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    Clinical Trial Results:
    An open-label primary vaccination study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Inactivated Poliomyelitis vaccine (IPV) Poliorix administered as a three-dose primary vaccination course at 2, 3 and 4 months of age in healthy infants in China

    Summary
    EudraCT number
    		 2017-001607-80
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Nov 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2018
    First version publication date
    05 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    112581
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00937404
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut, 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, ((44)2089) 904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, ((44)2089) 904466, 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
    13 Nov 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Nov 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and reactogenicity of GSK Biologicals’ Poliorix vaccine administered as a three-dose primary vaccination course
    Protection of trial subjects
    All subjects will be observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Aug 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: 25
    Worldwide total number of subjects
    25
    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)
    25
    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
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 25
    Number of subjects completed
    		 25

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

    Arms
    Arm title
    		 IPV Group
    Arm description
    		 Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the 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
    All subjects received three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh

    Number of subjects in period 1
    		IPV Group
    Started
    25
    Completed
    23
    Not completed
    2
         Consent withdrawn by subject
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IPV Group
    Reporting group description
    		 Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.

    Reporting group values
    		 IPV Group Total
    Number of subjects
    		 25
    Age categorical
    Units: Subjects
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 9.6 ( 1.38 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 10 10
    Race/Ethnicity, Customized
    Units: Subjects
        Asian-Chinese Heritage
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    IPV Group
    Reporting group description
    		 Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.

    Primary: Number of subjects reporting solicited local symptoms

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    End point title
    		 Number of subjects reporting solicited local symptoms [1]
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site.
    End point type
    Primary
    End point timeframe
    During the 4-day follow-up period after each dose of study vaccine.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 IPV Group
    Number of subjects analysed
    25
    Units: Participants
        Any Pain, Dose 1
    1
        Grade 3 Pain, Dose 1
    0
        Any Redness, Dose 1
    2
        Grade 3 Redness, Dose 1
    0
        Any Swelling, Dose 1
    1
        Grade 3 Swelling, Dose 1
    0
        Any Pain, Dose 2 (N=23)
    2
        Grade 3 Pain, Dose 2 (N=23)
    0
        Any Redness, Dose 2 (N=23)
    1
        Grade 3 Redness, Dose 2 (N=23)
    0
        Any Swelling, Dose 2 (N=23)
    1
        Grade 3 Swelling, Dose 2 (N=23)
    0
        Any Pain, Dose 3 (N=23)
    1
        Grade 3 Pain, Dose 3 (N=23)
    0
        Any Redness, Dose 3 (N=23)
    0
        Grade 3 Redness, Dose 3 (N=23)
    0
        Any Swelling, Dose 3 (N=23)
    0
        Grade 3 Swelling, Dose 3 (N=23)
    0
        Any Pain, Across doses
    3
        Grade 3 Pain, Across doses
    0
        Any Redness, Across doses
    2
        Grade 3 Redness, Across doses
    0
        Any Swelling, Across doses
    2
        Grade 3 Swelling, Across doses
    0
    No statistical analyses for this end point

    Primary: Number of subjects reporting solicited general symptoms

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    End point title
    		 Number of subjects reporting solicited general symptoms [2]
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade of 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 fever = fever above (>) 39.0°C. Related = symptom assessed by the investigator as related to vaccination.
    End point type
    Primary
    End point timeframe
    During the 4-day follow-up period after each dose of study vaccine.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 IPV Group
    Number of subjects analysed
    25
    Units: Participants
        Any Drowsiness, Dose 1
    7
        Grade 3 Drowsiness, Dose 1
    0
        Related Drowsiness, Dose 1
    7
        Any Irritability, Dose 1
    10
        Grade 3 Irritability, Dose 1
    0
        Related Irritability, Dose 1
    10
        Any Loss of appetite, Dose 1
    7
        Grade 3 Loss of appetite, Dose 1
    0
        Related Loss of appetite, Dose 1
    7
        Any Fever, Dose 1
    8
        Grade 3 Fever, Dose 1
    0
        Related Fever, Dose 1
    6
        Any Drowsiness, Dose 2 (N=23)
    2
        Grade 3 Drowsiness, Dose 2 (N=23)
    0
        Related Drowsiness, Dose 2 (N=23)
    2
        Any Irritability, Dose 2 (N=23)
    7
        Grade 3 Irritability, Dose 2 (N=23)
    0
        Related Irritability, Dose 2 (N=23)
    6
        Any Loss of appetite, Dose 2 (N=23)
    4
        Grade 3 Loss of appetite, Dose 2 (N=23)
    0
        Related Loss of appetite, Dose 2 (N=23)
    3
        Any Fever, Dose 2 (N=23)
    3
        Grade 3 Fever, Dose 2 (N=23)
    0
        Related Fever, Dose 2 (N=23)
    3
        Any Drowsiness, Dose 3 (N=23)
    3
        Grade 3 Drowsiness, Dose 3 (N=23)
    0
        Related Drowsiness, Dose 3 (N=23)
    1
        Any Irritability, Dose 3 (N=23)
    7
        Grade 3 Irritability, Dose 3 (N=23)
    2
        Related Irritability, Dose 3 (N=23)
    3
        Any Loss of appetite, Dose 3 (N=23)
    6
        Grade 3 Loss of appetite, Dose 3 (N=23)
    0
        Related Loss of appetite, Dose 3 (N=23)
    3
        Any Fever, Dose 3 (N=23)
    4
        Grade 3 Fever, Dose 3 (N=23)
    0
        Related Fever, Dose 3 (N=23)
    2
        Any Drowsiness, Across doses
    8
        Grade 3 Drowsiness, Across doses
    0
        Related Drowsiness, Across doses
    8
        Any Irritability, Across doses
    14
        Grade 3 Irritability, Across doses
    2
        Related Irritability, Across doses
    12
        Any Loss of appetite, Across doses
    9
        Grade 3 Loss of appetite, Across doses
    0
        Related Loss of appetite, Across doses
    8
        Any Fever, Across doses
    12
        Grade 3 Fever, Across doses
    0
        Related Fever, Across doses
    9
    No statistical analyses for this end point

    Primary: Number of subjects reporting unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AEs) [3]
    End point description
    Unsolicited AE covers any AE 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 = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
    End point type
    Primary
    End point timeframe
    During the 31-days follow-up period after each dose of the study vaccine.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 IPV Group
    Number of subjects analysed
    25
    Units: Participants
        Participants
    15
    No statistical analyses for this end point

    Primary: Number of subjects reporting serious adverse events (SAEs)

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs) [4]
    End point description
    SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Primary
    End point timeframe
    During the entire study period (from Dose 1 up to one month following last vaccine dose).
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 IPV Group
    Number of subjects analysed
    25
    Units: Participants
        Participants
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: during 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during 31-day post-vaccination period after each vaccine dose. SAEs: during entire study period (from Dose 1 up to one month following last vaccine dose)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    IPV Group
    Reporting group description
    		 Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.

    Serious adverse events
    		 IPV Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 IPV Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 25 (80.00%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    8 / 25 (32.00%)
         occurrences all number
    12
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    16 / 25 (64.00%)
         occurrences all number
    21
    Swelling
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    5 / 25 (20.00%)
         occurrences all number
    7
    Dyspepsia
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    3
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    14 / 25 (56.00%)
         occurrences all number
    24
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    9
    Skin infection
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 25 (28.00%)
         occurrences all number
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 25 (36.00%)
         occurrences all number
    17

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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