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    Clinical Trial Results:
    A phase II, observer-blind follow-up study with two groups to assess the reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine (GSK1024850A), when either given as a booster dose (at 20-23 months of age) in children previously primed with three doses of the study vaccine, or when given as a two-dose catch-up immunization (at 18-21 and 20-23 months of age) in unprimed children, all previously enrolled in the 10PN-PD-DIT-005 primary vaccination study.

    Summary
    EudraCT number
    		 2015-001449-93
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Aug 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Apr 2021
    First version publication date
    29 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections in safety section.

    Trial information

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    Trial identification
    Sponsor protocol code
    110031
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00513409
    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
    16 Feb 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the reactogenicity of study vaccines in terms of the occurrence of adverse events with intensity grade 3
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Aug 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Chile: 163
    Worldwide total number of subjects
    163
    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)
    163
    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
    		 The study included an active phase, from Month 0 to Month 3, aka one month post Dose 2 of vaccine, followed by an extended safety follow-up phase of 5 months.

    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 Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Investigator, Data analyst [2]
    Blinding implementation details
    This study was conducted in an observer-blind fashion. A different person than that who performed immunogenicity & safety assessments administered study vaccines. The person responsible for preparing and administering vaccine did not have access to safety & reactogenicity information of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix Booster Group
    Arm description
    		 Subjectsin this group had been previously primed with Synflorix™ and Infanrix™ hexa as part of the 10PN-PD-DIT-005 primary vaccination study, received in this study one dose of Havrix™ co-administered with one dose of Infanrix™ hexa at Month 0 (Dose 1) and one dose of Synflorix™ at Month 2 (Dose 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    10Pn-PD-DiT
    Other name
    10Pn, Synforix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection Intramuscular injection, administered in the right thigh or deltoid region.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    DTPa-HBV-IPV/Hib
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection administered in the left thigh or deltoid region

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    HAV 720
    Other name
    HAV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection administered in the right thigh or deltoid region

    Arm title
    		 Synflorix Catch-up Group
    Arm description
    		 Subjects in this group were subjects previously primed with Havrix™ and Infanrix™ hexa co-administered with Infanrix™ hexa as part of 10PN-PD-DIT-005 primary vaccination study and who received in this study a catch-up dose of Synflorix™ co-administered with Infanrix™ hexa at Month 0 (Dose 1) and one booster dose of Synflorix™ at Month 2 (Dose 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent pneumococcal conjugate vaccine
    Investigational medicinal product code
    10Pn-PD-DiT
    Other name
    10Pn, Synforix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two intramuscular injections administered in the right thigh or deltoid region

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    DTPa-HBV-IPV/Hib
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One intramuscular injection administered in the left thigh or deltoid region

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: This study was conducted in an observer-blind fashion. A different person than that who performed immunogenicity & safety assessments administered study vaccines. The person responsible for preparing and administering vaccine did not have access to safety & reactogenicity information of the study.
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This study was conducted in an observer-blind fashion. A different person than that who performed immunogenicity & safety assessments administered study vaccines. The person responsible for preparing and administering vaccine did not have access to safety & reactogenicity information of the study.
    Number of subjects in period 1
    		Synflorix Booster Group Synflorix Catch-up Group
    Started
    84
    79
    Completed
    82
    73
    Not completed
    2
    6
         Consent withdrawn by subject
    -
    2
         Physician Decision
    1
    -
         Adverse event, non-fatal
    -
    1
         Month 3 (Visit 3) not done
    -
    2
         Lost to follow-up
    -
    1
         Visit 3 not done
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix Booster Group
    Reporting group description
    		 Subjectsin this group had been previously primed with Synflorix™ and Infanrix™ hexa as part of the 10PN-PD-DIT-005 primary vaccination study, received in this study one dose of Havrix™ co-administered with one dose of Infanrix™ hexa at Month 0 (Dose 1) and one dose of Synflorix™ at Month 2 (Dose 2).

    Reporting group title
    Synflorix Catch-up Group
    Reporting group description
    		 Subjects in this group were subjects previously primed with Havrix™ and Infanrix™ hexa co-administered with Infanrix™ hexa as part of 10PN-PD-DIT-005 primary vaccination study and who received in this study a catch-up dose of Synflorix™ co-administered with Infanrix™ hexa at Month 0 (Dose 1) and one booster dose of Synflorix™ at Month 2 (Dose 2).

    Reporting group values
    		 Synflorix Booster Group Synflorix Catch-up Group Total
    Number of subjects
    		 84 79 163
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 84 79 163
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 18.3 ( 0.44 ) 18.3 ( 0.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 39 44 83
        Male
    		 45 35 80

    End points

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    End points reporting groups
    Reporting group title
    Synflorix Booster Group
    Reporting group description
    		 Subjectsin this group had been previously primed with Synflorix™ and Infanrix™ hexa as part of the 10PN-PD-DIT-005 primary vaccination study, received in this study one dose of Havrix™ co-administered with one dose of Infanrix™ hexa at Month 0 (Dose 1) and one dose of Synflorix™ at Month 2 (Dose 2).

    Reporting group title
    Synflorix Catch-up Group
    Reporting group description
    		 Subjects in this group were subjects previously primed with Havrix™ and Infanrix™ hexa co-administered with Infanrix™ hexa as part of 10PN-PD-DIT-005 primary vaccination study and who received in this study a catch-up dose of Synflorix™ co-administered with Infanrix™ hexa at Month 0 (Dose 1) and one booster dose of Synflorix™ at Month 2 (Dose 2).

    Primary: Number of subjects reporting grade 3 symptoms (solicited and unsolicited)

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    End point title
    		 Number of subjects reporting grade 3 symptoms (solicited and unsolicited) [1]
    End point description
    Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
    End point type
    Primary
    End point timeframe
    Within 4 days after the administration of any study 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
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    84
    78
    Units: Subjects
        Any symptoms
    32
    36
        General symptoms
    6
    14
        Local symptoms
    30
    32
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms

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    End point title
    		 Number of subjects reporting solicited local symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling
    End point type
    Secondary
    End point timeframe
    Within 4 days after the administration of any study vaccine dose
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    84
    78
    Units: Subjects
        Pain
    57
    63
        Redness
    49
    52
        Swelling
    44
    47
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general symptoms

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    End point title
    		 Number of subjects reporting solicited general symptoms
    End point description
    Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as rectal temperature ≥ 38 degrees Celsius.
    End point type
    Secondary
    End point timeframe
    Within 4 days after the administration of any study vaccine dose
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    84
    78
    Units: Subjects
        Drowsiness
    33
    36
        Fever
    30
    40
        Irritability
    56
    55
        Loss of appetite
    35
    37
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AEs)
    End point description
    An Adverse Event is 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.
    End point type
    Secondary
    End point timeframe
    Within 31 days after the administration of any study vaccine dose
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    84
    79
    Units: Subjects
        Unsolicited AEs
    47
    47
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAEs) during the active phase of the study

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs) during the active phase of the study
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Throughout the active phase of the study, from Month 0 to Month 3 (Month 0/Dose 1 administration up to 1 month after the Dose 2 of vaccine)
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    84
    79
    Units: Subjects
        SAEs
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAEs) throughout the entire study period

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs) throughout the entire study period
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    84
    79
    Units: Subjects
        SAEs
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine pneumococcal serotype antibody concentrations above the cut-off value

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    End point title
    		 Number of subjects with vaccine pneumococcal serotype antibody concentrations above the cut-off value
    End point description
    Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
    End point type
    Secondary
    End point timeframe
    Before (pre) and at Month 3, or one month after the administration of Dose 2 (post)
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    80
    73
    Units: Subjects
        Anti-1 Pre (N=79; 72)
    43
    1
        Anti-1 Post (N=78; 70)
    78
    70
        Anti-4 Pre (N=75; 73)
    45
    3
        Anti-4 Post (N=77; 70)
    77
    70
        Anti-5 Pre (N=76; 70)
    58
    7
        Anti-5 Post (N=78; 70)
    77
    70
        Anti-6A Pre (N=76; 72)
    66
    36
        Anti-6A Post (N=77; 70)
    71
    64
        Anti-6B Pre (N=76; 73)
    55
    1
        Anti-6B Post (N=78; 70)
    76
    59
        Anti-7F Pre (N=70; 68)
    60
    8
        Anti-7F Post (N=78; 70)
    77
    70
        Anti-9V Pre (N=78; 72)
    71
    6
        Anti-9V Post (N=79; 70)
    79
    69
        Anti-14 Pre (N=76; 71)
    69
    20
        Anti-14 Post (N=79; 70)
    79
    70
        Anti-18C Pre (N=77; 73)
    68
    5
        Anti-18C Post (N=78; 70)
    78
    70
        Anti-19A Pre (N=78; 73)
    72
    50
        Anti-19A Post (N=78; 70)
    78
    70
        Anti-19F Pre (N=80; 72)
    76
    19
        Anti-19F Post (N=78; 70)
    78
    70
        Anti-23F Pre (N=76; 71)
    59
    3
        Anti-23F Post (N=78; 70)
    78
    66
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes above the cut-off value

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    End point title
    		 Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes above the cut-off value
    End point description
    Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8 The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
    End point type
    Secondary
    End point timeframe
    Before (pre) and at Month 3, or one month after the administration of Dose 2 (post)
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    29
    28
    Units: Subjects
        Opsono-1 Pre (N=28; 25)
    12
    1
        Opsono-1 Post (N=25; 25)
    25
    13
        Opsono-4 Pre (N=17; 19)
    7
    1
        Opsono-4 Post (N=24; 18)
    24
    18
        Opsono-5 Pre (N=19; 23)
    13
    1
        Opsono-5 Post (N=20; 25)
    20
    21
        Opsono-6A Pre (N=20; 25)
    12
    2
        Opsono-6A Post (N=19; 19)
    14
    12
        Opsono-6B Pre (N=22; 25)
    12
    3
        Opsono-6B Post (N=24; 27)
    22
    13
        Opsono-7F Pre (N=17; 12)
    16
    4
        Opsono-7F Post (N=25; 26)
    25
    26
        Opsono-9V Pre (N=20; 17)
    20
    11
        Opsono-9V Post (N=23; 23)
    23
    22
        Opsono-14 Pre (N=16; 11)
    14
    5
        Opsono-14 Post (N=21; 25)
    21
    25
        Opsono-18C Pre (N=29; 28)
    12
    3
        Opsono-18C Post (N=26; 27)
    25
    27
        Opsono-19A Pre (N=18; 18)
    0
    0
        Opsono-19A Post (N=23; 19)
    14
    5
        Opsono-19F Pre (N=22; 23)
    17
    2
        Opsono-19F Post (N=20; 21)
    20
    20
        Opsono-23F Pre (N=21; 16)
    18
    8
        Opsono-23F Post (N=25; 25)
    25
    25
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-protein D antibody concentrations above the cut-off value

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    End point title
    		 Number of subjects with anti-protein D antibody concentrations above the cut-off value
    End point description
    Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Before (pre) and at Month 3, or one month after the administration of Dose 2 (post)
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    77
    70
    Units: Subjects
        Pre (N= 73; 69)
    72
    44
        Post (N= 77; 70)
    77
    70
    No statistical analyses for this end point

    Secondary: Anti-hepatitis A virus antibodies concentration

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    End point title
    		 Anti-hepatitis A virus antibodies concentration
    End point description
    Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Before (pre) and at Month 3, or one month after the administration of Dose 2 (post)
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    19
    21
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Pre (N=18; 21)
    30.3 (16.3 to 56.3)
    539.9 (231 to 1261.9)
        Post (N=19; 19)
    495.5 (228 to 1076.7)
    478.5 (199.4 to 1148.2)
    No statistical analyses for this end point

    Secondary: Number of subjects With Anti-hepatitis A antibody concentrations above the cut-off value

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    End point title
    		 Number of subjects With Anti-hepatitis A antibody concentrations above the cut-off value
    End point description
    Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Before (pre) and at Month 3, or one month after the administration of Dose 2 (post)
    End point values
    		 Synflorix Booster Group Synflorix Catch-up Group
    Number of subjects analysed
    19
    21
    Units: Subjects
        Pre (N=18; 21)
    12
    21
        Post (N=19; 19)
    18
    19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms and unsolicited : 4-day (Days 0-3) and 31-day (Days 0-30) follow-up periods post vaccination(s), across doses, erspectively. SAEs : Month 0 to Month 8
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Synflorix booster group
    Reporting group description
    		 Subjectsin this group had been previously primed with Synflorix™ as part of the 10PN-PD-DIT-005 primary vaccination study, received in this study one dose of Havrix™ co-administered with one dose of Infanrix™ hexa at Month 0 (Dose 1) and one dose of Synflorix™ at Month 2 (Dose 2).

    Reporting group title
    Synflorix catch-up group
    Reporting group description
    		 Subjects in this group were subjects previously primed with Havrix™ co-administered with Infanrix™ hexa as part of 10PN-PD-DIT-005 primary vaccination study and who received in this study a catch-up dose of Synflorix™ co-administered with Infanrix™ hexa at Month 0 (Dose 1) and one booster dose of Synflorix™ at Month 2 (Dose 2)

    Serious adverse events
    		 Synflorix booster group Synflorix catch-up group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 79 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synflorix booster group Synflorix catch-up group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 84 (92.86%)
    75 / 79 (94.94%)
    General disorders and administration site conditions
    Injection site induration
         subjects affected / exposed
    7 / 84 (8.33%)
    7 / 79 (8.86%)
         occurrences all number
    7
    7
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    57 / 84 (67.86%)
    63 / 79 (79.75%)
         occurrences all number
    57
    63
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    49 / 84 (58.33%)
    52 / 79 (65.82%)
         occurrences all number
    49
    52
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    44 / 84 (52.38%)
    47 / 79 (59.49%)
         occurrences all number
    44
    47
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    33 / 84 (39.29%)
    36 / 79 (45.57%)
         occurrences all number
    33
    36
    Fever (Rectally)
    alternative assessment type: Systematic
         subjects affected / exposed
    30 / 84 (35.71%)
    40 / 79 (50.63%)
         occurrences all number
    30
    40
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    56 / 84 (66.67%)
    55 / 79 (69.62%)
         occurrences all number
    56
    55
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    35 / 84 (41.67%)
    37 / 79 (46.84%)
         occurrences all number
    35
    37
    Pyrexia
         subjects affected / exposed
    4 / 84 (4.76%)
    5 / 79 (6.33%)
         occurrences all number
    4
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 84 (7.14%)
    8 / 79 (10.13%)
         occurrences all number
    6
    8
    Vomiting
         subjects affected / exposed
    5 / 84 (5.95%)
    2 / 79 (2.53%)
         occurrences all number
    5
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    15 / 84 (17.86%)
    16 / 79 (20.25%)
         occurrences all number
    15
    16
    Nasopharyngitis
         subjects affected / exposed
    6 / 84 (7.14%)
    14 / 79 (17.72%)
         occurrences all number
    6
    14
    Rhinitis
         subjects affected / exposed
    5 / 84 (5.95%)
    4 / 79 (5.06%)
         occurrences all number
    5
    4
    Pharyngitis
         subjects affected / exposed
    6 / 84 (7.14%)
    8 / 79 (10.13%)
         occurrences all number
    6
    8

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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