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    Clinical Trial Results:
    A phase IV, open-label, multicentre, non-comparative study to assess reactogenicity and safety of co-administration of GlaxoSmithKline (GSK) Biologicals’ inactivated poliomyelitis vaccine PoliorixTM and DTPa-vaccine InfanrixTM in frame of three-doses primary immunization course in healthy children of 3, 4.5 and 6 months on age in Russian Federation.

    Summary
    EudraCT number
    2013-002804-15
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    27 Oct 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Apr 2016
    First version publication date
    11 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    113586
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01094171
    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, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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
    26 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Oct 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Reactogenicity and safety assessment of co-administration of GlaxoSmithKline (GSK) Biologicals’ inactivated poliomyelitis vaccine PoliorixTM and GlaxoSmithKline (GSK) Biologicals’ DTPa-vaccine InfanrixTM in frame of three-doses primary im-munization course in healthy children of 3, 4.5 and 6 months on age in Russian Federation.
    Protection of trial subjects
    All subjects were observed closely for at least 30 minutes with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 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
    Russian Federation: 400
    Worldwide total number of subjects
    400
    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)
    400
    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
    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 period
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Poliorix Group
    Arm description
    Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
    Arm type
    Experimental

    Investigational medicinal product name
    Poliorix™
    Investigational medicinal product code
    Other name
    IPV
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses administered intramuscularly in the anterolateral side of the left thigh.

    Investigational medicinal product name
    Infanrix™
    Investigational medicinal product code
    Other name
    DTPa
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses administered intramuscularly in the anterolateral side the right thigh.

    Number of subjects in period 1
    Poliorix Group
    Started
    400
    Completed
    390
    Not completed
    10
         Migration from the study area
    3
         Unspecified
    1
         Consent withdrawn by subject
    4
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Poliorix Group
    Reporting group description
    Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).

    Reporting group values
    Poliorix Group Total
    Number of subjects
    400 400
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    3.4 ± 0.5 -
    Gender categorical
    Units: Subjects
        Female
    178 178
        Male
    222 222

    End points

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    End points reporting groups
    Reporting group title
    Poliorix Group
    Reporting group description
    Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).

    Primary: Number of subjects reporting any and grade 3 solicited local symptoms

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    End point title
    Number of subjects reporting any and grade 3 solicited local symptoms [1]
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)
    End point type
    Primary
    End point timeframe
    During 4 days follow-up period (i.e. the day of vaccination and 3 following days) after administration of each vaccine dose.
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Poliorix Group
    Number of subjects analysed
    400
    Units: Subjects
        Any Pain; Dose 1
    66
        Grade 3 Pain; Dose 1
    6
        Any Redness; Dose 1
    135
        Grade 3 Redness; Dose 1
    3
        Any Swelling; Dose 1
    44
        Grade 3 Swelling; Dose 1
    3
        Any Pain; Dose 2
    63
        Grade 3 Pain; Dose 2
    3
        Any Redness; Dose 2
    194
        Grade 3 Redness; Dose 2
    4
        Any Swelling; Dose 2
    101
        Grade 3 Swelling; Dose 2
    3
        Any Pain; Dose 3
    60
        Grade 3 Pain; Dose 3
    0
        Any Redness; Dose 3
    188
        Grade 3 Redness; Dose 3
    6
        Any Swelling; Dose 3
    103
        Grade 3 Swelling; Dose 3
    4
        Any Pain; Across Doses
    114
        Grade 3 Pain; Across Doses
    7
        Any Redness; Across Doses
    258
        Grade 3 Redness; Across Doses
    12
        Any Swelling; Across Doses
    152
        Grade 3 Swelling; Across Doses
    8
    No statistical analyses for this end point

    Primary: Number of subjects reporting any and grade 3 solicited general symptoms

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    End point title
    Number of subjects reporting any and grade 3 solicited general symptoms [2]
    End point description
    Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.
    End point type
    Primary
    End point timeframe
    During 31 days follow-up period (i.e. the day of vaccination and 30 following days) after administration of each vaccine dose.
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Poliorix Group
    Number of subjects analysed
    400
    Units: Subjects
        Any Drowsiness; Dose 1
    166
        Grade 3 Drowsiness; Dose 1
    10
        Any Irritability; Dose 1
    179
        Grade 3 Irritability; Dose 1
    15
        Any Loss of appetite; Dose 1
    80
        Grade 3 Loss of appetite; Dose 1
    5
        Any Temperature; Dose 1
    31
        Grade 3 Temperature; Dose 1
    0
        Any Drowsiness; Dose 2
    132
        Grade 3 Drowsiness; Dose 2
    2
        Any Irritability; Dose 2
    149
        Grade 3 Irritability; Dose 2
    3
        Any Loss of appetite; Dose 2
    50
        Grdae 3 Loss of appetite; Dose 2
    3
        Any Temperature; Dose 2
    28
        Grade 3 Temperature; Dose 2
    1
        Any Drowsiness; Dose 3
    103
        Grade 3 Drowsiness; Dose 3
    4
        Any Irritability; Dose 3
    125
        Grdae 3 Irritability; Dose 3
    4
        Any Loss of appetite; Dose 3
    58
        Grade 3 Loss of appetite; Dose 3
    2
        Any Temperature; Dose 3
    32
        Grdae 3 Temperature; Dose 3
    0
        Any Drowsiness; Across Doses
    227
        Grade 3 Drowsiness; Across Doses
    15
        Any Irritability; Across Doses
    240
        Grdae 3 Irritability; Across Doses
    20
        Any Loss of appetite; Across Doses
    133
        Grade 3 Loss of appetite; Across Doses
    10
        Any Temperature; Across Doses
    69
        Grade 3 Temperature; Across Doses
    1
    No statistical analyses for this end point

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

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    End point title
    Number of subjects reporting any 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
    End point type
    Primary
    End point timeframe
    During 31 days follow-up period (i.e. the day of vaccination and 30 following days) after administration of each vaccine dose.
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Poliorix Group
    Number of subjects analysed
    400
    Units: Subjects
    91
    No statistical analyses for this end point

    Primary: Number of subjects with Serious Adverse Events (SAEs).

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    End point title
    Number of subjects with Serious Adverse Events (SAEs). [4]
    End point description
    SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Primary
    End point timeframe
    During the entire study period (Day 0-Month 4).
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Poliorix Group
    Number of subjects analysed
    400
    Units: Subjects
        Any SAEs
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
    Adverse event reporting additional description
    The number of occurrences reported for solicited symptoms, adverse events, and serious 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
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Poliorix Group
    Reporting group description
    Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).

    Serious adverse events
    Poliorix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 400 (1.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    1 / 400 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Body temperature increased
         subjects affected / exposed
    1 / 400 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Periproctitis
         subjects affected / exposed
    1 / 400 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 400 (0.25%)
         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
    Poliorix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    258 / 400 (64.50%)
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    27 / 400 (6.75%)
         occurrences all number
    27
    Cough
         subjects affected / exposed
    23 / 400 (5.75%)
         occurrences all number
    23
    General disorders and administration site conditions
    Pain; Across Doses
    alternative assessment type: Systematic
         subjects affected / exposed
    114 / 400 (28.50%)
         occurrences all number
    114
    Redness; Across Doses
    alternative assessment type: Systematic
         subjects affected / exposed
    258 / 400 (64.50%)
         occurrences all number
    258
    Swelling; Across Doses
    alternative assessment type: Systematic
         subjects affected / exposed
    152 / 400 (38.00%)
         occurrences all number
    152
    Drowsiness; Across Doses
    alternative assessment type: Systematic
         subjects affected / exposed
    227 / 400 (56.75%)
         occurrences all number
    227
    Irritability; Across Doses
    alternative assessment type: Systematic
         subjects affected / exposed
    240 / 400 (60.00%)
         occurrences all number
    240
    Loss of appetite; Aross Doses
    alternative assessment type: Systematic
         subjects affected / exposed
    133 / 400 (33.25%)
         occurrences all number
    133
    Fever; Across Doses
    alternative assessment type: Systematic
         subjects affected / exposed
    69 / 400 (17.25%)
         occurrences all number
    69
    Body temperature increased
         subjects affected / exposed
    20 / 400 (5.00%)
         occurrences all number
    20
    Pain; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed
    66 / 400 (16.50%)
         occurrences all number
    66
    Redness; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed
    135 / 400 (33.75%)
         occurrences all number
    135
    Swelling; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed
    44 / 400 (11.00%)
         occurrences all number
    44
    Pain; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed
    63 / 400 (15.75%)
         occurrences all number
    63
    Redness; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed
    194 / 400 (48.50%)
         occurrences all number
    194
    Swelling; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed
    101 / 400 (25.25%)
         occurrences all number
    101
    Pain; Dose 3
    alternative assessment type: Systematic
         subjects affected / exposed
    60 / 400 (15.00%)
         occurrences all number
    60
    Redness; Dose 3
    alternative assessment type: Systematic
         subjects affected / exposed
    188 / 400 (47.00%)
         occurrences all number
    188
    Swelling; Dose 3
    alternative assessment type: Systematic
         subjects affected / exposed
    103 / 400 (25.75%)
         occurrences all number
    103
    Drowsiness; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed
    166 / 400 (41.50%)
         occurrences all number
    166
    Irritability; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed
    179 / 400 (44.75%)
         occurrences all number
    179
    Loss of appetite; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed
    80 / 400 (20.00%)
         occurrences all number
    80
    Temperature; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed
    31 / 400 (7.75%)
         occurrences all number
    31
    Drowsiness; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed
    132 / 400 (33.00%)
         occurrences all number
    132
    Irritability; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed
    149 / 400 (37.25%)
         occurrences all number
    149
    Loss of appetite; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed
    50 / 400 (12.50%)
         occurrences all number
    50
    Temperature; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed
    28 / 400 (7.00%)
         occurrences all number
    28
    Drowsiness; Dose 3
    alternative assessment type: Systematic
         subjects affected / exposed
    103 / 400 (25.75%)
         occurrences all number
    103
    Irritability; Dose 3
    alternative assessment type: Systematic
         subjects affected / exposed
    125 / 400 (31.25%)
         occurrences all number
    125
    Loss of appetite; Dose 3
    alternative assessment type: Systematic
         subjects affected / exposed
    58 / 400 (14.50%)
         occurrences all number
    58
    Temperature; Dose 3
    alternative assessment type: Systematic
         subjects affected / exposed
    32 / 400 (8.00%)
         occurrences all number
    32

    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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