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    Clinical Trial Results:
    A randomised, open-label study to assess the immunogenicity and safety of GSK Biologicals’ IPV vaccine administered as a three-dose primary vaccination course at 2-3-4 months of age in healthy infants in China.

    Summary
    EudraCT number
    		 2011-003167-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    05 Jul 2010

    Results information
    Results version number
    		 v3(current)
    This version publication date
    19 Apr 2023
    First version publication date
    01 Jul 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    112679
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01021293
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.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
    15 Feb 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jul 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of GSK Biologicals’ IPV vaccine as compared to the Chinese OPV vaccine in terms of the immune response to poliovirus type 1, 2 and 3, one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to the three poliovirus antigens will be demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference [Control Group minus Poliorix Group] in the percentage of seroprotected subjects is less than or equal to 10%.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of anaphylaxis following the administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Nov 2009
    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: 1101
    Worldwide total number of subjects
    1101
    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)
    1101
    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
    		 Of the 1101 enrolled subjects, one subject was not randomised and administered any vaccine as the parents of the subject refused to vaccinate their child after blood collection at Visit 1 and withdrew their consent.

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Poliorix Group
    Arm description
    		 Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Poliorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of IPV vaccine administered intramuscularly into the anterolateral side of the right thigh.

    Arm title
    		 Control Group
    Arm description
    		 Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oral Poliomyelitis Vaccine (OPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    3 doses of OPV vaccine administered orally.

    Number of subjects in period 1 [1]
    		Poliorix Group Control Group
    Started
    550
    550
    Completed
    538
    526
    Not completed
    12
    24
         Adverse event, serious fatal
    2
    1
         Consent withdrawn by subject
    1
    3
         Adverse event, non-fatal
    2
    1
         Migrated/moved from study area
    6
    18
         Lost to follow-up
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the 1101 enrolled subjects, one subject was not randomised and administered any vaccine as the parents of the subject refused to vaccinate their child after blood collection at Visit 1 and withdrew their consent.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Poliorix Group
    Reporting group description
    		 Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.

    Reporting group title
    Control Group
    Reporting group description
    		 Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.

    Reporting group values
    		 Poliorix Group Control Group Total
    Number of subjects
    		 550 550 1100
    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)
    		 550 550 1100
        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: weeks
        arithmetic mean (standard deviation)
    		 10 ( 1.16 ) 10.1 ( 1.18 ) -
    Gender categorical
    Units: Subjects
        Female
    		 268 259 527
        Male
    		 282 291 573
    Race/Ethnicity
    Units: Subjects
        Asian-Chinese heritage
    		 550 550 1100

    End points

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    End points reporting groups
    Reporting group title
    Poliorix Group
    Reporting group description
    		 Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.

    Reporting group title
    Control Group
    Reporting group description
    		 Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.

    Primary: Number of seroprotected subjects against poliovirus types 1, 2 and 3

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    End point title
    		 Number of seroprotected subjects against poliovirus types 1, 2 and 3
    End point description
    A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
    End point type
    Primary
    End point timeframe
    At Month 3, one month after the third vaccine dose
    End point values
    		 Poliorix Group Control Group
    Number of subjects analysed
    306
    296
    Units: Subjects
        Anti-poliovirus 1
    306
    296
        Anti-poliovirus 2
    306
    296
        Anti-poliovirus 3
    306
    291
    Statistical analysis title
    		 Non-inferiority of IPV as compared to OPV
    Statistical analysis description
    Non-inferiority of IPV vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 1 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference [Control Group minus IPV Group] in the percentage of seroprotected subjects was lesser than or equas to (≤) 10%.
    Comparison groups
    Control Group v Poliorix Group
    Number of subjects included in analysis
    602
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 1.24
    Statistical analysis title
    		 Non-inferiority of IPV as compared to OPV
    Statistical analysis description
    Non-inferiority of IPV vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 2 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference [Control Group minus IPV Group] in the percentage of seroprotected subjects was ≤ 10%.
    Comparison groups
    Poliorix Group v Control Group
    Number of subjects included in analysis
    602
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 1.24
    Statistical analysis title
    		 Non-inferiority of IPV as compared to OPV
    Statistical analysis description
    Non-inferiority of IPV vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 3 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference [Control Group minus IPV Group] in the percentage of seroprotected subjects was ≤ 10%.
    Comparison groups
    Poliorix Group v Control Group
    Number of subjects included in analysis
    602
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in seroprotection rate
    Point estimate
    -1.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 -0.44

    Secondary: Number of seroprotected subjects against poliovirus types 1, 2 and 3

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    End point title
    		 Number of seroprotected subjects against poliovirus types 1, 2 and 3
    End point description
    A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers greater than or equal to (≥) 8 ED50.
    End point type
    Secondary
    End point timeframe
    At Day 0, prior to the first vaccine dose
    End point values
    		 Poliorix Group Control Group
    Number of subjects analysed
    306
    296
    Units: Subjects
        Anti-poliovirus 1
    131
    113
        Anti-poliovirus 2
    93
    99
        Anti-poliovirus 3
    48
    52
    No statistical analyses for this end point

    Secondary: Anti-poliovirus types 1, 2 and 3 antibody titers

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    End point title
    		 Anti-poliovirus types 1, 2 and 3 antibody titers
    End point description
    Antibody titers were presented as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3)
    End point values
    		 Poliorix Group Control Group
    Number of subjects analysed
    306
    296
    Units: Titre
    geometric mean (confidence interval 95%)
        Anti-poliovirus 1; Day 0
    8.7 (7.6 to 9.8)
    7.8 (6.9 to 8.9)
        Anti-poliovirus 2; Day 0
    6.5 (5.9 to 7.1)
    7.2 (6.5 to 8.1)
        Anti-poliovirus 3; Day 0
    5.2 (4.8 to 5.7)
    5.2 (4.8 to 5.7)
        Anti-poliovirus 1; Month 3
    485.1 (436.7 to 538.9)
    2817 (2479.5 to 3200.4)
        Anti-poliovirus 2; Month 3
    234.3 (209 to 262.6)
    468.5 (416.6 to 526.9)
        Anti-poliovirus 3; Month 3
    824.3 (725.3 to 936.9)
    423.4 (363.3 to 493.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and grade 3 solicited local symptoms [1]
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects from the IPV Group only.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0–3) post-vaccination period following each vaccine dose and across doses
    Notes
    [1] - 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: This endpoint is only reporting values for the Poliorix Group.
    End point values
    		 Poliorix Group
    Number of subjects analysed
    550
    Units: Subjects
        Any Pain, Dose 1 [N=550]
    80
        Grade 3 Pain, Dose 1 [N=550]
    1
        Any Redness, Dose 1 [N=550]
    20
        Grade 3 Redness, Dose 1 [N=550]
    0
        Any Swelling, Dose 1 [N=550]
    9
        Grade 3 Sweliing, Dose 1 [N=550]
    0
        Any Pain, Dose 2 [N=543]
    58
        Grade 3 Pain, Dose 2 [N=543]
    2
        Any Redness, Dose 2 [N=543]
    23
        Grade 3 Redness, Dose 2 [N=543]
    1
        Any Swelling, Dose 2 [N=543]
    8
        Grade 3 Swelling, Dose 2 [N=543]
    1
        Any Pain, Dose 3 [N=540]
    41
        Grade 3 Pain, Dose 3 [N=540]
    0
        Any Redness, Dose 3 [N=540]
    15
        Grade 3 Redness, Dose 3 [N=540]
    0
        Any Swelling, Dose 3 [N=540]
    6
        Grade 3 Swelling, Dose 3 [N=540]
    0
        Any Pain, Across doses [N=550]
    113
        Grade 3 Pain, Across doses [N=550]
    3
        Any Redness, Across doses [N=550]
    46
        Grade 3 Redness, Across doses [N=550]
    1
        Any Swelling, Across doses [N=550]
    18
        Grade 3 Swelling, Across doses [N=550]
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever [defined as axillary temperature higher than (>) 37.0°C degrees Celsius]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature > 39°C. Related = symptom assessed by the investigator as causally related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0 -3) post-vaccination period following each vaccine dose and across doses
    End point values
    		 Poliorix Group Control Group
    Number of subjects analysed
    550
    550
    Units: Subjects
        Any Drowsiness, Dose 1 [N=550;550]
    99
    75
        Grade 3 Drowsiness, Dose 1 [N=550;550]
    0
    1
        Related Drowsiness, Dose 1 [N=550;550]
    71
    51
        Any Gastrointestinal symptoms, Dose 1 [N=550;550]
    102
    89
        Grade 3 Gastrointestinal symptoms, Dose 1 [N=550;5
    0
    2
        Related Gastrointestinal symptoms, Dose 1 [N=550;5
    44
    43
        Any Irritability/Fussiness, Dose 1 [N=550;550]
    160
    151
        Grade 3 Irritability/Fussiness, Dose 1 [N=550;550]
    1
    5
        Related Irritability/Fussiness, Dose 1 [N=550;550]
    130
    105
        Any Loss of appetite, Dose 1 [N=550;550]
    82
    83
        Grade 3 Loss of appetite, Dose 1 [N=550;550]
    0
    1
        Related Loss of appetite, Dose 1 [N=550;550]
    54
    47
        Any Temperature, Dose 1 [N=550;550]
    39
    20
        Grade 3 Temperature, Dose 1 [N=550;550]
    0
    0
        Related Temperature, Dose 1 [N=550;550]
    28
    10
        Any Drowsiness, Dose 2 [N=543;544]
    68
    50
        Grade 3 Drowsiness, Dose 2 [N=543;544]
    2
    0
        Related Drowsiness, Dose 2 [N=543;544]
    51
    25
        Any Gastrointestinal symptoms, Dose 2 [N=543;544]
    66
    67
        Grade 3 Gastrointestinal symptoms, Dose 2 [N=543;5
    2
    1
        Related Gastrointestinal symptoms, Dose 2 [N=543;5
    32
    35
        Any Irritability/Fussiness, Dose 2 [N=543;544]
    121
    86
        Grade 3 Irritability/Fussiness, Dose 2 [N=543;544]
    7
    2
        Related Irritability/Fussiness, Dose 2 [N=543;544]
    105
    50
        Any Loss of appetite, Dose 2 [N=543;544]
    70
    78
        Grade 3 Loss of appetite, Dose 2 [N=543;544]
    3
    0
        Related Loss of appetite, Dose 2 [N=543;544]
    48
    47
        Any Temperature, Dose 2 [N=543;544]
    39
    26
        Grade 3 Temperature, Dose 2 [N=543;544]
    2
    1
        Related Temperature, Dose 2 [N=543;544]
    28
    11
        Any Drowsiness, Dose 3 [N=540;534]
    47
    45
        Grade 3 Drowsiness, Dose 3 [N=540;534]
    2
    1
        Related Drowsiness, Dose 3 [N=540;534]
    36
    25
        Any Gastrointestinal symtpoms, Dose 3 [N=540;534]
    46
    67
        Grade 3 Gastrointestinal symtpoms, Dose 3 [N=540;5
    3
    0
        Related Gastrointestinal symtpoms, Dose 3 [N=540;5
    16
    25
        Any Irritability/Fussiness, Dose 3 [N=540;534]
    87
    72
        Grade 3Irritability/Fussiness, Dose 3 [N=540;534]
    2
    2
        Related Irritability/Fussiness, Dose 3 [N=540;534]
    77
    44
        Any Loss of appetite, Dose 3 [N=540;534]
    52
    64
        Grade 3 Loss of appetite, Dose 3 [N=540;534]
    0
    0
        Related Loss of appetite, Dose 3 [N=540;534]
    34
    36
        Any Temperature, Dose 3 [N=540;534]
    33
    32
        Grade 3 Temperature, Dose 3 [N=540;534]
    0
    2
        Related Temperature, Dose 3 [N=540;534]
    18
    17
        Any Drowsiness, Across doses [N=550;550]
    140
    125
        Grade 3 Drowsiness, Across doses [N=550;550]
    4
    2
        Related Drowsiness, Across doses [N=550;550]
    115
    80
        Any Gastrointestinal, Across doses [N=550;550]
    154
    156
        Grade 3 Gastrointestinal, Across doses [N=550;550]
    5
    3
        Related Gastrointestinal, Across doses [N=550;550]
    76
    87
        Any Irritability, Across doses [N=550;550]
    244
    216
        Grade 3 Irritability, Across doses [N=550;550]
    10
    9
        Related Irritability, Across doses [N=550;550]
    214
    159
        Any Loss of appetite, Across doses [N=550;550]
    147
    168
        Grade 3 Loss of appetite, Across doses [N=550;550
    3
    1
        Related Loss of appetite, Across doses [N=550;550]
    100
    109
        Any Fever, Across doses [N=550;550]
    99
    71
        Grade 3 Fever, Across doses [N=550;550]
    2
    3
        Related Fever, Across doses [N=550;550]
    69
    36
    No statistical analyses for this end point

    Secondary: Number of subjects with any unsolicited adverse events

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    End point title
    		 Number of subjects with any unsolicited adverse events
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) post-vaccination period
    End point values
    		 Poliorix Group Control Group
    Number of subjects analysed
    550
    550
    Units: Subjects
        Any AE(s)
    155
    162
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to Month 3)
    End point values
    		 Poliorix Group Control Group
    Number of subjects analysed
    550
    550
    Units: Subjects
        Any SAE(s)
    3
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
    Adverse event reporting additional description
    The number of occurrences reported for adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.

    Reporting group title
    Poliorix Group
    Reporting group description
    		 Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.

    Serious adverse events
    		 Control Group Poliorix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 550 (1.09%)
    3 / 550 (0.55%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Cardiac failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 550 (0.18%)
    0 / 550 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 550 (0.18%)
    0 / 550 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 550 (0.00%)
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 550 (0.18%)
    0 / 550 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 550 (0.00%)
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 550 (0.18%)
    0 / 550 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 550 (0.18%)
    0 / 550 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 550 (0.36%)
    0 / 550 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 550 (0.18%)
    0 / 550 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 550 (0.00%)
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 550 (0.18%)
    0 / 550 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control Group Poliorix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    366 / 550 (66.55%)
    391 / 550 (71.09%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 550 (0.00%)
    113 / 550 (20.55%)
         occurrences all number
    0
    113
    Drowsiness
         subjects affected / exposed
    125 / 550 (22.73%)
    140 / 550 (25.45%)
         occurrences all number
    125
    140
    Gastrointestinal Symptoms
         subjects affected / exposed
    156 / 550 (28.36%)
    154 / 550 (28.00%)
         occurrences all number
    156
    154
    Irritability/Fussiness
         subjects affected / exposed
    216 / 550 (39.27%)
    244 / 550 (44.36%)
         occurrences all number
    216
    244
    Loss of appetite
         subjects affected / exposed
    168 / 550 (30.55%)
    147 / 550 (26.73%)
         occurrences all number
    168
    147
    Fever (Axillary)
         subjects affected / exposed
    71 / 550 (12.91%)
    99 / 550 (18.00%)
         occurrences all number
    71
    99
    Redness
         subjects affected / exposed
    46 / 550 (8.36%)
    0 / 550 (0.00%)
         occurrences all number
    46
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    97 / 550 (17.64%)
    99 / 550 (18.00%)
         occurrences all number
    97
    99
    Nasopharyngitis
         subjects affected / exposed
    38 / 550 (6.91%)
    32 / 550 (5.82%)
         occurrences all number
    38
    32

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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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