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    Clinical Trial Results:
    An open-label study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ IPV vaccine (Poliorix) administered as a booster dose at 18 months of age in healthy Chinese toddlers previously primed with the same vaccine in the study IPV-018 (NCT01323647).

    Summary
    EudraCT number
    		 2012-004513-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Sep 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Nov 2020
    First version publication date
    12 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    114306
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01323647
    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 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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
    25 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess the immunological response to a booster dose of GSK Biologicals’ IPV in terms of poliovirus type 1, 2 and 3 antibodies, one month after the booster dose in subjects primed with three doses of the same IPV in study IPV-018. • To assess the persistence of antibodies to poliovirus types 1, 2 and 3 antigens at 18 months of age in subjects primed with three doses of GSK Biologicals’ IPV or three doses of OPV in study IPV-018.
    Protection of trial subjects
    The 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 vaccine.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Apr 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: 957
    Worldwide total number of subjects
    957
    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)
    957
    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 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
    		 Subjects previously primed with 3 doses of Poliorix Vaccine in the primary study and who received a booster dose of Poliorix Vaccine co-administered with Infanrix-Hib vaccine in the current study.
    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
    One dose administered intramuscularly into the anterolateral side of the thigh.

    Investigational medicinal product name
    Infanrix-Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose administered intramuscularly into the anterolateral side of the thigh. Part of the local standard of care. No outcome measures associated.

    Arm title
    		 Control Group
    Arm description
    		 Subjects previously primed with 3 doses of Chinese OPV vaccine in the primary study and who received a dose of Infanrix-Hib vaccine in the current study.
    Arm type
    		 Active comparator

    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
    One dose administered intramuscularly into the anterolateral side of the thigh.

    Investigational medicinal product name
    Infanrix-Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose administered intramuscularly into the anterolateral side of the thigh. Part of the local standard of care. No outcome measures associated.

    Number of subjects in period 1
    		Poliorix Group Control Group
    Started
    470
    487
    Completed
    461
    487
    Not completed
    9
    0
         Consent withdrawn by subject
    5
    -
         Migrated/moved from study area
    2
    -
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Poliorix Group
    Reporting group description
    		 Subjects previously primed with 3 doses of Poliorix Vaccine in the primary study and who received a booster dose of Poliorix Vaccine co-administered with Infanrix-Hib vaccine in the current study.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects previously primed with 3 doses of Chinese OPV vaccine in the primary study and who received a dose of Infanrix-Hib vaccine in the current study.

    Reporting group values
    		 Poliorix Group Control Group Total
    Number of subjects
    		 470 487 957
    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)
    		 470 487 957
        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: months
        arithmetic mean (standard deviation)
    		 18.7 ± 0.93 18.8 ± 1.01 -
    Gender categorical
    Units: Subjects
        Female
    		 234 227 461
        Male
    		 236 260 496

    End points

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    End points reporting groups
    Reporting group title
    Poliorix Group
    Reporting group description
    		 Subjects previously primed with 3 doses of Poliorix Vaccine in the primary study and who received a booster dose of Poliorix Vaccine co-administered with Infanrix-Hib vaccine in the current study.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects previously primed with 3 doses of Chinese OPV vaccine in the primary study and who received a dose of Infanrix-Hib vaccine in the current study.

    Primary: Number of subjects seroprotected for poliovirus types 1, 2 and 3 antibodies above the cut-off value.

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    End point title
    		 Number of subjects seroprotected for poliovirus types 1, 2 and 3 antibodies above the cut-off value. [1] [2]
    End point description
    A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.
    End point type
    Primary
    End point timeframe
    One month after Poliorix booster vaccination.
    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 primary end point was descriptive, no statistical hypothesis test was performed.
    [2] - 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 concerns subjects in the Poliorix Group only.
    End point values
    		 Poliorix Group
    Number of subjects analysed
    456
    Units: Subjects
        Anti-poliovirus 1
    456
        Anti-poliovirus 2
    456
        Anti-poliovirus 3
    456
    No statistical analyses for this end point

    Primary: Number of subjects seroprotected for poliovirus types 1, 2 and 3 antibodies above the cut-off value.

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    End point title
    		 Number of subjects seroprotected for poliovirus types 1, 2 and 3 antibodies above the cut-off value. [3]
    End point description
    A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
    End point type
    Primary
    End point timeframe
    Before booster vaccination.
    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 primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Poliorix Group Control Group
    Number of subjects analysed
    470
    484
    Units: Subjects
        Anti-poliovirus 1
    462
    479
        Anti-poliovirus 2
    445
    482
        Anti-poliovirus 3
    446
    465
    No statistical analyses for this end point

    Primary: Antibody titres against poliovirus type 1, 2 and 3.

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    End point title
    		 Antibody titres against poliovirus type 1, 2 and 3. [4] [5]
    End point description
    Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.
    End point type
    Primary
    End point timeframe
    One month after Poliorix booster vaccination.
    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 primary end point was descriptive, no statistical hypothesis test was performed.
    [5] - 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 concerns subjects in the Poliorix Group only.
    End point values
    		 Poliorix Group
    Number of subjects analysed
    456
    Units: Titres
    geometric mean (confidence interval 95%)
        Anti-poliovirus 1
    3420.8 (3153.8 to 3710.5)
        Anti-poliovirus 2
    1886.8 (1732.7 to 2054.5)
        Anti-poliovirus 3
    5097 (4706.8 to 5519.6)
    No statistical analyses for this end point

    Primary: Antibody titres against poliovirus type 1, 2 and 3.

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    End point title
    		 Antibody titres against poliovirus type 1, 2 and 3. [6]
    End point description
    Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
    End point type
    Primary
    End point timeframe
    Before booster vaccination.
    Notes
    [6] - 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 primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Poliorix Group Control Group
    Number of subjects analysed
    470
    484
    Units: Titres
    geometric mean (confidence interval 95%)
        Anti-poliovirus 1
    97.6 (87.3 to 109.2)
    533.0 (468.0 to 607.0)
        Anti-poliovirus 2
    87.8 (75.4 to 102.2)
    205.5 (185.6 to 227.5)
        Anti-poliovirus 3
    109.7 (94.2 to 127.8)
    85.0 (76.1 to 95.0)
    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. [7]
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects in the Poliorix Group only.
    End point type
    Secondary
    End point timeframe
    Within 4-days (Days 0-3) post Poliorix booster vaccination.
    Notes
    [7] - 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 concerns subjects in the Poliorix Group only.
    End point values
    		 Poliorix Group
    Number of subjects analysed
    467
    Units: Subjects
        Any Pain
    49
        Grade 3 Pain
    3
        Any Redness
    22
        Grade 3 Redness
    0
        Any Swelling
    11
        Grade 3 Swelling
    0
    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. [8]
    End point description
    Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever [defined as axillary temperature ≥ 37.1 degrees Celsius (°C)]. Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 fever = fever (axillary temperature) >39.0°C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as causally related to the vaccination. This outcome measure concerns subjects in the Poliorix Group only.
    End point type
    Secondary
    End point timeframe
    Within 4-days (Days 0-3) post Poliorix booster vaccination.
    Notes
    [8] - 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 concerns subjects in the Poliorix Group only.
    End point values
    		 Poliorix Group
    Number of subjects analysed
    467
    Units: Subjects
        Any Drowsiness
    59
        Grade 3 Drowsiness
    1
        Related Drowsiness
    59
        Any Irritability
    86
        Grade 3 Irritability
    2
        Related Irritability
    84
        Any Loss of appetite
    84
        Grade 3 Loss of appetite
    1
        Related Loss of appetite
    83
        Any temperature
    156
        Grade 3 temperature
    8
        Related temperature
    153
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse event (AE).

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    End point title
    		 Number of subjects reporting any unsolicited adverse event (AE). [9]
    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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.
    End point type
    Secondary
    End point timeframe
    Within the 31-day follow-up period after the Poliorix booster vaccination.
    Notes
    [9] - 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 concerns subjects in the Poliorix Group only.
    End point values
    		 Poliorix Group
    Number of subjects analysed
    470
    Units: Subjects
        Any AE(s)
    22
    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 resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to Month 1).
    End point values
    		 Poliorix Group Control Group
    Number of subjects analysed
    470
    487
    Units: Subjects
        Any SAE(s)
    0
    1
    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 4-day (Days 0-3) post-Poliorix booster vaccination period; Unsolicited symptoms: during 31-day (Days 0-30) post-Poliorix booster vaccination period. SAEs: during the entire study period (Day 0 to Month 1).
    Adverse event reporting additional description
    Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Poliorix Group
    Reporting group description
    		 Subjects previously primed with 3 doses of Poliorix Vaccine in the primary study and who received a booster dose of Poliorix Vaccine co-administered with Infanrix-Hib vaccine in the current study.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects previously primed with 3 doses of Chinese OPV vaccine in the primary study and who received a dose of Infanrix-Hib vaccine in the current study.

    Serious adverse events
    		 Poliorix Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 470 (0.00%)
    1 / 487 (0.21%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 470 (0.00%)
    1 / 487 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Poliorix Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    202 / 470 (42.98%)
    0 / 487 (0.00%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    49 / 470 (10.43%)
    0 / 487 (0.00%)
         occurrences all number
    49
    0
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    59 / 470 (12.55%)
    0 / 487 (0.00%)
         occurrences all number
    59
    0
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    86 / 470 (18.30%)
    0 / 487 (0.00%)
         occurrences all number
    86
    0
    Decreased appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    84 / 470 (17.87%)
    0 / 487 (0.00%)
         occurrences all number
    84
    0
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    157 / 470 (33.40%)
    0 / 487 (0.00%)
         occurrences all number
    158
    0

    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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