Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomised, open-label study to assess the immunogenicity and reactogenicity 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
    		 v1
    This version publication date
    08 Apr 2016
    First version publication date
    01 Jul 2015
    Other versions
    		 v2 , v3

    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
    05 Jul 2010
    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

    		 Close Top of page
    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
    		 IPV Group
    Arm description
    		 Subjects received 3 doses of IPV vaccine at 2, 3 and 4 months of age.
    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
    		 Subjects received 3 doses of OPV vaccine at 2, 3 and 4 months of age.
    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]
    		IPV 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

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    IPV Group
    Reporting group description
    		 Subjects received 3 doses of IPV vaccine at 2, 3 and 4 months of age.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received 3 doses of OPV vaccine at 2, 3 and 4 months of age.

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

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    IPV Group
    Reporting group description
    		 Subjects received 3 doses of IPV vaccine at 2, 3 and 4 months of age.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received 3 doses of OPV vaccine at 2, 3 and 4 months of age.

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

    		 Close Top of page
    End point title
    		 Number of seroprotected subjects against anti-poliovirus types 1, 2 and 3
    End point description
    End point type
    Primary
    End point timeframe
    One month after the third dose of primary vaccination (Month 3).
    End point values
    		 IPV 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 ≤ 10%.
    Comparison groups
    IPV 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 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
    IPV 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
    IPV 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 anti-poliovirus types 1, 2 and 3

    		 Close Top of page
    End point title
    		 Number of seroprotected subjects against anti-poliovirus types 1, 2 and 3
    End point description
    A seroprotected subject was defined as a subject whose antibody titre was ≥ 8 ED50.
    End point type
    Secondary
    End point timeframe
    Prior to the first dose of primary vaccination (Day 0)
    End point values
    		 IPV 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: Antibody titres against each of the three poliovirus types

    		 Close Top of page
    End point title
    		 Antibody titres against each of the three poliovirus types
    End point description
    Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs. The three virus types were poliovirus types 1, 2 and 3
    End point type
    Secondary
    End point timeframe
    Prior to the first dose and one month after the third dose of primary vaccination (Day 0 and Month 3)
    End point values
    		 IPV 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 reporting any and grade 3 solicited local symptoms

    		 Close Top of page
    End point title
    		 Number of subjects reporting 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 (Day 0–3) follow-up period following each dose of the study vaccines
    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 outcome measure concerns subjects from the IPV Group only.
    End point values
    		 IPV Group
    Number of subjects analysed
    550
    Units: Subjects
        Any Pain; Dose 1
    80
        Grade 3 Pain; Dose 1
    1
        Any Redness; Dose 1
    20
        Grade 3 Redness; Dose 1
    0
        Any Swelling; Dose 1
    9
        Grade 3 Swelling; Dose 1
    0
        Any Pain; Dose 2
    58
        Grade 3 Pain; Dose 2
    2
        Any Redness; Dose 2
    23
        Grade 3 Redness; Dose 2
    1
        Any Swelling; Dose 2
    8
        Grade 3 Swelling; Dose 2
    1
        Any Pain; Dose 3
    41
        Grade 3 Pain; Dose 3
    0
        Any Redness; Dose 3
    15
        Grade 3 Redness; Dose 3
    0
        Any Swelling; Dose 3
    6
        Grade 3 Swelling; Dose 3
    0
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting 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. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. 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. Related = symptom assessed by the investigator as causally related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0–3) follow-up period following each dose of the study vaccines
    End point values
    		 IPV Group Control Group
    Number of subjects analysed
    550
    550
    Units: Subjects
        Any Drowsiness; Dose 1
    99
    75
        Grade 3 Drowsiness; Dose 1
    0
    1
        Related Drowsiness; Dose 1
    71
    51
        Any Gastrointestinal Symptoms; Dose 1
    102
    89
        Grade 3 Gastrointestinal Symptoms, Dose 1
    0
    2
        Related Gastrointestinal Symptoms; Dose 1
    44
    43
        Any Irritability/Fussiness; Dose 1
    160
    151
        Grade 3 Irritability/Fussiness; Dose 1
    1
    5
        Related Irritability/Fussiness; Dose 1
    130
    105
        Any Loss of appetite; Dose 1
    82
    83
        Grade 3 Loss of appetite; Dose 1
    0
    1
        Related Loss of appetite; Dose 1
    54
    47
        Any temperature; Dose 1
    39
    20
        Grade 3 temperature; Dose 1
    0
    0
        Related temperature; Dose 1
    28
    10
        Any Drowsiness; Dose 2
    68
    50
        Grade 3 Drowsiness; Dose 2
    2
    0
        Related Drowsiness; Dose 2
    51
    25
        Any Gastrointestinal Symptoms; Dose 2
    66
    67
        Grade 3 Gastrointestinal Symptoms, Dose 2
    2
    1
        Related Gastrointestinal Symptoms; Dose 2
    32
    35
        Any Irritability/Fussiness; Dose 2
    121
    86
        Grade 3 Irritability/Fussiness; Dose 2
    7
    2
        Related Irritability/Fussiness; Dose 2
    105
    50
        Any Loss of appetite; Dose 2
    70
    78
        Grade 3 Loss of appetite; Dose 2
    3
    0
        Related Loss of appetite; Dose 2
    48
    47
        Any temperature; Dose 2
    39
    26
        Grade 3 temperature; Dose 2
    2
    1
        Related temperature; Dose 2
    29
    11
        Any Drowsiness; Dose 3
    47
    45
        Grade 3 Drowsiness; Dose 3
    2
    1
        Related Drowsiness; Dose 3
    36
    25
        Any Gastrointestinal Symptoms; Dose 3
    46
    67
        Grade 3 Gastrointestinal Symptoms, Dose 3
    3
    0
        Related Gastrointestinal Symptoms; Dose 3
    16
    25
        Any Irritability/Fussiness; Dose 3
    87
    72
        Grade 3 Irritability/Fussiness; Dose 3
    2
    2
        Related Irritability/Fussiness; Dose 3
    77
    44
        Any Loss of appetite; Dose 3
    52
    64
        Grade 3 Loss of appetite; Dose 3
    0
    0
        Related Loss of appetite; Dose 3
    34
    36
        Any temperature; Dose 3
    33
    32
        Grade 3 temperature; Dose 3
    0
    2
        Related temperature; Dose 3
    18
    17
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse event

    		 Close Top of page
    End point title
    		 Number of subjects reporting any unsolicited adverse event
    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. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    Within the 31-day follow-up period following each dose of the study vaccines
    End point values
    		 IPV 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)

    		 Close Top of page
    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
    		 IPV 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

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited local & general symptoms were collected during the 4-day post-vaccination period. Unsolicited AEs were collected within the 31-day follow-up period after each vaccine dose.SAEs were collected during the entire study period (Day 0 - Month 3)
    Adverse event reporting additional description
    The number of occurrences reported for 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
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    IPV Group
    Reporting group description
    		 Subjects received 3 doses of IPV vaccine at 2, 3 and 4 months of age.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received 3 doses of OPV vaccine at 2, 3 and 4 months of age.

    Serious adverse events
    		 IPV Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 550 (0.55%)
    6 / 550 (1.09%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Cardiac failure
    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
    Nervous system disorders
    Epilepsy
    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
    Hydrocephalus
    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
    Gastrointestinal disorders
    Abdominal distension
    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
    Diarrhoea
    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
    Enteritis
    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
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
    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
    Infections and infestations
    Bronchopneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 550 (0.00%)
    2 / 550 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    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
    Herpes zoster
    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
    Upper respiratory tract infection
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IPV Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    160 / 550 (29.09%)
    151 / 550 (27.45%)
    General disorders and administration site conditions
    Pain; Dose 1
         subjects affected / exposed
    80 / 550 (14.55%)
    0 / 550 (0.00%)
         occurrences all number
    80
    0
    Pain; Dose 2
         subjects affected / exposed [1]
    58 / 543 (10.68%)
    0 / 543 (0.00%)
         occurrences all number
    58
    0
    Pain; Dose 3
         subjects affected / exposed [2]
    41 / 540 (7.59%)
    0 / 540 (0.00%)
         occurrences all number
    41
    0
    Drowsiness; Dose 1
         subjects affected / exposed
    99 / 550 (18.00%)
    75 / 550 (13.64%)
         occurrences all number
    99
    75
    Gastrointestinal Symptoms; Dose 1
         subjects affected / exposed
    102 / 550 (18.55%)
    89 / 550 (16.18%)
         occurrences all number
    102
    89
    Irritability/Fussiness; Dose 1
         subjects affected / exposed
    160 / 550 (29.09%)
    151 / 550 (27.45%)
         occurrences all number
    160
    151
    Loss of appetite; Dose 1
         subjects affected / exposed
    82 / 550 (14.91%)
    83 / 550 (15.09%)
         occurrences all number
    82
    83
    Fever; Dose 1
         subjects affected / exposed
    39 / 550 (7.09%)
    20 / 550 (3.64%)
         occurrences all number
    39
    20
    Drowsiness; Dose 2
         subjects affected / exposed [3]
    68 / 543 (12.52%)
    50 / 544 (9.19%)
         occurrences all number
    68
    50
    Gastrointestinal Symptoms; Dose 2
         subjects affected / exposed [4]
    66 / 543 (12.15%)
    67 / 544 (12.32%)
         occurrences all number
    66
    67
    Irritability/Fussiness; Dose 2
         subjects affected / exposed [5]
    121 / 543 (22.28%)
    86 / 544 (15.81%)
         occurrences all number
    121
    86
    Loss of appetite; Dose 2
         subjects affected / exposed [6]
    70 / 543 (12.89%)
    78 / 544 (14.34%)
         occurrences all number
    70
    78
    Fever; Dose 2
         subjects affected / exposed [7]
    39 / 543 (7.18%)
    26 / 544 (4.78%)
         occurrences all number
    39
    26
    Drowsiness; Dose 3
         subjects affected / exposed [8]
    47 / 540 (8.70%)
    45 / 534 (8.43%)
         occurrences all number
    47
    45
    Gastrointestinal Symptoms; Dose 3
         subjects affected / exposed [9]
    46 / 540 (8.52%)
    67 / 534 (12.55%)
         occurrences all number
    46
    67
    Irritability/Fussiness; Dose 3
         subjects affected / exposed [10]
    87 / 540 (16.11%)
    72 / 534 (13.48%)
         occurrences all number
    87
    72
    Loss of appetite; Dose 3
         subjects affected / exposed [11]
    52 / 540 (9.63%)
    64 / 534 (11.99%)
         occurrences all number
    52
    64
    Fever; Dose 3
         subjects affected / exposed [12]
    33 / 540 (6.11%)
    32 / 534 (5.99%)
         occurrences all number
    33
    32
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    99 / 550 (18.00%)
    97 / 550 (17.64%)
         occurrences all number
    99
    97
    Nasopharyngitis
         subjects affected / exposed
    32 / 550 (5.82%)
    38 / 550 (6.91%)
         occurrences all number
    32
    38
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed).

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 05 04:33:08 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA