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    Clinical Trial Results:
    Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-Dose Primary and Booster Vaccination in Infants in Japan

    Summary
    EudraCT number
    2015-005187-42
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    08 Nov 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Apr 2016
    First version publication date
    16 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IPV35_EFC12403
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01389687
    WHO universal trial number (UTN)
    U1111-1120-1735
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur K.K.
    Sponsor organisation address
    3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan, 163-1488
    Public contact
    Head of Local Medical Operation, Sanofi Aventis K.K., Toshiaki.Sato@sanofi.com
    Scientific contact
    Head of Local Medical Operation, Sanofi Aventis K.K., Toshiaki.Sato@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
    08 Nov 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV).
    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
    01 Jul 2011
    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: 74
    Worldwide total number of subjects
    74
    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)
    74
    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
    Study subjects were enrolled from 01 July 2011 to 08 November 2011 (primary series) and to 30 June 2012 (booster series) at 2 clinic centers in Japan.

    Pre-assignment
    Screening details
    A total of 74 subjects who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated in the primary series study; 73 subjects in the booster series.

    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
    SP059 (Inactivated Poliovirus Vaccine; IPV)
    Arm description
    Subjects received three doses of Inactivated poliovirus vaccine (IPV) administered 3-8 weeks (21-56 days) apart as a three-dose primary vaccination starting at 3-68 (recommended 3-8 months) of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    SP059 (Inactivated Poliovirus vaccine types 1, 2, and 3)
    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 into the internal area of upper arm, 1 injection each at Day 0, 56, and 112 as primary vaccination series and a single booster dose 6-18 months post-dose 3.

    Number of subjects in period 1
    SP059 (Inactivated Poliovirus Vaccine; IPV)
    Started
    74
    Completed
    74

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SP059 (Inactivated Poliovirus Vaccine; IPV)
    Reporting group description
    Subjects received three doses of Inactivated poliovirus vaccine (IPV) administered 3-8 weeks (21-56 days) apart as a three-dose primary vaccination starting at 3-68 (recommended 3-8 months) of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.

    Reporting group values
    SP059 (Inactivated Poliovirus Vaccine; IPV) Total
    Number of subjects
    74 74
    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)
    74 74
        Children (2-11 years)
    0 0
        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: months
        arithmetic mean (standard deviation)
    5.1 ± 1.1 -
    Gender categorical
    Units: Subjects
        Female
    35 35
        Male
    39 39
    Subject analysis sets

    Subject analysis set title
    SP059 (Inactivated Poliovirus vaccine; IPV; Booster dose)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects received a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.

    Subject analysis sets values
    SP059 (Inactivated Poliovirus vaccine; IPV; Booster dose)
    Number of subjects
    73
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    73
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    14.9 ± 1.4
    Gender categorical
    Units: Subjects
        Female
    35
        Male
    38

    End points

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    End points reporting groups
    Reporting group title
    SP059 (Inactivated Poliovirus Vaccine; IPV)
    Reporting group description
    Subjects received three doses of Inactivated poliovirus vaccine (IPV) administered 3-8 weeks (21-56 days) apart as a three-dose primary vaccination starting at 3-68 (recommended 3-8 months) of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.

    Subject analysis set title
    SP059 (Inactivated Poliovirus vaccine; IPV; Booster dose)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects received a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.

    Primary: Percentage of Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Before and Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    Percentage of Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Before and Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [1]
    End point description
    Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection was defined as Anti-Poliovirus 1, 2, and 3 antibody titers ≥ 8 (1/dil).
    End point type
    Primary
    End point timeframe
    Pre-Primary and Post-Primary 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
    SP059 (Inactivated Poliovirus Vaccine; IPV)
    Number of subjects analysed
    74
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; Pre-Primary
    2.7
        Anti-Poliovirus 1; Post-Primary
    100
        Anti-Poliovirus 2; Pre-Primary
    18.9
        Anti-Poliovirus 2; Post-Primary
    100
        Anti-Poliovirus 3; Pre-Primary
    0
        Anti-Poliovirus 3; Post-Primary
    100
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Anti-polio 1, 2, and 3 Antibodies Before and Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    Geometric Mean Titers of Anti-polio 1, 2, and 3 Antibodies Before and Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [2]
    End point description
    Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
    End point type
    Primary
    End point timeframe
    Pre-Primary and Post-Primary Vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    SP059 (Inactivated Poliovirus Vaccine; IPV)
    Number of subjects analysed
    74
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Pre-Primary
    2.2 (2.1 to 2.4)
        Anti-Poliovirus 1; Post-Primary
    291.9 (242.1 to 351.8)
        Anti-Poliovirus 2; Pre-Primary
    3.3 (2.5 to 4.3)
        Anti-Poliovirus 2; Post-Primary
    559.6 (463.5 to 675.7)
        Anti-Poliovirus 3; Pre-Primary
    2.1 (2 to 2.2)
        Anti-Poliovirus 3; Post-Primary
    432.6 (348.4 to 537.1)
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios of Anti-polio 1, 2, and 3 Antibodies Before and Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    Geometric Mean Titer Ratios of Anti-polio 1, 2, and 3 Antibodies Before and Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [3]
    End point description
    Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
    End point type
    Primary
    End point timeframe
    Post-Primary/Pre-Primary Vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    SP059 (Inactivated Poliovirus Vaccine; IPV)
    Number of subjects analysed
    74
    Units: Titer ratio (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Post-Primary
    130.4 (108.1 to 157.3)
        Anti-Poliovirus 2; Post-Primary
    171.9 (130.7 to 226)
        Anti-Poliovirus 3; Post-Primary
    208.3 (166 to 261.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [4]
    End point description
    Solicited injection site reactions (3 to 23 months): Tenderness, Erythema, and Swelling; (2 to 11 years): Pain, Erythema, and Swelling. Solicited systemic reactions (3 to 23 months): Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability and (2 to 11 years): Fever, Headache, Malaise, and Myalgia. Grade 3 injection site reactions: Tenderness (3 to 23 months), Cries when injected limb is moved or the movement of the injected limb is reduced; Pain (2 to 11 years), Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 50 mm. Grade 3 systemic reactions (3 to 23 months): Fever, ≥ 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable and (2 to 11 years): Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-any dose primary series
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    SP059 (Inactivated Poliovirus Vaccine; IPV)
    Number of subjects analysed
    74
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness; Post-dose 1
    2.7
        Grade 3 Injection site Tenderness; Post-dose 1
    0
        Any Injection site Tenderness; Post-dose 2
    1.4
        Grade 3 Injection site Tenderness; Post-dose 2
    0
        Any Injection site Tenderness; Post-dose 3
    5.4
        Grade 3 Injection site Tenderness; Post-dose 3
    0
        Any Injection site Tenderness; Primary series
    8.1
        Grade 3 Injection site Tenderness; Primary series
    0
        Any Injection site Erythema; Post-dose 1
    51.4
        Grade 3 Injection site Erythema; Post-dose 1
    0
        Any Injection site Erythema; Post-dose 2
    51.4
        Grade 3 Injection site Erythema; Post-dose 2
    0
        Any Injection site Erythema; Post-dose 3
    47.3
        Grade 3 Injection site Erythema; Post-dose 3
    0
        Any Injection site Erythema; Primary series
    66.2
        Grade 3 Injection site Erythema; Primary series
    0
        Any Injection site Swelling; Post-dose 1
    20.3
        Grade 3 Injection site Swelling; Post-dose 1
    0
        Any Injection site Swelling; Post-dose 2
    27
        Grade 3 Injection site Swelling; Post-dose 2
    0
        Any Injection site Swelling; Post-dose 3
    21.6
        Grade 3 Injection site Swelling; Post-dose 3
    0
        Any Injection site Swelling; Primary series
    37.8
        Grade 3 Injection site Swelling; Primary series
    0
        Any Fever; Post-dose 1
    5.4
        Grade 3 Fever; Post-dose 1
    0
        Any Fever; Post-dose 2
    5.4
        Grade 3 Fever; Post-dose 2
    0
        Any Fever; Post-dose 3
    4.1
        Grade 3 Fever; Post-dose 3
    2.7
        Any Fever; Primary series
    14.9
        Grade 3 Fever; Primary series
    2.7
        Any Vomiting; Post-dose 1
    8.1
        Grade 3 Vomiting; Post-dose 1
    0
        Any Vomiting; Post-dose 2
    10.8
        Grade 3 Vomiting; Post-dose 2
    0
        Any Vomiting; Post-dose 3
    5.4
        Grade 3 Vomiting; Post-dose 3
    0
        Any Vomiting; Primary series
    18.9
        Grade 3 Vomiting; Primary series
    0
        Any Crying abnormal; Post-dose 1
    6.8
        Grade 3 Crying abnormal; Post-dose 1
    0
        Any Crying abnormal; Post-dose 2
    10.8
        Grade 3 Crying abnormal; Post-dose 2
    0
        Any Crying abnormal; Post-dose 3
    5.4
        Grade 3 Crying abnormal; Post-dose 3
    0
        Any Crying abnormal; Primary series
    17.6
        Grade 3 Crying abnormal; Primary series
    0
        Any Drowsiness; Post-dose 1
    12.2
        Grade 3 Drowsiness; Post-dose 1
    0
        Any Drowsiness; Post-dose 2
    17.6
        Grade 3 Drowsiness; Post-dose 2
    0
        Any Drowsiness; Post-dose 3
    12.2
        Grade 3 Drowsiness; Post-dose 3
    0
        Any Drowsiness; Primary series
    29.7
        Grade 3 Drowsiness; Primary series
    0
        Any Appetite lost; Post-dose 1
    6.8
        Grade 3 Appetite lost; Post-dose 1
    0
        Any Appetite lost; Post-dose 2
    6.8
        Grade 3 Appetite lost; Post-dose 2
    0
        Any Appetite lost; Post-dose 3
    1.4
        Grade 3 Appetite lost; Post-dose 3
    0
        Any Appetite lost; Primary series
    12.2
        Grade 3 Appetite lost; Primary series
    0
        Any Irritability; Post-dose 1
    17.6
        Grade 3 Irritability; Post-dose 1
    1.4
        Any Irritability; Post-dose 2
    16.2
        Grade 3 Irritability; Post-dose 2
    0
        Any Irritability; Post-dose 3
    14.9
        Grade 3 Irritability; Post-dose 3
    0
        Any Irritability; Primary series
    32.4
        Grade 3 Irritability; Primary series
    1.4
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Before and Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    Percentage of Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Before and Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [5]
    End point description
    Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Seroprotection was defined as Anti-Poliovirus 1, 2, and 3 antibody titers ≥ 8 (1/dil).
    End point type
    Primary
    End point timeframe
    Pre-Booster and Post-Booster Vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    SP059 (Inactivated Poliovirus vaccine; IPV; Booster dose)
    Number of subjects analysed
    73
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; Pre-Booster
    100
        Anti-Poliovirus 1; Post-Booster
    100
        Anti-Poliovirus 2; Pre-Booster
    100
        Anti-Poliovirus 2; Post-Booster
    100
        Anti-Poliovirus 3; Pre-Booster
    97.3
        Anti-Poliovirus 3; Post-Booster
    100
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Anti-polio 1, 2, and 3 Antibodies Before and Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

    Close Top of page
    End point title
    Geometric Mean Titers of Anti-polio 1, 2, and 3 Antibodies Before and Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [6]
    End point description
    Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
    End point type
    Primary
    End point timeframe
    Pre-Booster and Post-Booster Vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    SP059 (Inactivated Poliovirus vaccine; IPV; Booster dose)
    Number of subjects analysed
    73
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Pre-Booster
    281.5 (224 to 353.7)
        Anti-Poliovirus 1; Post-Booster
    3906.1 (3217.1 to 4742.6)
        Anti-Poliovirus 2; Pre-Booster
    519.3 (429.7 to 627.6)
        Anti-Poliovirus 2; Post-Booster
    3742.7 (3046.8 to 4597.6)
        Anti-Poliovirus 3; Pre-Booster
    98.6 (72.2 to 134.6)
        Anti-Poliovirus 3; Post-Booster
    6775.1 (5292 to 8673.8)
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios of Anti-polio 1, 2, and 3 Antibodies Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    Geometric Mean Titer Ratios of Anti-polio 1, 2, and 3 Antibodies Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [7]
    End point description
    Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
    End point type
    Primary
    End point timeframe
    Post-Booster/Pre-Booster Vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    SP059 (Inactivated Poliovirus vaccine; IPV; Booster dose)
    Number of subjects analysed
    73
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Post-Booster
    13.9 (10.5 to 18.3)
        Anti-Poliovirus 2; Post-Booster
    7.2 (5.6 to 9.3)
        Anti-Poliovirus 3; Post-Booster
    68.7 (47.8 to 98.8)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [8]
    End point description
    Solicited injection site reactions (3 to 23 months): Tenderness, Erythema, and Swelling; (2 to 11 years): Pain, Erythema, and Swelling. Solicited systemic reactions (3 to 23 months): Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability and (2 to 11 years): Fever, Headache, Malaise, and Myalgia. Grade 3 injection site reactions: Tenderness (3 to 23 months), Cries when injected limb is moved or the movement of the injected limb is reduced; Pain (2 to 11 years), Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 50 mm. Grade 3 systemic reactions (3 to 23 months): Fever, ≥ 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable and (2 to 11 years): Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-booster vaccination
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    SP059 (Inactivated Poliovirus vaccine; IPV; Booster dose)
    Number of subjects analysed
    73
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    13.7
        Grade 3 Injection site Tenderness
    0
        Any Injection site Erythema
    52.1
        Grade 3 Injection site Erythema
    0
        Any Injection site Swelling
    27.4
        Grade 3 Injection site Swelling
    0
        Any Fever
    21.9
        Grade 3 Fever
    5.5
        Any Vomiting
    6.8
        Grade 3 Vomiting
    0
        Any Crying abnormal
    11
        Grade 3 Crying abnormal
    0
        Any Drowsiness
    17.8
        Grade 3 Drowsiness
    0
        Any Appetite lost
    17.8
        Grade 3 Appetite lost
    0
        Any Irritability
    21.9
        Grade 3 Irritability
    1.4
    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 of primary series up to Day 7 post-booster vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    SP059 (Inactivated Poliovirus Vaccine; IPV)
    Reporting group description
    Subjects received three doses of Inactivated poliovirus vaccine (IPV) administered 3-8 weeks (21-56 days) apart as a three-dose primary vaccination starting at 3-68 (recommended 3-8 months) of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.

    Reporting group title
    SP059 (Inactivated Poliovirus Vaccine; IPV; Booster dose)
    Reporting group description
    All subjects received a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.

    Serious adverse events
    SP059 (Inactivated Poliovirus Vaccine; IPV) SP059 (Inactivated Poliovirus Vaccine; IPV; Booster dose)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 74 (6.76%)
    9 / 73 (12.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Tremor
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Afebrile convulsion
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 74 (0.00%)
    3 / 73 (4.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Asthmatic bronchitis
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute bronchitis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 74 (0.00%)
    3 / 73 (4.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    SP059 (Inactivated Poliovirus Vaccine; IPV) SP059 (Inactivated Poliovirus Vaccine; IPV; Booster dose)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 74 (71.62%)
    41 / 73 (56.16%)
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation
         subjects affected / exposed
    16 / 74 (21.62%)
    11 / 73 (15.07%)
         occurrences all number
    16
    11
    Nervous system disorders
    Any Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 74 (29.73%)
    13 / 73 (17.81%)
         occurrences all number
    22
    13
    General disorders and administration site conditions
    Any Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 74 (8.11%)
    10 / 73 (13.70%)
         occurrences all number
    6
    10
    Any Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    49 / 74 (66.22%)
    38 / 73 (52.05%)
         occurrences all number
    49
    38
    Any Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    28 / 74 (37.84%)
    20 / 73 (27.40%)
         occurrences all number
    28
    20
    Any Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 74 (14.86%)
    16 / 73 (21.92%)
         occurrences all number
    11
    16
    Psychiatric disorders
    Any Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 74 (17.57%)
    8 / 73 (10.96%)
         occurrences all number
    13
    8
    Any Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 74 (32.43%)
    16 / 73 (21.92%)
         occurrences all number
    24
    16
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 74 (9.46%)
    3 / 73 (4.11%)
         occurrences all number
    7
    3
    Any Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 74 (18.92%)
    5 / 73 (6.85%)
         occurrences all number
    14
    5
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    5 / 74 (6.76%)
    0 / 73 (0.00%)
         occurrences all number
    5
    0
    Eczema
         subjects affected / exposed
    4 / 74 (5.41%)
    2 / 73 (2.74%)
         occurrences all number
    4
    2
    Metabolism and nutrition disorders
    Any Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 74 (12.16%)
    13 / 73 (17.81%)
         occurrences all number
    9
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 74 (13.51%)
    6 / 73 (8.22%)
         occurrences all number
    10
    6
    Bronchitis
         subjects affected / exposed
    5 / 74 (6.76%)
    5 / 73 (6.85%)
         occurrences all number
    5
    5
    Gastroenteritis
         subjects affected / exposed
    4 / 74 (5.41%)
    5 / 73 (6.85%)
         occurrences all number
    4
    5
    Hand-foot-and-mouth disease
         subjects affected / exposed
    4 / 74 (5.41%)
    0 / 73 (0.00%)
         occurrences all number
    4
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jun 2011
    Added the secondary endpoint for the evaluation of immunogenicity.

    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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