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    Clinical Trial Results:
    Immunogenicity and Safety of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine Given in Japanese Subjects

    Summary
    EudraCT number
    		 2015-005195-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Sep 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Mar 2016
    First version publication date
    03 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TYP31(SFY12079)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01608815
    WHO universal trial number (UTN)
    		 U1111-1124-7699
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur KK
    Sponsor organisation address
    3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan, 163-1488
    Public contact
    Medical Director, Sanofi Pasteur KK, 81 3 6301 3603, Toshihiro.emori@sanofi.com
    Scientific contact
    Medical Director, Sanofi Pasteur KK, 81 3 6301 3603, Toshihiro.emori@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Dec 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To describe the seroconversion rate (percentage of subjects with at least a 4-fold increase of their Vi antibody titer) between Day 0 before vaccination and Day 28 after vaccination with typhoid Vi polysaccharide (SP093) vaccine in subjects aged 2 years and above.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    26 May 2012
    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
    Japan: 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)
    0
    Children (2-11 years)
    5
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    188
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study subjects were enrolled from 26 May 2012 to 31 August 2012 at 4 clinic centers in Japan.

    Pre-assignment
    Screening details
    		 A total of 200 subjects who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adults (Group 1)
    Arm description
    		 Subjects ≥ 18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SP093, Typhoid Vi Polysaccharide Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0 (Visit 1).

    Arm title
    		 Adolescents (Group 2)
    Arm description
    		 Subjects 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SP093, Typhoid Vi Polysaccharide Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0 (Visit 1).

    Arm title
    		 Children (Group 3)
    Arm description
    		 Subjects 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SP093, Typhoid Vi Polysaccharide Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0 (Visit 1).

    Number of subjects in period 1
    		Adults (Group 1) Adolescents (Group 2) Children (Group 3)
    Started
    188
    7
    5
    Completed
    188
    7
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adults (Group 1)
    Reporting group description
    		 Subjects ≥ 18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.

    Reporting group title
    Adolescents (Group 2)
    Reporting group description
    		 Subjects 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.

    Reporting group title
    Children (Group 3)
    Reporting group description
    		 Subjects 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.

    Reporting group values
    		 Adults (Group 1) Adolescents (Group 2) Children (Group 3) Total
    Number of subjects
    		 188 7 5 200
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 5 5
        Adolescents (12-17 years)
    		 0 7 0 7
        Adults (18-64 years)
    		 188 0 0 188
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.2 ( 11.4 ) 15.6 ( 2 ) 5.2 ( 3.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 72 3 1 76
        Male
    		 116 4 4 124

    End points

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    End points reporting groups
    Reporting group title
    Adults (Group 1)
    Reporting group description
    		 Subjects ≥ 18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.

    Reporting group title
    Adolescents (Group 2)
    Reporting group description
    		 Subjects 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.

    Reporting group title
    Children (Group 3)
    Reporting group description
    		 Subjects 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.

    Primary: Number of Subjects With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine

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    End point title
    		 Number of Subjects With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine [1]
    End point description
    Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) to Day 28 (post-vaccination)
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Adults (Group 1) Adolescents (Group 2) Children (Group 3)
    Number of subjects analysed
    188
    7
    5
    Units: Number of subjects
    number (not applicable)
        Subjects With a 4-Fold Rise in Vi Antibody Titers
    173
    6
    5
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With a Typhoid Vi Polysaccharide Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With a Typhoid Vi Polysaccharide Vaccine
    End point description
    Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-vaccination
    End point values
    		 Adults (Group 1) Adolescents (Group 2) Children (Group 3)
    Number of subjects analysed
    188
    7
    5
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        GMT (pre-vaccination)
    6.6 (5.8 to 7.4)
    10.2 (2.9 to 35.9)
    3.7 (3.7 to 3.7)
        GMT (post-vaccination)
    148.6 (126.9 to 174)
    320 (230.6 to 444.2)
    501.7 (305.3 to 824.5)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With a Typhoid Vi Polysaccharide Vaccine

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    End point title
    		 Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With a Typhoid Vi Polysaccharide Vaccine
    End point description
    Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    Day 28 post-vaccination
    End point values
    		 Adults (Group 1) Adolescents (Group 2) Children (Group 3)
    Number of subjects analysed
    188
    7
    5
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        GMTRs of Antibodies to Vi Antibody
    22.6 (19.1 to 26.8)
    31.4 (9.2 to 107.9)
    135.6 (82.5 to 222.8)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination With a Typhoid Vi Polysaccharide Vaccine

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    End point title
    		 Number of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination With a Typhoid Vi Polysaccharide Vaccine
    End point description
    Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 Injection site (Children): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 50 mm; Grade 3 Injection site (Adolescents and Adults): Pain, Significant, prevents daily activity; Erythema and Swelling, > 100 mm. Grade 3 Systemic reactions: Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 Adults (Group 1) Adolescents (Group 2) Children (Group 3)
    Number of subjects analysed
    188
    7
    5
    Units: Number of subjects
    number (not applicable)
        Injection site Pain
    139
    6
    3
        Grade 3 Injection site Pain
    0
    0
    0
        Injection site Erythema
    0
    0
    2
        Grade 3 Injection site Erythema
    0
    0
    0
        Injection site Swelling
    1
    0
    0
        Grade 3 Injection site Swelling
    0
    0
    0
        Fever
    2
    0
    1
        Grade 3 Fever
    0
    0
    0
        Headache
    14
    0
    0
        Grade 3 Headache
    1
    0
    0
        Malaise
    23
    0
    0
        Grade 3 Malaise
    2
    0
    0
        Myalgia
    93
    4
    1
        Grade 3 Myalgia
    2
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Adults (Group 1)
    Reporting group description
    		 Subjects ≥ 18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.

    Reporting group title
    Adolescents (Group 2)
    Reporting group description
    		 Subjects 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.

    Reporting group title
    Children (Group 3)
    Reporting group description
    		 Subjects 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine.

    Serious adverse events
    		 Adults (Group 1) Adolescents (Group 2) Children (Group 3)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 188 (0.53%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 188 (0.53%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adults (Group 1) Adolescents (Group 2) Children (Group 3)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    139 / 188 (73.94%)
    6 / 7 (85.71%)
    3 / 5 (60.00%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 188 (7.45%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    14
    0
    0
    General disorders and administration site conditions
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 188 (1.06%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    0
    1
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 7 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    0
    2
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    139 / 188 (73.94%)
    6 / 7 (85.71%)
    3 / 5 (60.00%)
         occurrences all number
    139
    6
    3
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    23 / 188 (12.23%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    23
    0
    0
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    1 / 188 (0.53%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    93 / 188 (49.47%)
    4 / 7 (57.14%)
    1 / 5 (20.00%)
         occurrences all number
    93
    4
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 188 (3.72%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    7
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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