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    Clinical Trial Results:
    A Phase I/IIa, Open-label, Randomised, Controlled, Multi-country, Dose-escalation Study to Assess the Safety and Immunogenicity of AS37 in Combination with the Hepatitis B surface antigen (HBsAg), According to a 0-1 Schedule, in Healthy, HBs naïve, Adults aged 18-45 years

    Summary
    EudraCT number
    		 2021-005629-25
    Trial protocol
    		 DE   BE  
    Global end of trial date
    29 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Dec 2025
    First version publication date
    10 Dec 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    215301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Feb 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the reactogenicity and safety in all study groups.
    Protection of trial subjects
    Study participants were observed closely for at least 60 minutes after the administration of the study interventions. Appropriate medical treatment was readily available during the observation period in case of anaphylaxis or syncope.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2022
    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
    Belgium: 22
    Country: Number of subjects enrolled
    Germany: 65
    Country: Number of subjects enrolled
    United Kingdom: 35
    Worldwide total number of subjects
    122
    EEA total number of subjects
    87
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    122
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All enrolled participants received study intervention and were included in the Exposed set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is an open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HBs-alum Group
    Arm description
    		 Participants received 3 doses of GSK's Hepatitis B (HBs) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK's HB vaccine adjuvanted with aluminum hydroxide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered at Days 1, 31 and 181 in the non-dominant arm.

    Arm title
    		 HBs-AS03 Group
    Arm description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK\'s HBsAg candidate vaccine adjuvanted with GSK\'s AS03 adjuvant system
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered at Days 1 and 31 in the non-dominant arm.

    Arm title
    		 HBs-AS04 Group
    Arm description
    		 Participants received 2 doses of GSK's Hepatitis B vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered at Days 1 and 31 in the non-dominant arm.

    Arm title
    		 HBs-AS37_formulation 1 (Low dose) Group
    Arm description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 1 (Low dose), at Day 1 and Day 31.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection, Suspension for injection, Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered at Days 1 and 31 in the non-dominant arm.

    Arm title
    		 HBs-AS37_formulation 2 (High dose) Group
    Arm description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 2 (High dose), at Day 1 and Day 31.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection, Suspension for injection, Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered at Days 1 and 31 in the non-dominant arm.

    Number of subjects in period 1
    		HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Started
    25
    25
    24
    25
    23
    Completed
    24
    23
    23
    24
    23
    Not completed
    1
    2
    1
    1
    0
         Not specified
    1
    -
    1
    -
    -
         Lost to follow-up
    -
    1
    -
    1
    -
         Consent withdrawal, not due to (S)AE
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HBs-alum Group
    Reporting group description
    		 Participants received 3 doses of GSK's Hepatitis B (HBs) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.

    Reporting group title
    HBs-AS03 Group
    Reporting group description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.

    Reporting group title
    HBs-AS04 Group
    Reporting group description
    		 Participants received 2 doses of GSK's Hepatitis B vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.

    Reporting group title
    HBs-AS37_formulation 1 (Low dose) Group
    Reporting group description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 1 (Low dose), at Day 1 and Day 31.

    Reporting group title
    HBs-AS37_formulation 2 (High dose) Group
    Reporting group description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 2 (High dose), at Day 1 and Day 31.

    Reporting group values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group Total
    Number of subjects
    		 25 25 24 25 23 122
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 25 25 24 25 23 122
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.9 ( 5.8 ) 37.5 ( 6.4 ) 34.5 ( 7.9 ) 38.6 ( 6.0 ) 37.3 ( 7.7 ) -
    Sex: Female, Male
    Units: Participants
        MALE
    		 14 15 14 15 13 71
        FEMALE
    		 11 10 10 10 10 51
    Race/Ethnicity, Customized
    Asian and Black or African American are considered minority races in this study and are presented together under the category "Other Races".
    Units: Subjects
        Other Races
    		 2 0 2 2 1 7
        White
    		 23 25 22 23 22 115

    End points

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    End points reporting groups
    Reporting group title
    HBs-alum Group
    Reporting group description
    		 Participants received 3 doses of GSK's Hepatitis B (HBs) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.

    Reporting group title
    HBs-AS03 Group
    Reporting group description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.

    Reporting group title
    HBs-AS04 Group
    Reporting group description
    		 Participants received 2 doses of GSK's Hepatitis B vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.

    Reporting group title
    HBs-AS37_formulation 1 (Low dose) Group
    Reporting group description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 1 (Low dose), at Day 1 and Day 31.

    Reporting group title
    HBs-AS37_formulation 2 (High dose) Group
    Reporting group description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 2 (High dose), at Day 1 and Day 31.

    Subject analysis set title
    HBs-AS37_formulation 2 (Low dose) Group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 2 (Low dose), at Day 1 and Day 31.

    Subject analysis set title
    HBs-AS37_formulation 2 Group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 2, at Day 1 and Day 31.

    Primary: Number of participants with solicited administration site adverse events (AEs) after dose 1

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    End point title
    		 Number of participants with solicited administration site adverse events (AEs) after dose 1 [1]
    End point description
    Assessed solicited administration site events after vaccination included erythema, pain, and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. The analysis was performed on the Exposed Set (ES), which included all participants who received at least 1 dose of the study intervention. Only participants with solicited administration site events diary card available after dose 1 administration for the specified duration were included in this analysis.
    End point type
    Primary
    End point timeframe
    Day 1 (day of administration) to Day 14
    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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Participants
        Erythema
    0
    0
    0
    0
    0
        Pain
    6
    17
    21
    16
    18
        Swelling
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with solicited administration site AEs after dose 2

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    End point title
    		 Number of participants with solicited administration site AEs after dose 2 [2]
    End point description
    Assessed solicited administration site events after vaccination included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. The analysis was performed on the ES. Only participants with solicited administration site events diary card available after dose 2 administration for the specified duration were included in this analysis.
    End point type
    Primary
    End point timeframe
    Day 31 (day of administration) to Day 45
    Notes
    [2] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    24
    23
    25
    23
    Units: Participants
        Erythema
    0
    0
    0
    0
    0
        Pain
    1
    15
    16
    14
    14
        Swelling
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with solicited systemic AEs after dose 1

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    End point title
    		 Number of participants with solicited systemic AEs after dose 1 [3]
    End point description
    Assessed solicited systemic events included fever (defined as temperature greater than or equal to (>=) 38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea. The analysis was performed on the ES. Only participants with solicited systemic events diary card available after dose 1 administration for the specified duration were included in this analysis.
    End point type
    Primary
    End point timeframe
    Day 1 (day of administration) to Day 14
    Notes
    [3] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Participants
        Arthralgia
    1
    2
    2
    2
    1
        Chills
    2
    0
    0
    1
    1
        Diarrhea
    3
    2
    4
    0
    2
        Fatigue
    9
    10
    10
    12
    11
        Headache
    8
    9
    8
    10
    10
        Loss of appetite
    1
    4
    2
    1
    0
        Malaise
    8
    2
    7
    3
    2
        Myalgia
    8
    6
    14
    7
    9
        Nausea
    6
    0
    3
    1
    1
        Fever
    1
    2
    1
    2
    0
        Vomiting
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with solicited systemic AEs after dose 2

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    End point title
    		 Number of participants with solicited systemic AEs after dose 2 [4]
    End point description
    Assessed solicited systemic events included fever (defined as temperature >=38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea. The analysis was performed on the ES. Only participants with solicited systemic events diary card available after dose 2 administration for the specified duration were included in this analysis.
    End point type
    Primary
    End point timeframe
    Day 31 (day of administration) to Day 45
    Notes
    [4] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    24
    23
    25
    23
    Units: Participants
        Arthralgia
    2
    3
    1
    1
    1
        Chills
    2
    4
    0
    1
    2
        Diarrhea
    3
    2
    1
    1
    1
        Fatigue
    9
    8
    8
    7
    5
        Headache
    9
    8
    7
    7
    4
        Loss of appetite
    3
    2
    0
    0
    1
        Malaise
    6
    7
    1
    3
    2
        Myalgia
    2
    7
    12
    6
    7
        Nausea
    2
    1
    3
    1
    2
        Fever
    1
    1
    1
    1
    1
        Vomiting
    0
    0
    0
    1
    1
    No statistical analyses for this end point

    Primary: Duration in days of solicited administration site AEs after dose 1

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    End point title
    		 Duration in days of solicited administration site AEs after dose 1 [5]
    End point description
    Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period. The only solicited administration site event presented is pain. The analysis was performed on the ES. Only participants who experienced solicited administration site events after dose 1 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited administration site events at dose 1. 99999= no data available.
    End point type
    Primary
    End point timeframe
    Day 1 (day of administration) to Day 14
    Notes
    [5] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    6
    17
    21
    16
    18
    Units: Days
        median (inter-quartile range (Q1-Q3))
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 3.0)
    3.0 (1.0 to 4.0)
    2.0 (1.0 to 3.0)
    1.0 (1.0 to 2.0)
    No statistical analyses for this end point

    Primary: Duration in days of solicited administration site AEs after dose 2

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    End point title
    		 Duration in days of solicited administration site AEs after dose 2 [6]
    End point description
    Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period. The only solicited administration site event presented is pain. The analysis was performed on the ES. Only participants who experienced solicited administration site events after dose 2 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited administration site events at dose 2.
    End point type
    Primary
    End point timeframe
    Day 31 (day of administration) to Day 45
    Notes
    [6] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    1
    15
    16
    14
    14
    Units: Days
        median (inter-quartile range (Q1-Q3))
    1.0 (1.0 to 1.0)
    2.0 (2.0 to 3.0)
    4.0 (2.5 to 5.0)
    1.5 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
    No statistical analyses for this end point

    Primary: Duration in days of solicited systemic AEs after dose 1

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    End point title
    		 Duration in days of solicited systemic AEs after dose 1 [7]
    End point description
    Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period. The analysis was performed on the ES. Only participants who experienced solicited systemic events after dose 1 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited systemic events at dose 1. 99999= no data available.
    End point type
    Primary
    End point timeframe
    Day 1 (day of administration) to Day 14
    Notes
    [7] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    9
    10
    14
    12
    11
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Arthralgia (N=1,2,2,2,1)
    2.0 (2.0 to 2.0)
    1.5 (1.0 to 2.0)
    1.0 (1.0 to 1.0)
    2.0 (1.0 to 3.0)
    1.0 (1.0 to 1.0)
        Chills (N=2,0,0,1,1)
    1.5 (1.0 to 2.0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    1.0 (1.0 to 1.0)
    3.0 (3.0 to 3.0)
        Diarrhea (N=3,2,4,0,2)
    1.0 (1.0 to 3.0)
    1.0 (1.0 to 1.0)
    1.5 (1.0 to 2.0)
    99999 (99999 to 99999)
    1.0 (1.0 to 1.0)
        Fatigue (N=9,10,10,12,11)
    1.0 (1.0 to 3.0)
    2.0 (1.0 to 4.0)
    1.0 (1.0 to 3.0)
    1.0 (1.0 to 2.0)
    2.0 (1.0 to 2.0)
        Headache (N=8,9,8,10,10)
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
    1.5 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 1.0)
        Loss of appetite (N=1,4,2,1,0)
    5.0 (5.0 to 5.0)
    1.5 (1.0 to 2.0)
    1.5 (1.0 to 2.0)
    4.0 (4.0 to 4.0)
    99999 (99999 to 99999)
        Malaise (N=8,2,7,3,2)
    1.0 (1.0 to 2.0)
    1.5 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 3.0)
    1.0 (1.0 to 1.0)
        Myalgia (N-8,6,14,7,9)
    1.5 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
    2.0 (1.0 to 4.0)
    1.0 (1.0 to 2.0)
    2.0 (1.0 to 2.0)
        Nausea (6,0,3,1,1)
    1.0 (1.0 to 2.0)
    99999 (99999 to 99999)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        Fever (N=1,2,1,2,0)
    1.0 (1.0 to 1.0)
    2.5 (2.0 to 3.0)
    3.0 (3.0 to 3.0)
    3.0 (2.0 to 4.0)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Primary: Duration in days of solicited systemic AEs after dose 2

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    End point title
    		 Duration in days of solicited systemic AEs after dose 2 [8]
    End point description
    Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period. The analysis was performed on the ES. Only participants who experienced solicited systemic events after dose 2 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited systemic events at dose 2.
    End point type
    Primary
    End point timeframe
    Day 31 (day of administration) to Day 45
    Notes
    [8] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    9
    8
    12
    7
    7
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Arthralgia (N=2,3,1,1,1)
    2.0 (1.0 to 3.0)
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 1.0)
    5.0 (5.0 to 5.0)
    1.0 (1.0 to 1.0)
        Chills (N=2,4,0,1,2)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.5)
    99999 (99999 to 99999)
    1.0 (1.0 to 1.0)
    1.5 (1.0 to 2.0)
        Diarrhea (N=3,2,1,1,1)
    1.0 (1.0 to 2.0)
    1.5 (1.0 to 2.0)
    2.0 (2.0 to 2.0)
    2.0 (2.0 to 2.0)
    1.0 (1.0 to 1.0)
        Fatigue (N=9,8,8,7,5)
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.5)
    1.5 (1.0 to 4.0)
    2.0 (1.0 to 3.0)
    1.0 (1.0 to 1.0)
        Headache (N=9,8,7,7,4)
    1.0 (1.0 to 1.0)
    1.5 (1.0 to 2.5)
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 4.0)
    2.0 (1.0 to 3.5)
        Loss of appetite (N=3,2,0,0,1)
    1.0 (1.0 to 5.0)
    2.0 (1.0 to 3.0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    1.0 (1.0 to 1.0)
        Malaise (N=6,7,1,3,2)
    2.5 (2.0 to 3.0)
    1.0 (1.0 to 2.0)
    3.0 (3.0 to 3.0)
    2.0 (1.0 to 6.0)
    1.5 (1.0 to 2.0)
        Myalgia (N=2,7,12,6,7)
    2.5 (1.0 to 4.0)
    2.0 (1.0 to 4.0)
    2.5 (1.5 to 3.5)
    2.0 (1.0 to 3.0)
    1.0 (1.0 to 3.0)
        Nausea (N=2,1,3,1,2)
    2.5 (2.0 to 3.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    2.0 (2.0 to 2.0)
    1.0 (1.0 to 1.0)
        Fever (N=1,1,1,1,1)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    4.0 (4.0 to 4.0)
    1.0 (1.0 to 1.0)
    2.0 (2.0 to 2.0)
        Vomiting (N=0,0,0,1,1)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    1.0 (1.0 to 1.0)
    2.0 (2.0 to 2.0)
    No statistical analyses for this end point

    Primary: Number of participants with any unsolicited AEs after dose 1

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    End point title
    		 Number of participants with any unsolicited AEs after dose 1 [9]
    End point description
    An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. The analysis was performed on the ES. Only participants with unsolicited AEs after dose 1 administration for the specified duration were included in this analysis.
    End point type
    Primary
    End point timeframe
    Day 1 (day of administration) to Day 31
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Participants
    7
    2
    6
    4
    5
    No statistical analyses for this end point

    Primary: Number of participants with any unsolicited AEs after dose 2

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    End point title
    		 Number of participants with any unsolicited AEs after dose 2 [10]
    End point description
    Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. The analysis was performed on the ES. Only participants with unsolicited AEs after dose 2 administration for the specified duration were included in this analysis.
    End point type
    Primary
    End point timeframe
    Day 31 (day of administration) to Day 61
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    24
    23
    25
    23
    Units: Participants
    5
    7
    6
    6
    6
    No statistical analyses for this end point

    Primary: Number of participants with serious AEs (SAEs)

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    End point title
    		 Number of participants with serious AEs (SAEs) [11]
    End point description
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is an abnormal pregnancy outcome. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. The analysis was performed on the ES.
    End point type
    Primary
    End point timeframe
    Throughout the entire study period (from Day 1 to Day 361)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Participants
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of participants with medically attended AEs (MAEs)

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    End point title
    		 Number of participants with medically attended AEs (MAEs) [12]
    End point description
    An MAE is any AE with medically attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the MAE regardless of intensity grade or relation to the study vaccination. The analysis was performed on the ES.
    End point type
    Primary
    End point timeframe
    Throughout the entire study period (from Day 1 to Day 361)
    Notes
    [12] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Participants
    8
    2
    2
    3
    4
    No statistical analyses for this end point

    Primary: Number of participants with AEs leading to study withdrawal

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    End point title
    		 Number of participants with AEs leading to study withdrawal [13]
    End point description
    An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. The analysis was performed on the ES.
    End point type
    Primary
    End point timeframe
    Throughout the entire study period (from Day 1 to Day 361)
    Notes
    [13] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Participants
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with potential mediated immune diseases (pIMDs)

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    End point title
    		 Number of participants with potential mediated immune diseases (pIMDs) [14]
    End point description
    pIMDs are a subset of adverse events that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. The analysis was performed on the ES.
    End point type
    Primary
    End point timeframe
    Throughout the entire study period (from Day 1 to Day 361)
    Notes
    [14] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Participants
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 1

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    End point title
    		 Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 1 [15]
    End point description
    In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified duration were included in analysis.
    End point type
    Primary
    End point timeframe
    At Day 1 (baseline)
    Notes
    [15] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Participants
        ALT|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        AST|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Bicarbonate, Day 1|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    1
        Blood urea nitrogen|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Chloride|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        C Reactive Protein|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Creatinine|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Potassium|Below (N=25,25,24,25,23)
    0
    0
    1
    0
    0
        Sodium|Below (N=25,25,24,25,23)
    0
    0
    0
    1
    0
        Eosinophils|Below (N=25,25,24,25,23)
    1
    1
    1
    3
    2
        Erythrocytes|Below (N=25,25,24,25,23)
    1
    1
    3
    2
    1
        Hemoglobin|Below (N=25,25,24,25,23)
    3
    0
    5
    3
    3
        Lymphocytes|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Platelets|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Monocytes|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    1
        Neutrophils|Below (N=25,25,24,25,23)
    1
    1
    2
    1
    1
        WBC|Below (N=24,25,24,25,23)
    3
    1
    1
    0
    1
        ALT|Within (N=25,25,24,25,23)
    21
    21
    23
    23
    21
        AST|Within (N=25,25,24,25,23)
    22
    24
    24
    25
    22
        Bicarbonate, Day 1|Within (N=25,25,24,25,23)
    25
    25
    24
    25
    22
        Blood urea nitrogen|Within (N=25,25,24,25,23)
    24
    23
    22
    24
    23
        Chloride|Within (N=25,25,24,25,23)
    25
    24
    24
    25
    23
        C Reactive Protein|Within (N=25,25,24,25,23)
    24
    24
    21
    23
    20
        Creatinine|Within (N=25,25,24,25,23)
    24
    22
    22
    23
    23
        Potassium|Within (N=25,25,24,25,23)
    25
    25
    23
    25
    23
        Sodium|Within (N=25,25,24,25,23)
    25
    25
    24
    24
    23
        Eosinophils|Within (N=25,25,24,25,23)
    24
    23
    22
    21
    21
        Erythrocytes|Within (N=25,25,24,25,23)
    24
    24
    21
    22
    22
        Hemoglobin|Within (N=25,25,24,25,23)
    22
    25
    19
    22
    20
        Lymphocytes|Within (N=25,25,24,25,23)
    25
    25
    24
    25
    23
        Platelets|Within (N=25,25,24,25,23)
    25
    24
    22
    25
    23
        Monocytes|Within (N=25,25,24,25,23)
    25
    25
    24
    25
    22
        Neutrophils|Within (N=25,25,24,25,23)
    24
    24
    22
    24
    22
        WBC|Within (N=24,25,24,25,23)
    21
    23
    23
    24
    22
        ALT|Above (N=25,25,24,25,23)
    4
    4
    1
    2
    2
        AST|Above (N=25,25,24,25,23)
    3
    1
    0
    0
    1
        Bicarbonate, Day 1|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Blood urea nitrogen|Above (N=25,25,24,25,23)
    1
    2
    2
    1
    0
        Chloride|Above (N=25,25,24,25,23)
    0
    1
    0
    0
    0
        C Reactive Protein|Above (N=25,25,24,25,23)
    1
    1
    3
    2
    3
        Creatinine|Above (N=25,25,24,25,23)
    1
    3
    2
    2
    0
        Potassium|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Sodium|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Eosinophils|Above (N=25,25,24,25,23)
    0
    1
    1
    1
    0
        Erythrocytes|Above (N=25,25,24,25,23)
    0
    0
    0
    1
    0
        Hemoglobin|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Lymphocytes|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Platelets|Above (N=25,25,24,25,23)
    0
    1
    2
    0
    0
        Monocytes|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Neutrophils|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        WBC|Above (N=24,25,24,25,23)
    0
    1
    0
    1
    0
        ALT|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        AST|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Bicarbonate, Day 1|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Blood urea nitrogen|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Chloride|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        C Reactive Protein|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Creatinine|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Potassium|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Sodium|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Eosinophils|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Erythrocytes|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Hemoglobin|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Lymphocytes|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Platelets|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Monocytes|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Neutrophils|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        WBC|Missing (N=24,25,24,25,23)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 8

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    End point title
    		 Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 8 [16]
    End point description
    In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified duration were included in analysis.
    End point type
    Primary
    End point timeframe
    At Day 8
    Notes
    [16] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Participants
        ALT|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        AST|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Bicarbonate|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Blood urea nitrogen|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Chloride|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    1
        C Reactive Protein|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Creatinine|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Potassium|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Sodium|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    1
        Eosinophils|Below (N=25,25,24,25,23)
    2
    0
    1
    2
    2
        Erythrocytes|Below (N=25,25,24,25,23)
    1
    0
    2
    1
    1
        Hemoglobin|Below (N=25,25,24,25,23)
    4
    0
    5
    1
    3
        Lymphocytes|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Platelets|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Monocytes|Below (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Neutrophils|Below (N=25,25,24,25,23)
    1
    1
    1
    0
    1
        WBC|Below (N=24,25,24,25,23)
    1
    1
    1
    0
    1
        ALT|Within (N=25,25,24,25,23)
    23
    22
    22
    22
    21
        AST|Within (N=25,25,24,25,23)
    24
    24
    24
    24
    23
        Bicarbonate|Within (N=25,25,24,25,23)
    24
    25
    24
    25
    23
        Blood urea nitrogen|Within (N=25,25,24,25,23)
    25
    22
    23
    25
    22
        Chloride|Within (N=25,25,24,25,23)
    25
    25
    23
    25
    22
        C Reactive Protein|Within (N=25,25,24,25,23)
    23
    24
    21
    24
    21
        Creatinine|Within (N=25,25,24,25,23)
    23
    23
    24
    24
    20
        Potassium|Within (N=25,25,24,25,23)
    24
    25
    23
    24
    23
        Sodium|Within (N=25,25,24,25,23)
    25
    25
    24
    25
    22
        Eosinophils|Within (N=25,25,24,25,23)
    22
    24
    23
    21
    19
        Erythrocytes|Within (N=25,25,24,25,23)
    23
    25
    22
    23
    21
        Hemoglobin|Within (N=25,25,24,25,23)
    20
    25
    19
    24
    19
        Lymphocytes|Within (N=25,25,24,25,23)
    24
    25
    24
    24
    22
        Platelets|Within (N=25,25,24,25,23)
    24
    23
    22
    25
    22
        Monocytes|Within (N=25,25,24,25,23)
    24
    25
    24
    24
    22
        Neutrophils|Within (N=25,25,24,25,23)
    23
    24
    22
    24
    21
        WBC|Within (N=24,25,24,25,23)
    22
    24
    23
    24
    20
        ALT|Above (N=25,25,24,25,23)
    2
    3
    2
    3
    2
        AST|Above (N=25,25,24,25,23)
    1
    1
    0
    1
    0
        Bicarbonate|Above (N=25,25,24,25,23)
    1
    0
    0
    0
    0
        Blood urea nitrogen|Above (N=25,25,24,25,23)
    0
    3
    1
    0
    1
        Chloride|Above (N=25,25,24,25,23)
    0
    0
    1
    0
    0
        C Reactive Protein|Above (N=25,25,24,25,23)
    2
    1
    3
    1
    2
        Creatinine|Above (N=25,25,24,25,23)
    2
    2
    0
    1
    3
        Potassium|Above (N=25,25,24,25,23)
    1
    0
    1
    1
    0
        Sodium|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Eosinophils|Above (N=25,25,24,25,23)
    0
    1
    0
    1
    1
        Erythrocytes|Above (N=25,25,24,25,23)
    0
    0
    0
    1
    0
        Hemoglobin|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Lymphocytes|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Platelets|Above (N=25,25,24,25,23)
    0
    2
    1
    0
    0
        Monocytes|Above (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Neutrophils|Above (N=25,25,24,25,23)
    0
    0
    1
    0
    0
        WBC|Above (N=24,25,24,25,23)
    1
    0
    0
    1
    1
        ALT|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        AST|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Bicarbonate|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Blood urea nitrogen|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Chloride|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        C Reactive Protein|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Creatinine|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Potassium|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Sodium|Missing (N=25,25,24,25,23)
    0
    0
    0
    0
    0
        Eosinophils|Missing (N=25,25,24,25,23)
    1
    0
    0
    1
    1
        Erythrocytes|Missing (N=25,25,24,25,23)
    1
    0
    0
    0
    1
        Hemoglobin|Missing (N=25,25,24,25,23)
    1
    0
    0
    0
    1
        Lymphocytes|Missing (N=25,25,24,25,23)
    1
    0
    0
    1
    1
        Platelets|Missing (N=25,25,24,25,23)
    1
    0
    1
    0
    1
        Monocytes|Missing (N=25,25,24,25,23)
    1
    0
    0
    1
    1
        Neutrophils|Missing (N=25,25,24,25,23)
    1
    0
    0
    1
    1
        WBC|Missing (N=24,25,24,25,23)
    0
    0
    0
    0
    1
    No statistical analyses for this end point

    Primary: Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 31

    		 Close Top of page
    End point title
    		 Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 31 [17]
    End point description
    In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified duration were included in analysis.
    End point type
    Primary
    End point timeframe
    At Day 31
    Notes
    [17] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    24
    23
    25
    23
    Units: Participants
        ALT|Below
    0
    0
    0
    0
    0
        AST|Below
    0
    0
    0
    0
    0
        Bicarbonate|Below
    0
    0
    0
    0
    0
        Blood urea nitrogen|Below
    0
    0
    0
    0
    0
        Chloride|Below
    0
    0
    0
    0
    0
        C Reactive Protein|Below
    0
    0
    0
    0
    0
        Creatinine|Below
    0
    0
    0
    0
    0
        Potassium|Below
    0
    1
    0
    1
    0
        Sodium|Below
    0
    1
    1
    0
    2
        Eosinophils|Below
    0
    0
    1
    2
    1
        Erythrocytes|Below
    0
    1
    5
    1
    2
        Hemoglobin|Below
    3
    1
    5
    2
    4
        Lymphocytes|Below
    0
    0
    0
    0
    0
        Platelets|Below
    0
    0
    0
    0
    0
        Monocytes|Below
    1
    0
    0
    0
    0
        Neutrophils|Below
    0
    1
    0
    1
    1
        WBC|Below
    1
    1
    0
    1
    1
        ALT|Within
    19
    19
    22
    21
    22
        AST|Within
    22
    23
    21
    24
    23
        Bicarbonate|Within
    24
    24
    23
    24
    23
        Blood urea nitrogen|Within
    23
    21
    22
    23
    20
        Chloride|Within
    24
    24
    23
    23
    22
        C Reactive Protein|Within
    22
    23
    17
    25
    20
        Creatinine|Within
    24
    22
    23
    22
    22
        Potassium|Within
    24
    23
    23
    22
    23
        Sodium|Within
    24
    23
    22
    24
    21
        Eosinophils|Within
    23
    23
    22
    21
    22
        Erythrocytes|Within
    24
    23
    18
    23
    21
        Hemoglobin|Within
    21
    23
    17
    22
    19
        Lymphocytes|Within
    24
    24
    23
    24
    23
        Platelets|Within
    23
    23
    22
    24
    22
        Monocytes|Within
    23
    24
    23
    24
    23
        Neutrophils|Within
    24
    23
    23
    23
    20
        WBC|Within
    22
    22
    23
    22
    21
        ALT|Above
    5
    5
    1
    3
    1
        AST|Above
    2
    1
    2
    0
    0
        Bicarbonate|Above
    0
    0
    0
    0
    0
        Blood urea nitrogen|Above
    1
    3
    1
    1
    3
        Chloride|Above
    0
    0
    0
    1
    1
        C Reactive Protein|Above
    2
    1
    6
    0
    3
        Creatinine|Above
    0
    2
    0
    2
    1
        Potassium|Above
    0
    0
    0
    1
    0
        Sodium|Above
    0
    0
    0
    0
    0
        Eosinophils|Above
    1
    1
    0
    1
    0
        Erythrocytes|Above
    0
    0
    0
    0
    0
        Hemoglobin|Above
    0
    0
    1
    0
    0
        Lymphocytes|Above
    0
    0
    0
    0
    0
        Platelets|Above
    1
    1
    1
    0
    1
        Monocytes|Above
    0
    0
    0
    0
    0
        Neutrophils|Above
    0
    0
    0
    0
    2
        WBC|Above
    1
    1
    0
    1
    1
        ALT|Missing
    0
    0
    0
    1
    0
        AST|Missing
    0
    0
    0
    1
    0
        Bicarbonate|Missing
    0
    0
    0
    1
    0
        Blood urea nitrogen|Missing
    0
    0
    0
    1
    0
        Chloride|Missing
    0
    0
    0
    1
    0
        C Reactive Protein|Missing
    0
    0
    0
    0
    0
        Creatinine|Missing
    0
    0
    0
    1
    0
        Potassium|Missing
    0
    0
    0
    1
    0
        Sodium|Missing
    0
    0
    0
    1
    0
        Eosinophils|Missing
    0
    0
    0
    1
    0
        Erythrocytes|Missing
    0
    0
    0
    1
    0
        Hemoglobin|Missing
    0
    0
    0
    1
    0
        Lymphocytes|Missing
    0
    0
    0
    1
    0
        Platelets|Missing
    0
    0
    0
    1
    0
        Monocytes|Missing
    0
    0
    0
    1
    0
        Neutrophils|Missing
    0
    0
    0
    1
    0
        WBC|Missing
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 38

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    End point title
    		 Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 38 [18]
    End point description
    In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified duration were included in analysis.
    End point type
    Primary
    End point timeframe
    At Day 38
    Notes
    [18] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    23
    22
    25
    23
    Units: Participants
        ALT|Below
    0
    0
    0
    0
    0
        AST|Below
    0
    0
    0
    0
    0
        Bicarbonate|Below
    1
    0
    1
    0
    1
        Blood urea nitrogen|Below
    0
    0
    0
    0
    0
        Chloride|Below
    0
    0
    0
    0
    1
        C Reactive Protein|Below
    0
    0
    0
    0
    0
        Creatinine|Below
    0
    0
    0
    0
    0
        Potassium|Below
    0
    0
    1
    0
    0
        Sodium|Below
    0
    1
    0
    0
    1
        Eosinophils|Below
    0
    1
    0
    0
    1
        Erythrocytes|Below
    1
    0
    1
    1
    1
        Hemoglobin|Below
    3
    1
    6
    2
    5
        Lymphocytes|Below
    0
    1
    0
    0
    1
        Platelets|Below
    0
    0
    0
    0
    0
        Monocytes|Below
    0
    0
    0
    0
    0
        Neutrophils|Below
    3
    2
    0
    1
    0
        WBC|Below
    3
    2
    0
    0
    0
        ALT|Within
    19
    21
    20
    23
    22
        AST|Within
    22
    22
    22
    24
    23
        Bicarbonate|Within
    21
    22
    21
    25
    21
        Blood urea nitrogen|Within
    23
    22
    20
    24
    22
        Chloride|Within
    22
    23
    22
    25
    22
        C Reactive Protein|Within
    19
    20
    17
    24
    21
        Creatinine|Within
    22
    21
    21
    25
    21
        Potassium|Within
    23
    23
    20
    25
    22
        Sodium|Within
    23
    22
    22
    25
    22
        Eosinophils|Within
    21
    21
    22
    24
    22
        Erythrocytes|Within
    22
    23
    21
    23
    22
        Hemoglobin|Within
    20
    22
    16
    23
    18
        Lymphocytes|Within
    22
    22
    21
    25
    22
        Platelets|Within
    23
    23
    20
    25
    22
        Monocytes|Within
    22
    23
    21
    25
    23
        Neutrophils|Within
    18
    19
    22
    23
    23
        WBC|Within
    19
    19
    21
    24
    23
        ALT|Above
    4
    2
    2
    2
    1
        AST|Above
    1
    1
    0
    1
    0
        Bicarbonate|Above
    1
    1
    0
    0
    1
        Blood urea nitrogen|Above
    0
    1
    2
    1
    1
        Chloride|Above
    1
    0
    0
    0
    0
        C Reactive Protein|Above
    4
    3
    5
    1
    2
        Creatinine|Above
    1
    2
    1
    0
    2
        Potassium|Above
    0
    0
    1
    0
    1
        Sodium|Above
    0
    0
    0
    0
    0
        Eosinophils|Above
    1
    1
    0
    1
    0
        Erythrocytes|Above
    0
    0
    0
    1
    0
        Hemoglobin|Above
    0
    0
    0
    0
    0
        Lymphocytes|Above
    0
    0
    1
    0
    0
        Platelets|Above
    0
    0
    2
    0
    1
        Monocytes|Above
    0
    0
    1
    0
    0
        Neutrophils|Above
    1
    2
    0
    1
    0
        WBC|Above
    1
    2
    1
    1
    0
        ALT|Missing
    1
    0
    0
    0
    0
        AST|Missing
    1
    0
    0
    0
    0
        Bicarbonate|Missing
    1
    0
    0
    0
    0
        Blood urea nitrogen|Missing
    1
    0
    0
    0
    0
        Chloride|Missing
    1
    0
    0
    0
    0
        C Reactive Protein|Missing
    1
    0
    0
    0
    0
        Creatinine|Missing
    1
    0
    0
    0
    0
        Potassium|Missing
    1
    0
    0
    0
    0
        Sodium|Missing
    1
    0
    0
    0
    0
        Eosinophils|Missing
    2
    0
    0
    0
    0
        Erythrocytes|Missing
    1
    0
    0
    0
    0
        Hemoglobin|Missing
    1
    0
    0
    0
    0
        Lymphocytes|Missing
    2
    0
    0
    0
    0
        Platelets|Missing
    1
    0
    0
    0
    0
        Monocytes|Missing
    2
    0
    0
    0
    0
        Neutrophils|Missing
    2
    0
    0
    0
    0
        WBC|Missing
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 61

    		 Close Top of page
    End point title
    		 Number of participants with abnormal hematology and biochemistry laboratory parameter values at Day 61 [19]
    End point description
    In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified duration were included in analysis.
    End point type
    Primary
    End point timeframe
    At Day 61
    Notes
    [19] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    24
    23
    25
    23
    Units: Participants
        ALT|Below (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        AST|Below (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Bicarbonate|Below (N=24,24,23,25,23)
    0
    0
    0
    2
    1
        Blood urea nitrogen|Below (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Chloride|Below (N=24,24,23,25,23)
    0
    0
    0
    0
    1
        C Reactive Protein|Below (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Creatinine|Below (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Potassium|Below (N=24,24,23,25,23)
    0
    0
    1
    0
    0
        Sodium|Below (N=24,24,23,25,23)
    0
    0
    0
    0
    2
        Eosinophils|Below (N=24,24,23,25,23)
    0
    0
    1
    0
    1
        Erythrocytes|Below (N=24,24,23,25,23)
    1
    1
    4
    3
    0
        Hemoglobin|Below (N=24,24,23,25,23)
    4
    1
    5
    4
    3
        Lymphocytes|Below (N=23,24,23,25,23)
    0
    0
    0
    0
    1
        Platelets|Below (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Monocytes|Below (N=23,24,23,25,23)
    0
    0
    0
    1
    0
        Neutrophils|Below (N=23,24,23,25,23)
    0
    0
    1
    2
    0
        WBC|Below (N=24,24,23,25,23)
    1
    2
    0
    1
    0
        ALT|Within (N=24,24,23,25,23)
    21
    20
    21
    23
    20
        AST|Within (N=24,24,23,25,23)
    21
    21
    22
    24
    22
        Bicarbonate|Within (N=24,24,23,25,23)
    24
    23
    23
    23
    22
        Blood urea nitrogen|Within (N=24,24,23,25,23)
    23
    22
    21
    25
    23
        Chloride|Within (N=24,24,23,25,23)
    24
    23
    22
    25
    22
        C Reactive Protein|Within (N=24,24,23,25,23)
    20
    21
    17
    24
    20
        Creatinine|Within (N=24,24,23,25,23)
    23
    21
    22
    24
    22
        Potassium|Within (N=24,24,23,25,23)
    23
    21
    22
    24
    23
        Sodium|Within (N=24,24,23,25,23)
    24
    23
    23
    25
    21
        Eosinophils|Within (N=24,24,23,25,23)
    21
    23
    22
    24
    22
        Erythrocytes|Within (N=24,24,23,25,23)
    22
    23
    19
    21
    23
        Hemoglobin|Within (N=24,24,23,25,23)
    19
    23
    18
    21
    20
        Lymphocytes|Within (N=23,24,23,25,23)
    23
    24
    23
    25
    22
        Platelets|Within (N=24,24,23,25,23)
    22
    22
    21
    24
    23
        Monocytes|Within (N=23,24,23,25,23)
    23
    24
    23
    24
    23
        Neutrophils|Within (N=23,24,23,25,23)
    21
    23
    22
    22
    23
        WBC|Within (N=24,24,23,25,23)
    20
    21
    23
    22
    22
        ALT|Above (N=24,24,23,25,23)
    3
    4
    2
    2
    3
        AST|Above (N=24,24,23,25,23)
    3
    3
    1
    1
    1
        Bicarbonate|Above (N=24,24,23,25,23)
    0
    1
    0
    0
    0
        Blood urea nitrogen|Above (N=24,24,23,25,23)
    1
    2
    2
    0
    0
        Chloride|Above (N=24,24,23,25,23)
    0
    1
    1
    0
    0
        C Reactive Protein|Above (N=24,24,23,25,23)
    4
    3
    5
    1
    3
        Creatinine|Above (N=24,24,23,25,23)
    1
    3
    1
    1
    1
        Potassium|Above (N=24,24,23,25,23)
    1
    3
    0
    1
    0
        Sodium|Above (N=24,24,23,25,23)
    0
    1
    0
    0
    0
        Eosinophils|Above (N=24,24,23,25,23)
    1
    1
    0
    1
    0
        Erythrocytes|Above (N=24,24,23,25,23)
    0
    0
    0
    1
    0
        Hemoglobin|Above (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Lymphocytes|Above (N=23,24,23,25,23)
    0
    0
    0
    0
    0
        Platelets|Above (N=24,24,23,25,23)
    0
    2
    2
    0
    0
        Monocytes|Above (N=23,24,23,25,23)
    0
    0
    0
    0
    0
        Neutrophils|Above (N=24,24,23,25,23)
    2
    1
    0
    1
    0
        WBC|Above (N=24,24,23,25,23)
    2
    1
    0
    2
    1
        ALT|Missing (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        AST|Missing (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Bicarbonate|Missing (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Blood urea nitrogen|Missing (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Chloride|Missing (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        C Reactive Protein|Missing (N=24,24,23,25,23)
    0
    0
    1
    0
    0
        Creatinine|Missing (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Potassium|Missing (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Sodium|Missing (N=24,24,23,25,23)
    0
    0
    0
    0
    0
        Eosinophils|Missing (N=24,24,23,25,23)
    2
    0
    0
    0
    0
        Erythrocytes|Missing (N=24,24,23,25,23)
    1
    0
    0
    0
    0
        Hemoglobin|Missing (N=24,24,23,25,23)
    1
    0
    0
    0
    0
        Lymphocytes|Missing (N=23,24,23,25,23)
    0
    0
    0
    0
    0
        Platelets|Missing (N=24,24,23,25,23)
    2
    0
    0
    1
    0
        Monocytes|Missing (N=23,24,23,25,23)
    0
    0
    0
    0
    0
        Neutrophils|Missing (N=23,24,23,25,23)
    0
    0
    0
    0
    0
        WBC|Missing (N=24,24,23,25,23)
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Mean percent change from baseline (pre-vaccination, Day 1) in hematology and biochemistry parameters post-dose 1 (Day 8 relative to baseline [pre-vaccination Day 1])

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    End point title
    		 Mean percent change from baseline (pre-vaccination, Day 1) in hematology and biochemistry parameters post-dose 1 (Day 8 relative to baseline [pre-vaccination Day 1]) [20]
    End point description
    In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC). The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 1 administration were available for the specified duration were included in analysis.
    End point type
    Primary
    End point timeframe
    At Day 8 (relative to baseline [pre-vaccination Day 1])
    Notes
    [20] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    25
    24
    25
    23
    Units: Mean percent change from baseline
    arithmetic mean (standard deviation)
        ALT (N=25,25,24,25,23)
    -3.04 ( 20.322 )
    -6.69 ( 14.117 )
    -1.13 ( 34.221 )
    8.14 ( 25.853 )
    0.95 ( 15.926 )
        AST (N=25,25,24,25,23)
    4.74 ( 17.106 )
    -5.62 ( 14.509 )
    -1.79 ( 18.626 )
    7.35 ( 24.486 )
    2.28 ( 16.477 )
        Bicarbonate (N=25,25,24,25,23)
    0.52 ( 7.789 )
    -0.19 ( 8.276 )
    3.68 ( 8.491 )
    0.06 ( 10.180 )
    4.16 ( 7.337 )
        Blood urea nitrogen (N=25,25,24,25,23)
    2.60 ( 29.717 )
    -3.03 ( 19.264 )
    1.84 ( 32.456 )
    0.09 ( 25.501 )
    -0.63 ( 15.543 )
        Chloride (N=25,25,24,25,23)
    0.79 ( 1.921 )
    0.23 ( 2.119 )
    -0.11 ( 2.000 )
    -0.33 ( 2.247 )
    -0.24 ( 2.119 )
        C Reactive Protein (N=25,25,24,25,23)
    78.43 ( 349.570 )
    41.16 ( 124.844 )
    129.65 ( 393.365 )
    5.72 ( 57.451 )
    -6.50 ( 45.671 )
        Creatinine (N=25,25,24,25,23)
    0.34 ( 8.164 )
    -2.35 ( 10.278 )
    -2.01 ( 7.209 )
    -0.10 ( 9.989 )
    0.76 ( 9.176 )
        Potassium (N=25,25,24,25,23)
    1.88 ( 8.648 )
    -0.14 ( 8.133 )
    1.91 ( 8.313 )
    2.43 ( 7.932 )
    0.27 ( 6.323 )
        Sodium (N=25,25,24,25,23)
    0.26 ( 1.204 )
    0.18 ( 1.376 )
    0.27 ( 1.438 )
    0.04 ( 1.481 )
    0.19 ( 1.253 )
        Eosinophils (N=24,25,24,24,22)
    20.35 ( 45.285 )
    31.51 ( 76.423 )
    -3.33 ( 46.839 )
    18.15 ( 45.276 )
    12.86 ( 38.767 )
        Erythrocytes (N=24,25,24,25,22)
    -2.06 ( 3.756 )
    -1.01 ( 3.786 )
    -0.67 ( 4.423 )
    0.45 ( 5.160 )
    -0.21 ( 4.384 )
        Hemoglobin (N=24,25,24,25,22)
    -2.17 ( 3.729 )
    -0.94 ( 3.817 )
    -0.60 ( 3.892 )
    0.74 ( 5.156 )
    -0.36 ( 4.075 )
        Lymphocytes (N=24,25,24,25,22)
    8.79 ( 18.849 )
    6.58 ( 23.996 )
    1.25 ( 25.224 )
    7.80 ( 32.898 )
    4.04 ( 15.252 )
        Platelets (N=24,25,24,25,22)
    1.56 ( 10.141 )
    2.84 ( 7.234 )
    5.10 ( 10.605 )
    4.72 ( 10.952 )
    5.67 ( 11.517 )
        Monocytes (N=24,25,24,25,22)
    8.83 ( 23.264 )
    6.20 ( 24.148 )
    7.31 ( 36.121 )
    12.52 ( 35.758 )
    4.98 ( 24.417 )
        Neutrophils (N=24,25,24,25,22)
    2.69 ( 27.341 )
    -2.23 ( 28.410 )
    14.24 ( 38.460 )
    2.03 ( 25.842 )
    4.70 ( 28.444 )
        WBC (N=24,25,24,25,22)
    4.06 ( 16.847 )
    0.88 ( 17.754 )
    7.58 ( 19.074 )
    0.26 ( 21.314 )
    3.53 ( 18.126 )
    No statistical analyses for this end point

    Primary: Mean percent change from baseline (pre-vaccination, Day 1) in hematology and biochemistry parameters post-dose 1 (Day 31 compared with baseline [pre-vaccination, Day 1])

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    End point title
    		 Mean percent change from baseline (pre-vaccination, Day 1) in hematology and biochemistry parameters post-dose 1 (Day 31 compared with baseline [pre-vaccination, Day 1]) [21]
    End point description
    In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 1 administration were available for the specified duration were included in analysis.
    End point type
    Primary
    End point timeframe
    At Day 31 (compared with baseline [pre-vaccination, Day 1])
    Notes
    [21] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    24
    23
    25
    23
    Units: Mean percent change from baseline
    arithmetic mean (standard deviation)
        ALT (N=24,24,23,24,23)
    -2.45 ( 32.837 )
    12.52 ( 81.650 )
    2.94 ( 25.235 )
    5.89 ( 25.561 )
    3.07 ( 27.915 )
        AST (N=24,24,23,24,23)
    -0.60 ( 22.151 )
    0.12 ( 25.394 )
    3.33 ( 31.456 )
    3.21 ( 22.040 )
    4.57 ( 21.930 )
        Bicarbonate (N=24,24,23,24,23)
    0.58 ( 11.020 )
    -2.47 ( 9.490 )
    0.78 ( 10.526 )
    -0.20 ( 9.834 )
    4.65 ( 12.535 )
        Blood urea nitrogen (N=24,24,23,24,23)
    -1.04 ( 17.638 )
    1.42 ( 23.387 )
    -5.65 ( 27.995 )
    -3.27 ( 27.699 )
    3.70 ( 23.551 )
        Chloride (N=24,24,23,24,23)
    0.76 ( 2.430 )
    0.29 ( 2.668 )
    -0.16 ( 1.836 )
    0.09 ( 2.059 )
    0.17 ( 2.022 )
        C Reactive Protein (N=24,24,23,24,23)
    23.07 ( 94.084 )
    37.95 ( 143.597 )
    130.90 ( 518.895 )
    12.48 ( 63.081 )
    77.00 ( 358.139 )
        Creatinine (N=24,24,23,24,23)
    -3.73 ( 8.529 )
    -4.69 ( 9.817 )
    -1.37 ( 7.374 )
    -1.77 ( 9.931 )
    -2.23 ( 9.222 )
        Potassium (N=24,24,23,24,23)
    -1.60 ( 6.867 )
    0.23 ( 7.493 )
    -0.78 ( 7.674 )
    2.46 ( 8.750 )
    -1.54 ( 6.611 )
        Sodium (N=24,24,23,24,23)
    0.18 ( 1.273 )
    0.49 ( 1.486 )
    -0.28 ( 1.113 )
    0.31 ( 1.221 )
    0.13 ( 1.318 )
        Eosinophils (N=24,24,23,24,23)
    61.95 ( 156.721 )
    10.80 ( 47.476 )
    6.13 ( 42.536 )
    43.03 ( 99.613 )
    0.88 ( 44.640 )
        Erythrocytes (N=24,24,23,24,23)
    -2.30 ( 3.813 )
    -0.71 ( 3.877 )
    -1.14 ( 5.730 )
    0.76 ( 4.317 )
    -1.06 ( 5.496 )
        Hemoglobin (N=24,24,23,24,23)
    -1.99 ( 4.925 )
    -0.25 ( 3.795 )
    -0.75 ( 5.168 )
    0.92 ( 4.328 )
    -1.06 ( 4.325 )
        Lymphocytes (N=24,24,23,24,23)
    3.44 ( 15.877 )
    5.02 ( 23.147 )
    4.16 ( 24.245 )
    -0.47 ( 22.632 )
    0.61 ( 17.722 )
        Platelets (N=24,24,23,24,23)
    -4.21 ( 10.893 )
    -1.86 ( 13.771 )
    1.72 ( 10.562 )
    2.92 ( 9.752 )
    0.68 ( 10.344 )
        Monocytes (N=24,24,23,24,23)
    8.76 ( 44.115 )
    9.84 ( 30.487 )
    5.31 ( 30.151 )
    7.75 ( 34.218 )
    9.96 ( 29.752 )
        Neutrophils (N=24,24,23,24,23)
    10.63 ( 43.055 )
    2.47 ( 29.935 )
    8.26 ( 27.070 )
    -0.67 ( 24.740 )
    12.13 ( 32.091 )
        WBC (N=24,24,23,24,23)
    6.65 ( 26.757 )
    2.37 ( 18.732 )
    5.78 ( 20.170 )
    -2.04 ( 18.832 )
    6.17 ( 19.512 )
    No statistical analyses for this end point

    Primary: Mean percent change from baseline (pre-vaccination, Day 1) in hematology and biochemistry parameters post-dose 2 (Day 38 compared with baseline [pre-vaccination, Day 1])

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    End point title
    		 Mean percent change from baseline (pre-vaccination, Day 1) in hematology and biochemistry parameters post-dose 2 (Day 38 compared with baseline [pre-vaccination, Day 1]) [22]
    End point description
    In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 2 administration were available for the specified duration were included in analysis.
    End point type
    Primary
    End point timeframe
    At Day 38 (compared with baseline [pre-vaccination, Day 1])
    Notes
    [22] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    23
    23
    22
    25
    23
    Units: Mean percent change from baseline
    arithmetic mean (standard deviation)
        ALT (N=23,23,22,25,23)
    -1.70 ( 28.091 )
    -9.56 ( 28.152 )
    8.70 ( 40.893 )
    7.81 ( 24.159 )
    -4.15 ( 19.568 )
        AST(N=23,23,22,25,23)
    1.91 ( 26.199 )
    -7.81 ( 21.151 )
    11.34 ( 41.922 )
    5.63 ( 17.430 )
    -2.19 ( 18.087 )
        Bicarbonate(N=23,23,22,25,23)
    -0.10 ( 11.002 )
    1.04 ( 7.590 )
    4.41 ( 12.016 )
    0.75 ( 9.389 )
    5.04 ( 11.085 )
        Blood urea nitrogen(N=23,23,22,25,23)
    2.83 ( 30.148 )
    -1.73 ( 23.632 )
    2.30 ( 39.154 )
    0.69 ( 28.712 )
    5.34 ( 23.796 )
        Chloride(N=23,23,22,25,23)
    0.39 ( 1.824 )
    -0.18 ( 2.413 )
    -0.96 ( 2.079 )
    -0.46 ( 2.004 )
    0.39 ( 2.058 )
        C Reactive Protein(N=23,23,22,25,23)
    57.03 ( 191.211 )
    131.87 ( 475.577 )
    55.41 ( 110.350 )
    146.04 ( 584.663 )
    3.02 ( 66.364 )
        Creatinine (N=23,23,22,25,23)
    1.18 ( 10.007 )
    -2.71 ( 8.546 )
    -0.25 ( 7.389 )
    0.61 ( 11.670 )
    1.40 ( 9.723 )
        Potassium (N=23,23,22,25,23)
    -0.11 ( 8.188 )
    0.30 ( 10.244 )
    1.76 ( 10.350 )
    1.83 ( 8.246 )
    2.15 ( 7.425 )
        Sodium (N=23,23,22,25,23)
    0.31 ( 0.802 )
    0.32 ( 1.833 )
    -0.03 ( 1.268 )
    0.01 ( 1.225 )
    0.38 ( 1.128 )
        Eosinophils (N=23,23,22,25,23)
    103.21 ( 216.663 )
    64.45 ( 142.771 )
    27.38 ( 65.060 )
    35.67 ( 96.666 )
    6.21 ( 58.498 )
        Erythrocytes (N=23,23,22,25,23)
    -2.59 ( 4.677 )
    -0.54 ( 3.879 )
    0.01 ( 5.660 )
    0.66 ( 4.466 )
    -1.46 ( 5.741 )
        Hemoglobin (N=23,23,22,25,23)
    -1.89 ( 5.602 )
    -0.44 ( 3.530 )
    -0.05 ( 5.064 )
    0.88 ( 4.548 )
    -2.32 ( 3.201 )
        Lymphocytes (N=22,23,22,25,23)
    2.35 ( 22.056 )
    8.61 ( 23.233 )
    15.80 ( 31.316 )
    2.46 ( 25.691 )
    0.10 ( 23.742 )
        Platelets (N=23,23,22,25,23)
    1.41 ( 11.656 )
    5.25 ( 14.869 )
    6.56 ( 11.374 )
    2.33 ( 10.113 )
    3.02 ( 14.577 )
        Monocytes (N=22,23,22,25,23)
    20.33 ( 52.053 )
    5.44 ( 29.929 )
    23.51 ( 31.162 )
    10.00 ( 32.556 )
    10.95 ( 42.691 )
        Neutrophils (N=22,23,22,25,23)
    8.11 ( 39.675 )
    10.17 ( 55.015 )
    12.80 ( 27.430 )
    -5.36 ( 24.208 )
    -3.26 ( 32.341 )
        WBC (N=23,23,22,25,23)
    5.34 ( 24.916 )
    8.19 ( 34.765 )
    12.42 ( 18.141 )
    -3.72 ( 16.095 )
    -3.79 ( 19.528 )
    No statistical analyses for this end point

    Primary: Mean percent change from baseline (pre-vaccination, Day 1) in hematology and biochemistry parameters post-dose 2 (Day 61 compared with baseline [pre-vaccination, Day 1])

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    End point title
    		 Mean percent change from baseline (pre-vaccination, Day 1) in hematology and biochemistry parameters post-dose 2 (Day 61 compared with baseline [pre-vaccination, Day 1]) [23]
    End point description
    In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 2 administration were available for the specified duration were included in analysis.
    End point type
    Primary
    End point timeframe
    At Day 61 (compared with baseline [pre-vaccination, Day 1])
    Notes
    [23] - 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: This endpoint was descriptive, hence no statistical hypothesis was tested.
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    24
    23
    25
    23
    Units: Mean percent change from baseline
    arithmetic mean (standard deviation)
        ALT (N=24,24,23,25,23)
    -4.71 ( 27.145 )
    61.39 ( 318.144 )
    12.94 ( 49.927 )
    4.67 ( 36.939 )
    13.83 ( 63.700 )
        AST (N=24,24,23,25,23)
    8.19 ( 43.555 )
    42.91 ( 171.398 )
    18.51 ( 68.383 )
    8.78 ( 47.643 )
    3.47 ( 33.308 )
        Bicarbonate (N=24,24,23,25,23)
    0.66 ( 8.676 )
    -2.36 ( 8.453 )
    3.17 ( 9.880 )
    -3.21 ( 10.373 )
    4.64 ( 12.554 )
        Blood urea nitrogen (N=24,24,23,25,23)
    8.26 ( 26.719 )
    -1.24 ( 32.101 )
    -4.94 ( 21.078 )
    -2.00 ( 25.429 )
    2.60 ( 21.312 )
        Chloride (N=24,24,23,25,23)
    -0.22 ( 2.006 )
    0.48 ( 2.157 )
    0.09 ( 1.691 )
    -0.14 ( 2.311 )
    0.01 ( 1.803 )
        C Reactive Protein (N=24,24,23,25,23)
    64.02 ( 180.495 )
    121.89 ( 432.514 )
    79.61 ( 218.741 )
    91.49 ( 237.304 )
    109.50 ( 512.035 )
        Creatinine (N=24,24,23,25,23)
    2.96 ( 13.010 )
    -1.84 ( 13.034 )
    1.15 ( 11.041 )
    -3.95 ( 8.215 )
    -1.20 ( 7.048 )
        Potassium (N=24,24,23,25,23)
    0.33 ( 9.316 )
    3.34 ( 10.727 )
    -1.88 ( 7.115 )
    1.17 ( 8.379 )
    -0.21 ( 6.832 )
        Sodium (N=24,24,23,25,23)
    -0.35 ( 1.278 )
    0.34 ( 1.881 )
    0.44 ( 1.278 )
    -0.33 ( 1.156 )
    0.25 ( 1.335 )
        Eosinophils (N=23,24,23,25,23)
    20.20 ( 32.608 )
    32.37 ( 59.533 )
    42.38 ( 91.920 )
    57.74 ( 144.539 )
    17.59 ( 63.368 )
        Erythrocytes (N=23,24,23,25,23)
    -0.86 ( 5.037 )
    0.65 ( 5.327 )
    -0.76 ( 5.901 )
    0.51 ( 4.813 )
    -0.63 ( 5.596 )
        Hemoglobin (N=23,24,23,25,23)
    -0.86 ( 6.190 )
    0.49 ( 4.971 )
    -0.85 ( 5.363 )
    0.60 ( 4.671 )
    -1.01 ( 3.466 )
        Lymphocytes (N=23,24,23,25,23)
    6.43 ( 21.692 )
    2.32 ( 18.547 )
    9.74 ( 32.460 )
    -1.74 ( 27.336 )
    4.92 ( 21.356 )
        Platelets (N=22,24,23,25,23)
    -1.29 ( 11.369 )
    2.12 ( 15.566 )
    1.35 ( 12.342 )
    3.77 ( 10.156 )
    3.47 ( 11.839 )
        Monocytes (N=23,24,23,25,23)
    21.95 ( 56.206 )
    12.47 ( 32.131 )
    15.05 ( 30.852 )
    5.66 ( 35.371 )
    15.01 ( 42.423 )
        Neutrophils (N=23,24,23,25,23)
    3.81 ( 33.133 )
    -6.10 ( 40.627 )
    8.68 ( 31.904 )
    4.91 ( 34.720 )
    12.12 ( 42.077 )
        WBC (N=23,24,23,25,23)
    5.16 ( 22.729 )
    -3.20 ( 25.520 )
    9.32 ( 24.511 )
    0.84 ( 24.001 )
    7.14 ( 25.180 )
    No statistical analyses for this end point

    Secondary: Geometric mean concentration (GMC) of anti-HBs antibody concentrations

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    End point title
    		 Geometric mean concentration (GMC) of anti-HBs antibody concentrations
    End point description
    Anti-HBs antibody concentration was measured as GMC and expressed in milli international units per milliliter (mIU/mL). The analysis was performed on the Per-Protocol set (PPS), which included all participants who received all doses as per protocol, had immunogenicity results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at the specified timepoints were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Day 1, Day 31, Day 61 and Day 361
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    25
    24
    23
    24
    23
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Day 1 (N=25,24,23,24,23)
    3.4 (3.0 to 3.8)
    3.1 (3.1 to 3.1)
    3.1 (3.1 to 3.1)
    3.1 (3.1 to 3.1)
    3.1 (3.1 to 3.1)
        Day 31 (N=24,22,23,22,21)
    7.7 (3.0 to 20.0)
    204.9 (62.8 to 668.4)
    8.3 (3.4 to 20.2)
    22.0 (10.4 to 46.6)
    95.2 (27.6 to 327.5)
        Day 61 (N=24,21,24,22,21)
    40.3 (14.3 to 113.1)
    7193.0 (4062.5 to 12735.8)
    86.3 (41.1 to 181.0)
    401.3 (212.0 to 759.8)
    1574.2 (600.6 to 4125.7)
        Day 361 (N=21,19,22,20,23)
    1055.9 (359.2 to 3103.7)
    3211.8 (2252.4 to 4579.7)
    41.4 (18.9 to 90.6)
    153.2 (81.6 to 287.7)
    586.3 (242.2 to 1419.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants who seroconverted for anti-HBs

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    End point title
    		 Percentage of participants who seroconverted for anti-HBs
    End point description
    A participant who seroconverted for anti-HBs is defined as a participant with an anti-HBs antibody concentration higher than (>) 6.2 mIU/mL. The analysis was performed on the PPS. Only participants with data available at the specified timepoints were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Day 31, Day 61 and Day 361
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    22
    23
    22
    23
    Units: Percentage of participants
    number (confidence interval 95%)
        Day 31 (N=24,22,23,22,21)
    16.7 (4.7 to 37.4)
    95.5 (77.2 to 99.9)
    21.7 (7.5 to 43.7)
    59.1 (36.4 to 79.3)
    81.0 (58.1 to 94.6)
        Day 61 (N=24,21,23,22,21)
    75.0 (53.3 to 90.2)
    100 (83.9 to 100)
    87.0 (66.4 to 97.2)
    100 (84.6 to 100)
    100 (83.9 to 100)
        Day 361 (N=21,19,22,20,23)
    95.2 (76.2 to 99.9)
    100 (82.4 to 100)
    72.7 (49.8 to 89.3)
    100 (83.2 to 100)
    100 (85.2 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of participants seroprotected for anti-HBs

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    End point title
    		 Percentage of participants seroprotected for anti-HBs
    End point description
    A participant seroprotected for anti-HBs is defined as a participant with an anti-HBs antibody concentration >10 mIU/mL. The analysis was performed on the PPS. Only participants with data available at the specified timepoints were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Day 31, Day 61 and Day 361
    End point values
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Number of subjects analysed
    24
    22
    23
    22
    23
    Units: Percentage of participants
    number (confidence interval 95%)
        Day 31 (N=24,22,23,22,21)
    16.7 (4.7 to 37.4)
    95.5 (77.2 to 99.9)
    21.7 (7.5 to 43.7)
    59.1 (36.4 to 79.3)
    81.0 (58.1 to 94.6)
        Day 61 (N=24,21,23,22,21)
    62.5 (40.6 to 81.2)
    100 (83.9 to 100)
    87.0 (66.4 to 97.2)
    100 (84.6 to 100)
    100 (83.9 to 100)
        Day 361 (N=21,19,22,20,23)
    95.2 (76.2 to 99.9)
    100 (82.4 to 100)
    72.7 (49.8 to 89.3)
    100 (83.2 to 100)
    100 (85.2 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: within 14 days after any vaccination. Unsolicited AEs: within 31 days after any vaccination. All-cause mortality, SAEs, MAEs, AEs leading to withdrawal and pIMDs: from first vaccination (Day 1) until study end (Day 361)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    HBs-alum Group
    Reporting group description
    		 Participants received 3 doses of GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.

    Reporting group title
    HBs-AS03 Group
    Reporting group description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.

    Reporting group title
    HBs-AS04 Group
    Reporting group description
    		 Participants received 2 doses of GSK's Hepatitis B vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.

    Reporting group title
    HBs-AS37_formulation 1 (Low dose) Group
    Reporting group description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 1 (Low dose), at Day 1 and Day 31.

    Reporting group title
    HBs-AS37_formulation 2 (High dose) Group
    Reporting group description
    		 Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS37 adjuvant system formulation 2 (High dose), at Day 1 and Day 31.

    Serious adverse events
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HBs-alum Group HBs-AS03 Group HBs-AS04 Group HBs-AS37_formulation 1 (Low dose) Group HBs-AS37_formulation 2 (High dose) Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 25 (96.00%)
    21 / 25 (84.00%)
    23 / 24 (95.83%)
    23 / 25 (92.00%)
    23 / 23 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    10 / 25 (40.00%)
    7 / 25 (28.00%)
    8 / 24 (33.33%)
    4 / 25 (16.00%)
    4 / 23 (17.39%)
         occurrences all number
    14
    9
    8
    6
    4
    Administration site pain
         subjects affected / exposed
    7 / 25 (28.00%)
    20 / 25 (80.00%)
    22 / 24 (91.67%)
    18 / 25 (72.00%)
    21 / 23 (91.30%)
         occurrences all number
    7
    32
    37
    30
    32
    Fatigue
         subjects affected / exposed
    15 / 25 (60.00%)
    14 / 25 (56.00%)
    12 / 24 (50.00%)
    14 / 25 (56.00%)
    11 / 23 (47.83%)
         occurrences all number
    18
    18
    18
    19
    16
    Chills
         subjects affected / exposed
    4 / 25 (16.00%)
    4 / 25 (16.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    3 / 23 (13.04%)
         occurrences all number
    4
    4
    0
    2
    3
    Pyrexia
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 25 (8.00%)
    1 / 24 (4.17%)
    2 / 25 (8.00%)
    1 / 23 (4.35%)
         occurrences all number
    2
    3
    2
    3
    1
    Injection site inflammation
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Swelling face
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vaccination site discomfort
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Throat irritation
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood potassium increased
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    1
    0
    0
    2
    Arthropod sting
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Tendon injury
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 25 (52.00%)
    12 / 25 (48.00%)
    10 / 24 (41.67%)
    13 / 25 (52.00%)
    12 / 23 (52.17%)
         occurrences all number
    17
    17
    15
    18
    17
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    5 / 25 (20.00%)
    4 / 25 (16.00%)
    5 / 24 (20.83%)
    1 / 25 (4.00%)
    3 / 23 (13.04%)
         occurrences all number
    6
    4
    5
    1
    3
    Nausea
         subjects affected / exposed
    7 / 25 (28.00%)
    1 / 25 (4.00%)
    5 / 24 (20.83%)
    1 / 25 (4.00%)
    2 / 23 (8.70%)
         occurrences all number
    8
    1
    6
    2
    3
    Vomiting
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    1 / 24 (4.17%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    Arthralgia
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 25 (20.00%)
    3 / 24 (12.50%)
    3 / 25 (12.00%)
    2 / 23 (8.70%)
         occurrences all number
    3
    5
    3
    3
    2
    Myalgia
         subjects affected / exposed
    10 / 25 (40.00%)
    11 / 25 (44.00%)
    15 / 24 (62.50%)
    9 / 25 (36.00%)
    13 / 23 (56.52%)
         occurrences all number
    10
    13
    28
    13
    16
    Neck pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    0
    1
    1
    Pain in extremity
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 25 (12.00%)
    1 / 24 (4.17%)
    3 / 25 (12.00%)
    2 / 23 (8.70%)
         occurrences all number
    1
    3
    1
    3
    2
    Bacterial vaginosis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cervicitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Chronic sinusitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Fungal foot infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 25 (16.00%)
    5 / 25 (20.00%)
    2 / 24 (8.33%)
    1 / 25 (4.00%)
    1 / 23 (4.35%)
         occurrences all number
    4
    6
    2
    1
    1
    Increased appetite
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Aug 2022
    The amendment was developed to update the study holding rules, delete reference to emergency unblinding, and to preform minor editorial corrections.
    17 Nov 2023
    The amendment was developed to revise the enrollment number necessary for the study.
    17 Sep 2024
    The amendment was developed to update the tertiary objectives based on data obtained in the main immunogenicity analysis and availability of alternative assays.

    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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