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    Clinical Trial Results:
    A Phase 2 single-blind, randomized, controlled, single center study to assess the immunogenicity and safety of a 2-dose schedule with GVGH altSonflex1-2-3 vaccine in African infants (H06_02TP)

    Summary
    EudraCT number
    		 2023-000945-18
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Feb 2026

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2026
    First version publication date
    20 Jun 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    219449
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    79 New Oxford Street, London, WC1A 1DG, United Kingdom, TW8 9GS
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Feb 2026
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Feb 2026
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity profile and the seroresponse of the altSonflex1-2-3 vaccine (low, medium and high dose) administered at 9 and 15 months of age using anti-LPS/OAg enzyme-linked immunosorbent assay (ELISA).
    Protection of trial subjects
    Participants were closely monitored for safety including vaccine reactogenicity and any symptoms of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Nov 2024
    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
    Kenya: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    200
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All 200 participants enrolled in the study 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
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 altSonflex1-2-3 Low Dose Group
    Arm description
    		 Participants received 2 low doses of altSonflex1-2-3 and 2 doses of the measles and rubella vaccine (MR-VAC) one each on Day 1 and Day 169.
    Arm type
    		 Experimental

    Investigational medicinal product name
    measles and rubella vaccine (MR-VAC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 doses of MR-VAC administered on Day 1 and Day 169.

    Investigational medicinal product name
    altSonflex1-2-3 low dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 low doses of altSonflex1-2-3 administered on Day 1 and Day 169.

    Arm title
    		 altSonflex1-2-3 Medium Dose Group
    Arm description
    		 Participants received 2 medium doses of altSonflex1-2-3 and 2 doses of MR-VAC one each on Day 1 and Day 169.
    Arm type
    		 Experimental

    Investigational medicinal product name
    measles and rubella vaccine (MR-VAC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 doses of MR-VAC administered on Day 1 and Day 169.

    Investigational medicinal product name
    altSonflex1-2-3 medium dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 medium doses of altSonflex1-2-3 administered on Day 1 and Day 169.

    Arm title
    		 altSonflex1-2-3 High Dose Group
    Arm description
    		 Participants received 2 high doses of altSonflex1-2-3 and 2 doses of MR-VAC one each on Day 1 and Day 169.
    Arm type
    		 Experimental

    Investigational medicinal product name
    altSonflex1-2-3 high dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 high doses of altSonflex1-2-3 administered on Day 1 and Day 169.

    Investigational medicinal product name
    measles and rubella vaccine (MR-VAC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 doses of MR-VAC administered on Day 1 and Day 169.

    Arm title
    		 Control Group
    Arm description
    		 Participants received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix Hexa vaccine on Day 169, along with 2 doses of MR-VAC on Day 1 and Day 169.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    measles and rubella vaccine (MR-VAC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 doses of MR-VAC administered on Day 1 and Day 169.

    Investigational medicinal product name
    Infanrix Hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of the Infanrix Hexa vaccine administered on Day 169.

    Investigational medicinal product name
    Typhibev
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of the Typhibev vaccine administered on Day 1.

    Number of subjects in period 1
    		altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Started
    50
    50
    50
    50
    Completed
    47
    42
    48
    48
    Not completed
    3
    8
    2
    2
         Consent withdrawn by subject
    1
    5
    2
    2
         Not specified
    -
    1
    -
    -
         Lost to follow-up
    2
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    altSonflex1-2-3 Low Dose Group
    Reporting group description
    		 Participants received 2 low doses of altSonflex1-2-3 and 2 doses of the measles and rubella vaccine (MR-VAC) one each on Day 1 and Day 169.

    Reporting group title
    altSonflex1-2-3 Medium Dose Group
    Reporting group description
    		 Participants received 2 medium doses of altSonflex1-2-3 and 2 doses of MR-VAC one each on Day 1 and Day 169.

    Reporting group title
    altSonflex1-2-3 High Dose Group
    Reporting group description
    		 Participants received 2 high doses of altSonflex1-2-3 and 2 doses of MR-VAC one each on Day 1 and Day 169.

    Reporting group title
    Control Group
    Reporting group description
    		 Participants received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix Hexa vaccine on Day 169, along with 2 doses of MR-VAC on Day 1 and Day 169.

    Reporting group values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group Total
    Number of subjects
    		 50 50 50 50 200
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 50 50 50 50 200
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Months
        arithmetic mean (standard deviation)
    		 9.3 ( 0.5 ) 9.3 ( 0.5 ) 9.3 ( 0.5 ) 9.3 ( 0.5 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 29 21 27 35 112
        Male
    		 21 29 23 15 88
    Race/Ethnicity, Customized
    Units: Subjects
        BLACK OR AFRICAN AMERICAN
    		 50 50 50 50 200

    End points

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    End points reporting groups
    Reporting group title
    altSonflex1-2-3 Low Dose Group
    Reporting group description
    		 Participants received 2 low doses of altSonflex1-2-3 and 2 doses of the measles and rubella vaccine (MR-VAC) one each on Day 1 and Day 169.

    Reporting group title
    altSonflex1-2-3 Medium Dose Group
    Reporting group description
    		 Participants received 2 medium doses of altSonflex1-2-3 and 2 doses of MR-VAC one each on Day 1 and Day 169.

    Reporting group title
    altSonflex1-2-3 High Dose Group
    Reporting group description
    		 Participants received 2 high doses of altSonflex1-2-3 and 2 doses of MR-VAC one each on Day 1 and Day 169.

    Reporting group title
    Control Group
    Reporting group description
    		 Participants received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix Hexa vaccine on Day 169, along with 2 doses of MR-VAC on Day 1 and Day 169.

    Primary: Geometric mean concentrations (GMCs) of anti-serotype specific Shigella lipopolysaccharide (LPS)/O-Antigen (OAg) serum immunoglobulin G (IgG)

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    End point title
    		 Geometric mean concentrations (GMCs) of anti-serotype specific Shigella lipopolysaccharide (LPS)/O-Antigen (OAg) serum immunoglobulin G (IgG) [1]
    End point description
    Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL) of serum. S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes were tested. The analysis was performed on the Immunogenicity Set which included all eligible 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 anti-serotype specific Shigella LPS/OAg serum IgG data available at Day1 were reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    At Day 1 (before administration of Dose 1)
    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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    50
    50
    50
    50
    Units: EU/mL
    geometric mean (confidence interval 95%)
        S. sonnei
    7.4 (6.5 to 8.3)
    8.1 (7.0 to 9.5)
    8.7 (6.6 to 11.5)
    9.2 (7.3 to 11.7)
        S. flexneri 1b
    5.5 (4.4 to 6.9)
    8.3 (5.7 to 12.1)
    7.6 (5.6 to 10.4)
    6.1 (4.7 to 7.9)
        S. flexneri 2a
    5.1 (3.8 to 6.9)
    4.9 (3.4 to 7.1)
    4.6 (3.1 to 6.8)
    4.0 (2.9 to 5.6)
        S. flexneri 3a
    3.9 (2.9 to 5.2)
    5.1 (3.4 to 7.6)
    4.2 (3.0 to 6.0)
    4.2 (3.0 to 5.7)
    No statistical analyses for this end point

    Primary: GMCs of anti-serotype specific Shigella LPS/OAg serum IgG at Day 29

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    End point title
    		 GMCs of anti-serotype specific Shigella LPS/OAg serum IgG at Day 29 [2]
    End point description
    The analysis was performed on the Immunogenicity Set. Only participants with anti-serotype specific Shigella LPS/OAg serum IgG data available at Day 29 were reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    At Day 29 (28 days after administration of Dose 1)
    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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    48
    44
    48
    48
    Units: EU/mL
    geometric mean (confidence interval 95%)
        S. sonnei
    44.6 (32.2 to 61.7)
    66.4 (46.9 to 93.9)
    59.5 (44.7 to 79.1)
    8.7 (7.0 to 10.8)
        S. flexneri 1b
    20.2 (13.9 to 29.5)
    48.7 (35.1 to 67.7)
    30.5 (20.4 to 45.6)
    6.5 (4.8 to 8.9)
        S. flexneri 2a
    71.3 (43.1 to 117.8)
    98.4 (64.0 to 151.3)
    77.1 (53.8 to 110.5)
    4.5 (3.1 to 6.7)
        S. flexneri 3a
    11.0 (7.1 to 16.9)
    24.1 (15.4 to 37.9)
    16.6 (11.2 to 24.6)
    5.2 (3.5 to 7.6)
    No statistical analyses for this end point

    Primary: GMCs of anti-serotype specific Shigella LPS/OAg serum IgG at Day 169

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    End point title
    		 GMCs of anti-serotype specific Shigella LPS/OAg serum IgG at Day 169 [3]
    End point description
    The analysis was performed on the Immunogenicity Set. Only participants with anti-serotype specific Shigella LPS/OAg serum IgG data available at Day 169 were reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    At Day 169 (before administration of Dose 2)
    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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    47
    44
    45
    46
    Units: EU/mL
    geometric mean (confidence interval 95%)
        S. sonnei
    26.0 (16.4 to 41.3)
    34.7 (22.9 to 52.6)
    33.5 (23.3 to 48.3)
    10.6 (7.1 to 15.8)
        S. flexneri 1b
    12.0 (8.3 to 17.2)
    16.2 (11.2 to 23.4)
    14.4 (10.0 to 20.9)
    13.2 (9.0 to 19.3)
        S. flexneri 2a
    11.2 (7.2 to 17.5)
    13.4 (8.8 to 20.6)
    9.6 (6.2 to 14.8)
    6.0 (4.0 to 8.9)
        S. flexneri 3a
    6.0 (4.0 to 9.0)
    10.1 (6.8 to 14.9)
    8.0 (5.4 to 12.0)
    8.4 (5.5 to 12.7)
    No statistical analyses for this end point

    Primary: GMCs of anti-serotype specific Shigella LPS/OAg serum IgG at Day 197

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    End point title
    		 GMCs of anti-serotype specific Shigella LPS/OAg serum IgG at Day 197 [4]
    End point description
    The analysis was performed on the Immunogenicity Set. Only participants with anti-serotype specific Shigella LPS/OAg serum IgG data available at Day 197 were reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    At Day 197 (28 days after administration of Dose 2)
    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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    44
    42
    44
    45
    Units: EU/mL
    geometric mean (confidence interval 95%)
        S. sonnei
    802.1 (521.4 to 1234.0)
    1320.3 (903.8 to 1928.8)
    1080.7 (675.7 to 1728.5)
    10.6 (7.2 to 15.6)
        S. flexneri 1b
    32.0 (23.9 to 42.9)
    39.8 (28.3 to 55.9)
    32.3 (22.5 to 46.3)
    12.4 (8.5 to 18.3)
        S. flexneri 2a
    83.5 (58.0 to 120.1)
    92.8 (63.7 to 135.1)
    75.3 (52.3 to 108.4)
    5.1 (3.5 to 7.3)
        S. flexneri 3a
    19.8 (13.4 to 29.2)
    31.9 (23.0 to 44.3)
    19.1 (12.4 to 29.5)
    7.9 (5.1 to 12.1)
    No statistical analyses for this end point

    Primary: Number of participants with at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG at Day 29 compared to Day 1

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    End point title
    		 Number of participants with at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG at Day 29 compared to Day 1 [5]
    End point description
    S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes were tested. The analysis was performed on the Immunogenicity Set. Only participants with immunogenicity data available for the specified analysis at the specified time points were reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    At Day 29 compared to baseline (before administration of Dose 1 on Day 1)
    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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    48
    44
    48
    48
    Units: Participants
        S. sonnei
    32
    31
    35
    0
        S. flexneri 1b
    21
    30
    27
    3
        S. flexneri 2a
    37
    38
    39
    3
        S. flexneri 3a
    19
    23
    22
    4
    No statistical analyses for this end point

    Primary: Number of participants with at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG at Day 197 to Day 1

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    End point title
    		 Number of participants with at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG at Day 197 to Day 1 [6]
    End point description
    The analysis was performed on the Immunogenicity Set. Only participants with immunogenicity data available for the specified analysis at the specified time points were reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    At Day 197 compared to baseline (before administration of Dose 1 on Day 1)
    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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    44
    42
    44
    45
    Units: Participants
        S. sonnei
    42
    42
    43
    5
        S. flexneri 1b
    28
    22
    22
    11
        S. flexneri 2a
    40
    37
    37
    8
        S. flexneri 3a
    22
    24
    27
    12
    No statistical analyses for this end point

    Primary: Number of participants with at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG at Day 197 compared to Day 169

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    End point title
    		 Number of participants with at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG at Day 197 compared to Day 169 [7]
    End point description
    The analysis was performed on the Immunogenicity Set. Only participants with immunogenicity data available for the specified analysis at the specified time points were reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    At Day 197 compared to pre-Dose 2 at Day 169
    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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    44
    42
    44
    45
    Units: Participants
        S. sonnei
    36
    39
    41
    0
        S. flexneri 1b
    13
    8
    8
    1
        S. flexneri 2a
    31
    30
    29
    0
        S. flexneri 3a
    16
    15
    7
    3
    No statistical analyses for this end point

    Secondary: Number of participants with solicited administration site events

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    End point title
    		 Number of participants with solicited administration site events
    End point description
    The solicited administration site events assessed were erythema, pain and swelling. The analysis was performed on the Exposed Set (ES) which included all participants who received at least 1 dose of the study intervention. Only the participants with solicited administration site events data available for the specified time period were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    During the 7 days after each study intervention administration (study intervention administered at Day 1 and Day 169)
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    50
    50
    50
    50
    Units: Participants
        Erythema, post-Dose 1 (N=50, 50, 50, 50)
    7
    6
    6
    3
        Erythema, post-Dose 2 (N=48, 44, 45, 49)
    3
    3
    7
    4
        Pain, post-Dose 1 (N=50, 50, 50, 50)
    11
    14
    17
    3
        Pain, post-Dose 2 (N=48, 44, 45, 49)
    11
    13
    11
    13
        Swelling, post-Dose 1 (N=50, 50, 50, 50)
    7
    9
    12
    2
        Swelling, post-Dose 2 (N=48, 44, 45, 49)
    7
    10
    7
    6
    No statistical analyses for this end point

    Secondary: Number of participants with solicited systemic events

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    End point title
    		 Number of participants with solicited systemic events
    End point description
    The solicited systemic event assessed was fever (pyrexia). Fever is defined as temperature ≥38.0°Celsius (C), measured axillary. The analysis was performed on the Exposed Set. Only the participants with solicited systemic events data available for the specified time period were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    During the 7 days after each study intervention administration (study interventions administered at Day 1 and Day 169)
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    50
    50
    50
    50
    Units: Participants
        Fever, post-Dose 1 (N=50 50, 50, 50)
    10
    6
    9
    7
        Fever, post-Dose 2 (N=48, 44, 45, 49)
    4
    10
    5
    6
    No statistical analyses for this end point

    Secondary: Number of participants with unsolicited adverse events (AEs)

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    End point title
    		 Number of participants with unsolicited adverse events (AEs)
    End point description
    An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. The analysis was performed on the Exposed Set. Only the participants with unsolicited AE data available for the specified time period were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    During the 28 days after each study intervention administration (study interventions administered at Day 1 and Day 169)
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    50
    50
    50
    50
    Units: Participants
        After Day 1 intervention (N=50, 50, 50, 50)
    23
    23
    24
    24
        After Day 169 intervention (N=48, 44, 45, 49)
    9
    14
    12
    17
    No statistical analyses for this end point

    Secondary: Number of participants with change from baseline in hematological, renal, and hepatic panel test results with respect to laboratory reference ranges at Day 8

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    End point title
    		 Number of participants with change from baseline in hematological, renal, and hepatic panel test results with respect to laboratory reference ranges at Day 8
    End point description
    Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, blood urea, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Categories reported when comparing Day 1 (baseline) and laboratory reference range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. The analysis was performed on the Exposed Set. Only the participants with haematological, renal, and hepatic panel test data available at Day 8 were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 8 compared to baseline (pre-Dose 1 at Day 1)
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    49
    46
    50
    49
    Units: Participants
        ALT, Below, Below
    0
    0
    1
    0
        ALT, Below, Within
    0
    0
    0
    0
        ALT, Below, Above
    0
    0
    0
    0
        ALT, Within, Below
    0
    1
    0
    0
        ALT, Within, Within
    48
    43
    47
    47
        ALT, Within, Above
    1
    1
    1
    1
        ALT, Above, Below
    0
    0
    0
    0
        ALT, Above, Within
    0
    1
    1
    1
        ALT, Above, Above
    0
    0
    0
    0
        AST, Below, Below
    0
    0
    0
    0
        AST, Below, Within
    0
    0
    0
    0
        AST, Below, Above
    0
    0
    0
    0
        AST, Within, Below
    0
    0
    0
    0
        AST, Within, Within
    48
    45
    50
    48
        AST, Within, Above
    0
    0
    0
    1
        AST, Above, Below
    0
    0
    0
    0
        AST, Above, Within
    0
    1
    0
    0
        AST, Above, Above
    1
    0
    0
    0
        Creatinine, Below, Below
    49
    46
    50
    49
        Creatinine, Below, Within
    0
    0
    0
    0
        Creatinine, Below, Above
    0
    0
    0
    0
        Creatinine, Within, Below
    0
    0
    0
    0
        Creatinine, Within, Within
    0
    0
    0
    0
        Creatinine, Within, Above
    0
    0
    0
    0
        Creatinine, Above, Below
    0
    0
    0
    0
        Creatinine, Above, Within
    0
    0
    0
    0
        Creatinine, Above, Above
    0
    0
    0
    0
        Potassium, Below, Below
    0
    0
    0
    0
        Potassium, Below, Within
    0
    0
    0
    0
        Potassium, Below, Above
    0
    0
    0
    0
        Potassium, Within, Below
    1
    0
    0
    0
        Potassium, Within, Within
    48
    46
    50
    49
        Potassium, Within, Above
    0
    0
    0
    0
        Potassium, Above, Below
    0
    0
    0
    0
        Potassium, Above, Within
    0
    0
    0
    0
        Potassium, Above, Above
    0
    0
    0
    0
        Sodium, Below, Below
    0
    0
    0
    0
        Sodium, Below, Within
    1
    1
    0
    0
        Sodium, Below, Above
    0
    0
    0
    0
        Sodium, Within, Below
    0
    1
    0
    0
        Sodium, Within, Within
    31
    35
    37
    35
        Sodium, Within, Above
    10
    6
    7
    6
        Sodium, Above, Below
    0
    0
    0
    0
        Sodium, Above, Within
    4
    3
    6
    5
        Sodium, Above, Above
    3
    0
    0
    3
        Urea, Below, Below
    23
    29
    20
    24
        Urea, Below, Within
    11
    1
    7
    7
        Urea, Below, Above
    0
    0
    0
    0
        Urea, Within, Below
    6
    6
    10
    10
        Urea, Within, Within
    9
    9
    13
    8
        Urea, Within, Above
    0
    1
    0
    0
        Urea, Above, Below
    0
    0
    0
    0
        Urea, Above, Within
    0
    0
    0
    0
        Urea, Above, Above
    0
    0
    0
    0
        Basophils, Below, Below
    0
    0
    0
    0
        Basophils, Below, Within
    0
    0
    0
    0
        Basophils, Below, Above
    0
    0
    0
    0
        Basophils, Within, Below
    0
    0
    0
    0
        Basophils, Within, Within
    27
    28
    33
    32
        Basophils, Within, Above
    3
    6
    4
    4
        Basophils, Above, Below
    0
    0
    0
    0
        Basophils, Above, Within
    11
    8
    9
    8
        Basophils, Above, Above
    8
    4
    4
    5
        Eosinophils, Below, Below
    0
    0
    0
    0
        Eosinophils, Below, Within
    1
    0
    1
    0
        Eosinophils, Below, Above
    0
    0
    0
    0
        Eosinophils, Within, Below
    2
    3
    0
    0
        Eosinophils, Within, Within
    40
    40
    48
    45
        Eosinophils, Within, Above
    2
    1
    0
    2
        Eosinophils, Above, Below
    0
    0
    0
    0
        Eosinophils, Above, Within
    3
    0
    0
    1
        Eosinophils, Above, Above
    1
    2
    1
    1
        Erythrocytes, Below, Below
    0
    0
    0
    0
        Erythrocytes, Below, Within
    0
    0
    0
    0
        Erythrocytes, Below, Above
    0
    0
    0
    0
        Erythrocytes, Within, Below
    1
    1
    0
    1
        Erythrocytes, Within, Within
    25
    28
    28
    29
        Erythrocytes, Within, Above
    7
    3
    4
    3
        Erythrocytes, Above, Below
    0
    0
    0
    0
        Erythrocytes, Above, Within
    1
    6
    6
    4
        Erythrocytes, Above, Above
    15
    8
    12
    12
        Hematocrit, Below, Below
    0
    0
    1
    1
        Hematocrit, Below, Within
    2
    3
    0
    3
        Hematocrit, Below, Above
    0
    0
    0
    0
        Hematocrit, Within, Below
    1
    3
    0
    0
        Hematocrit, Within, Within
    38
    36
    38
    34
        Hematocrit, Within, Above
    6
    0
    5
    4
        Hematocrit, Above, Below
    0
    0
    0
    0
        Hematocrit, Above, Within
    1
    1
    3
    4
        Hematocrit, Above, Above
    1
    3
    3
    3
        Hemoglobin, Below, Below
    5
    3
    4
    2
        Hemoglobin, Below, Within
    1
    3
    2
    4
        Hemoglobin, Below, Above
    0
    0
    0
    0
        Hemoglobin, Within, Below
    1
    4
    1
    1
        Hemoglobin, Within, Within
    40
    32
    37
    38
        Hemoglobin, Within, Above
    1
    1
    2
    2
        Hemoglobin, Above, Below
    0
    0
    0
    0
        Hemoglobin, Above, Within
    1
    2
    2
    2
        Hemoglobin, Above, Above
    0
    1
    2
    0
        Leukocytes, Below, Below
    0
    0
    3
    1
        Leukocytes, Below, Within
    1
    2
    3
    2
        Leukocytes, Below, Above
    0
    0
    0
    0
        Leukocytes, Within, Below
    4
    1
    1
    2
        Leukocytes, Within, Within
    31
    30
    31
    33
        Leukocytes, Within, Above
    3
    4
    4
    1
        Leukocytes, Above, Below
    0
    0
    0
    0
        Leukocytes, Above, Within
    5
    9
    4
    7
        Leukocytes, Above, Above
    5
    0
    4
    3
        Lymphocytes, Below, Below
    0
    0
    0
    0
        Lymphocytes, Below, Within
    0
    0
    0
    0
        Lymphocytes, Below, Above
    0
    0
    0
    0
        Lymphocytes, Within, Below
    0
    0
    0
    0
        Lymphocytes, Within, Within
    30
    30
    26
    33
        Lymphocytes, Within, Above
    5
    3
    8
    5
        Lymphocytes, Above, Below
    0
    0
    0
    0
        Lymphocytes, Above, Within
    6
    6
    7
    6
        Lymphocytes, Above, Above
    8
    7
    9
    5
        Monocytes, Below, Below
    0
    1
    0
    0
        Monocytes, Below, Within
    2
    3
    0
    4
        Monocytes, Below, Above
    0
    0
    0
    0
        Monocytes, Within, Below
    1
    0
    1
    1
        Monocytes, Within, Within
    27
    29
    39
    27
        Monocytes, Within, Above
    12
    8
    6
    11
        Monocytes, Above, Below
    0
    0
    0
    0
        Monocytes, Above, Within
    2
    2
    3
    4
        Monocytes, Above, Above
    5
    3
    1
    2
        Neutrophils, Below, Below
    3
    3
    2
    7
        Neutrophils, Below, Within
    4
    6
    2
    3
        Neutrophils, Below, Above
    0
    0
    0
    0
        Neutrophils, Within, Below
    10
    1
    8
    6
        Neutrophils, Within, Within
    31
    33
    35
    33
        Neutrophils, Within, Above
    1
    1
    1
    0
        Neutrophils, Above, Below
    0
    0
    0
    0
        Neutrophils, Above, Within
    0
    2
    2
    0
        Neutrophils, Above, Above
    0
    0
    0
    0
        Platelets, Below, Below
    0
    0
    0
    0
        Platelets, Below, Within
    0
    0
    1
    0
        Platelets, Below, Above
    0
    0
    0
    0
        Platelets, Within, Below
    0
    0
    0
    0
        Platelets, Within, Within
    7
    5
    10
    24
        Platelets, Within, Above
    9
    7
    8
    3
        Platelets, Above, Below
    0
    0
    0
    0
        Platelets, Above, Within
    8
    10
    2
    11
        Platelets, Above, Above
    25
    24
    29
    11
    No statistical analyses for this end point

    Secondary: Number of participants with serious AEs (SAEs)

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    End point title
    		 Number of participants with serious AEs (SAEs)
    End point description
    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. The analysis was performed on the Exposed Set. Only the participants with SAE data available for the specified time period were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 197
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    50
    50
    50
    50
    Units: Participants
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with change from baseline in hematological, renal, and hepatic panel test results with respect to laboratory reference ranges at Day 176

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    End point title
    		 Number of participants with change from baseline in hematological, renal, and hepatic panel test results with respect to laboratory reference ranges at Day 176
    End point description
    Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, blood urea, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Categories reported when comparing Day 169 (baseline) and laboratory reference range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. The analysis was performed on the Exposed Set. Only the participants with haematological, renal, and hepatic panel test data available at Day 176 were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 176 compared to pre-Dose 2 at Day 169
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    46
    43
    46
    49
    Units: Participants
        ALT, Below, Below
    0
    1
    1
    0
        ALT, Below, Within
    0
    0
    0
    0
        ALT, Below, Above
    0
    0
    0
    0
        ALT, Within, Below
    0
    0
    0
    0
        ALT, Within, Within
    44
    42
    44
    46
        ALT, Within, Above
    1
    0
    0
    1
        ALT, Above, Below
    0
    0
    0
    0
        ALT, Above, Within
    0
    0
    0
    1
        ALT, Above, Above
    1
    0
    1
    1
        AST, Below, Below
    0
    0
    0
    0
        AST, Below, Within
    0
    0
    0
    0
        AST, Below, Above
    0
    0
    0
    0
        AST, Within, Below
    0
    0
    0
    0
        AST, Within, Within
    43
    41
    45
    47
        AST, Within, Above
    0
    0
    0
    1
        AST, Above, Below
    0
    0
    0
    0
        AST, Above, Within
    1
    2
    0
    0
        AST, Above, Above
    2
    0
    1
    1
        Creatinine, Below, Below
    45
    43
    45
    47
        Creatinine, Below, Within
    0
    0
    1
    1
        Creatinine, Below, Above
    1
    0
    0
    0
        Creatinine, Within, Below
    0
    0
    0
    1
        Creatinine, Within, Within
    0
    0
    0
    0
        Creatinine, Within, Above
    0
    0
    0
    0
        Creatinine, Above, Below
    0
    0
    0
    0
        Creatinine, Above, Within
    0
    0
    0
    0
        Creatinine, Above, Above
    0
    0
    0
    0
        Potassium, Below, Below
    0
    0
    0
    0
        Potassium, Below, Within
    0
    0
    0
    0
        Potassium, Below, Above
    0
    0
    0
    0
        Potassium, Within, Below
    0
    0
    0
    0
        Potassium, Within, Within
    11
    11
    6
    17
        Potassium, Within, Above
    9
    10
    14
    13
        Potassium, Above, Below
    0
    0
    0
    0
        Potassium, Above, Within
    9
    6
    6
    2
        Potassium, Above, Above
    17
    16
    20
    17
        Sodium, Below, Below
    0
    0
    0
    0
        Sodium, Below, Within
    0
    0
    0
    0
        Sodium, Below, Above
    0
    0
    0
    0
        Sodium, Within, Below
    0
    0
    0
    0
        Sodium, Within, Within
    37
    38
    40
    39
        Sodium, Within, Above
    6
    3
    2
    2
        Sodium, Above, Below
    0
    0
    0
    0
        Sodium, Above, Within
    3
    2
    4
    8
        Sodium, Above, Above
    0
    0
    0
    0
        Urea, Below, Below
    17
    17
    16
    19
        Urea, Below, Within
    11
    4
    9
    11
        Urea, Below, Above
    0
    0
    0
    0
        Urea, Within, Below
    7
    4
    6
    10
        Urea, Within, Within
    11
    18
    15
    9
        Urea, Within, Above
    0
    0
    0
    0
        Urea, Above, Below
    0
    0
    0
    0
        Urea, Above, Within
    0
    0
    0
    0
        Urea, Above, Above
    0
    0
    0
    0
        Basophils, Below, Below
    0
    0
    0
    0
        Basophils, Below, Within
    0
    0
    0
    0
        Basophils, Below, Above
    0
    0
    0
    0
        Basophils, Within, Below
    1
    0
    0
    0
        Basophils, Within, Within
    39
    37
    43
    45
        Basophils, Within, Above
    2
    2
    1
    2
        Basophils, Above, Below
    0
    0
    0
    0
        Basophils, Above, Within
    1
    2
    2
    1
        Basophils, Above, Above
    3
    2
    0
    1
        Eosinophils, Below, Below
    0
    0
    0
    0
        Eosinophils, Below, Within
    0
    1
    0
    1
        Eosinophils, Below, Above
    0
    0
    0
    0
        Eosinophils, Within, Below
    0
    2
    0
    0
        Eosinophils, Within, Within
    38
    29
    40
    39
        Eosinophils, Within, Above
    2
    2
    4
    2
        Eosinophils, Above, Below
    0
    0
    0
    0
        Eosinophils, Above, Within
    2
    0
    1
    5
        Eosinophils, Above, Above
    4
    9
    1
    2
        Erythrocytes, Below, Below
    0
    0
    0
    0
        Erythrocytes, Below, Within
    0
    0
    0
    0
        Erythrocytes, Below, Above
    0
    0
    0
    0
        Erythrocytes, Within, Below
    0
    0
    0
    0
        Erythrocytes, Within, Within
    29
    31
    28
    28
        Erythrocytes, Within, Above
    2
    3
    3
    2
        Erythrocytes, Above, Below
    0
    0
    0
    0
        Erythrocytes, Above, Within
    3
    3
    5
    6
        Erythrocytes, Above, Above
    12
    6
    10
    13
        Hematocrit, Below, Below
    0
    0
    1
    1
        Hematocrit, Below, Within
    0
    1
    2
    1
        Hematocrit, Below, Above
    0
    0
    0
    0
        Hematocrit, Within, Below
    1
    1
    1
    1
        Hematocrit, Within, Within
    32
    36
    33
    33
        Hematocrit, Within, Above
    4
    2
    3
    3
        Hematocrit, Above, Below
    0
    0
    0
    0
        Hematocrit, Above, Within
    2
    1
    4
    6
        Hematocrit, Above, Above
    7
    2
    2
    4
        Hemoglobin, Below, Below
    2
    6
    4
    6
        Hemoglobin, Below, Within
    1
    1
    2
    1
        Hemoglobin, Below, Above
    0
    0
    0
    0
        Hemoglobin, Within, Below
    0
    1
    1
    1
        Hemoglobin, Within, Within
    35
    31
    38
    35
        Hemoglobin, Within, Above
    2
    1
    1
    2
        Hemoglobin, Above, Below
    0
    0
    0
    0
        Hemoglobin, Above, Within
    4
    2
    0
    1
        Hemoglobin, Above, Above
    2
    1
    0
    3
        Leukocytes, Below, Below
    0
    1
    0
    1
        Leukocytes, Below, Within
    1
    2
    4
    2
        Leukocytes, Below, Above
    0
    0
    0
    0
        Leukocytes, Within, Below
    1
    0
    0
    0
        Leukocytes, Within, Within
    30
    32
    28
    40
        Leukocytes, Within, Above
    4
    3
    6
    3
        Leukocytes, Above, Below
    0
    0
    0
    0
        Leukocytes, Above, Within
    5
    2
    3
    1
        Leukocytes, Above, Above
    5
    3
    5
    2
        Lymphocytes, Below, Below
    0
    0
    0
    0
        Lymphocytes, Below, Within
    0
    0
    0
    0
        Lymphocytes, Below, Above
    0
    0
    0
    0
        Lymphocytes, Within, Below
    0
    0
    0
    0
        Lymphocytes, Within, Within
    28
    33
    25
    35
        Lymphocytes, Within, Above
    7
    3
    7
    9
        Lymphocytes, Above, Below
    0
    0
    0
    0
        Lymphocytes, Above, Within
    2
    2
    4
    2
        Lymphocytes, Above, Above
    9
    5
    10
    3
        Monocytes, Below, Below
    0
    0
    0
    0
        Monocytes, Below, Within
    0
    0
    0
    0
        Monocytes, Below, Above
    0
    0
    0
    0
        Monocytes, Within, Below
    0
    0
    0
    0
        Monocytes, Within, Within
    36
    36
    38
    42
        Monocytes, Within, Above
    3
    3
    3
    5
        Monocytes, Above, Below
    0
    0
    0
    0
        Monocytes, Above, Within
    7
    1
    4
    2
        Monocytes, Above, Above
    0
    3
    1
    0
        Neutrophils, Below, Below
    2
    2
    3
    0
        Neutrophils, Below, Within
    4
    3
    0
    7
        Neutrophils, Below, Above
    0
    0
    0
    0
        Neutrophils, Within, Below
    2
    6
    2
    2
        Neutrophils, Within, Within
    35
    32
    40
    38
        Neutrophils, Within, Above
    0
    0
    0
    1
        Neutrophils, Above, Below
    0
    0
    0
    0
        Neutrophils, Above, Within
    3
    0
    1
    1
        Neutrophils, Above, Above
    0
    0
    0
    0
        Platelets, Below, Below
    0
    0
    0
    0
        Platelets, Below, Within
    0
    0
    0
    0
        Platelets, Below, Above
    1
    1
    1
    0
        Platelets, Within, Below
    0
    0
    0
    0
        Platelets, Within, Within
    7
    5
    6
    20
        Platelets, Within, Above
    10
    6
    12
    12
        Platelets, Above, Below
    0
    0
    0
    0
        Platelets, Above, Within
    3
    4
    3
    3
        Platelets, Above, Above
    25
    27
    24
    14
    No statistical analyses for this end point

    Secondary: The number of participants with abnormal hematological, renal, and hepatic panel test results by Grade values at Day 8 versus baseline (Day 1) Grade values

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    End point title
    		 The number of participants with abnormal hematological, renal, and hepatic panel test results by Grade values at Day 8 versus baseline (Day 1) Grade values
    End point description
    Panel tests include measures of ALT, AST, creatinine, hemoglobin, neutrophils decrease, platelets decrease and white blood cells (WBC) decrease. Categories reported when comparing Day 1 (baseline) and laboratory reference range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at timing>, where Grade 0=within reference range, Grade 1= mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life threatening laboratory abnormality. The analysis was performed on the Exposed Set. Only the participants with haematological, renal, and hepatic panel test data available at Day 8 were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 8 compared to baseline (before administration of Dose 1 at Day 1)
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    49
    46
    50
    49
    Units: Participants
        ALT, Grade 0, Grade 0
    49
    45
    50
    48
        ALT, Grade 0, Grade 1
    0
    1
    0
    1
        AST, Grade 0, Grade 0
    49
    46
    50
    49
        Creatinine, Grade 0, Grade 0
    49
    46
    50
    49
        Hemoglobin, Grade 0, Grade 0
    42
    36
    43
    42
        Hemoglobin, Grade 0, Grade 1
    1
    4
    1
    1
        Hemoglobin, Grade 1, Grade 0
    1
    3
    2
    4
        Hemoglobin, Grade 1, Grade 1
    5
    2
    4
    2
        Hemoglobin, Grade 2, Grade 2
    0
    1
    0
    0
        Neutrophils Decrease, Grade 0, Grade 0
    32
    36
    38
    33
        Neutrophils Decrease, Grade 0, Grade 1
    8
    1
    8
    6
        Neutrophils Decrease, Grade 1, Grade 0
    1
    5
    2
    2
        Neutrophils Decrease, Grade 1, Grade 1
    1
    2
    1
    5
        Neutrophils Decrease, Grade 1, Grade 2
    0
    0
    0
    1
        Neutrophils Decrease, Grade 1, Grade 3
    0
    1
    0
    1
        Neutrophils Decrease, Grade 1, Grade 4
    1
    0
    0
    0
        Neutrophils Decrease, Grade 2, Grade 0
    2
    0
    0
    1
        Neutrophils Decrease, Grade 2, Grade 1
    1
    0
    0
    0
        Neutrophils Decrease, Grade 3, Grade 0
    1
    1
    0
    0
        Neutrophils Decrease, Grade 3, Grade 1
    0
    0
    1
    0
        Platelets Decrease, Grade 0, Grade 0
    49
    46
    49
    49
        Platelets Decrease, Grade 1, Grade 0
    0
    0
    1
    0
        WBC Decrease, Grade 0, Grade 0
    44
    43
    43
    44
        WBC Decrease, Grade 0, Grade 1
    4
    1
    1
    2
        WBC Decrease, Grade 1, Grade 0
    1
    2
    3
    2
        WBC Decrease, Grade 1, Grade 1
    0
    0
    3
    1
    No statistical analyses for this end point

    Secondary: The number of participants with abnormal hematological, renal, and hepatic panel test results by Grade values at Day 176 versus Day 169 Grade values

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    End point title
    		 The number of participants with abnormal hematological, renal, and hepatic panel test results by Grade values at Day 176 versus Day 169 Grade values
    End point description
    Panel tests include measures of ALT, AST, creatinine, hemoglobin, neutrophils decrease, platelets decrease and white blood cells (WBC) decrease. Categories reported when comparing Day 169 and laboratory reference range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at timing>, where Grade 0=within reference range, Grade 1= mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life threatening laboratory abnormality. The analysis was performed on the Exposed Set. Only the participants with haematological, renal, and hepatic panel test data available at Day 176 were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 176 compared to pre-Dose 2 at Day 169
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    46
    43
    46
    49
    Units: Participants
        ALT, Grade 0, Grade 0
    45
    43
    45
    48
        ALT, Grade 0, Grade 1
    0
    0
    0
    1
        ALT, Grade 1, Grade 0
    1
    0
    0
    0
        ALT, Grade 1, Grade 2
    0
    0
    1
    0
        AST, Grade 0, Grade 0
    45
    43
    45
    48
        AST, Grade 1, Grade 0
    1
    0
    0
    1
        AST, Grade 1, Grade 1
    0
    0
    1
    0
        Creatinine, Grade 0, Grade 0
    45
    43
    46
    48
        Creatinine, Grade 0, Grade 2
    1
    0
    0
    1
        Hemoglobin, Grade 0, Grade 0
    43
    35
    39
    41
        Hemoglobin, Grade 0, Grade 1
    0
    1
    1
    1
        Hemoglobin, Grade 1, Grade 0
    1
    1
    2
    1
        Hemoglobin, Grade 1, Grade 1
    1
    3
    0
    2
        Hemoglobin, Grade 1, Grade 2
    0
    1
    2
    3
        Hemoglobin, Grade 2, Grade 1
    0
    2
    2
    0
        Hemoglobin, Grade 2, Grade 2
    1
    0
    0
    0
        Hemoglobin, Grade 2, Grade 3
    0
    0
    0
    1
        Neutrophils Decrease, Grade 0, Grade 0
    38
    32
    41
    41
        Neutrophils Decrease, Grade 0, Grade 1
    2
    6
    2
    1
        Neutrophils Decrease, Grade 1, Grade 0
    2
    2
    0
    7
        Neutrophils Decrease, Grade 1, Grade 1
    2
    0
    3
    0
        Neutrophils Decrease, Grade 1, Grade 2
    0
    0
    0
    0
        Neutrophils Decrease, Grade 1, Grade 3
    0
    0
    0
    0
        Neutrophils Decrease, Grade 1, Grade 4
    0
    0
    0
    0
        Neutrophils Decrease, Grade 2, Grade 0
    2
    0
    0
    0
        Neutrophils Decrease, Grade 2, Grade 1
    0
    0
    0
    0
        Neutrophils Decrease, Grade 2, Grade 2
    0
    1
    0
    0
        Neutrophils Decrease, Grade 3, Grade 0
    0
    1
    0
    0
        Neutrophils Decrease, Grade 3, Grade 1
    0
    1
    0
    0
        Platelets Decrease, Grade 0, Grade 0
    45
    42
    45
    49
        Platelets Decrease, Grade 1, Grade 0
    1
    1
    1
    0
        WBC Decrease, Grade 0, Grade 0
    44
    40
    42
    46
        WBC Decrease, Grade 0, Grade 1
    1
    0
    0
    0
        WBC Decrease, Grade 1, Grade 0
    1
    2
    4
    2
        WBC Decrease, Grade 1, Grade 1
    0
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Anti-measles IgG concentrations expressed as GMCs

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    End point title
    		 Anti-measles IgG concentrations expressed as GMCs
    End point description
    Anti-measles IgG concentrations were expressed as GMCs in EU/mL. The analysis was performed on the Immunogenicity Set. Only the participants with anti-measles IgG concentrations data available at the specified timepoints were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    At Day 1 (before the first MR-VAC) and at Day 197 (28 days after the second MR-VAC vaccination)
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    50
    50
    50
    50
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 1 (N= 50, 50, 50, 50)
    25.4 (24.6 to 26.2)
    25.0 (25.0 to 25.0)
    25.5 (24.5 to 26.4)
    25.8 (24.2 to 27.5)
        Day 197 (N=44, 42, 44, 45)
    1005.0 (855.0 to 1181.3)
    835.6 (685.7 to 1018.3)
    923.9 (783.7 to 1089.0)
    954.1 (836.2 to 1088.6)
    No statistical analyses for this end point

    Secondary: Anti-rubella IgG concentrations expressed as GMCs

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    End point title
    		 Anti-rubella IgG concentrations expressed as GMCs
    End point description
    Anti-rubella IgG concentrations were expressed as GMCs in EU/mL. The analysis was performed on the Immunogenicity Set. Only the participants with anti-rubella IgG concentrations data available at the specified timepoint were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    At Day 1 (before the first MR-VAC) and at Day 197 (28 days after the second MR-VAC vaccination)
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    50
    50
    50
    50
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 1 (N=50, 50, 50, 50)
    1.0 (1.0 to 1.1)
    1.1 (1.0 to 1.2)
    1.2 (1.1 to 1.4)
    1.1 (1.0 to 1.2)
        Day 197 (N=44, 42, 44, 45)
    91.1 (84.4 to 98.3)
    78.3 (68.2 to 89.8)
    85.1 (76.9 to 94.2)
    84.4 (77.7 to 91.7)
    No statistical analyses for this end point

    Secondary: Number of participants achieving anti-measles IgG concentrations of ≥150 international units per milliliter (IU/mL) and ≥200 IU/mL

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    End point title
    		 Number of participants achieving anti-measles IgG concentrations of ≥150 international units per milliliter (IU/mL) and ≥200 IU/mL
    End point description
    The analysis was performed on the Immunogenicity Set. Only the participants with anti-measles IgG concentrations data available at Day 197 were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    At Day 197 (28 days after the second MR-VAC vaccination)
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    44
    42
    44
    45
    Units: Participants
        ≥ 150 IU/L
    44
    41
    44
    45
        ≥ 200 IU/L
    44
    41
    44
    45
    No statistical analyses for this end point

    Secondary: Number of participants achieving anti-rubella IgG concentrations of ≥4 IU/mL and ≥10 IU/mL

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    End point title
    		 Number of participants achieving anti-rubella IgG concentrations of ≥4 IU/mL and ≥10 IU/mL
    End point description
    The analysis was performed on the Immunogenicity Set. Only the participants with anti-rubella IgG concentrations data available at Day 197 were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    At Day 197 (28 days after the second MR-VAC vaccination)
    End point values
    		 altSonflex1-2-3 Low Dose Group altSonflex1-2-3 Medium Dose Group altSonflex1-2-3 High Dose Group Control Group
    Number of subjects analysed
    44
    42
    44
    45
    Units: Participants
        ≥ 4 IU/mL
    44
    42
    44
    45
        ≥ 10 IU/mL
    44
    41
    44
    45
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 28 days after any vaccination. All-cause mortality, SAEs and abnormal laboratory parameters: from Day 1 until Day 197.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.1
    Reporting groups
    Reporting group title
    altSonflex1-2-3 Low Dose
    Reporting group description
    		 Participants received 2 low doses of altSonflex1-2-3 along with the measles and rubella vaccine (MR-VAC) on Day 1 and Day 169.

    Reporting group title
    Control
    Reporting group description
    		 Participants received 1 dose of the Typhibev on Day 1 and 1 dose of the Infanrix Hexa vaccine on Day 169, along with 2 doses of MR-VAC on Day 1 and Day 169.

    Reporting group title
    altSonflex1-2-3 High Dose
    Reporting group description
    		 Participants received 2 high doses of altSonflex1-2-3 along with MR-VAC on Day 1 and Day 169.

    Reporting group title
    altSonflex1-2-3 Medium Dose
    Reporting group description
    		 Participants received 2 medium doses of altSonflex1-2-3 along with MR-VAC on Day 1 and Day 169.

    Serious adverse events
    		 altSonflex1-2-3 Low Dose Control altSonflex1-2-3 High Dose altSonflex1-2-3 Medium Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 altSonflex1-2-3 Low Dose Control altSonflex1-2-3 High Dose altSonflex1-2-3 Medium Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 50 (82.00%)
    40 / 50 (80.00%)
    42 / 50 (84.00%)
    35 / 50 (70.00%)
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 50 (2.00%)
    4 / 50 (8.00%)
    2 / 50 (4.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    4
    2
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Platelet count increased
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Fontanelle bulging
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Administration site pain
         subjects affected / exposed
    15 / 50 (30.00%)
    15 / 50 (30.00%)
    23 / 50 (46.00%)
    19 / 50 (38.00%)
         occurrences all number
    22
    16
    28
    27
    Pyrexia
         subjects affected / exposed
    12 / 50 (24.00%)
    10 / 50 (20.00%)
    9 / 50 (18.00%)
    12 / 50 (24.00%)
         occurrences all number
    14
    13
    14
    16
    Administration site swelling
         subjects affected / exposed
    12 / 50 (24.00%)
    8 / 50 (16.00%)
    18 / 50 (36.00%)
    13 / 50 (26.00%)
         occurrences all number
    14
    8
    19
    19
    Feeling hot
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Administration site erythema
         subjects affected / exposed
    8 / 50 (16.00%)
    7 / 50 (14.00%)
    10 / 50 (20.00%)
    7 / 50 (14.00%)
         occurrences all number
    10
    7
    13
    9
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    3 / 50 (6.00%)
    2 / 50 (4.00%)
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences all number
    3
    2
    1
    1
    Eye disorders
    Eye discharge
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Teething
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 50 (6.00%)
    3 / 50 (6.00%)
    4 / 50 (8.00%)
         occurrences all number
    3
    3
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    2
    2
    Rhinitis allergic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    1
    0
    3
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Rash
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    0
    1
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Infections and infestations
    Amoebiasis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    3
    4
    Tonsillitis
         subjects affected / exposed
    5 / 50 (10.00%)
    1 / 50 (2.00%)
    4 / 50 (8.00%)
    1 / 50 (2.00%)
         occurrences all number
    5
    1
    4
    1
    Gastroenteritis
         subjects affected / exposed
    4 / 50 (8.00%)
    6 / 50 (12.00%)
    2 / 50 (4.00%)
    5 / 50 (10.00%)
         occurrences all number
    4
    6
    2
    5
    Rhinitis
         subjects affected / exposed
    5 / 50 (10.00%)
    12 / 50 (24.00%)
    8 / 50 (16.00%)
    8 / 50 (16.00%)
         occurrences all number
    5
    13
    8
    8
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 50 (16.00%)
    13 / 50 (26.00%)
    6 / 50 (12.00%)
    8 / 50 (16.00%)
         occurrences all number
    10
    13
    6
    8
    Nasopharyngitis
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    1
    0
    1
    Foot and mouth disease
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Escherichia infection
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Malaria
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    1
    0
    2
    Oral candidiasis
         subjects affected / exposed
    1 / 50 (2.00%)
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Otitis media
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    1 / 50 (2.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    1
    1
    2
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Rotavirus infection
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Otitis media acute
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Norovirus infection
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Scabies
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    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
    19 Apr 2024
    The amendment has been prepared to improve safety monitoring of participants by modifying the creatinine grading scale based on normal reference range that better represents the population being evaluated and by introducing blood urea, sodium, and potassium testing to ensure further monitoring of the renal function. Endpoints have been added to capture the potential impact of vaccination on the respective endpoints as a broader evaluation of the vaccine profile. Other administrative changes have been made as requested by ethics committee reviewer and updated internal company guidance.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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