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    Clinical Trial Results:
    Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan (IPV46)

    Summary
    EudraCT number
    		 2015-003279-31
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2016
    First version publication date
    12 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IPV46/EFC13614
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02005536
    WHO universal trial number (UTN)
    		 U1111-1143-8561
    Sponsors
    Sponsor organisation name
    Sanofi K.K.
    Sponsor organisation address
    3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan, 163-1488
    Public contact
    PMS Management Supervisor, Sanofi K.K., 33 4376 56799, Emmanuel.vidor@sanofipasteur.com
    Scientific contact
    PMS Management Supervisor, Sanofi K.K., 33 4376 56799, Emmanuel.vidor@sanofipasteur.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
    03 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as a second booster.
    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
    02 Dec 2013
    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: 60
    Worldwide total number of subjects
    60
    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)
    60
    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
    		 Subjects were enrolled from 02 December 2013 to 28 April 2014 at 4 clinic centers in Japan.

    Pre-assignment
    Screening details
    		 A total of 60 subjects who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated. A subject with an exclusion criteria was later discovered and was excluded in the per-protocol analysis set.

    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
    Arm title
    		 IMOVAX POLIO® Vaccine Group
    Arm description
    		 Subjects received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SP059, IMOVAX POLIO® (Inactivated Poliovirus Vaccine; IPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, single dose.

    Number of subjects in period 1
    		IMOVAX POLIO® Vaccine Group
    Started
    60
    Completed
    60

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IMOVAX POLIO® Vaccine Group
    Reporting group description
    		 Subjects received a single booster dose of IMOVAX POLIO® vaccine on Day 0.

    Reporting group values
    		 IMOVAX POLIO® Vaccine Group Total
    Number of subjects
    		 60 60
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 60 60
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 4 ± 0.2 -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 35 35

    End points

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    End points reporting groups
    Reporting group title
    IMOVAX POLIO® Vaccine Group
    Reporting group description
    		 Subjects received a single booster dose of IMOVAX POLIO® vaccine on Day 0.

    Primary: Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®

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    End point title
    		 Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® [1]
    End point description
    A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.
    End point type
    Primary
    End point timeframe
    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 group and the study vaccine administered for this outcome.
    End point values
    		 IMOVAX POLIO® Vaccine Group
    Number of subjects analysed
    59
    Units: Percentage of subjects
    number (not applicable)
        Anti-Polio 1
    78
        Anti-Polio 2
    78
        Anti-Polio 3
    79.7
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Vaccine Antigens Before and After Vacination With IMOVAX POLIO®

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    End point title
    		 Geometric Mean Titers of Vaccine Antigens Before and After Vacination With IMOVAX POLIO®
    End point description
    Anti-polio virus antibodies were assessed by virus neutralization assay.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
    End point values
    		 IMOVAX POLIO® Vaccine Group
    Number of subjects analysed
    59
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Polio 1 (pre-vaccination)
    312.6 (241.8 to 404.1)
        Anti-Polio 1 (post-vaccination)
    3794.9 (3011.5 to 4782.1)
        Anti-Polio 2 (pre-vaccination)
    795.4 (591.8 to 1069.1)
        Anti-Polio 2 (post-vaccination)
    9213.2 (6754.5 to 12567)
        Anti-Polio 3 (pre-vaccination)
    314.5 (219.5 to 450.4)
        Anti-Polio 3 (post-vaccination)
    5242.1 (3912.9 to 7022.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®

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    End point title
    		 Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
    End point description
    Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
    End point values
    		 IMOVAX POLIO® Vaccine Group
    Number of subjects analysed
    59
    Units: Percentage of subjects
    number (not applicable)
        Anti-Polio 1 (pre-vaccination)
    100
        Anti-Polio 1 (post-vaccination)
    100
        Anti-Polio 2 (pre-vaccination)
    100
        Anti-Polio 2 (post-vaccination)
    100
        Anti-Polio 3 (pre-vaccination)
    98.3
        Anti-Polio 3 (post-vaccination)
    100
    No statistical analyses for this end point

    Secondary: Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vacination With IMOVAX POLIO®

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    End point title
    		 Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vacination With IMOVAX POLIO®
    End point description
    Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.
    End point type
    Secondary
    End point timeframe
    Day 28 post-booster vaccination
    End point values
    		 IMOVAX POLIO® Vaccine Group
    Number of subjects analysed
    59
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Polio 1
    12.1 (8.5 to 17.4)
        Anti-Polio 2
    11.6 (7.7 to 17.5)
        Anti-Polio 3
    16.7 (9.8 to 28.4)
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®

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    End point title
    		 Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
    End point description
    Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    		 IMOVAX POLIO® Vaccine Group
    Number of subjects analysed
    60
    Units: Number of subjects
    number (not applicable)
        Any Injection site Pain
    13
        Grade 3 Injection site Pain
    0
        Any Injection site Erythema
    41
        Grade 3 Injection site Erythema
    1
        Any Injection site Swelling
    21
        Grade 3 Injection site Swelling
    0
        Any Fever
    8
        Grade 3 Fever
    2
        Any Headache
    4
        Grade 3 Headache
    0
        Any Malaise
    18
        Grade 3 Malaise
    0
        Any Myalgia
    1
        Grade 3 Myalgia
    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-booster vaccination) up to Day 28 post-booster vaccination.
    Adverse event reporting additional description
    The total number (47) reporting other adverse events at the 5% frequency are those subjects with solicited injection site and systemic reactions.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    IMOVAX POLIO® Vaccine Group
    Reporting group description
    		 Subjects received a single booster dose of IMOVAX POLIO® vaccine on Day 0.

    Serious adverse events
    		 IMOVAX POLIO® Vaccine Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IMOVAX POLIO® Vaccine Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 60 (78.33%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    4
    General disorders and administration site conditions
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 60 (13.33%)
         occurrences all number
    8
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    41 / 60 (68.33%)
         occurrences all number
    41
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 60 (21.67%)
         occurrences all number
    13
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 60 (35.00%)
         occurrences all number
    21
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 60 (30.00%)
         occurrences all number
    18
    Pyrexia
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    4
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    3
    Nasopharyngitis
         subjects affected / exposed
    11 / 60 (18.33%)
         occurrences all number
    11
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    4
    Varicella
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Sep 2013
    Minor logistic modifications.
    25 Sep 2013
    Minor logistic modifications

    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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