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    Clinical Trial Results:
    Immunogenicity and Safety of the Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered at 2, 3, and 4 Months of Age and Followed by a Booster Dose at 18 Months of age in Healthy Infants in China, versus Commercially Available Oral Poliomyelitis Vaccine

    Summary
    EudraCT number
    		 2015-005182-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Mar 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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IPV13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00348387
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur China
    Sponsor organisation address
    6th floor, No. 112 Jian Guo Lu, Chaoyang District, Beijing, China, 100022
    Public contact
    Local Medical Director, Sanofi Pasteur China, 86 10 6568 5588, Reinel.Zhang@sanofipasteur.com
    Scientific contact
    Local Medical Director, Sanofi Pasteur China, 86 10 6568 5588, Reinel.Zhang@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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Nov 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To demonstrate the non-inferiority in terms of seroprotection rates (polio types 1, 2 and 3) of IMOVAX Polio™ versus commercially available OPV one month after the 3-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
    21 Jun 2006
    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
    China: 600
    Worldwide total number of subjects
    600
    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)
    600
    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 21 June 2006 to 27 September 2006 at 1 clinic center in China.

    Pre-assignment
    Screening details
    		 A total of 600 infants met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in the primary vaccination phase of this study; 267 infants in the IPV group received the booster vaccination.

    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
    		 IMOVAX Polio™ Group
    Arm description
    		 Infants received the IMOVAX Polio™ (IPV) vaccine at 2, 3, and 4 months of age and a booster dose of IPV vaccine 14-16 months after the three-dose primary vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPV vaccine (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 injection each at 2, 3, and 4 months of age.

    Arm title
    		 Oral Poliomyelitis Vaccine Group
    Arm description
    		 Infants received the commercially available Oral Poliomyelitis Vaccine (OPV) vaccine at 2, 3, and 4 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell), Live OPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    1 g dragee, oral, 1 administration each at 2, 3, and 4 months of age.

    Number of subjects in period 1
    		IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Started
    300
    300
    Completed
    264
    282
    Not completed
    36
    18
         Consent withdrawn by subject
    29
    14
         Adverse event, non-fatal
    1
    1
         Serious adverse event
    1
    -
         Lost to follow-up
    4
    3
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IMOVAX Polio™ Group
    Reporting group description
    		 Infants received the IMOVAX Polio™ (IPV) vaccine at 2, 3, and 4 months of age and a booster dose of IPV vaccine 14-16 months after the three-dose primary vaccination.

    Reporting group title
    Oral Poliomyelitis Vaccine Group
    Reporting group description
    		 Infants received the commercially available Oral Poliomyelitis Vaccine (OPV) vaccine at 2, 3, and 4 months of age.

    Reporting group values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group Total
    Number of subjects
    		 300 300 600
    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)
    		 300 300 600
        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)
    		 64.7 ± 3 64.9 ± 2.9 -
    Gender categorical
    Units: Subjects
        Female
    		 132 128 260
        Male
    		 168 172 340

    End points

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    End points reporting groups
    Reporting group title
    IMOVAX Polio™ Group
    Reporting group description
    		 Infants received the IMOVAX Polio™ (IPV) vaccine at 2, 3, and 4 months of age and a booster dose of IPV vaccine 14-16 months after the three-dose primary vaccination.

    Reporting group title
    Oral Poliomyelitis Vaccine Group
    Reporting group description
    		 Infants received the commercially available Oral Poliomyelitis Vaccine (OPV) vaccine at 2, 3, and 4 months of age.

    Primary: Percentage of Infant Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Following A Three-Dose Primary Vaccination series with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine

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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 Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure. Seroprotection was defined as Anti-Poliovirus type 1, 2, and 3 antibody titers ≥ 8 (1/dil).
    End point type
    Primary
    End point timeframe
    1 month post-dose 3 primary vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    186
    193
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1
    100
    97.41
        Anti-Poliovirus 2
    97.31
    100
        Anti-Poliovirus 3
    98.92
    95.34
    Statistical analysis title
    		 Non-inferiority; Anti-Poliovirus 1
    Statistical analysis description
    This was a non-inferiority analysis of IMOVAX Polio™ compared to OPV for Anti-Poliovirus type 1.
    Comparison groups
    IMOVAX Polio™ Group v Oral Poliomyelitis Vaccine Group
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 IPV-OPV
    Point estimate
    2.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 5.92
    Notes
    [1] - Non-inferiority was established if the lower limit of the two-sided 95% CI for seroprotection rate was greater than -10%. IMOVAX Polio™ was non-inferior to OPV for Anti-Poliovirus type 1.
    Statistical analysis title
    		 Non-inferiority; Anti-Poliovirus 2
    Statistical analysis description
    This was a non-inferiority analysis of IMOVAX Polio™ compared to OPV for Anti-Poliovirus type 2.
    Comparison groups
    IMOVAX Polio™ Group v Oral Poliomyelitis Vaccine Group
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 IPV-OPV
    Point estimate
    -2.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.14
         upper limit
    		 -0.21
    Notes
    [2] - Non-inferiority was established if the lower limit of the two-sided 95% CI for seroprotection rate was greater than -10%. IMOVAX Polio™ was non-inferior to OPV for Anti-Poliovirus type 2.
    Statistical analysis title
    		 Non-inferiority; Anti-Poliovirus 3
    Statistical analysis description
    This was a non-inferiority analysis of IMOVAX Polio™ compared to OPV for Anti-Poliovirus type 3.
    Comparison groups
    IMOVAX Polio™ Group v Oral Poliomyelitis Vaccine Group
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 IPV-OPV
    Point estimate
    3.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 7.62
    Notes
    [3] - Non-inferiority was established if the lower limit of the two-sided 95% CI for seroprotection rate was greater than -10%. IMOVAX Polio™ was non-inferior to OPV for Anti-Poliovirus type 3.

    Secondary: Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Before and Following A Three-Dose Primary Vaccination series with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine

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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 Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure.
    End point type
    Secondary
    End point timeframe
    Pre-Primary, Adjusted Pre-Primary, and Post-Primary Vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    186
    193
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Pre-Primary
    8.8 (7.5 to 10.4)
    9.3 (8 to 10.9)
        Anti-Poliovirus 1; Adjusted Pre-Primary
    0.8 (0.7 to 1)
    0.8 (0.7 to 1)
        Anti-Poliovirus 1; Post-Primary
    151.2 (129.5 to 176.6)
    1089.5 (892.1 to 1330.5)
        Anti-Poliovirus 2; Pre-Primary
    8.3 (7.1 to 9.7)
    7.6 (6.7 to 8.7)
        Anti-Poliovirus 2; Adjusted Pre-Primary
    0.8 (0.6 to 0.9)
    0.7 (0.6 to 0.8)
        Anti-Poliovirus 2; Post-Primary
    86.7 (74.3 to 101.1)
    538.2 (470 to 616.3)
        Anti-Poliovirus 3; Pre-Primary
    5.2 (4.7 to 5.7)
    5.2 (4.8 to 5.7)
        Anti-Poliovirus 3; Adjusted Pre-Primary
    0.5 (0.4 to 0.5)
    0.5 (0.4 to 0.5)
        Anti-Poliovirus 3; Post-Primary
    211.3 (179.6 to 248.6)
    203.7 (167.9 to 247.1)
    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 Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine

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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 Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure. Geometric mean titer ratios (GMTR) and adjusted GMTR are reported. Adjusted was defined as a 4-fold increase calculated with individual titers adjusted on 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
    Day 0 (pre-vaccination) and Day 30 post-primary vaccinations
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    186
    193
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Individual Ratio
    17.1 (13.5 to 21.7)
    119.4 (92.4 to 154.4)
        Anti-Poliovirus 1; Individual Adjusted Ratio
    187.1 (147.8 to 236.9)
    1309 (1012.6 to 1692.2)
        Anti-Poliovirus 2; Individual Ratio
    10.4 (8.2 to 13.2)
    70.8 (58.9 to 85)
        Anti-Poliovirus 2; Individual Adjusted Ratio
    113.4 (89.4 to 143.9)
    774.8 (643.3 to 933.1)
        Anti-Poliovirus 3; Individual Ratio
    40.9 (33.6 to 49.8)
    38.6 (31.2 to 47.9)
        Anti-Poliovirus 3; Individual Adjusted Ratio
    446.9 (367.1 to 544)
    422.9 (341.2 to 524.1)
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with Seroprotection Against poliovirus 1, 2 and 3 Before and Following A Three-Dose Primary Vaccination series with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    		 Percentage of Infant Subjects with Seroprotection Against poliovirus 1, 2 and 3 Before and Following A Three-Dose Primary Vaccination series with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure. Seroprotection was defined as Anti-Poliovirus type 1, 2, and 3 antibody titers ≥ 8 (1/dil).
    End point type
    Secondary
    End point timeframe
    Pre-Primary, Adjusted Pre-Primary, Post-Primary Vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    186
    193
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; Pre-Primary
    44.8
    47.6
        Anti-Poliovirus 1; Adjusted Pre-Primary
    5.5
    5.2
        Anti-Poliovirus 1; Post-Primary
    100
    97.4
        Anti-Poliovirus 2; Pre-Primary
    39.2
    40.3
        Anti-Poliovirus 2; Adjusted Pre-Primary
    4.4
    1.6
        Anti-Poliovirus 2; Post-Primary
    97.3
    100
        Anti-Poliovirus 3; Pre-Primary
    18.2
    17.3
        Anti-Poliovirus 3; Adjusted Pre-Primary
    0
    0.5
        Anti-Poliovirus 3; Post-Primary
    98.9
    95.3
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with ≥4-fold increase in Antibodies Against Poliovirus 1, 2 and 3 After A Three-Dose Primary Vaccination series with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio) or Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    		 Percentage of Infant Subjects with ≥4-fold increase in Antibodies Against Poliovirus 1, 2 and 3 After A Three-Dose Primary Vaccination series with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio) or Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure. A 4-fold increase was calculated with individual titers adjusted on 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-Primary/Pre-Primary Vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    186
    193
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; Individual Ratio
    85.1
    93.2
        Anti-Poliovirus 1; Individual Adjusted Ratio
    98.3
    98.4
        Anti-Poliovirus 2; Individual Ratio
    75.7
    97.9
        Anti-Poliovirus 2; Individual Adjusted Ratio
    93.9
    100
        Anti-Poliovirus 3; Individual Ratio
    95.6
    92.1
        Anti-Poliovirus 3; Individual Adjusted Ratio
    99.4
    97.9
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies in Subjects with Pre-Primary Anti-Polio Titers of < 8 (1/dil) and ≥8 (1/dil) Before and After Primary Vaccination with Inactivated Poliomyelitis Vaccine or Oral Poliomyelitis Vaccine

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    End point title
    		 Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies in Subjects with Pre-Primary Anti-Polio Titers of < 8 (1/dil) and ≥8 (1/dil) Before and After Primary Vaccination with Inactivated Poliomyelitis Vaccine or Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure.
    End point type
    Secondary
    End point timeframe
    Pre-Primary and Post-Primary Vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    300
    300
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; All Subjects; Pre-Primary
    8.8 (7.5 to 10.4)
    9.3 (8 to 10.9)
        Anti-Poliovirus 1; All Subjects; Post-Primary
    151.2 (129.5 to 176.6)
    1089.5 (892.1 to 1330.5)
        Anti-Poliovirus 1; < 8 (1/dil); Pre-Primary
    4 (4 to 4)
    4 (4 to 4)
        Anti-Poliovirus 1; < 8 (1/dil); Post-Primary
    176.1 (144.3 to 214.9)
    1116.7 (825.1 to 1511.3)
        Anti-Poliovirus 1; ≥ 8 (1/dil); Pre-Primary
    23.6 (18.9 to 29.4)
    23.5 (19.3 to 28.6)
        Anti-Poliovirus 1; ≥ 8 (1/dil); Post-Primary
    125.9 (97.6 to 162.5)
    1068.9 (816.4 to 1399.5)
        Anti-Poliovirus 2; All Subjects; Pre-Primary
    8.3 (7.1 to 9.7)
    7.6 (6.7 to 8.7)
        Anti-Poliovirus 2; All Subjects; Post-Primary
    86.7 (74.3 to 101.1)
    538.2 (470 to 616.3)
        Anti-Poliovirus 2; < 8 (1/dil); Pre-Primary
    4 (4 to 4)
    4 (4 to 4)
        Anti-Poliovirus 2; < 8 (1/dil); Post-Primary
    100.3 (83.3 to 120.8)
    497.9 (418.5 to 592.4)
        Anti-Poliovirus 2; ≥ 8 (1/dil); Pre-Primary
    25.8 (20.6 to 32.3)
    19.6 (16.5 to 23.4)
        Anti-Poliovirus 2; ≥ 8 (1/dil); Post-Primary
    68.3 (52.6 to 88.7)
    601.5 (480.9 to 752.3)
        Anti-Poliovirus 3; All Subjects; Pre-Primary
    5.2 (4.7 to 5.7)
    5.2 (4.8 to 5.7)
        Anti-Poliovirus 3; All Subjects; Post-Primary
    211.3 (179.6 to 248.6)
    203.7 (167.9 to 247.1)
        Anti-Poliovirus 3; < 8 (1/dil); Pre-Primary
    4 (4 to 4)
    4 (4 to 4)
        Anti-Poliovirus 3; < 8 (1/dil); Post-Primary
    218.2 (180.7 to 263.4)
    202.5 (163.2 to 251.4)
        Anti-Poliovirus 3; ≥ 8 (1/dil); Pre-Primary
    17.2 (13.2 to 22.3)
    18.8 (14.6 to 24.3)
        Anti-Poliovirus 3; ≥ 8 (1/dil); Post-Primary
    194.3 (135.5 to 278.6)
    197.5 (122.7 to 317.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies in Subjects with Pre-Primary Anti-Polio Titers of < 8 (1/dil) and ≥8 (1/dil) After Primary Vaccination with Inactivated Poliomyelitis Vaccine or Oral Poliomyelitis Vaccine

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    End point title
    		 Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies in Subjects with Pre-Primary Anti-Polio Titers of < 8 (1/dil) and ≥8 (1/dil) After Primary Vaccination with Inactivated Poliomyelitis Vaccine or Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure. Geometric mean titer ratios (GMTR) and adjusted GMTR are reported. Adjusted was defined as a 4-fold increase calculated with individual titers adjusted on 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
    Day 0 (pre-vaccination) and Day 30 post-primary vaccinations
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    300
    300
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; GMTR; All Subjects
    17.1 (13.5 to 21.7)
    119.4 (92.4 to 154.4)
        Anti-Poliovirus 1; GMTR; < 8 (1/dil)
    44 (36.1 to 53.7)
    279.2 (206.3 to 377.8)
        Anti-Poliovirus 1; GMTR; ≥ 8 (1/dil)
    5.3 (3.9 to 7.4)
    47.4 (33.9 to 66.2)
        Anti-Poliovirus 1; Adjusted GMTR; All Subjects
    187.1 (147.8 to 236.9)
    1309 (1012.6 to 1692.2)
        Anti-Poliovirus 1; Adjusted GMTR; < 8 (1/dil)
    477.7 (390.6 to 584.1)
    3081.2 (2282.4 to 4159.6)
        Anti-Poliovirus 1; Adjusted GMTR; ≥ 8 (1/dil)
    58.8 (42.7 to 81.1)
    515.4 (368.6 to 720.6)
        Anti-Poliovirus 2; GMTR; All Subjects
    10.4 (8.2 to 13.2)
    70.8 (58.9 to 85)
        Anti-Poliovirus 2; GMTR; < 8 (1/dil)
    25.1 (20.8 to 30.2)
    124.5 (104.6 to 148.1)
        Anti-Poliovirus 2; GMTR; ≥ 8 (1/dil)
    2.6 (1.8 to 3.7)
    30.7 (22.9 to 41.1)
        Anti-Poliovirus 2; Adjusted GMTR; All Subjects
    113.4 (89.4 to 143.9)
    774.8 (643.3 to 933.1)
        Anti-Poliovirus 2; Adjusted GMTR; <8 (1/dil)
    271.7 (226.3 to 326.2)
    1365.6 (1145.3 to 1628.2)
        Anti-Poliovirus 2; Adjusted GMTR; ≥ 8 (1/dil)
    28.9 (20.4 to 40.9)
    334.8 (248.7 to 450.5)
        Anti-Poliovirus 3; GMTR; All Subjects
    40.9 (33.6 to 49.8)
    38.6 (31.2 to 47.9)
        Anti-Poliovirus 3; GMTR; < 8 (1/dil)
    54.5 (45.2 to 65.9)
    50.6 (40.8 to 62.8)
        Anti-Poliovirus 3; GMTR; ≥ 8 (1/dil)
    11.3 (6.9 to 18.4)
    10.3 (6.2 to 17.3)
        Anti-Poliovirus 3; Adjusted GMTR; All Subjects
    446.9 (367.1 to 544)
    422.9 (341.2 to 524.1)
        Anti-Poliovirus 3; Adjusted GMTR; < 8 (1/dil)
    593.6 (491.5 to 717)
    553.7 (446.9 to 685.9)
        Anti-Poliovirus 3; Adjusted GMTR; ≥ 8 (1/dil)
    126.1 (77.8 to 204.3)
    113.7 (67.5 to 191.7)
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with Pre-Primary Anti-Polio Titers of < 8 (1/dil) and ≥8 (1/dil) with Seroprotection Against Poliovirus 1, 2 and 3 Before and After Primary Vaccination with Inactivated Poliomyelitis Vaccine or Oral Poliomyelitis Vaccine

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    End point title
    		 Percentage of Infant Subjects with Pre-Primary Anti-Polio Titers of < 8 (1/dil) and ≥8 (1/dil) with Seroprotection Against Poliovirus 1, 2 and 3 Before and After Primary Vaccination with Inactivated Poliomyelitis Vaccine or Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure.
    End point type
    Secondary
    End point timeframe
    Pre-Primary and Post-Primary Vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    300
    300
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; All Subjects; Pre-Primary
    44.8
    47.6
        Anti-Poliovirus 1; All Subjects; Post-Primary
    100
    97.4
        Anti-Poliovirus 1; < 8 (1/dil); Pre-Primary
    0
    0
        Anti-Poliovirus 1; < 8 (1/dil); Post-Primary
    100
    96
        Anti-Poliovirus 1; ≥ 8 (1/dil); Pre-Primary
    100
    100
        Anti-Poliovirus 1; ≥ 8 (1/dil); Post-Primary
    100
    98.9
        Anti-Poliovirus 2; All Subjects; Pre-Primary
    39.2
    40.3
        Anti-Poliovirus 2; All Subjects; Post-Primary
    97.3
    100
        Anti-Poliovirus 2; < 8 (1/dil); Pre-Primary
    0
    0
        Anti-Poliovirus 2; < 8 (1/dil); Post-Primary
    98.2
    100
        Anti-Poliovirus 2; ≥ 8 (1/dil); Pre-Primary
    100
    100
        Anti-Poliovirus 2; ≥ 8 (1/dil); Post-Primary
    95.8
    100
        Anti-Poliovirus 3; All Subjects; Pre-Primary
    18.2
    17.3
        Anti-Poliovirus 3; All Subjects; Post-Primary
    98.9
    95.3
        Anti-Poliovirus 3; < 8 (1/dil); Pre-Primary
    0
    0
        Anti-Poliovirus 3; < 8 (1/dil); Post-Primary
    98.6
    95.6
        Anti-Poliovirus 3; ≥ 8 (1/dil); Pre-Primary
    100
    100
        Anti-Poliovirus 3; ≥ 8 (1/dil); Post-Primary
    100
    93.9
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with Pre-Primary Anti-Polio Titers of < 8 (1/dil) and ≥8 (1/dil) with ≥4-Fold Increase in Antibodies Against Poliovirus 1, 2 and 3 After Primary Vaccination with Inactivated Poliomyelitis Vaccine or Oral Poliomyelitis Vaccine

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    End point title
    		 Percentage of Infant Subjects with Pre-Primary Anti-Polio Titers of < 8 (1/dil) and ≥8 (1/dil) with ≥4-Fold Increase in Antibodies Against Poliovirus 1, 2 and 3 After Primary Vaccination with Inactivated Poliomyelitis Vaccine or Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure. Adjusted was defined as a 4-fold increase calculated with individual titers adjusted on 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-Primary Vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    300
    300
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; ≥ 4-fold increase; All Subjects
    85.1
    93.2
        Anti-Poliovirus 1; ≥ 4-fold increase; < 8 (1/dil)
    100
    96
        Anti-Poliovirus 1; ≥ 4-fold increase; ≥ 8 (1/dil)
    66.7
    90.1
        Anti-Polio 1; Adj. ≥ 4-fold increase; All Subjects
    98.3
    98.4
        Anti-Polio 1; Adj. ≥ 4-fold increase; < 8 (1/dil)
    100
    98
        Anti-Polio 1; Adj. ≥ 4-fold increase; ≥ 8 (1/dil)
    96.3
    98.9
        Anti-Poliovirus 2; ≥ 4-fold increase; All Subjects
    75.7
    97.9
        Anti-Poliovirus 2; ≥ 4-fold increase; < 8 (1/dil)
    96.4
    100
        Anti-Poliovirus 2; ≥ 4-fold increase; ≥ 8 (1/dil)
    43.7
    94.8
        Anti-Polio 2; Adj. ≥ 4-fold increase; All Subjects
    93.9
    100
        Anti-Polio 2; Adj. ≥ 4-fold increase; < 8 (1/dil)
    98.2
    100
        Anti-Polio 2; Adj. ≥ 4-fold increase; ≥ 8 (1/dil)
    87.3
    100
        Anti-Poliovirus 3; ≥ 4-fold increase; All Subjects
    95.6
    92.1
        Anti-Poliovirus 3; ≥ 4-fold increase; < 8 (1/dil)
    98
    95.6
        Anti-Poliovirus 3; ≥ 4-fold increase; ≥ 8 (1/dil)
    84.8
    75.8
        Anti-Polio 3; Adj. ≥ 4-fold increase; All Subjects
    99.4
    97.9
        Anti-Polio 3; Adj. ≥ 4-fold increase; < 8 (1/dil)
    99.3
    98.7
        Anti-Polio 3; Adj. ≥ 4-fold increase; ≥ 8 (1/dil)
    100
    93.9
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Post-Primary and Pre-Booster Vaccination with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    		 Percentage of Infant Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Post-Primary and Pre-Booster Vaccination with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure. Seroprotection was defined as Anti-Poliovirus type 1, 2, and 3 antibody titers ≥ 8 (1/dil).
    End point type
    Secondary
    End point timeframe
    Post-Primary and Pre-Booster Vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    179
    192
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; Post-Primary
    100
    97.4
        Anti-Poliovirus 1; Pre-Booster
    88.3
    96.9
        Anti-Poliovirus 2; Post-Primary
    97.2
    100
        Anti-Poliovirus 2; Pre-Booster
    83.2
    99.5
        Anti-Poliovirus 3; Post-Primary
    98.9
    94.8
        Anti-Poliovirus 3; Pre-Booster
    82.7
    91.1
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Post-Primary and Pre-Booster Vaccination with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    		 Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Post-Primary and Pre-Booster Vaccination with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure.
    End point type
    Secondary
    End point timeframe
    Post-Primary and Pre-Booster Vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    179
    192
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Post-Primary
    152.9 (130.2 to 179.5)
    1096.2 (896.2 to 1340.8)
        Anti-Poliovirus 1; Pre-Booster
    44.3 (35.2 to 55.7)
    215.1 (177.1 to 261.2)
        Anti-Poliovirus 2; Post-Primary
    86.7 (74.1 to 101.5)
    538.7 (470 to 617.4)
        Anti-Poliovirus 2; Pre-Booster
    47.3 (34.3 to 65)
    175.5 (145 to 212.2)
        Anti-Poliovirus 3; Post-Primary
    207.3 (175.8 to 244.4)
    196.4 (161 to 239.5)
        Anti-Poliovirus 3; Pre-Booster
    45.6 (34.1 to 60.9)
    63.3 (51.6 to 77.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies Post-Primary and Pre-Booster Vaccination with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    		 Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies Post-Primary and Pre-Booster Vaccination with Either Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-primary vaccinations
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    179
    192
    Units: Titer ratio (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1
    0.3 (0.2 to 0.4)
    0.2 (0.2 to 0.2)
        Anti-Poliovirus 2
    0.6 (0.4 to 0.8)
    0.3 (0.3 to 0.4)
        Anti-Poliovirus 3
    0.2 (0.2 to 0.3)
    0.3 (0.3 to 0.4)
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Post-Primary, Pre- and Post-Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Percentage of Infant Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Post-Primary, Pre- and Post-Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [4]
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure. Seroprotection was defined as Anti-Poliovirus type 1, 2, and 3 antibody titers ≥ 8 (1/dil).
    End point type
    Secondary
    End point timeframe
    Post-Primary, Pre-Booster, and Post-Booster Vaccination
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: A booster vaccination was not administered in the OPV group; therefore, seroprotection data are not available for this group.
    End point values
    		 IMOVAX Polio™ Group
    Number of subjects analysed
    176
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; Post-Primary
    100
        Anti-Poliovirus 1; Pre-Booster
    88.1
        Anti-Poliovirus 1; Post-Booster
    100
        Anti-Poliovirus 2; Post-Primary
    97.2
        Anti-Poliovirus 2; Pre-Booster
    83
        Anti-Poliovirus 2; Post-Booster
    100
        Anti-Poliovirus 3; Post-Primary
    98.9
        Anti-Poliovirus 3; Pre-Booster
    82.4
        Anti-Poliovirus 3; Post-Booster
    100
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Post-Primary, Pre- and Post-Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Post-Primary, Pre- and Post-Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [5]
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure.
    End point type
    Secondary
    End point timeframe
    Post-Primary, Pre-Booster, Post-Booster Vaccination
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: A booster vaccination was not administered in the OPV group; therefore, geometric mean titer data are not available for this group.
    End point values
    		 IMOVAX Polio™ Group
    Number of subjects analysed
    176
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Post-Primary
    150.3 (128.5 to 175.7)
        Anti-Poliovirus 1; Pre-Booster
    44.5 (35.2 to 56.1)
        Anti-Poliovirus 1; Post-Booster
    2011.8 (1762.4 to 2296.6)
        Anti-Poliovirus 2; Post-Primary
    85.2 (72.8 to 99.8)
        Anti-Poliovirus 2; Pre-Booster
    47.8 (34.6 to 66.2)
        Anti-Poliovirus 2; Post-Booster
    1480.6 (1305.6 to 1679.1)
        Anti-Poliovirus 3; Post-Primary
    208.9 (176.9 to 246.7)
        Anti-Poliovirus 3; Pre-Booster
    45.7 (34 to 61.3)
        Anti-Poliovirus 3; Post-Booster
    4393.4 (3849.8 to 5013.7)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies Post-Primary and Post-Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies Post-Primary and Post-Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [6]
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-primary vaccinations and Day 0 (pre-vaccination) and Day 30 post-booster vaccination
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: A booster vaccination was not administered in the OPV group; therefore, geometric mean titer ratios data are not available for this group.
    End point values
    		 IMOVAX Polio™ Group
    Number of subjects analysed
    176
    Units: Titer ratio (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Post/Pre-Primary
    16.6 (13.1 to 21.2)
        Anti-Poliovirus 1; Post/Pre-Booster
    45.2 (34.9 to 58.7)
        Anti-Poliovirus 2; Post/Pre-Primary
    10.3 (8 to 13.1)
        Anti-Poliovirus 2; Post/Pre-Booster
    30.9 (22.5 to 42.6)
        Anti-Poliovirus 3; Post/Pre-Primary
    40.7 (33.2 to 49.8)
        Anti-Poliovirus 3; Post/Pre-Booster
    96.2 (69.1 to 133.9)
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with ≥4-Fold Increase in Antibodies Against Poliovirus 1, 2 and 3 Post-Primary and Post-Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Percentage of Infant Subjects with ≥4-Fold Increase in Antibodies Against Poliovirus 1, 2 and 3 Post-Primary and Post-Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [7]
    End point description
    Anti-Poliovirus types 1, 2, and 3 antibody titers were assayed by microneutralization on cell culture based on World Health Organization standardized procedure.
    End point type
    Secondary
    End point timeframe
    Post-Primary and Post-Booster Vaccination
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: A booster vaccination was not administered in the OPV group; therefore, data for subjects with ≥ 4-fold increase in antibodies are not available for this group.
    End point values
    		 IMOVAX Polio™ Group
    Number of subjects analysed
    176
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; Post-Primary
    84.2
        Anti-Poliovirus 1; Post-Booster
    92
        Anti-Poliovirus 2; Post-Primary
    76
        Anti-Poliovirus 2; Post-Booster
    83
        Anti-Poliovirus 3; Post-Primary
    95.3
        Anti-Poliovirus 3; Post-Booster
    89.2
    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 Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine

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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 Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) or Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Solicited injection site reactions: Tenderness, Erythema, Swelling. Solicited systemic reaction: Fever (as per China State Food and Drug Administration), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. OPV is an oral vaccine and does not have solicited injection site data. Grade 3 Solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Solicited systemic reactions: Fever, >39°C (Axillary); Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficulty in waking up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability; Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 8 post-any and each primary vaccination
    End point values
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Number of subjects analysed
    300
    297 [8]
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    36.7
    0
        Injection site Tenderness; Post-dose 1
    27.4
    0
        Grade 3 Injection site Tenderness; Post-dose 1
    0.3
    0
        Injection site Tenderness; Post-dose 2
    20.1
    0
        Grade 3 Injection site Tenderness; Post-dose 2
    0
    0
        Injection site Tenderness; Post-dose 3
    14.4
    0
        Grade 3 Injection site Tenderness; Post-dose 3
    0
    0
        Any Injection site Erythema
    14.8
    0
        Injection site Erythema; Post-dose 1
    8.4
    0
        Grade 3 Injection site Erythema; Post-dose 1
    0
    0
        Injection site Erythema; Post-dose 2
    7.6
    0
        Grade 3 Injection site Erythema; Post-dose 2
    0
    0
        Injection site Erythema; Post-dose 3
    6.8
    0
        Grade 3 Injection site Erythema; Post-dose 3
    0.4
    0
        Any Injection site Swelling
    4.7
    0
        Injection site Swelling; Post-dose 1
    4.1
    0
        Grade 3 Injection site Swelling; Post-dose 1
    0
    0
        Injection site Swelling; Post-dose 2
    1.1
    0
        Grade 3 Injection site Swelling; Post-dose 2
    0
    0
        Injection site Swelling; Post-dose 3
    0.7
    0
        Grade 3 Injection site Swelling; Post-dose 3
    0
    0
        Any Fever
    25.9
    25
        Fever; Post-dose 1
    15.2
    10.3
        Grade 3 Fever; Post-dose 1
    0
    0.3
        Fever; Post-dose 2
    10
    8.5
        Grade 3 Fever; Post-dose 2
    0
    0.4
        Fever; Post-dose 3
    6.5
    12.1
        Grade 3 Fever; Post-dose 3
    0.4
    0
        Any Vomiting
    43.7
    39.7
        Vomiting; Post-dose 1
    36.1
    30.1
        Grade 3 Vomiting; Post-dose 1
    0.3
    0.7
        Vomiting; Post-dose 2
    22.5
    17.6
        Grade 3 Vomiting; Post-dose 2
    0
    0
        Vomiting; Post-dose 3
    12.2
    11.3
        Grade 3 Vomiting; Post-dose 3
    0.4
    0
        Any Crying abnormal
    46.1
    29.1
        Crying abnormal; Post-dose 1
    35.7
    22.9
        Grade 3 Crying abnormal; Post-dose 1
    2
    1.4
        Crying abnormal; Post-dose 2
    24.3
    10.6
        Grade 3 Crying abnormal; Post-dose 2
    0.7
    1.1
        Crying abnormal; Post-dose 3
    12.2
    8.9
        Grade 3 Crying abnormal; Post-dose 3
    0
    0
        Any Drowsiness
    31.9
    19.5
        Drowsiness; Post-dose 1
    25.9
    17.5
        Grade 3 Drowsiness; Post-dose 1
    1.7
    1
        Drowsiness; Post-dose 2
    11.1
    4.6
        Grade 3 Drowsiness; Post-dose 2
    0
    0.4
        Drowsiness; Post-dose 3
    6.1
    3.2
        Grade 3 Drowsiness; Post-dose 3
    0
    0
        Any Appetite lost
    30.2
    21.9
        Appetite lost; Post-dose 1
    24.1
    15.4
        Grade 3 Appetite lost; Post-dose 1
    1
    1
        Appetite lost; Post-dose 2
    14.3
    8.1
        Grade 3 Appetite lost; Post-dose 2
    0
    0.4
        Appetite lost; Post-dose 3
    8.3
    9.2
        Grade 3 Appetite lost; Post-dose 3
    0
    0.4
        Any Irritability
    32.2
    18.8
        Irritability; Post-dose 1
    24.1
    16.8
        Grade 3 Irritability; Post-dose 1
    0.7
    2.4
        Irritability; Post-dose 2
    16.1
    6.3
        Grade 3 Irritability; Post-dose 2
    0.7
    1.1
        Irritability; Post-dose 3
    9.4
    3.9
        Grade 3 Irritability; Post-dose 3
    0.4
    0
    Notes
    [8] - N=0 for solicited injection site reactions because Oral Polio Vaccine (OPV) was administered.
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions Following Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions Following Booster Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [9]
    End point description
    Solicited injection site reactions: Tenderness, Erythema, Swelling. Solicited systemic reaction: Fever (as per China State Food and Drug Administration), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. OPV was not administered as a booster vaccination and data is not available for this group. Grade 3 Solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Solicited systemic reactions: Fever, >39°C (Axillary); Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficulty in waking up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability; Inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 8 post-booster vaccination
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: A booster vaccination was not administered in the OPV group; therefore, solicited injection site and systemic reaction data are not available for this group.
    End point values
    		 IMOVAX Polio™ Group
    Number of subjects analysed
    300
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    20
        Grade 3 Injection site Tenderness
    0
        Any Injection site Erythema
    7.9
        Grade 3 Injection site Erythema
    0
        Any Injection site Swelling
    2.3
        Grade 3 Injection site Swelling
    0
        Any Fever
    14.7
        Grade 3 Fever
    1.5
        Any Vomiting
    3.4
        Grade 3 Vomiting
    0
        Any Crying abnormal
    10.2
        Grade 3 Crying abnormal
    0
        Any Drowsiness
    6.4
        Grade 3 Drowsiness
    0
        Any Appetite lost
    8.6
        Grade 3 Appetite lost
    0
        Any Irritability
    9.8
        Grade 3 Irritability
    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 of primary series vaccination up to Day 8 post-booster vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    IMOVAX Polio™ Group
    Reporting group description
    		 Infants received the IMOVAX Polio™ (IPV) vaccine at 2, 3, and 4 months of age and a booster dose of IPV vaccine 14-16 months after the three-dose primary vaccination.

    Reporting group title
    Oral Poliomyelitis Vaccine Group
    Reporting group description
    		 Infants received the commercially available Oral Poliomyelitis Vaccine (OPV) vaccine at 2, 3, and 4 months of age.

    Serious adverse events
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 300 (3.00%)
    7 / 297 (2.36%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    3 / 300 (1.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal scratch
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysentery
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis and cellulitis
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis (viral)
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IMOVAX Polio™ Group Oral Poliomyelitis Vaccine Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    136 / 300 (45.33%)
    116 / 297 (39.06%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    94 / 295 (31.86%)
    57 / 292 (19.52%)
         occurrences all number
    94
    57
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    109 / 297 (36.70%)
    0 / 292 (0.00%)
         occurrences all number
    109
    0
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    44 / 297 (14.81%)
    0 / 292 (0.00%)
         occurrences all number
    44
    0
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    14 / 297 (4.71%)
    0 / 292 (0.00%)
         occurrences all number
    14
    0
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    77 / 297 (25.93%)
    73 / 292 (25.00%)
         occurrences all number
    77
    73
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    129 / 295 (43.73%)
    116 / 292 (39.73%)
         occurrences all number
    129
    116
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed [7]
    25 / 297 (8.42%)
    17 / 292 (5.82%)
         occurrences all number
    25
    17
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    136 / 295 (46.10%)
    85 / 292 (29.11%)
         occurrences all number
    136
    85
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    95 / 295 (32.20%)
    55 / 292 (18.84%)
         occurrences all number
    95
    55
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    89 / 295 (30.17%)
    64 / 292 (21.92%)
         occurrences all number
    89
    64
    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 8 days post-any primary series injection; 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 8 days post-any primary series injection; 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 8 days post-any primary series injection; 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 8 days post-any primary series injection; 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 8 days post-any primary series injection; 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 8 days post-any primary series injection; 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 an unsolicited adverse event that occurred within 8 days post-any primary series injection; the total number (N) reflects those subjects 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 8 days post-any primary series injection; 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.
    [9] - 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 8 days post-any primary series injection; 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.
    [10] - 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 8 days post-any primary series injection; 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.

    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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