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    Clinical Trial Results:
    A Phase 3, Multicenter, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 18 Years in Taiwan.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-004973-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Jan 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Jun 2016
    First version publication date
    15 Mar 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    re-QC study because of EudraCT system glitch and updates to results are required.

    Trial information

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    Trial identification
    Sponsor protocol code
    V59_49
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01410474
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l
    Sponsor organisation address
    Via Fiorentina 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines , RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines , RegistryContactVaccinesUS@novartis.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
    21 Jan 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity of a single injection of MenACWY-CRM as measured by the percentage of subjects with Human Serum Bactericidal Assay (hSBA) seroresponse, directed against N meningitidis serogroups A, C, W135 and Y.
    Protection of trial subjects
    This trial was performed with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with GCP according to International Conference on Harmonisation (ICH) guidelines, the applicable regulatory requirements(s) for the country in which the study was conducted, and applicable standard operating procedures (SOPs).
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    15 Aug 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Taiwan: 341
    Worldwide total number of subjects
    341
    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)
    0
    Children (2-11 years)
    202
    Adolescents (12-17 years)
    128
    Adults (18-64 years)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at three study centers in Taiwan.

    Pre-assignment
    Screening details
    		 All enrolled subjects were included in the trial.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ACWY 2-10 Yrs
    Arm description
    		 Subjects 2-10 years of age received one MenACWY-CRM vaccination
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY-CRM
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5 mL dose of MenACWY-CRM was administered by IM injection.

    Arm title
    		 ACWY 11-18 Yrs
    Arm description
    		 Subjects 11-18 years of age received one MenACWY-CRM vaccination
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY-CRM
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5 mL dose of MenACWY-CRM was administered by IM injection.

    Number of subjects in period 1
    		ACWY 2-10 Yrs ACWY 11-18 Yrs
    Started
    173
    168
    Completed
    173
    167
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ACWY 2-10 Yrs
    Reporting group description
    		 Subjects 2-10 years of age received one MenACWY-CRM vaccination

    Reporting group title
    ACWY 11-18 Yrs
    Reporting group description
    		 Subjects 11-18 years of age received one MenACWY-CRM vaccination

    Reporting group values
    		 ACWY 2-10 Yrs ACWY 11-18 Yrs Total
    Number of subjects
    		 173 168 341
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 173 29 202
        Adolescents (12-17 years)
    		 0 128 128
        Adults (18-64 years)
    		 0 11 11
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.3 ± 2.6 14 ± 2.2 -
    Gender categorical
    Units: Subjects
        Female
    		 92 88 180
        Male
    		 81 80 161

    End points

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    End points reporting groups
    Reporting group title
    ACWY 2-10 Yrs
    Reporting group description
    		 Subjects 2-10 years of age received one MenACWY-CRM vaccination

    Reporting group title
    ACWY 11-18 Yrs
    Reporting group description
    		 Subjects 11-18 years of age received one MenACWY-CRM vaccination

    Subject analysis set title
    All Enrolled Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who have signed an informed consent, undergone screening procedure(s), and have a subject number assigned.

    Subject analysis set title
    Modified Intention-to-treat (MITT) population, Immunogenicity
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    This population is defined by visit (visit 1, visit 2, both visits) and by serogroup. All subjects in the exposed population who provided evaluable serum samples whose assay results are available for at least one serogroup on Day 1 and/or Day 29

    Subject analysis set title
    ACWY 2-5 Yrs
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects 2 to 5 years of age received one MenACWY-CRM vaccination

    Subject analysis set title
    Overall (2 - 18 Yrs)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects 2 to 8 years of age received one MenACWY-CRM vaccination

    Subject analysis set title
    ACWY 6-10 Yrs
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects 6-10 years of age received one MenACWY-CRM vaccination

    Subject analysis set title
    ACWY 11- 18 Yrs
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects 11-18 years of age received one MenACWY-CRM vaccination

    Subject analysis set title
    Overall (6-18 Yrs)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects 6-18 years of age received one MenACWY-CRM vaccination

    Primary: 1. Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.

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    End point title
    		 1. Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. [1]
    End point description
    Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as: a. for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8. b. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer. Analysis was done on modified intention-to-treat (MITT) population.
    End point type
    Primary
    End point timeframe
    Day 29
    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: There was no statistical analyses specified for this primary end point.
    End point values
    		 Overall (2 - 18 Yrs)
    Number of subjects analysed
    335
    Units: Percentage of subjects
    number (confidence interval 95%)
        MenA
    83 (79 to 87)
        MenC (N= 333)
    93 (90 to 96)
        MenW (N=334)
    50 (45 to 55)
        MenY (N= 333)
    65 (60 to 70)
    No statistical analyses for this end point

    Secondary: 2. Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group

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    End point title
    		 2. Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
    End point description
    Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups. Analysis was done on modified intention-to-treat (MITT) population.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 ACWY 2-10 Yrs ACWY 11-18 Yrs
    Number of subjects analysed
    170
    166
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Men A (N=170,165)
    77 (70 to 83)
    89 (83 to 93)
        MenC (N=167,166)
    92 (86 to 95)
    95 (90 to 97)
        MenW (N=168,166)
    54 (46 to 62)
    46 (38 to 54)
        MenY (N=167,166)
    61 (53 to 69)
    69 (62 to 76)
    No statistical analyses for this end point

    Secondary: 3. Geometric Mean Titers (GMTs) of Subjects, Directed Against N. meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.

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    End point title
    		 3. Geometric Mean Titers (GMTs) of Subjects, Directed Against N. meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
    End point description
    Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 29
    End point values
    		 ACWY 2-10 Yrs ACWY 11-18 Yrs Overall (2 - 18 Yrs)
    Number of subjects analysed
    170
    165
    335
    Units: Titers
    geometric mean (confidence interval 95%)
        MenA (Day 1)
    2.05 (1.92 to 2.2)
    2.2 (2.05 to 2.36)
    2.12 (2.02 to 2.24)
        MenC (Day 1) (N=167,166,333)
    2.66 (2.35 to 3.02)
    3.64 (3.21 to 4.12)
    3.11 (2.83 to 3.42)
        MenW (Day 1) (N=168,166,334)
    7.32 (5.65 to 9.49)
    15 (12 to 19)
    10 (8.62 to 13)
        MenY (Day 1) (N=167,166,333)
    3.21 (2.69 to 3.83)
    3.95 (3.31 to 4.71)
    3.56 (3.12 to 4.06)
        MenA (Day 29)
    32 (24 to 43)
    88 (66 to 117)
    53 (42 to 65)
        MenC (Day 29) (N=167,166,333)
    117 (93 to 147)
    273 (218 to 342)
    179 (151 to 211)
        MenW (Day 29) (N=168,166,334)
    49 (40 to 60)
    104 (85 to 127)
    71 (61 to 82)
        MenY (Day 29) (N=167,166,333)
    26 (20 to 33)
    56 (43 to 72)
    38 (31 to 46)
    No statistical analyses for this end point

    Secondary: 4. Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.

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    End point title
    		 4. Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
    End point description
    Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    Day 29 post-vaccination / Day 1 pre-vaccination
    End point values
    		 ACWY 2-10 Yrs ACWY 11-18 Yrs Overall (2 - 18 Yrs)
    Number of subjects analysed
    170
    165
    335
    Units: Ratio
    geometric mean (confidence interval 95%)
        MenA
    16 (12 to 21)
    40 (30 to 53)
    25 (20 to 31)
        MenC (N=167,166,333)
    44 (35 to 56)
    75 (59 to 95)
    57 (48 to 69)
        MenW (N=168,166,334)
    6.66 (5.19 to 8.5)
    6.91 (5.39 to 8.85)
    6.78 (5.63 to 8.16)
        MenY (N=167,166,333)
    8.02 (6.09 to 11)
    14 (11 to 19)
    11 (8.67 to 13)
    No statistical analyses for this end point

    Secondary: 5. Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.

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    End point title
    		 5. Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
    End point description
    Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWYCRM vaccination (Day 29), bye age group and overall. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 29
    End point values
    		 ACWY 2-10 Yrs ACWY 11-18 Yrs Overall (2 - 18 Yrs)
    Number of subjects analysed
    170
    165
    335
    Units: Percentage of Subjects
    number (confidence interval 95%)
        MenA (Day 1)
    1 (0 to 4)
    4 (2 to 9)
    3 (1 to 5)
        MenC (Day 1) (N=167,166,333)
    11 (7 to 17)
    23 (17 to 31)
    17 (13 to 22)
        MenW (Day 1) (N=168,166,334)
    47 (39 to 55)
    70 (62 to 77)
    58 (53 to 64)
        MenY (Day 1) (N=167,166,333)
    22 (16 to 29)
    26 (19 to 33)
    24 (19 to 29)
        MenA (Day 29)
    77 (70 to 83)
    90 (84 to 94)
    83 (79 to 87)
        MenC (Day 29) (N=167,166,333)
    95 (90 to 98)
    98 (95 to 100)
    96 (94 to 98)
        MenW (Day 29) (N=168,166,334)
    93 (88 to 96)
    99 (96 to 100)
    96 (93 to 98)
        MenY (Day 290) (N=167,166,333)
    78 (71 to 84)
    86 (79 to 91)
    82 (77 to 86)
    No statistical analyses for this end point

    Secondary: 6. Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years.

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    End point title
    		 6. Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years.
    End point description
    Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination. Analysis was done on safety population.
    End point type
    Secondary
    End point timeframe
    From Day 1 through Day 7 postvaccination
    End point values
    		 ACWY 2-5 Yrs
    Number of subjects analysed
    72
    Units: Number of Subjects
        Injection site tenderness
    27
        Injection site erythema
    7
        Injection site induration
    6
        Change in eating habits
    2
        Sleepiness
    3
        Irritability
    5
        Vomiting
    7
        Diarrhea
    2
        Rash - Any
    4
        Rash - Urticarial
    1
        Fever (≥38°C)
    4
        Temperature >= 40 C
    0
        Analges. Antipyr. Meds
    4
    No statistical analyses for this end point

    Secondary: 7. Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 6 to 18 Years.

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    End point title
    		 7. Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 6 to 18 Years.
    End point description
    Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination. Analysis was done on safety population.
    End point type
    Secondary
    End point timeframe
    From Day 1 through Day 7 postvaccination
    End point values
    		 ACWY 6-10 Yrs ACWY 11- 18 Yrs Overall (6-18 Yrs)
    Number of subjects analysed
    101
    167
    268
    Units: Number of Subjects
        Injection site pain
    37
    62
    99
        Injection site erythema
    17
    17
    34
        Injection site induration
    14
    12
    26
        Chills
    2
    6
    8
        Nausea
    10
    10
    20
        Malaise
    13
    35
    48
        Myalgia
    20
    49
    69
        Arthralgia
    3
    13
    16
        Headache
    11
    29
    40
        Rash - Any
    7
    4
    11
        Rash - Urticarial
    3
    3
    6
        Fever (≥38°C)
    3
    2
    5
    No statistical analyses for this end point

    Secondary: 8. Number of Subjects Reporting Unsolicited AEs, After Men ACWY-CRM Vaccination, Age 2 to 18 Years.

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    End point title
    		 8. Number of Subjects Reporting Unsolicited AEs, After Men ACWY-CRM Vaccination, Age 2 to 18 Years.
    End point description
    Safety was assessed as the number of subjects aged 2 to 18 years who reported unsolicited AEs within days 1 through 7 after MenACWY-CRM vaccination. Analysis was done on safety population.
    End point type
    Secondary
    End point timeframe
    From Day 1 through Day 7 postvaccination
    End point values
    		 ACWY 2-10 Yrs ACWY 11-18 Yrs Overall (2 - 18 Yrs)
    Number of subjects analysed
    170
    165
    335
    Units: Number of Subjects
        Any adverse event (AE)
    27
    20
    47
        At least possibly related AEs
    11
    10
    21
        Any SAE
    1
    0
    1
        Possibly/Probably related SAE
    0
    0
    0
        AE leading to withdrawal
    0
    0
    0
        Medically attended AEs
    49
    20
    69
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period (from Day 1 through Day 29).
    Adverse event reporting additional description
    A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ACWY 2-10 Yrs
    Reporting group description
    		 Subjects 2-10 years of age received one MenACWY-CRM vaccination.

    Reporting group title
    ACWY 11-18 Yrs
    Reporting group description
    		 Subjects 11-18 years of age received one MenACWY-CRM vaccination.

    Reporting group title
    Overall (2 - 18 Years)
    Reporting group description
    		 Subjects 2 to 18 years of age received one MenACWY-CRM vaccination.

    Serious adverse events
    		 ACWY 2-10 Yrs ACWY 11-18 Yrs Overall (2 - 18 Years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    1 / 340 (0.29%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 167 (0.00%)
    1 / 340 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ACWY 2-10 Yrs ACWY 11-18 Yrs Overall (2 - 18 Years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    110 / 173 (63.58%)
    98 / 167 (58.68%)
    208 / 340 (61.18%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 173 (7.51%)
    29 / 167 (17.37%)
    42 / 340 (12.35%)
         occurrences all number
    15
    36
    51
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    58 / 173 (33.53%)
    43 / 167 (25.75%)
    101 / 340 (29.71%)
         occurrences all number
    61
    45
    106
    Injection site induration
         subjects affected / exposed
    49 / 173 (28.32%)
    36 / 167 (21.56%)
    85 / 340 (25.00%)
         occurrences all number
    53
    40
    93
    Injection site pain
         subjects affected / exposed
    64 / 173 (36.99%)
    62 / 167 (37.13%)
    126 / 340 (37.06%)
         occurrences all number
    65
    62
    127
    Malaise
         subjects affected / exposed
    13 / 173 (7.51%)
    35 / 167 (20.96%)
    48 / 340 (14.12%)
         occurrences all number
    15
    38
    53
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    10 / 173 (5.78%)
    10 / 167 (5.99%)
    20 / 340 (5.88%)
         occurrences all number
    11
    11
    22
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    11 / 173 (6.36%)
    4 / 167 (2.40%)
    15 / 340 (4.41%)
         occurrences all number
    12
    4
    16
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 173 (1.73%)
    13 / 167 (7.78%)
    16 / 340 (4.71%)
         occurrences all number
    3
    15
    18
    Myalgia
         subjects affected / exposed
    20 / 173 (11.56%)
    49 / 167 (29.34%)
    69 / 340 (20.29%)
         occurrences all number
    21
    51
    72
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 173 (5.78%)
    2 / 167 (1.20%)
    12 / 340 (3.53%)
         occurrences all number
    10
    2
    12
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 173 (9.25%)
    6 / 167 (3.59%)
    22 / 340 (6.47%)
         occurrences all number
    17
    6
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2011
    The protocol amendment was implemented before first subject has entered the study and consisted of the change of the MenACWY-CRM presentation, instead of prefilled syringe; vial-vial presentation was introduced and used.

    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.
    Not specified
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    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
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