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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects with Chronic HCV

    Summary
    EudraCT number
    		 2014-001683-35
    Trial protocol
    		 DE   GB   IT   BE   FR  
    Global end of trial date
    23 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Oct 2016
    First version publication date
    07 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-342-1138
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02201940
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.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
    23 Sep 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jul 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 104
    Country: Number of subjects enrolled
    Belgium: 45
    Country: Number of subjects enrolled
    France: 158
    Country: Number of subjects enrolled
    Germany: 52
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Canada: 62
    Country: Number of subjects enrolled
    United States: 279
    Country: Number of subjects enrolled
    China: 23
    Worldwide total number of subjects
    741
    EEA total number of subjects
    377
    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)
    641
    From 65 to 84 years
    100
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States, Canada, Europe, and Asia. The first participant was screened on 18 July 2014. The last study visit occurred on 23 September 2015.

    Pre-assignment
    Screening details
    		 847 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOF/VEL
    Arm description
    		 SOF/VEL for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/velpatasvir
    Investigational medicinal product code
    Other name
    Epclusa®, GS-7977/GS-5816
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100 mg FDC tablet administered once daily

    Arm title
    		 Placebo
    Arm description
    		 SOF/VEL placebo for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administered once daily

    Number of subjects in period 1 [1]
    		SOF/VEL Placebo
    Started
    624
    116
    Completed
    613
    0
    Not completed
    11
    116
         Withdrew Consent
    2
    1
         Adverse event, non-fatal
    -
    1
         Death
    1
    -
         Investigator's Discretion
    1
    1
         Lost to follow-up
    5
    -
         Lack of efficacy
    2
    113
    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: 1 participant who was enrolled but not treated is not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    		 SOF/VEL for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 SOF/VEL placebo for 12 weeks

    Reporting group values
    		 SOF/VEL Placebo Total
    Number of subjects
    		 624 116 740
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54 ( 10.9 ) 53 ( 10.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 250 48 298
        Male
    		 374 68 442
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 31 5 36
        Not Hispanic or Latino
    		 589 111 700
        Not Disclosed
    		 4 0 4
    Race
    Units: Subjects
        Black or African American
    		 52 12 64
        White
    		 493 89 582
        Asian
    		 62 11 73
        American Indian/ Alaska Native
    		 7 0 7
        Hawaiian or Pacific Islander
    		 1 1 2
        Other
    		 6 3 9
        Not Disclosed
    		 3 0 3
    HCV Genotype
    Units: Subjects
        Genotype 1
    		 328 65 393
        Genotype 2
    		 104 21 125
        Genotype 4
    		 116 22 138
        Genotype 5
    		 35 0 35
        Genotype 6
    		 41 8 49
    IL28b Status
    CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 186 36 222
        CT
    		 339 53 392
        TT
    		 94 26 120
        Missing
    		 5 1 6
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 163 29 192
        ≥ 800,000 IU/mL
    		 461 87 548
    Cirrhosis Status
    Units: Subjects
        Present
    		 121 21 142
        Absent
    		 501 95 596
        Missing
    		 2 0 2
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.3 ( 0.66 ) 6.3 ( 0.58 ) -

    End points

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    End points reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    		 SOF/VEL for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 SOF/VEL placebo for 12 weeks

    Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Posttreatment Week 12
    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: Statistical analysis was performed against a performance goal of 85% and not between the treatment groups.
    End point values
    		 SOF/VEL Placebo
    Number of subjects analysed
    624
    116
    Units: percentage of participants
        number (confidence interval 95%)
    99 (97.9 to 99.6)
    0 (0 to 3.1)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [2]
    End point description
    Safety Analysis Set: participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 12 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 SOF/VEL Placebo
    Number of subjects analysed
    624
    116
    Units: percentage of participants
        number (not applicable)
    0.2
    1.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

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    End point title
    		 Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 SOF/VEL Placebo
    Number of subjects analysed
    624
    116
    Units: percentage of participants
    number (confidence interval 95%)
        SVR4
    99.2 (98.1 to 99.7)
    0 (0 to 3.1)
        SVR24
    99 (97.9 to 99.6)
    0 (0 to 3.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 6, 8, 10, and 12
    End point values
    		 SOF/VEL Placebo
    Number of subjects analysed
    624
    116
    Units: percentage of participants
    number (confidence interval 95%)
        Week 1 (SOF/VEL: N = 624; Placebo: N = 116)
    18.8 (15.8 to 22)
    0 (0 to 3.1)
        Week 2 (SOF/VEL: N = 624; Placebo: N = 116)
    56.9 (52.9 to 60.8)
    0 (0 to 3.1)
        Week 4 (SOF/VEL: N = 623; Placebo: N = 116)
    90.5 (88 to 92.7)
    0 (0 to 3.1)
        Week 6 (SOF/VEL: N = 623; Placebo: N = 115)
    98.9 (97.7 to 99.5)
    0 (0 to 3.2)
        Week 8 (SOF/VEL: N = 622; Placebo: N = 114)
    99.7 (98.8 to 100)
    0 (0 to 3.2)
        Week 10 (SOF/VEL: N = 622; Placebo: N = 114)
    100 (99.4 to 100)
    0 (0 to 3.2)
        Week 12 (SOF/VEL: N = 622; Placebo: N = 113)
    100 (99.4 to 100)
    0 (0 to 3.2)
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12

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    End point title
    		 Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12
    End point values
    		 SOF/VEL Placebo
    Number of subjects analysed
    624
    116
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Wk 1 (SOF/VEL: N= 617; Placebo: N= 114)
    -4.29 ( 0.647 )
    -0.05 ( 0.561 )
        Change at Wk 2 (SOF/VEL: N= 622; Placebo: N= 116)
    -4.82 ( 0.685 )
    0.01 ( 0.28 )
        Change at Wk 4 (SOF/VEL: N= 617; Placebo: N= 114)
    -5.08 ( 0.656 )
    -0.01 ( 0.297 )
        Change at Wk 6 (SOF/VEL: N= 623; Placebo: N= 115)
    -5.11 ( 0.664 )
    0.07 ( 0.298 )
        Change at Wk 8 (SOF/VEL: N= 622; Placebo: N= 113)
    -5.11 ( 0.664 )
    0.05 ( 0.281 )
        Change at Wk 10 (SOF/VEL: N= 622; Placebo: N= 112)
    -5.12 ( 0.662 )
    0.05 ( 0.337 )
        Change at Wk 12 (SOF/VEL: N= 622; Placebo: N= 111)
    -5.12 ( 0.662 )
    -0.06 ( 0.58 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virologic Failure

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    End point title
    		 Percentage of Participants With Virologic Failure
    End point description
    Virologic failure was defined as: 1) On-treatment virologic failure: • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), OR 2) Virologic relapse: • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last ontreatment visit. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 SOF/VEL Placebo
    Number of subjects analysed
    624
    116
    Units: percentage of participants
        number (not applicable)
    0.3
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 weeks plus 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    		 SOF/VEL for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 SOF/VEL placebo for 12 weeks

    Serious adverse events
    		 SOF/VEL Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 624 (2.40%)
    0 / 116 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Extremity necrosis
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Mania
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 624 (0.16%)
    0 / 116 (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
    		 SOF/VEL Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    393 / 624 (62.98%)
    77 / 116 (66.38%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    182 / 624 (29.17%)
    33 / 116 (28.45%)
         occurrences all number
    236
    39
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    127 / 624 (20.35%)
    24 / 116 (20.69%)
         occurrences all number
    132
    26
    Asthenia
         subjects affected / exposed
    42 / 624 (6.73%)
    9 / 116 (7.76%)
         occurrences all number
    46
    9
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    75 / 624 (12.02%)
    13 / 116 (11.21%)
         occurrences all number
    80
    14
    Diarrhoea
         subjects affected / exposed
    48 / 624 (7.69%)
    8 / 116 (6.90%)
         occurrences all number
    53
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    39 / 624 (6.25%)
    4 / 116 (3.45%)
         occurrences all number
    41
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    50 / 624 (8.01%)
    11 / 116 (9.48%)
         occurrences all number
    51
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    40 / 624 (6.41%)
    9 / 116 (7.76%)
         occurrences all number
    41
    11
    Back pain
         subjects affected / exposed
    29 / 624 (4.65%)
    11 / 116 (9.48%)
         occurrences all number
    29
    12
    Myalgia
         subjects affected / exposed
    25 / 624 (4.01%)
    6 / 116 (5.17%)
         occurrences all number
    27
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    80 / 624 (12.82%)
    12 / 116 (10.34%)
         occurrences all number
    87
    14

    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.
    There were no limitations affecting the analysis or results.
    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.

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