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    Clinical Trial Results:
    Immunogenicity and Safety of Fractional Doses of Sanofi Pasteur’s Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered Intradermally versus Full Doses of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered Intramuscularly in Healthy Infants in The Philippines

    Summary
    EudraCT number
    		 2015-005183-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Jul 2008

    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
    IPV25
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00604058
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Franchise Medical Director, Sanofi Pasteur SA, 33 4 37 37 70 26, RegistryContactUS@sanofipasteur.com
    Scientific contact
    Franchise Medical Director, Sanofi Pasteur SA, 33 4 37 37 70 26, RegistryContactUS@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
    04 Dec 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To demonstrate the non-inferiority of fractional doses of IPV administered intradermally versus full doses of IPV administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination.
    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
    19 Feb 2008
    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
    Philippines: 236
    Worldwide total number of subjects
    236
    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)
    236
    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
    		 The study subjects were enrolled from 19 February 2008 to 08 March 2008 at 1 clinic center in the Philippines.

    Pre-assignment
    Screening details
    		 A total of 236 subjects who met all inclusion and none of the exclusion criteria were randomized and vaccinated in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A; Fractional Dose of IMOVAX Polio™
    Arm description
    		 Infants received fractional doses (0.1 mL or 1/5 of a dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally at 6, 10, and 14 weeks of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPV (IMOVAX Polio™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, intradermal into the right upper arm, 1 dose each at 6, 10, and 14 weeks of age.

    Arm title
    		 Group B; Full Dose of IMOVAX Polio™
    Arm description
    		 Infants received full doses (0.5 mL) of IPV intramuscularly at 6, 10, and 14 weeks of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    IPV (IMOVAX Polio™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral area of the right thigh, 1 dose each at 6, 10, and 14 weeks of age.

    Number of subjects in period 1
    		Group A; Fractional Dose of IMOVAX Polio™ Group B; Full Dose of IMOVAX Polio™
    Started
    118
    118
    Completed
    115
    115
    Not completed
    3
    3
         Consent withdrawn by subject
    2
    3
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A; Fractional Dose of IMOVAX Polio™
    Reporting group description
    		 Infants received fractional doses (0.1 mL or 1/5 of a dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally at 6, 10, and 14 weeks of age.

    Reporting group title
    Group B; Full Dose of IMOVAX Polio™
    Reporting group description
    		 Infants received full doses (0.5 mL) of IPV intramuscularly at 6, 10, and 14 weeks of age.

    Reporting group values
    		 Group A; Fractional Dose of IMOVAX Polio™ Group B; Full Dose of IMOVAX Polio™ Total
    Number of subjects
    		 118 118 236
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 118 118 236
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 45.5 ( 2.1 ) 45.5 ( 2.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 59 74 133
        Male
    		 59 44 103

    End points

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    End points reporting groups
    Reporting group title
    Group A; Fractional Dose of IMOVAX Polio™
    Reporting group description
    		 Infants received fractional doses (0.1 mL or 1/5 of a dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally at 6, 10, and 14 weeks of age.

    Reporting group title
    Group B; Full Dose of IMOVAX Polio™
    Reporting group description
    		 Infants received full doses (0.5 mL) of IPV intramuscularly at 6, 10, and 14 weeks of age.

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

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    End point title
    		 Percentage of Infant Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Following A Three-Dose Primary Vaccination Series with Either Fractional Doses Or Full Doses of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)
    End point description
    Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection was defined as Anti-poliovirus types 1, 2, 3 titers ≥ 8 (1/dil).
    End point type
    Primary
    End point timeframe
    1 month post-dose 3 of primary vaccination
    End point values
    		 Group A; Fractional Dose of IMOVAX Polio™ Group B; Full Dose of IMOVAX Polio™
    Number of subjects analysed
    109
    114
    Units: Percentage of subjects
    number (not applicable)
        Anti-Polio 1
    100
    100
        Anti-Polio 2
    100
    100
        Anti-Polio 3
    99.1
    100
    Statistical analysis title
    		 Anti-Polio 1; Group A-Group B
    Statistical analysis description
    Non-inferiority analysis of fractional doses of IPV administered intradermally versus full doses of IPV administered intramuscularly, in terms of seroprotection rates one month after the three-dose primary vaccination administered at 6, 10, and 14 weeks of age.
    Comparison groups
    Group B; Full Dose of IMOVAX Polio™ v Group A; Fractional Dose of IMOVAX Polio™
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Group A-Group B
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 3.26
    Notes
    [1] - For each polio type, the non-inferiority is demonstrated if the 95% confidence interval of the difference lies entirely above -5%. Group A was non-inferior to Group B.
    Statistical analysis title
    		 Anti-Polio 2; Group A-Group B
    Statistical analysis description
    Non-inferiority analysis of fractional doses of IPV administered intradermally versus full doses of IPV administered intramuscularly, in terms of seroprotection rates one month after the three-dose primary vaccination administered at 6, 10, and 14 weeks of age.
    Comparison groups
    Group A; Fractional Dose of IMOVAX Polio™ v Group B; Full Dose of IMOVAX Polio™
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Group A-Group B
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 3.26
    Notes
    [2] - For each polio type, the non-inferiority is demonstrated if the 95% confidence interval of the difference lies entirely above -5%. Group A was non-inferior to Group B.
    Statistical analysis title
    		 Anti-Polio 3; Group A-Group B
    Statistical analysis description
    Non-inferiority analysis of fractional doses of IPV administered intradermally versus full doses of IPV administered intramuscularly, in terms of seroprotection rates one month after the three-dose primary vaccination administered at 6, 10, and 14 weeks of age.
    Comparison groups
    Group A; Fractional Dose of IMOVAX Polio™ v Group B; Full Dose of IMOVAX Polio™
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Group A-Group B
    Point estimate
    -0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.01
         upper limit
    		 2.43
    Notes
    [3] - For each polio type, the non-inferiority is demonstrated if the 95% confidence interval of the difference lies entirely above -5%. For Anti-Polio 3, the lower limit of -5.01% was equal to the clinically acceptable limit for non-inferiority (-5%).

    Secondary: Geometric Mean Titers of Anti-polio 1, 2, and 3 Antibodies Before and Following A Three-Dose Primary Vaccination series with Either Fractional Doses Or Full Doses 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 Vaccination series with Either Fractional Doses Or Full Doses of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)
    End point description
    Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
    End point type
    Secondary
    End point timeframe
    Pre-Primary, Adjusted Pre-Primary, and Post-Primary vaccination
    End point values
    		 Group A; Fractional Dose of IMOVAX Polio™ Group B; Full Dose of IMOVAX Polio™
    Number of subjects analysed
    109
    114
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Polio 1; Pre-Primary
    10.4 (8 to 13.4)
    11.7 (8.9 to 15.4)
        Anti-Polio 1; Adjusted Pre-Primary
    1.2 (0.9 to 1.5)
    1.3 (1 to 1.7)
        Anti-Polio 1; Post-Primary
    221.2 (188.8 to 259.1)
    585.3 (482.1 to 710.5)
        Anti-Polio 2; Pre-Primary
    16.5 (12.9 to 21.1)
    16.7 (12.8 to 21.6)
        Anti-Polio 2; Adjusted Pre-Primary
    1.9 (1.5 to 2.4)
    1.9 (1.4 to 2.4)
        Anti-Polio 2; Post-Primary
    234.2 (186.4 to 294.2)
    795.6 (638.1 to 992.1)
        Anti-Polio 3; Pre-Primary
    7.8 (6 to 10)
    6.7 (5.2 to 8.6)
        Anti-Polio 3; Adjusted Pre-Primary
    0.9 (0.7 to 1.1)
    0.7 (0.6 to 1)
        Anti-Polio 3; Post-Primary
    194.7 (157.7 to 240.4)
    774.2 (622.2 to 963.3)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Anti-polio 1, 2, and 3 Antibodies Following A Three-Dose Primary Vaccination series with Either Fractional Doses Or Full Doses 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 Three-Dose Primary Vaccination series with Either Fractional Doses Or Full Doses of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)
    End point description
    Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Geometric mean titer ratios were based on Post/Pre-Primary vaccination ≥ 4-fold increase. Individual adjusted ratios were calculated with individual titers adjusted according to the level of maternal anti-Polio antibodies in subjects' serum at V01 and their estimated levels that would have been observed at V04 if vaccination had not been performed.
    End point type
    Secondary
    End point timeframe
    Post/Pre-Primary
    End point values
    		 Group A; Fractional Dose of IMOVAX Polio™ Group B; Full Dose of IMOVAX Polio™
    Number of subjects analysed
    109
    114
    Units: Titer ratio (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Polio 1; Individual ratio
    21.3 (15.8 to 28.8)
    49.8 (34.6 to 71.8)
        Anti-Polio 2; Individual ratio
    14.2 (9.5 to 21.2)
    47.8 (31.9 to 71.6)
        Anti-Polio 3; Individual ratio
    25 (17.6 to 35.6)
    115.7 (80.6 to 166)
        Anti-Polio 1; Individual adjusted ratio
    188.3 (139.1 to 254.9)
    446.3 (310.1 to 642.4)
        Anti-Polio 2; Individual adjusted ratio
    125.7 (84.4 to 187.2)
    427.8 (285.9 to 640.2)
        Anti-Polio 3; Individual adjusted ratio
    221.3 (155.1 to 315.7)
    1035.9 (724.9 to 1480.3)
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with Anti-Poliovirus 1, 2 and 3 Titers of 1 ≥4 (1/dil) or 1 ≥8 (1/dil) Before and After A Three-Dose Primary Vaccination series with Either Fractional Doses Or Full Doses of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Percentage of Infant Subjects with Anti-Poliovirus 1, 2 and 3 Titers of 1 ≥4 (1/dil) or 1 ≥8 (1/dil) Before and After A Three-Dose Primary Vaccination series with Either Fractional Doses Or Full Doses of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)
    End point description
    Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
    End point type
    Secondary
    End point timeframe
    Pre-Primary, Adjusted Pre-Primary, and Post-Primary vaccination
    End point values
    		 Group A; Fractional Dose of IMOVAX Polio™ Group B; Full Dose of IMOVAX Polio™
    Number of subjects analysed
    109
    114
    Units: Percentage of subjects
    number (not applicable)
        Anti-Polio 1; Pre-Primary; ≥ 4 (1/dil)
    74.3
    76.3
        Anti-Polio 1; Adjusted Pre-Primary; ≥ 4 (1/dil)
    20.2
    22.8
        Anti-Polio 1; Post-Primary; ≥ 4 (1/dil)
    100
    100
        Anti-Polio 1; Pre-Primary; ≥ 8 (1/dil)
    59.6
    56.1
        Anti-Polio 1; Adjusted Pre-Primary; ≥ 8 (1/dil)
    10.1
    12.3
        Anti-Polio 1; Post-Primary; ≥ 8 (1/dil)
    100
    100
        Anti-Polio 2; Pre-Primary; ≥ 4 (1/dil)
    89
    86.8
        Anti-Polio 2; Adjusted Pre-Primary; ≥ 4 (1/dil)
    30.3
    33.3
        Anti-Polio 2; Post-Primary; ≥ 4 (1/dil)
    100
    100
        Anti-Polio 2; Pre-Primary; ≥ 8 (1/dil)
    71.6
    69.3
        Anti-Polio 2; Adjusted Pre-Primary; ≥ 8 (1/dil)
    16.5
    15.8
        Anti-Polio 2; Post-Primary; ≥ 8 (1/dil)
    100
    100
        Anti-Polio 3; Pre-Primary; ≥ 4 (1/dil)
    67
    58.8
        Anti-Polio 3; Adjusted Pre-Primary; ≥ 4 (1/dil)
    13.8
    14
        Anti-Polio 3; Post-Primary; ≥ 4 (1/dil)
    100
    100
        Anti-Polio 3; Pre-Primary; ≥ 8 (1/dil)
    45
    41.2
        Anti-Polio 3; Adjusted Pre-Primary; ≥ 8 (1/dil)
    9.2
    8.8
        Anti-Polio 3; Post-Primary; ≥ 8 (1/dil)
    99.1
    100
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions Following Any and Each Primary Series Vaccination with Either Fractional Doses Or Full Doses of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions Following Any and Each Primary Series Vaccination with Either Fractional Doses Or Full Doses of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)
    End point description
    Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) up to Day 8 post-any and each vaccine injection
    End point values
    		 Group A; Fractional Dose of IMOVAX Polio™ Group B; Full Dose of IMOVAX Polio™
    Number of subjects analysed
    118
    118
    Units: Percentage of subjects
    number (not applicable)
        Injection site Reaction; Post-Any Injection
    83.1
    59.8
        Injection site Tenderness; Post-Any Injection
    60.2
    50.4
        Injection site Tenderness; Post-Dose 1
    50.8
    41
        Injection site Tenderness; Post-Dose 2
    35.7
    27
        Injection site Tenderness; Post-Dose 3
    28.9
    18.3
        Injection site Erythema; Post-Any Injection
    69.5
    29.1
        Injection site Erythema; Post-Dose 1
    44.1
    12
        Injection site Erythema; Post-Dose 2
    48.7
    11.3
        Injection site Erythema; Post-Dose 3
    39.5
    12.2
        Injection site Swelling; Post-Any Injection
    21.2
    9.4
        Injection site Swelling; Post-Dose 1
    11
    6.8
        Injection site Swelling; Post-Dose 2
    11.3
    2.6
        Injection site Swelling; Post-Dose 3
    7
    3.5
        Solicited systemic reaction; Post-Any Injection
    65.3
    67.5
        Fever; Post-Any Injection
    5.9
    10.3
        Fever; Post-Dose 1
    4.2
    5.1
        Fever; Post-Dose 2
    0
    2.6
        Fever; Post-Dose 3
    1.8
    3.5
        Vomiting; Post-Any Injection
    15.3
    21.4
        Vomiting; Post-Dose 1
    12.7
    15.4
        Vomiting; Post-Dose 2
    2.6
    7
        Vomiting; Post-Dose 3
    1.8
    0
        Crying abnormal; Post-Any Injection
    33.9
    30.8
        Crying abnormal; Post-Dose 1
    23.7
    17.9
        Crying abnormal; Post-Dose 2
    10.4
    13
        Crying abnormal; Post-Dose 3
    7.9
    5.2
        Drowsiness; Post-Any Injection
    37.3
    35
        Drowsiness; Post-Dose 1
    30.5
    27.4
        Drowsiness; Post-Dose 2
    8.7
    9.6
        Drowsiness; Post-Dose 3
    8.8
    5.2
        Appetite lost; Post-Any Injection
    16.1
    19.7
        Appetite lost; Post-Dose 1
    12.7
    12.8
        Appetite lost; Post-Dose 2
    5.2
    4.3
        Appetite lost; Post-Dose 3
    2.6
    4.3
        Irritability; Post-Any Injection
    49.2
    43.6
        Irritability; Post-Dose 1
    43.2
    32.5
        Irritability; Post-Dose 2
    18.3
    13
        Irritability; Post-Dose 3
    10.5
    9.6
    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 up to 1 month post-dose 3 of the primary vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Group A; Fractional Dose of IMOVAX Polio™
    Reporting group description
    		 Infants received fractional doses (0.1 mL or 1/5 of a dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally at 6, 10, and 14 weeks of age.

    Reporting group title
    Group B; Full Dose of IMOVAX Polio™
    Reporting group description
    		 Infants received full doses (0.5 mL) of IPV intramuscularly at 6, 10, and 14 weeks of age.

    Serious adverse events
    		 Group A; Fractional Dose of IMOVAX Polio™ Group B; Full Dose of IMOVAX Polio™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 118 (1.69%)
    0 / 118 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 118 (1.69%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A; Fractional Dose of IMOVAX Polio™ Group B; Full Dose of IMOVAX Polio™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    98 / 118 (83.05%)
    79 / 118 (66.95%)
    Nervous system disorders
    Drowsiness; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    44 / 118 (37.29%)
    41 / 117 (35.04%)
         occurrences all number
    44
    41
    General disorders and administration site conditions
    Injection site Tenderness; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    71 / 118 (60.17%)
    59 / 117 (50.43%)
         occurrences all number
    71
    59
    Injection site Erythema; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed
    82 / 118 (69.49%)
    34 / 118 (28.81%)
         occurrences all number
    82
    34
    Injection site Swelling; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    25 / 118 (21.19%)
    11 / 117 (9.40%)
         occurrences all number
    25
    11
    Fever; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    7 / 118 (5.93%)
    12 / 117 (10.26%)
         occurrences all number
    7
    12
    Pyrexia
         subjects affected / exposed
    9 / 118 (7.63%)
    8 / 118 (6.78%)
         occurrences all number
    9
    8
    Gastrointestinal disorders
    Vomiting; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    18 / 118 (15.25%)
    25 / 117 (21.37%)
         occurrences all number
    18
    25
    Psychiatric disorders
    Crying abnormal; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    40 / 118 (33.90%)
    36 / 117 (30.77%)
         occurrences all number
    40
    36
    Irritability; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    58 / 118 (49.15%)
    51 / 117 (43.59%)
         occurrences all number
    58
    51
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    71 / 118 (60.17%)
    77 / 118 (65.25%)
         occurrences all number
    114
    122
    Viral infection
         subjects affected / exposed
    5 / 118 (4.24%)
    8 / 118 (6.78%)
         occurrences all number
    5
    9
    Metabolism and nutrition disorders
    Appetite lost; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    19 / 118 (16.10%)
    23 / 117 (19.66%)
         occurrences all number
    19
    23
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

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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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