
    23.2 (16.9 to 30.4)
    25 (10.7 to 44.9)
    32.6 (25.8 to 39.9)
        Injection-site swelling (D0-D4)
    0 (0 to 10.3)
    1.8 (0.4 to 5.3)
    7.1 (0.9 to 23.5)
    7.2 (3.9 to 12)
        At least 1 systemic AE (D0-D14)
    29.4 (15.1 to 47.5)
    18.3 (12.7 to 25.1)
    17.9 (6.1 to 36.9)
    20.4 (14.8 to 27.1)
        At least 1 solicited systemic AE: pyrexia (D0-D4)
    8.8 (1.9 to 23.7)
    3.7 (1.4 to 7.8)
    3.6 (0.1 to 18.3)
    2.8 (0.9 to 6.3)
        At least 1 vaccine-related pyrexia (D0-D4)
    0 (0 to 10.3)
    1.8 (0.4 to 5.3)
    3.6 (0.1 to 18.3)
    1.7 (0.3 to 4.8)
    No statistical analyses for this end point

    Secondary: Individual anti-HBs antibody titres 1 month after each extra-dose as measured at PPD Vaccines and Biologics LLC, USA

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    End point title
    		 Individual anti-HBs antibody titres 1 month after each extra-dose as measured at PPD Vaccines and Biologics LLC, USA
    End point description
    # Study participants were blood sampled 1 month after each extra-dose of either HBVaxPRO or ENGERIX-B. # Individual post extra-doses anti-HBs Ab titres expressed in mIU/mL were measured by the Ortho enhanced chemiluminescence (ECi) assay at the USA laboratory in 15 subjects 1 month after extra-dose 1, and in 3 subjects 1 month after extra-dose 2 of either HBVaxPRO or ENGERIX-B. Note: "0" means not applicable, "2.5" means anti-HBs titre <5 mIU/mL.
    End point type
    Secondary
    End point timeframe
    1 month after each extra-dose of either HBVaxPRO or ENGERIX-B.
    End point values
    		 HEXAVAC / HBVaxPRO (period 2) HEXAVAC / ENGERIX-B (period 2) INFANRIX-HEXA / ENGERIX-B (period 2)
    Number of subjects analysed
    1
    13
    1
    Units: Titres (mIU/mL)
    number (not applicable)
        Subject 04005 extra-dose 1
    19.8
    0
    0
        Subject 04012 extra-dose 1
    0
    401
    0
        Subject 04029 extra-dose 1
    0
    2.5
    0
        Subject 04029 extra-dose 2
    0
    52.8
    0
        Subject 04037 extra-dose 1
    0
    15.8
    0
        Subject 04051 extra-dose 1
    0
    2.5
    0
        Subject 04051 extra-dose 2
    0
    269
    0
        Subject 04056 extra-dose 1
    0
    190
    0
        Subject 04059 extra-dose 1
    0
    237
    0
        Subject 04063 extra-dose 1
    0
    680
    0
        Subject 04080 extra-dose 1
    0
    154
    0
        Subject 04086 extra-dose 1
    0
    11.5
    0
        Subject 04114 extra-dose 1
    0
    36.9
    0
        Subject 04136 extra-dose 1
    0
    2.5
    0
        Subject 04136 extra-dose 2
    0
    2.5
    0
        Subject 05049 extra-dose 1
    0
    93.3
    0
        Subject 07026 extra-dose 1
    0
    6.5
    0
        Subject 01031 extra-dose 1
    0
    0
    383
    No statistical analyses for this end point

    Post-hoc: Percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL and ≥100 mIU/mL 1 month after the booster dose of either HBVaxPRO or ENGERIX-B according to the pre-booster anti-HBs antibody titres (<10 mIU/mL or ≥10 mIU/mL)

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    End point title
    		 Percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL and ≥100 mIU/mL 1 month after the booster dose of either HBVaxPRO or ENGERIX-B according to the pre-booster anti-HBs antibody titres (<10 mIU/mL or ≥10 mIU/mL)
    End point description
    Percentage of subjects with an anti-HBs titre # ≥10 mIU/mL and # ≥100 mIU/mL measured by the Ortho enhanced chemiluminescence (ECi) assay at PPD Vaccines and Biologics LLC, USA, 1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B, according to the pre-booster anti-HBs antibody titres (<10 mIU/mL or ≥10 mIU/mL). Post-hoc analysis was done on the Per Protocol Set (PPS), i.e. all randomised subjects without protocol violation which may interfere with the immunogenicity evaluation. Note: (N=***, ***, ***, ***) represents the number of assessed subjects in the HEXAVAC / HBVaxPRO, HEXAVAC / ENGERIX-B, INFANRIX-HEXA / HBVaxPRO, and INFANRIX-HEXA / ENGERIX-B groups, respectively.
    End point type
    Post-hoc
    End point timeframe
    1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B.
    End point values
    		 HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1)
    Number of subjects analysed
    33
    159 [2]
    27
    171
    Units: Percentage of subjects
    number (confidence interval 95%)
        Pre- <10, post-booster ≥10 (N=14, 102, 6, 31)
    78.6 (49.2 to 95.3)
    86.3 (78 to 92.3)
    100 (54.1 to 100)
    90.3 (74.2 to 98)
        Pre- <10, post-booster ≥100 (N=14, 102, 6, 31)
    78.6 (49.2 to 95.3)
    70.6 (60.7 to 79.2)
    83.3 (35.9 to 99.6)
    77.4 (58.9 to 90.4)
        Pre- ≥10, post-booster ≥10 (N=19, 57, 21, 140)
    100 (82.4 to 100)
    100 (93.7 to 100)
    100 (83.9 to 100)
    99.3 (96.1 to 100)
        Pre- ≥10, post-booster ≥100 (N=19, 57, 21, 140)
    100 (82.4 to 100)
    100 (93.7 to 100)
    100 (83.9 to 100)
    99.3 (96.1 to 100)
    Notes
    [2] - 1 pre-booster missing data
    No statistical analyses for this end point

    Post-hoc: Geometric Mean Titres (GMT) of anti-HBs antibodies 1 month after the booster dose of either HBVaxPRO or ENGERIX-B according to the pre-booster anti-HBs antibody titres

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    End point title
    		 Geometric Mean Titres (GMT) of anti-HBs antibodies 1 month after the booster dose of either HBVaxPRO or ENGERIX-B according to the pre-booster anti-HBs antibody titres
    End point description
    Study participants were blood sampled on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose. Anti-HBs antibody titres expressed in mIU/mL were measured by the Ortho enhanced chemiluminescence (ECi) assay at PPD Vaccines and Biologics LLC, USA. Post-hoc analysis was done on the Per Protocol Set (PPS), i.e. all randomised subjects without protocol violation which may interfere with the immunogenicity evaluation. Note: (N=***, ***, ***, ***) represents the number of assessed subjects in the HEXAVAC / HBVaxPRO, HEXAVAC / ENGERIX-B, INFANRIX-HEXA / HBVaxPRO, and INFANRIX-HEXA / ENGERIX-B groups, respectively.
    End point type
    Post-hoc
    End point timeframe
    # Pre-booster: Day 0 (D0) before booster dose. # Post-booster: 1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B.
    End point values
    		 HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1)
    Number of subjects analysed
    33
    159 [3]
    27
    171
    Units: Titres
    geometric mean (confidence interval 95%)
        Pre- <10, pre-booster GMT (N=14, 102, 6, 31)
    3 (2 to 4)
    3 (3 to 3)
    3 (3 to 3)
    3 (3 to 3)
        Pre- <10, post-booster GMT (N=14, 102, 6, 31)
    239 (60 to 944)
    291 (178 to 476)
    564 (104 to 3054)
    307 (141 to 665)
        Pre- ≥10, pre-booster GMT (N=19, 57, 21, 140)
    36 (21 to 62)
    48 (34 to 68)
    118 (67 to 207)
    119 (92 to 153)
        Pre- ≥10, post-booster GMT (N=19, 57, 21, 140)
    4266 (2297 to 7921)
    6372 (4257 to 9538)
    13233 (6447 to 27162)
    15023 (11327 to 19925)
    Notes
    [3] - 1 pre-booster missing data
    No statistical analyses for this end point

    Post-hoc: Geometric Mean Titres Ratios (GMTR) of individual post-/pre-booster anti-HBs antibody titres 1 month after the booster dose of either HBVaxPRO or ENGERIX-B according to the pre-booster anti-HBs antibody titres

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    End point title
    		 Geometric Mean Titres Ratios (GMTR) of individual post-/pre-booster anti-HBs antibody titres 1 month after the booster dose of either HBVaxPRO or ENGERIX-B according to the pre-booster anti-HBs antibody titres
    End point description
    Study participants were blood sampled on Day 0 (D0) before booster dose (pre-booster) and 1 month (D28 to D42) after the booster dose. Anti-HBs antibody titres were measured by the Ortho enhanced chemiluminescence (ECi) assay at PPD Vaccines and Biologics LLC, USA. Individual post- (D28-D42) / pre-booster (D0) anti-HBs titres ratios were calculated. Post-hoc analysis was done on the Per Protocol Set (PPS), i.e. all randomised subjects without protocol violation which may interfere with the immunogenicity evaluation. Note: (N=***, ***, ***, ***) represents the number of assessed subjects in the HEXAVAC / HBVaxPRO, HEXAVAC / ENGERIX-B, INFANRIX-HEXA / HBVaxPRO, and INFANRIX-HEXA / ENGERIX-B groups, respectively.
    End point type
    Post-hoc
    End point timeframe
    1 month after the booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO or ENGERIX-B.
    End point values
    		 HEXAVAC / HBVaxPRO (period 1) HEXAVAC / ENGERIX-B (period 1) INFANRIX-HEXA / HBVaxPRO (period 1) INFANRIX-HEXA / ENGERIX-B (period 1)
    Number of subjects analysed
    33
    159 [4]
    27
    171
    Units: Not applicable
    geometric mean (confidence interval 95%)
        Pre-booster <10 mIU/mL, GMTR (N=14, 102, 6, 31)
    80 (23 to 279)
    100 (62 to 161)
    226 (42 to 1222)
    104 (49 to 221)
        Pre-booster ≥10 mIU/mL, GMTR (N=19, 57, 21, 140)
    117 (72 to 191)
    133 (92 to 193)
    112 (72 to 173)
    127 (99 to 162)
    Notes
    [4] - 1 pre-booster missing data
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited non-serious adverse events (AEs) were collected from D0 to D14 after booster dose. Serious AEs were collected through period 1. Deaths and vaccine-related serious AEs were collected throughout the study.
    Adverse event reporting additional description
    Analysis of AEs was performed on the Safety Analysis Set, i.e. all randomised subjects who received at least 1 vaccination and who had safety follow-up (N=407). Unsolicited non-serious systemic AEs (vaccine-related or not) with incidence ≥1% in at least 1 reporting group are presented hereafter. None of the serious AEs were vaccine-related.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    HBVaxPRO (HEXAVAC)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of HEXAVAC (at 3, 5, and 11 to 13 months of age) received 1 booster dose of HBVaxPRO (Hepatitis B virus surface antigen, recombinant 5 µg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular route at 4 to 7 years of age. # Respectively, 8 (23.5%) subjects reported at least 1 non-serious systemic AE and 1 (2.9%) subject reported 1 vaccine-related non-serious systemic AE within 14 days after booster dose.

    Reporting group title
    HBVaxPRO (INFANRIX-HEXA)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of INFANRIX-HEXA (at 3, 5, and 11 to 13 months of age) received 1 booster dose of HBVaxPRO (Hepatitis B virus surface antigen, recombinant 5 µg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular route at 4 to 7 years of age. # 5 (17.9%) subjects reported at least 1 non-serious systemic AE within 14 days after booster dose. No vaccine-related non-serious systemic AE was reported in this reporting group.

    Reporting group title
    ENGERIX-B (HEXAVAC)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of HEXAVAC (at 3, 5, and 11 to 13 months of age) received 1 booster dose of ENGERIX-B (Hepatitis B virus surface antigen (rDNA) 10 µg, adsorbed on amorphous aluminium oxide hydrated 0.25 mg) by intramuscular route at 4 to 7 years of age. # Respectively, 26 (15.9%) subjects reported at least 1 non-serious systemic AE and 2 (1.2%) subjects reported at least 1 vaccine-related non-serious systemic AE within 14 days after booster dose.

    Reporting group title
    ENGERIX-B (INFANRIX-HEXA)
    Reporting group description
    		 # Subjects previously vaccinated with 3 doses of INFANRIX-HEXA (at 3, 5, and 11 to 13 months of age) received 1 booster dose of ENGERIX-B (Hepatitis B virus surface antigen (rDNA) 10 µg, adsorbed on amorphous aluminium oxide hydrated 0.25 mg) by intramuscular route at 4 to 7 years of age. # Respectively, 34 (18.8%) subjects reported at least 1 non-serious systemic AE and 6 (3.3%) subjects reported at least 1 vaccine-related non-serious systemic AE within 14 days after booster dose.

    Serious adverse events
    		 HBVaxPRO (HEXAVAC) HBVaxPRO (INFANRIX-HEXA) ENGERIX-B (HEXAVAC) ENGERIX-B (INFANRIX-HEXA)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 28 (0.00%)
    3 / 164 (1.83%)
    1 / 181 (0.55%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 28 (0.00%)
    1 / 164 (0.61%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Infectious mononucleosis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 28 (0.00%)
    1 / 164 (0.61%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 28 (0.00%)
    1 / 164 (0.61%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis mycoplasmal
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 28 (0.00%)
    1 / 164 (0.61%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 28 (0.00%)
    0 / 164 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 HBVaxPRO (HEXAVAC) HBVaxPRO (INFANRIX-HEXA) ENGERIX-B (HEXAVAC) ENGERIX-B (INFANRIX-HEXA)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 34 (23.53%)
    5 / 28 (17.86%)
    26 / 164 (15.85%)
    34 / 181 (18.78%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 28 (0.00%)
    0 / 164 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    1
    0
    0
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 28 (3.57%)
    9 / 164 (5.49%)
    12 / 181 (6.63%)
         occurrences all number
    1
    1
    9
    12
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 28 (0.00%)
    2 / 164 (1.22%)
    1 / 181 (0.55%)
         occurrences all number
    1
    0
    2
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 28 (3.57%)
    1 / 164 (0.61%)
    1 / 181 (0.55%)
         occurrences all number
    1
    1
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 28 (0.00%)
    2 / 164 (1.22%)
    2 / 181 (1.10%)
         occurrences all number
    0
    0
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 28 (3.57%)
    2 / 164 (1.22%)
    6 / 181 (3.31%)
         occurrences all number
    1
    1
    2
    6
    Oropharyngeal pain
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 28 (0.00%)
    0 / 164 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    2
    0
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 28 (0.00%)
    0 / 164 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    0
    0
    0
    2
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 28 (7.14%)
    1 / 164 (0.61%)
    6 / 181 (3.31%)
         occurrences all number
    0
    3
    1
    7
    Influenza
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 28 (0.00%)
    0 / 164 (0.00%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 28 (3.57%)
    0 / 164 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    1
    1
    0
    2
    Pharyngitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 28 (3.57%)
    2 / 164 (1.22%)
    4 / 181 (2.21%)
         occurrences all number
    0
    1
    2
    4
    Rhinitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 28 (3.57%)
    0 / 164 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 28 (0.00%)
    1 / 164 (0.61%)
    2 / 181 (1.10%)
         occurrences all number
    0
    0
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2008
    Continuation of the study with ENGERIX-B for all subjects from 11 March 2009 due to expiration of the lot of HBVaxPRO used in the study on 14 March 2009.

    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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