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    Clinical Trial Results:
    An Open Label Study of the Safety and Efficacy of PRX 102 in Patients with Fabry Disease Currently Treated With REPLAGAL® (Agalsidase alfa)

    Summary
    EudraCT number
    		 2016-001318-11
    Trial protocol
    		 GB   ES   CZ   DE   SI   NL  
    Global end of trial date
    17 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2021
    First version publication date
    04 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PB-102-F30
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03018730
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Protalix.Ltd.
    Sponsor organisation address
    2 Snunit Street, Carmiel , Israel, 2161401
    Public contact
    Raul Chertkoff, Protalix Ltd., +972 4-902-8100, raul@protalix.com
    Scientific contact
    Sari Alon, Protalix Ltd., +972 4-902-8100, sari@protalix.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of PRX-102 (Pegunigalsidase alfa) in patients with Fabry disease treated with agalsidase alfa
    Protection of trial subjects
    Premedication, if used for the agalsidase alfa infusions before enrolment, continued through the first infusion with pegunigalsidase alfa and then gradually tapered at the investigator’s discretion during the first 2 months. The first infusions of PRX-102 will be administered under controlled conditions at the investigation site. The patients received their infusions at a home care setup once the investigator and Sponsor Medical Director agreed that it is safe to do so. Throughout the duration of the study, the Investigator closely monitor each subject for evidence of drug intolerance and for the development of clinical or laboratory evidence of adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 May 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety, Ethical reason
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Slovenia: 1
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Czechia: 8
    Worldwide total number of subjects
    22
    EEA total number of subjects
    12
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients treated with agalsidase alfa for at least 2 years and on a stable dose (>80% labelled dose/kg) for at least 6 months. No more than 25% of treated patients will be female.

    Pre-assignment
    Screening details
    		 A total of 27 patients were screened and evaluated over 3 months while continuing on agalsidase alfa, of whom 22 patients (15 males and 7 females) were enrolled and treated with PRX-102, and 20 patients completed the study with 12 month of treatment.

    Pre-assignment period milestones
    Number of subjects started
    		 22
    Number of subjects completed
    		 22

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

    Arms
    Arm title
    		 pegunigalsidase alfa
    Arm description
    		 pegunigalsidase alfa 1mg/Kg every other week
    Arm type
    		 Experimental

    Investigational medicinal product name
    pegunigalsidase alfa
    Investigational medicinal product code
    Other name
    PRX-102
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    pegunigalsidase alfa individual dose for each patient was prepared according to the patient’s weight. pegunigalsidase alfa administrated at 1 mg/kg, intravenously over 3 hours, every 2 weeks. After the first 2 months of treatment with pegunigalsidase alfa, infusion time may be reduced gradually to 1.5 hours pending patient tolerability.

    Number of subjects in period 1
    		pegunigalsidase alfa
    Started
    22
    Completed
    20
    Not completed
    2
         Adverse event, non-fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 22 22
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.0 ( 11.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 15 15
    Presence of proteinuria (UPCR ≥0.5 g/g)
    Presence of proteinuria defined as subjects with urine protein to creatinine ratio ≥0.5 g/g
    Units: Subjects
        yes
    		 4 4
        no
    		 6 6
        Protein undetectable
    		 12 12
    Treatment with ACEi or ARBs
    Treatment with Angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
    Units: Subjects
        yes
    		 12 12
        no
    		 10 10
    Baseline UPCR
    Urine Protein to Creatinine Ratio, assessed by spot urine test, based on 4 categories: Protein Undetectable (PU); Normal to mildly increased (UPCR <0.15 g/g); Moderately increased (UPCR ≥0.15 g/g and ≤0.5 g/g); Severely increased (UPCR >0.5 g/g).
    Units: Subjects
        No protein detectable
    		 12 12
        Normal to mildly increased
    		 3 3
        Moderately increased
    		 3 3
        Severely increased
    		 4 4
    Age started Fabry therapy
    Age at the start of Fabry therapy
    Units: years
        arithmetic mean (standard deviation)
    		 34.8 ( 11.9 ) -
    Residual enzyme activity in leukocytes (%)
    The residual Alpha-galactosidase-A enzymatic activity in leukocytes is a percentage of the normal laboratory mean
    Units: percentage
        arithmetic mean (standard deviation)
    		 12.2 ( 12.5 ) -
    Baseline eGFR (mL/min/1.73 m^2)
    An estimate of glomerular filtration rate (eGFR) is a mathematically derived value based on a patient’s serum creatinine level, age, sex and race, which used to indicate the level of kidney function.
    Units: mL/min/1.73 m^2
        arithmetic mean (standard deviation)
    		 82.49 ( 23.38 ) -
    Baseline annualized eGFR slope (mL/min/1.73 m^2/year)
    Mean baseline annualized eGFR slope while on Replagal® (i.e., pre-switch to PRX-102 treatment)
    Units: mL/min/1.73 m^2/year
        arithmetic mean (standard deviation)
    		 -5.3 ( 6.3 ) -
    Baseline plasma Lyso-Gb3 (nmol/L)
    Baseline levels of Plasma Lyso-Gb3 (globotriaosylsphingosine)
    Units: nmol/L
        arithmetic mean (standard deviation)
    		 38.30 ( 41.22 ) -
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population consists of all subjects who received any dose of pegunigalsidase alfa (PRX-102) in the study.

    Subject analysis set title
    Efficacy population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The efficacy population (EP) consists of all subjects who have at least one visit with an efficacy evaluation after the first pegunigalsidase alfa (PRX-102) infusion.

    Subject analysis set title
    Male
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Male subjects from Safety population.

    Subject analysis set title
    Female
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female subjects from Safety population.

    Subject analysis sets values
    		 Safety population Efficacy population Male Female
    Number of subjects
    22
    20
    15
    7
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    22
    20
    15
    7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.0 ( 11.0 )
    45.8 ( 9.9 )
    42.7 ( 10.6 )
    46.7 ( 12.3 )
    Gender categorical
    Units: Subjects
        Female
    7
    7
    0
    7
        Male
    15
    13
    15
    0
    Presence of proteinuria (UPCR ≥0.5 g/g)
    Presence of proteinuria defined as subjects with urine protein to creatinine ratio ≥0.5 g/g
    Units: Subjects
        yes
    4
    4
    4
    0
        no
    6
    6
    3
    3
        Protein undetectable
    12
    10
    8
    4
    Treatment with ACEi or ARBs
    Treatment with Angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
    Units: Subjects
        yes
    12
    11
    8
    4
        no
    10
    9
    7
    3
    Baseline UPCR
    Urine Protein to Creatinine Ratio, assessed by spot urine test, based on 4 categories: Protein Undetectable (PU); Normal to mildly increased (UPCR <0.15 g/g); Moderately increased (UPCR ≥0.15 g/g and ≤0.5 g/g); Severely increased (UPCR >0.5 g/g).
    Units: Subjects
        No protein detectable
    12
    10
    8
    4
        Normal to mildly increased
    3
    3
    2
    1
        Moderately increased
    3
    3
    1
    2
        Severely increased
    4
    4
    4
    0
    Age started Fabry therapy
    Age at the start of Fabry therapy
    Units: years
        arithmetic mean (standard deviation)
    34.8 ( 11.9 )
    36.6 ( 10.7 )
    32.6 ( 11.8 )
    39.4 ( 11.6 )
    Residual enzyme activity in leukocytes (%)
    The residual Alpha-galactosidase-A enzymatic activity in leukocytes is a percentage of the normal laboratory mean
    Units: percentage
        arithmetic mean (standard deviation)
    12.2 ( 12.5 )
    13.1 ( 12.7 )
    4.8 ( 2.5 )
    27.9 ( 10.2 )
    Baseline eGFR (mL/min/1.73 m^2)
    An estimate of glomerular filtration rate (eGFR) is a mathematically derived value based on a patient’s serum creatinine level, age, sex and race, which used to indicate the level of kidney function.
    Units: mL/min/1.73 m^2
        arithmetic mean (standard deviation)
    82.49 ( 23.38 )
    79.46 ( 22.01 )
    80.78 ( 25.97 )
    86.14 ( 17.78 )
    Baseline annualized eGFR slope (mL/min/1.73 m^2/year)
    Mean baseline annualized eGFR slope while on Replagal® (i.e., pre-switch to PRX-102 treatment)
    Units: mL/min/1.73 m^2/year
        arithmetic mean (standard deviation)
    -5.27 ( 6.27 )
    -5.90 ( 5.99 )
    -5.38 ( 7.12 )
    -5.03 ( 4.37 )
    Baseline plasma Lyso-Gb3 (nmol/L)
    Baseline levels of Plasma Lyso-Gb3 (globotriaosylsphingosine)
    Units: nmol/L
        arithmetic mean (standard deviation)
    38.30 ( 41.22 )
    38.51 ( 43.31 )
    49.73 ( 45.75 )
    13.81 ( 6.11 )

    End points

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    End points reporting groups
    Reporting group title
    pegunigalsidase alfa
    Reporting group description
    		 pegunigalsidase alfa 1mg/Kg every other week

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population consists of all subjects who received any dose of pegunigalsidase alfa (PRX-102) in the study.

    Subject analysis set title
    Efficacy population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The efficacy population (EP) consists of all subjects who have at least one visit with an efficacy evaluation after the first pegunigalsidase alfa (PRX-102) infusion.

    Subject analysis set title
    Male
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Male subjects from Safety population.

    Subject analysis set title
    Female
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female subjects from Safety population.

    Primary: Number of participants experiencing adverse events (AEs)

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    End point title
    		 Number of participants experiencing adverse events (AEs) [1]
    End point description
    Results represent the number of treatment-emergent adverse events (TEAE) that were considered possibly, probably, or definitely related to treatment
    End point type
    Primary
    End point timeframe
    12 months
    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: No formal statistical analysis was specified for this study, the data was summarized using descriptive statistics.
    End point values
    		 Safety population
    Number of subjects analysed
    22
    Units: subjects
        At least 1 TEAE
    21
        At least 1 mild or moderate TEAE
    19
        At least 1 severe TEAE
    4
        At least 1 SAE
    4
        At least 1 TEAE unrelated or unlikely related
    19
        At least 1 TEAE related to study treatment
    5
        At least 1 SAE related to study treatment
    2
        At least 1 TEAE leading to discontinuation
    2
        At least 1 TEAE leading to death
    0
    No statistical analyses for this end point

    Other pre-specified: Annualized Estimated Glomerular Filtration Rate Slope

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    End point title
    		 Annualized Estimated Glomerular Filtration Rate Slope
    End point description
    The annualized change in eGFR (slope) per patient was estimated using a linear regression, between the baseline annualized eGFR slope pre-switch to PRX-102 treatment (while on Replagal®) to the annualized eGFR slope post-switch to PRX-102 treatment, using all available eGFR values collected in the timeframe. eGFR was calculated based on the serum creatinine values according to the CKD-EPI formula.
    End point type
    Other pre-specified
    End point timeframe
    12 months
    End point values
    		 Efficacy population Male Female
    Number of subjects analysed
    20
    13
    7
    Units: mL/min/1.73 m^2/year
    arithmetic mean (standard error)
        pre-switch
    -5.90 ( 1.34 )
    -6.36 ( 1.89 )
    -5.03 ( 1.65 )
        post-switch
    -1.19 ( 1.77 )
    -1.73 ( 2.64 )
    -0.21 ( 1.47 )
        Change in eGFR slope from pre- to post-switch
    4.70 ( 2.26 )
    4.63 ( 3.48 )
    4.83 ( 1.09 )
    No statistical analyses for this end point

    Other pre-specified: Estimated Glomerular Filtration Rate

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    End point title
    		 Estimated Glomerular Filtration Rate
    End point description
    eGFR was calculated based on the serum creatinine values according to the CKD-EPI formula. The absolute change in eGFR from baseline measurement at visit 1 to last measurement at Month 12 was summarized using descriptive statistics.
    End point type
    Other pre-specified
    End point timeframe
    12 Month
    End point values
    		 Efficacy population Male Female
    Number of subjects analysed
    20
    13
    7
    Units: mL/min/1.73 m^2
    arithmetic mean (standard error)
        Baseline eGFR
    79.46 ( 4.92 )
    75.87 ( 6.62 )
    86.14 ( 6.72 )
        Month 12 eGFR
    76.91 ( 5.22 )
    74.27 ( 7.15 )
    81.80 ( 7.09 )
        Change in eGFR from baseline to Month 12
    -2.56 ( 2.14 )
    -1.60 ( 2.76 )
    -4.34 ( 3.54 )
    No statistical analyses for this end point

    Other pre-specified: Left Ventricular Mass Index

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    End point title
    		 Left Ventricular Mass Index
    End point description
    Left ventricular mass was determined based on cardiac MRI data and the LVMI was indexed to patient’s body surface area (g/m^2). In male patients the normal range for LVMI was 57-91 g/m2, in female patients 47–77 g/m2.
    End point type
    Other pre-specified
    End point timeframe
    12 Month
    End point values
    		 Efficacy population Male Female
    Number of subjects analysed
    20
    13
    7
    Units: g/m^2
    arithmetic mean (standard error)
        Baseline
    86.9 ( 6.9 )
    97.6 ( 8.9 )
    66.9 ( 5.8 )
        Visit 27 (Week 52)
    89.4 ( 6.1 )
    98.3 ( 7.8 )
    74.1 ( 7.2 )
        Change from Baseline
    4.1 ( 2.8 )
    2.4 ( 3.4 )
    7.1 ( 5.0 )
    No statistical analyses for this end point

    Other pre-specified: Quality of life by EQ VAS

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    End point title
    		 Quality of life by EQ VAS
    End point description
    The EQ VAS, of the EQ 5D 5L questionnaire, records the subject’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score "100") and ‘Worst imaginable health state’ (score "0").
    End point type
    Other pre-specified
    End point timeframe
    12 months
    End point values
    		 Efficacy population Male Female
    Number of subjects analysed
    20
    13
    7
    Units: score
    arithmetic mean (standard error)
        Baseline
    71.8 ( 4.3 )
    66.8 ( 5.3 )
    81.1 ( 6.1 )
        Month 12
    76.9 ( 4.5 )
    71.5 ( 5.4 )
    86.7 ( 7.0 )
        Change from Baseline
    5.1 ( 3.3 )
    4.8 ( 4.9 )
    5.6 ( 3.0 )
    No statistical analyses for this end point

    Other pre-specified: Plasma Lyso-Gb3

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    End point title
    		 Plasma Lyso-Gb3
    End point description
    Lyso-Gb3 is Fabry disease specific biomarker that can assess treatment outcome.
    End point type
    Other pre-specified
    End point timeframe
    12 month
    End point values
    		 Efficacy population Male Female
    Number of subjects analysed
    20
    13
    7
    Units: nM
    arithmetic mean (standard error)
        Baseline
    38.51 ( 9.68 )
    51.81 ( 13.60 )
    13.81 ( 2.31 )
        Visit 27 (Week 52)
    24.20 ( 5.10 )
    32.25 ( 6.89 )
    9.24 ( 1.08 )
        Change from Baseline
    -14.31 ( 5.13 )
    -19.55 ( 7.55 )
    -4.57 ( 1.42 )
    No statistical analyses for this end point

    Other pre-specified: Urine Protein/Creatinine Ratio (UPCR)

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    End point title
    		 Urine Protein/Creatinine Ratio (UPCR)
    End point description
    Urine Protein to Creatinine Ratio (UPCR), assessed by spot urine test, at Visit 27 (Week 52).
    End point type
    Other pre-specified
    End point timeframe
    12 month
    End point values
    		 Efficacy population Male Female
    Number of subjects analysed
    20
    13
    7
    Units: subjects
        Protein Undetectable
    9
    7
    2
        Normal to Mildly increased
    4
    2
    2
        Moderately increased
    2
    0
    2
        Severely increased
    5
    4
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from the beginning of the treatment throughout the 12 months of the study, including a follow-up at the end of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 Analysis of AEs was performed on TEAEs, defined as any AE occurring after the start of the first infusion of study treatment.

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 22 (18.18%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Immune system disorders
    Type I hypersensitivity
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infectious mononucleosis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 22 (4.55%)
         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
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 22 (95.45%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Infusion related reaction
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Cardiac disorders
    Plapitations
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    5
    Dizziness
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Immune system disorders
    Type 1 hypersensitivity
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Gastrointestinal disorders
    Gastroesophageal reflux disease
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Toothache
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    Oropharyngeal pain
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Rash pruritic
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Erythema
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 22 (31.82%)
         occurrences all number
    9
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2

    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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