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    Clinical Trial Results:
    Large scale safety study of IMOVAX Polio in selected cities in China, an observational post marketing study

    Summary
    EudraCT number
    2015-005186-23
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    12 May 2011

    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
    IPV34
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01278433
    WHO universal trial number (UTN)
    U1111-1115-6566
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur China
    Sponsor organisation address
    6th floor, No. 112 Jianguo Road, Chaoyang District, Beijing, China, 100022
    Public contact
    Medical Director, Medical Affairs Department, Sanofi Pasteur China, 86 10-6568 5588, RegistryContactUS@sanofipasteur.com
    Scientific contact
    Medical Director, Medical Affairs Department, Sanofi Pasteur China, 86 10-6568 5588, RegistryContactUS@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Oct 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To describe serious adverse events (SAEs) within 30 days after each dose of IMOVAX Polio administered to infants at 2, 3 and 4 months of age and lived in the study cities of China.
    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 kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were available on site in case of any immediate allergic reactions.
    Background therapy
    Not applicable.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    10 Dec 2010
    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: 5007
    Worldwide total number of subjects
    5007
    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)
    5007
    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 10 December 2010 to 31 July 2011 in clinical centers in China.

    Pre-assignment
    Screening details
    A total of 5007 subjects who met the inclusion, but none of the exclusion criteria were enrolled and vaccinated.

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

    Arms
    Arm title
    Study Group
    Arm description
    Subjects vaccinated with a primary dose series of IMOVAX Polio at 2, 3 and 4 months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    Inactivated Poliomyelitis Vaccine (IMOVAX Polio)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, Intramuscular (IM) injection to the local sites of the anterolateral thigh or upper arm deltoid.

    Number of subjects in period 1
    Study Group
    Started
    5007
    Completed
    4774
    Not completed
    233
         Protocol deviation
             9
         Adverse event, non-fatal
             5
         Consent withdrawn by subject
             136
         Lost to follow-up
             83

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    Infants subjects receiving IMOVAX Polio vaccine at 2, 3 and 4 months of age.

    Reporting group values
    Overall Total
    Number of subjects
    5007 5007
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    5007 5007
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    2.3 ± 0.4 -
    Gender categorical
    Units: Subjects
        Female
    2263 2263
        Male
    2744 2744

    End points

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    End points reporting groups
    Reporting group title
    Study Group
    Reporting group description
    Subjects vaccinated with a primary dose series of IMOVAX Polio at 2, 3 and 4 months of age.

    Primary: Number of Subjects With All and Related Serious Adverse Events within 30 Days After Any of A Three-Dose Primary Vaccination Series with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    Number of Subjects With All and Related Serious Adverse Events within 30 Days After Any of A Three-Dose Primary Vaccination Series with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [1]
    End point description
    Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), time to onset, duration, outcome, seriousness and relationship to vaccination of any SAEs reported up to 30 days after vaccination and whether the SAE led to early termination from the study.
    End point type
    Primary
    End point timeframe
    30 Days post-any injection
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    Study Group
    Number of subjects analysed
    5007
    Units: Number
    number (not applicable)
        Total Serious Adverse Events
    4
        Upper respiratory tract infection
    1
        Flow perceptual pneumonia
    2
        Orchitis
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events data were collected from Day 0 (post-vaccination) up to 30 Days post-vaccination.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Study Group
    Reporting group description
    Subjects vaccinated with a primary dose series of IMOVAX Polio at 2, 3 and 4 months of age.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The primary objective of the study is to solicit and record serious adverse events. Non-serious adverse events were not solicited.
    Serious adverse events
    Study Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 5007 (0.08%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Flow perceptual pneumonia
         subjects affected / exposed
    2 / 5007 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5007 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Orchitis
         subjects affected / exposed
    1 / 5007 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Study Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5007 (0.00%)

    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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