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    Clinical Trial Results:
    Immunogenicity and Safety of different sequential schedules of Inactivated Poliomyelitis Vaccine (IMOVAX Polio®) followed by Oral Poliomyelitis Vaccine in Healthy Infants in China versus Oral Poliomyelitis Vaccine Alone

    Summary
    EudraCT number
    2015-005188-17
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    24 Jun 2013

    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
    IPV30
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01475539
    WHO universal trial number (UTN)
    U1111-1122-1928
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur China
    Sponsor organisation address
    6th floor, No. 112 Jian Guo Lu, Chaoyang District, Beijing, China, 100022
    Public contact
    Director, Medical Affairs, Sanofi Pasteur China, 86 10 6568 5588, Jean-denis.shu@sanofipasteur.com
    Scientific contact
    Director, Medical Affairs, Sanofi Pasteur China, 86 10 6568 5588, Jean-denis.shu@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
    29 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2) poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of seroprotection rate 28 to 42 days after the third dose of the primary vaccination series.
    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
    07 Nov 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
    China: 456
    Worldwide total number of subjects
    456
    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)
    456
    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 07 November 2011 to 16 February 2012 at 1 clinic center in China.

    Pre-assignment
    Screening details
    A total of 456 subjects met all inclusion and none of the exclusion criteria and were enrolled 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
    IPV-OPV-OPV (Sequential 1)
    Arm description
    Infants ≥ 2 months and under 3 months of age sequentially received Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV; IMOVAX Polio™) at 2 months and commercially available Oral Poliovirus Vaccine (OPV) at 3 and 4 months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    IMOVAX Polio, injectable Inactivated Poliovirus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral area of the thigh, 1 injection at 2 months of age

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

    Arm title
    IPV-IPV-OPV (Sequential 2)
    Arm description
    Infants ≥ 2 months and under 3 months of age sequentially received Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV; IMOVAX Polio™) at 2 and 3 months and commercially available Oral Poliovirus Vaccine (OPV) at 4 months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    IMOVAX Polio, injectable Inactivated Poliovirus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the anterolateral area of the thigh, 1 injection each at 2 and 3 months of age

    Investigational medicinal product name
    Poliomyelitis Vaccine in Dragee Candy (Monkey Kidney Cell), Live (OPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 g dragee, oral, 1 administration at 4 months of age

    Arm title
    OPV-OPV-OPV (Control)
    Arm description
    Infants ≥ 2 months and under 3 months of age sequentially received commercially available Oral Poliovirus Vaccine (OPV) at 2, 3, and 4 months of age.
    Arm type
    Active comparator

    Investigational medicinal product name
    Poliomyelitis Vaccine in Dragee Candy (Monkey Kidney Cell), Live (OPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    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
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Started
    152
    152
    152
    Completed
    148
    150
    149
    Not completed
    4
    2
    3
         Protocol deviation
             -
             -
             1
         Consent withdrawn by subject
             4
             2
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IPV-OPV-OPV (Sequential 1)
    Reporting group description
    Infants ≥ 2 months and under 3 months of age sequentially received Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV; IMOVAX Polio™) at 2 months and commercially available Oral Poliovirus Vaccine (OPV) at 3 and 4 months of age.

    Reporting group title
    IPV-IPV-OPV (Sequential 2)
    Reporting group description
    Infants ≥ 2 months and under 3 months of age sequentially received Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV; IMOVAX Polio™) at 2 and 3 months and commercially available Oral Poliovirus Vaccine (OPV) at 4 months of age.

    Reporting group title
    OPV-OPV-OPV (Control)
    Reporting group description
    Infants ≥ 2 months and under 3 months of age sequentially received commercially available Oral Poliovirus Vaccine (OPV) at 2, 3, and 4 months of age.

    Reporting group values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control) Total
    Number of subjects
    152 152 152 456
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    152 152 152 456
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    0 0 0 0
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    2.5 ± 0.3 2.5 ± 0.3 2.5 ± 0.3 -
    Gender categorical
    Units: Subjects
        Female
    71 70 78 219
        Male
    81 82 74 237

    End points

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    End points reporting groups
    Reporting group title
    IPV-OPV-OPV (Sequential 1)
    Reporting group description
    Infants ≥ 2 months and under 3 months of age sequentially received Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV; IMOVAX Polio™) at 2 months and commercially available Oral Poliovirus Vaccine (OPV) at 3 and 4 months of age.

    Reporting group title
    IPV-IPV-OPV (Sequential 2)
    Reporting group description
    Infants ≥ 2 months and under 3 months of age sequentially received Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV; IMOVAX Polio™) at 2 and 3 months and commercially available Oral Poliovirus Vaccine (OPV) at 4 months of age.

    Reporting group title
    OPV-OPV-OPV (Control)
    Reporting group description
    Infants ≥ 2 months and under 3 months of age sequentially received commercially available Oral Poliovirus Vaccine (OPV) at 2, 3, and 4 months of age.

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

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    End point title
    Percentage of Subjects with Seroprotection Against Poliovirus 1, 2, and 3 Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, 3 neutralizing antibody titers were measured using microneutralization assay. Seroprotection was defined as Anti-Poliovirus types 1, 2, and 3 antibody titers ≥8 (1/dil).
    End point type
    Primary
    End point timeframe
    1 month post-primary vaccination series
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    150
    152
    148
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1
    100
    100
    100
        Anti-Poliovirus 2
    100
    100
    100
        Anti-Poliovirus 3
    99.33
    100
    100
    Statistical analysis title
    Non-inferiority;Anti-Polio 1; Sequential 1-Control
    Statistical analysis description
    Non-inferiority analysis of IPV-OPV-OPV (Sequential 1) over the OPV-OPV-OPV (control) for Anti-Poliovirus 1 was assessed.
    Comparison groups
    IPV-OPV-OPV (Sequential 1) v OPV-OPV-OPV (Control)
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Sequential 1 - Control
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    2.53
    Notes
    [1] - Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval of the observed difference was greater than -10% for each serotype and each comparison. IPV-OPV-OPV was non-inferior to OPV-OPV-OPV.
    Statistical analysis title
    Non-inferiority;Anti-Polio 2; Sequential 1-Control
    Statistical analysis description
    Non-inferiority analysis of IPV-OPV-OPV (Sequential 1) over the OPV-OPV-OPV (control) for Anti-Poliovirus 2 was assessed.
    Comparison groups
    IPV-OPV-OPV (Sequential 1) v OPV-OPV-OPV (Control)
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    Sequential 1 - Control
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    2.53
    Notes
    [2] - Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval of the observed difference was greater than -10% for each serotype and each comparison. IPV-OPV-OPV was non-inferior to OPV-OPV-OPV.
    Statistical analysis title
    Non-inferiority;Anti-Polio 3; Sequential 1-Control
    Statistical analysis description
    Non-inferiority analysis of IPV-OPV-OPV (Sequential 1) over the OPV-OPV-OPV (control) for Anti-Poliovirus 3 was assessed.
    Comparison groups
    IPV-OPV-OPV (Sequential 1) v OPV-OPV-OPV (Control)
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Parameter type
    Sequential 1 - Control
    Point estimate
    -0.67
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.68
         upper limit
    1.92
    Notes
    [3] - Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval of the observed difference was greater than -10% for each serotype and each comparison. IPV-OPV-OPV was non-inferior to OPV-OPV-OPV.
    Statistical analysis title
    Non-inferiority;Anti-Polio 1; Sequential 2-Control
    Statistical analysis description
    Non-inferiority analysis of IPV-IPV-OPV (Sequential 2) over the OPV-OPV-OPV (control) for Anti-Poliovirus 1 was assessed.
    Comparison groups
    IPV-IPV-OPV (Sequential 2) v OPV-OPV-OPV (Control)
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    Method
    Parameter type
    Sequential 2 - Control
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.47
         upper limit
    2.53
    Notes
    [4] - Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval of the observed difference was greater than -10% for each serotype and each comparison. IPV-IPV-OPV was non-inferior to OPV-OPV-OPV.
    Statistical analysis title
    Non-inferiority;Anti-Polio 2; Sequential 2-Control
    Statistical analysis description
    Non-inferiority analysis of IPV-IPV-OPV (Sequential 2) over the OPV-OPV-OPV (control) for Anti-Poliovirus 2 was assessed.
    Comparison groups
    IPV-IPV-OPV (Sequential 2) v OPV-OPV-OPV (Control)
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    Method
    Parameter type
    Sequential 2 - Control
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.47
         upper limit
    2.53
    Notes
    [5] - Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval of the observed difference was greater than -10% for each serotype and each comparison. IPV-IPV-OPV was non-inferior to OPV-OPV-OPV.
    Statistical analysis title
    Non-inferiority;Anti-Polio 3; Sequential 2-Control
    Statistical analysis description
    Non-inferiority analysis of IPV-IPV-OPV (Sequential 2) over the OPV-OPV-OPV (control) for Anti-Poliovirus 3 was assessed.
    Comparison groups
    IPV-IPV-OPV (Sequential 2) v OPV-OPV-OPV (Control)
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [6]
    Method
    Parameter type
    Sequential 2 - Control
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.47
         upper limit
    2.53
    Notes
    [6] - Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval of the observed difference was greater than -10% for each serotype and each comparison. IPV-IPV-OPV was non-inferior to OPV-OPV-OPV.

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

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    End point title
    Percentage of Subjects with Seroprotection Against Poliovirus 1, 2, and 3 Before and Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, 3 neutralizing antibody titers were measured using microneutralization assay. Seroprotection was defined as Anti-Poliovirus types 1, 2, and 3 antibody titers ≥ 8 (1/dil).
    End point type
    Secondary
    End point timeframe
    Pre-Primary and 1 month Post-Primary vaccination series
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    150
    152
    148
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; Pre-Primary
    44.7
    46.7
    43.9
        Anti-Poliovirus 1; Post-Primary
    100
    100
    100
        Anti-Poliovirus 2; Pre-Primary
    42
    34.2
    32.4
        Anti-Poliovirus 2; Post-Primary
    100
    100
    100
        Anti-Poliovirus 3; Pre-Primary
    28
    23
    21.6
        Anti-Poliovirus 3; Post-Primary
    99.3
    100
    100
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Before and Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and 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 Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, 3 neutralizing antibody titers were measured using microneutralization assay.
    End point type
    Secondary
    End point timeframe
    Pre-Primary and 1 month Post-Primary vaccination series
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    150
    152
    148
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Pre-Primary
    8.45 (7.11 to 10)
    9.08 (7.62 to 10.8)
    8.67 (7.27 to 10.3)
        Anti-Poliovirus 1; Post-Primary
    2101 (1715 to 2573)
    1542 (1251 to 1900)
    2764 (2299 to 3324)
        Anti-Poliovirus 2; Pre-Primary
    7.87 (6.75 to 9.18)
    6.92 (6 to 7.98)
    6.59 (5.74 to 7.57)
        Anti-Poliovirus 2; Post-Primary
    743 (653 to 844)
    2285 (1945 to 2683)
    744 (653 to 848)
        Anti-Poliovirus 3; Pre-Primary
    6.17 (5.39 to 7.07)
    5.6 (4.99 to 6.27)
    5.6 (4.91 to 6.38)
        Anti-Poliovirus 3; Post-Primary
    1473 (1235 to 1755)
    1854 (1442 to 2384)
    671 (563 to 799)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and 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 Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, 3 neutralizing antibody titers were measured using microneutralization assay.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 post-primary vaccinations.
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    150
    152
    148
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1
    249 (188 to 328)
    170 (128 to 224)
    319 (252 to 403)
        Anti-Poliovirus 2
    94.3 (75.8 to 117)
    330 (259 to 421)
    113 (93.6 to 136)
        Anti-Poliovirus 3
    239 (192 to 296)
    331 (248 to 442)
    120 (96.6 to 148)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Seroprotection Against Poliovirus 1, 2, and 3 Fourteen Months After A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    Percentage of Subjects with Seroprotection Against Poliovirus 1, 2, and 3 Fourteen Months After A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, 3 neutralizing antibody titers were measured using microneutralization assay. Seroprotection was defined as Anti-Poliovirus types 1, 2, and 3 antibody titers ≥ 8 (1/dil).
    End point type
    Secondary
    End point timeframe
    14 months post-dose 3 of primary vaccination series
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    148
    150
    149
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1
    100
    99.3
    100
        Anti-Poliovirus 2
    100
    100
    100
        Anti-Poliovirus 3
    98
    96.7
    100
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Each and Any Three-Dose Primary Series Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine.

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    End point title
    Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Each and Any Three-Dose Primary Series Vaccination with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine.
    End point description
    Solicited injection-site reactions, Tenderness, Erythema and Swelling, Systemic reactions, Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite and Irritability. Grade 3 Tenderness, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling ≥ 50 mm; Fever, > 39°C (axillary); Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Loss of appetite, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to 14 months post-vaccination
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    152
    152
    152
    Units: Percentage of Subjects
    number (not applicable)
        Injection-site Tenderness (Post-any injection)
    18.4
    21.1
    0
        Grade 3 Injection-site Tenderness (post-any inj.)
    0
    0
    0
        Injection-site Tenderness (Post- injection 1)
    18.4
    15.1
    0
        Grade 3 Injection-site Tenderness (Post- inj. 1)
    0
    0
    0
        Injection-site Tenderness (Post-injection 2)
    0
    13.8
    0
        Grade 3 Injection-site Tenderness (Post- inj. 2)
    0
    0
    0
        Injection-site Erythema (Post-any injection)
    7.9
    7.2
    0
        Grade 3 Injection-site Erythema (Post-any inj.)
    1.3
    0
    0
        Injection-site Erythema (Post-injection 1)
    7.9
    3.9
    0
        Grade 3 Injection-site Erythema (Post-inj. 1)
    1.3
    0
    0
        Injection-site Erythema (Post-injection 2)
    0
    3.9
    0
        Grade 3 Injection-site Erythema (Post-inj. 2)
    0
    0
    0
        Injection-site Swelling (Post-any injection)
    3.9
    0.7
    0
        Grade 3 Injection-site Swelling (Post-any inj)
    0
    0
    0
        Injection-site Swelling (Post-injection 1)
    3.9
    0.7
    0
        Grade 3 Injection-site Swelling (Post-inj. 1)
    0
    0
    0
        Injection-site Swelling (Post-injection 2)
    0
    0.7
    0
        Grade 3 Injection-site Swelling (Post-inj. 2)
    0
    0
    0
        Fever (Post-any injection)
    28.3
    29.6
    24.3
        Grade 3 Fever (Post-any injection)
    1.3
    0
    0.7
        Fever (Post-injection 1)
    6.6
    10.5
    7.9
        Grade 3 Fever (Post-injection 1)
    0.7
    0
    0
        Fever (Post-injection 2)
    11.2
    10.5
    7.2
        Grade 3 Fever (Post-injection 2)
    0
    0
    0
        Fever (Post-iinjection 3)
    14.5
    13.2
    14.6
        Grade 3 Fever (Post-injection 3)
    0.7
    0
    0.7
        Vomiting (Post-any injection)
    44.7
    36.8
    44.1
        Grade 3 Vomiting (Post-any injection)
    0.7
    2
    2.6
        Vomiting (Post-injection 1)
    33.6
    27.6
    33.6
        Grade 3 Vomiting (Post-injection 1)
    0.7
    0.7
    1.3
        Vomiting (Post-injection 2)
    17.8
    21.1
    18.4
        Grade 3 Vomiting (Post-injection 2)
    0
    0.7
    1.3
        Vomiting (Post-injection 3)
    11.8
    10.5
    13.9
        Grade 3 Vomiting (Post-injection 3)
    0
    0.7
    0
        Abnormal crying (Post-any injection)
    51.3
    50.7
    43.4
        Grade 3 Abnormal crying (Post-any injection)
    2.6
    2
    5.9
        Abnormal crying (Post-injection 1)
    37.5
    33.6
    30.3
        Grade 3 Abnormal crying (Post-injection 1)
    2.6
    1.3
    3.9
        Abnormal crying (Post-injection 2)
    23
    32.9
    18.9
        Grade 3 Abnormal crying (Post-injection 2)
    0.7
    0.7
    1.3
        Abnormal crying (Post-injection 3)
    16.4
    8.6
    16.6
        Grade 3 Abnormal crying (Post-injection 3)
    0
    0
    0.7
        Drowsiness (Post-any injection)
    32.9
    30.9
    28.9
        Grade 3 Drowsiness (Post-any injection)
    0.7
    1.3
    1.3
        Drowsiness (Post-injection 1)
    21.1
    23
    19.1
        Grade 3 Drowsiness (Post-injection 1)
    0.7
    1.3
    1.3
        Drowsiness (Post-injection 2)
    13.8
    13.8
    11.8
        Grade 3 Drowsiness (Post-injection 2)
    0
    0
    0
        Drowsiness (Post-injection 3)
    10.5
    5.9
    9.3
        Grade 3 Drowsiness (Post-injection 3)
    0
    0
    0
        Appetite Loss (Post-any injection)
    32.9
    34.9
    28.9
        Grade 3 Appetite Loss (Post-any injection)
    2.6
    0
    0.7
        Appetite Loss (Post-injection 1)
    21.1
    28.3
    17.1
        Grade 3 Appetite Loss (Post-injection 1)
    1.3
    0
    0.7
        Appetite Loss (Post-injection 2)
    7.9
    13.2
    12.5
        Grade 3 Appetite Loss (Post-injection 2)
    0.7
    0
    0
        Appetite Loss (Post-injection 3)
    13.2
    9.2
    8.6
        Grade 3 Appetite Loss (Post-injection 3)
    0.7
    0
    0
        Irritability (Post-any injection)
    32.2
    32.2
    25.7
        Grade 3 Irritability (Post-any injection)
    2
    0.7
    3.3
        Irritability (Post-injection 1)
    24.3
    21.7
    17.8
        Grade 3 Irritability (Post-injection 1)
    1.3
    0
    2
        Irritability (Post-injection 2)
    12.5
    15.1
    11.8
        Grade 3 Irritability (Post-injection 2)
    0.7
    0.7
    0.7
        Irritability (Post-injection 3)
    10.5
    5.9
    9.9
        Grade 3 Irritability (Post-injection 3)
    0
    0
    1.3
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Fourteen (14) Months Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Fourteen (14) Months Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, 3 neutralizing antibody titers were measured using microneutralization assay.
    End point type
    Other pre-specified
    End point timeframe
    14 months post-dose 3 of primary vaccination series
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    148
    150
    149
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1
    581 (467 to 723)
    342 (270 to 433)
    977 (789 to 1209)
        Anti-Poliovirus 2
    299 (253 to 354)
    361 (306 to 427)
    262 (223 to 309)
        Anti-Poliovirus 3
    242 (196 to 298)
    271 (205 to 357)
    177 (148 to 211)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seroprotection Against Poliovirus 1, 2, and 3 Before and Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    Percentage of Subjects with Seroprotection Against Poliovirus 1, 2, and 3 Before and Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, 3 neutralizing antibody titers were measured using microneutralization assay. Seroprotection was defined as Anti-Poliovirus types 1, 2, and 3 antibody titers ≥ 8 (1/dil).
    End point type
    Other pre-specified
    End point timeframe
    Pre-Primary, Post-Primary vaccination series
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    150
    152
    148
    Units: Percentage of subjects
    number (not applicable)
        Anti-Poliovirus 1; Pre-Primary
    18.4
    18.7
    17
        Anti-Poliovirus 1; Post-Primary
    100
    99.3
    100
        Anti-Poliovirus 2; Pre-Primary
    38.3
    24.8
    20
        Anti-Poliovirus 2; Post-Primary
    100
    100
    100
        Anti-Poliovirus 3; Pre-Primary
    20.9
    13.6
    15.9
        Anti-Poliovirus 3; Post-Primary
    100
    100
    99.3
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Before and Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and 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 Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, 3 neutralizing antibody titers were measured using microneutralization assay.
    End point type
    Other pre-specified
    End point timeframe
    Pre-Primary and Post-Primary vaccination series
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    150
    152
    148
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1; Pre-Primary
    3.37 (2.92 to 3.88)
    3.42 (2.95 to 3.97)
    3.26 (2.81 to 3.78)
        Anti-Poliovirus 1; Post-Primary
    1829 (1467 to 2280)
    2572 (2043 to 3239)
    442 (358 to 545)
        Anti-Poliovirus 2; Pre-Primary
    5.17 (4.37 to 6.11)
    4.11 (3.48 to 4.85)
    3.65 (3.16 to 4.21)
        Anti-Poliovirus 2; Post-Primary
    2190 (1914 to 2506)
    8229 (7152 to 9469)
    890 (763 to 1038)
        Anti-Poliovirus 3; Pre-Primary
    3.58 (3.13 to 4.09)
    3.22 (2.87 to 3.6)
    3.21 (2.82 to 3.66)
        Anti-Poliovirus 3; Post-Primary
    1409 (1171 to 1694)
    2053 (1580 to 2666)
    335 (277 to 406)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and 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 Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Anti-Poliovirus types 1, 2, 3 neutralizing antibody titers were measured using microneutralization assay.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 Post-Primary vaccinations
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    149
    150
    147
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Poliovirus 1
    557 (421 to 737)
    746 (557 to 998)
    134 (105 to 171)
        Anti-Poliovirus 2
    431 (338 to 549)
    2022 (1583 to 2583)
    244 (197 to 303)
        Anti-Poliovirus 3
    396 (318 to 494)
    637 (476 to 852)
    107 (85.7 to 135)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Fourteen Months After A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    Percentage of Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Fourteen Months After A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    Seroprotection was defined as post-vaccination antibody titers 1 ≥8 1/dil.
    End point type
    Other pre-specified
    End point timeframe
    Fourteen Months Post-Primary Vaccination Series
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    148
    150
    149
    Units: Percentage of Subjects
    number (not applicable)
        Anti-Polio 1 Antibody
    100
    99.3
    96.6
        Anti-Polio 2 Antibody
    100
    100
    100
        Anti-Polio 3 Antibody
    98
    98
    99.3
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers of Anti-polio 1, 2 and 3 Antibodies Fourteen Months Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine

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    End point title
    Geometric Mean Titers of Anti-polio 1, 2 and 3 Antibodies Fourteen Months Following A Sequential Three-Dose Primary Vaccination Series With Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) and Commercially Available Oral Poliomyelitis Vaccine
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Fourteen months post-primary series vaccination
    End point values
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Number of subjects analysed
    148
    150
    149
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1
    330 (267 to 407)
    390 (316 to 481)
    123 (98.7 to 153)
        Anti-Polio 2
    669 (562 to 795)
    1072 (897 to 1282)
    349 (291 to 418)
        Anti-Polio 3
    154 (126 to 189)
    199 (155 to 256)
    86.6 (72.7 to 103)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event were reported from Day 0 up to 16 months post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    IPV-OPV-OPV (Sequential 1)
    Reporting group description
    Infants ≥ 2 months and under 3 months of age sequentially received Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV; IMOVAX Polio™) at 2 months and commercially available Oral Poliovirus Vaccine (OPV) at 3 and 4 months of age.

    Reporting group title
    IPV-IPV-OPV (Sequential 2)
    Reporting group description
    Infants ≥ 2 months and under 3 months of age sequentially received Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV; IMOVAX Polio™) at 2 and 3 months and commercially available Oral Poliovirus Vaccine (OPV) at 4 months of age.

    Reporting group title
    OPV-OPV-OPV (Control)
    Reporting group description
    Infants ≥ 2 months and under 3 months of age sequentially received commercially available Oral Poliovirus Vaccine (OPV) at 2, 3, and 4 months of age.

    Serious adverse events
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 152 (3.29%)
    7 / 152 (4.61%)
    9 / 152 (5.92%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Tachycardia
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial damage
         subjects affected / exposed
    0 / 152 (0.00%)
    2 / 152 (1.32%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Infantile diarrhea
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hirschsprung’s disease
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Asthmatic bronchopneumonia
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthmatic bronchitis
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 152 (1.97%)
    1 / 152 (0.66%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 152 (0.66%)
    3 / 152 (1.97%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial pneumonia
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
    3 / 152 (1.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Severe pneumonia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral enteritis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    IPV-OPV-OPV (Sequential 1) IPV-IPV-OPV (Sequential 2) OPV-OPV-OPV (Control)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 152 (51.32%)
    77 / 152 (50.66%)
    67 / 152 (44.08%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    50 / 152 (32.89%)
    47 / 152 (30.92%)
    44 / 152 (28.95%)
         occurrences all number
    50
    47
    44
    General disorders and administration site conditions
    Injection site tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    28 / 152 (18.42%)
    32 / 152 (21.05%)
    0 / 152 (0.00%)
         occurrences all number
    28
    32
    0
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 152 (7.89%)
    11 / 152 (7.24%)
    0 / 152 (0.00%)
         occurrences all number
    12
    11
    0
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    43 / 152 (28.29%)
    45 / 152 (29.61%)
    37 / 152 (24.34%)
         occurrences all number
    43
    45
    37
    Psychiatric disorders
    Abnormal crying
    alternative assessment type: Systematic
         subjects affected / exposed
    78 / 152 (51.32%)
    77 / 152 (50.66%)
    66 / 152 (43.42%)
         occurrences all number
    78
    77
    66
    Irritability
         subjects affected / exposed
    49 / 152 (32.24%)
    49 / 152 (32.24%)
    39 / 152 (25.66%)
         occurrences all number
    49
    49
    39
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    68 / 152 (44.74%)
    56 / 152 (36.84%)
    67 / 152 (44.08%)
         occurrences all number
    68
    56
    67
    Metabolism and nutrition disorders
    Appetite loss
    alternative assessment type: Systematic
         subjects affected / exposed
    50 / 152 (32.89%)
    53 / 152 (34.87%)
    44 / 152 (28.95%)
         occurrences all number
    50
    53
    44

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Nov 2012
    The Sponsor's Responsible Medical Officer was changed; The age range for Visit 05 was clarified to 'between 18 and <19 months of age'; and an observational objective was added to the protocol in order to obtain the immunogenicity results from Global Clinical Immunology (GCI) Sanofi Pasteur, Swiftwater, PA. USA, in addition to the results from National Institute for Food and Drug Control (NIFDC), China.

    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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