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    Clinical Trial Results:
    A phase II, randomized, double-blind, placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) liquid vaccine, when given to healthy infants, in Philippines

    Summary
    EudraCT number
    		 2015-001544-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Sep 2007

    Results information
    Results version number
    		 v3(current)
    This version publication date
    28 Mar 2023
    First version publication date
    08 Jul 2015
    Other versions
    		 v1 (removed from public view) , v2
    Version creation reason
    • Correction of full data set
    Correction and alignment of full data set.

    Trial information

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    Trial identification
    Sponsor protocol code
    109216
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00432380
    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, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, 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
    04 Sep 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Sep 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity of GSK Biologicals’ HRV liquid vaccine versus placebo, in terms of anti-rotavirus Immunoglobulin A (IgA) antibody seroconversion at Month 3 (i.e. Visit 4), when administered concomitantly with the second and third routine EPI immunization.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Mar 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Philippines: 375
    Worldwide total number of subjects
    375
    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)
    375
    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
    		 -

    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 trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo-Rotarix-Rotarix Group
    Arm description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    SUB22357
    Other name
    HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two oral doses of the liquid HRV vaccine administered at Months 1 and 2.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Oral use
    Dosage and administration details
    1 oral dose of placebo administered at Day 0.

    Arm title
    		 Rotarix-Placebo-Rotarix Group
    Arm description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    SUB22357
    Other name
    HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two oral doses of the liquid HRV vaccine administered at Day 0 and Month 2.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Oral use
    Dosage and administration details
    1 oral dose of placebo administered at Month 1.

    Arm title
    		 Placebo Group
    Arm description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Oral use
    Dosage and administration details
    Three oral doses of placebo administered at Day 0, Months 1 and 2.

    Number of subjects in period 1
    		Placebo-Rotarix-Rotarix Group Rotarix-Placebo-Rotarix Group Placebo Group
    Started
    150
    150
    75
    Completed
    146
    146
    74
    Not completed
    4
    4
    1
         Adverse event, non-fatal
    1
    -
    -
         Migrated/moved from study area
    3
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo-Rotarix-Rotarix Group
    Reporting group description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

    Reporting group title
    Rotarix-Placebo-Rotarix Group
    Reporting group description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

    Reporting group values
    		 Placebo-Rotarix-Rotarix Group Rotarix-Placebo-Rotarix Group Placebo Group Total
    Number of subjects
    		 150 150 75 375
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 150 150 75 375
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 6.6 ± 1.07 6.5 ± 1 6.6 ± 1.02 -
    Gender categorical
    Units: Subjects
        Female
    		 59 76 40 175
        Male
    		 91 74 35 200

    End points

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    End points reporting groups
    Reporting group title
    Placebo-Rotarix-Rotarix Group
    Reporting group description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

    Reporting group title
    Rotarix-Placebo-Rotarix Group
    Reporting group description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

    Primary: Number of seroconverted subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody

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    End point title
    		 Number of seroconverted subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody [1] [2]
    End point description
    Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.
    End point type
    Primary
    End point timeframe
    At Month 3
    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 statistical analyses for this end point.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point.
    End point values
    		 Placebo-Rotarix-Rotarix Group
    Number of subjects analysed
    120
    Units: Subjects
        Anti-RV IgA
    84
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for Anti-RV IgA antibody

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    End point title
    		 Number of seroconverted subjects for Anti-RV IgA antibody [3]
    End point description
    Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.
    End point type
    Secondary
    End point timeframe
    At Month 3
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point.
    End point values
    		 Rotarix-Placebo-Rotarix Group
    Number of subjects analysed
    120
    Units: Subjects
        Anti-RV IgA
    71
    No statistical analyses for this end point

    Secondary: Serum IgA Antibody Concentrations Against Rotavirus

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    End point title
    		 Serum IgA Antibody Concentrations Against Rotavirus [4]
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.
    End point type
    Secondary
    End point timeframe
    At Month 3
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point.
    End point values
    		 Placebo-Rotarix-Rotarix Group Rotarix-Placebo-Rotarix Group
    Number of subjects analysed
    120
    120
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-rotavirus IgA antibody GMC
    68 (50.1 to 92.1)
    75.6 (52.5 to 109)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting grade “2” or grade “3” fever, vomiting or diarrhea

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    End point title
    		 Number of subjects reporting grade “2” or grade “3” fever, vomiting or diarrhea
    End point description
    Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = Rectal temperature greater than (>) 38.5 – less than or equal to (≤) 39.5 degrees Celsius (°C) or axillary temperature > 38.0 – ≤ 39.0°C, Grade 3 fever = Rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Day 0-Day 7) period following each dose of study vaccine or placebo and across doses
    End point values
    		 Placebo-Rotarix-Rotarix Group Rotarix-Placebo-Rotarix Group Placebo Group
    Number of subjects analysed
    150
    150
    75
    Units: Subjects
        Any symptom, Dose 1 [N=150, 150, 75]
    57
    68
    35
        Any symptom, Dose 2 [N=149, 147, 75]
    52
    36
    19
        Any symptom, Dose 3 [N= 146, 147, 75]
    29
    38
    24
        Any symptom, Across doses [N= 150, 150, 75]
    86
    91
    48
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 Cough/runny nose = cough/runny nose which prevented daily activity, Grade 2 Diarrhea: 4-5 looser than normal stools/ day, Grade 3 Diarrhea = ≥ 6 looser than normal stools/ day, Grade 3 Irritability = crying that could not be comforted/ prevented normal activity, Grade 3 Loss of appetite = not eating at all, Grade 2 Vomiting= 2 episodes of vomiting/ day and Grade 3 Vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Day 0-Day 7) period following each dose of study vaccine or placebo and across doses
    End point values
    		 Placebo-Rotarix-Rotarix Group Rotarix-Placebo-Rotarix Group Placebo Group
    Number of subjects analysed
    150
    150
    75
    Units: Subjects
        Between Dose 1 and before Dose 2 [N=150, 150, 75]
    1
    0
    1
        Between Dose 2 and before Dose 3 [N=149, 147, 75]
    0
    0
    0
        Between Dose 3 and Month 3 [N=146, 147, 75]
    0
    0
    0
        Between Dose 1 and Month 3 [N=150, 150, 75]
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse event

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    End point title
    		 Number of subjects reporting any unsolicited adverse event
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0-Day 30) period following any study vaccine dose or placebo
    End point values
    		 Placebo-Rotarix-Rotarix Group Rotarix-Placebo-Rotarix Group Placebo Group
    Number of subjects analysed
    150
    150
    75
    Units: Subjects
        Any AE(s)
    53
    60
    19
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Day 0 to Month 3)
    End point values
    		 Placebo-Rotarix-Rotarix Group Rotarix-Placebo-Rotarix Group Placebo Group
    Number of subjects analysed
    150
    150
    75
    Units: Subjects
        Any SAE(s)
    1
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms were collected during the 8-day (Days 0-7) post vaccination period. Unsolicited AEs were collected during the 31 day (Days 0-30) post vaccination. SAEs were collected throughout the entire study period (Months 0 to 3).
    Adverse event reporting additional description
    The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Placebo-Rotarix-Rotarix Group
    Reporting group description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

    Reporting group title
    Rotarix-Placebo-Rotarix Group
    Reporting group description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

    Serious adverse events
    		 Placebo-Rotarix-Rotarix Group Rotarix-Placebo-Rotarix Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 150 (0.67%)
    1 / 75 (1.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Immune system disorders
    Milk allergy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 150 (0.67%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis salmonella
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    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
    		 Placebo-Rotarix-Rotarix Group Rotarix-Placebo-Rotarix Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    139 / 150 (92.67%)
    137 / 150 (91.33%)
    69 / 75 (92.00%)
    General disorders and administration site conditions
    Cough/runny nose
         subjects affected / exposed
    82 / 150 (54.67%)
    69 / 150 (46.00%)
    40 / 75 (53.33%)
         occurrences all number
    82
    69
    40
    Diarrhea
         subjects affected / exposed
    8 / 150 (5.33%)
    6 / 150 (4.00%)
    7 / 75 (9.33%)
         occurrences all number
    8
    6
    7
    Fever (Rectally)
         subjects affected / exposed
    139 / 150 (92.67%)
    137 / 150 (91.33%)
    69 / 75 (92.00%)
         occurrences all number
    139
    137
    69
    Irritability
         subjects affected / exposed
    93 / 150 (62.00%)
    78 / 150 (52.00%)
    40 / 75 (53.33%)
         occurrences all number
    93
    78
    40
    Loss of appetite
         subjects affected / exposed
    40 / 150 (26.67%)
    46 / 150 (30.67%)
    23 / 75 (30.67%)
         occurrences all number
    40
    46
    23
    Vomiting
         subjects affected / exposed
    35 / 150 (23.33%)
    32 / 150 (21.33%)
    9 / 75 (12.00%)
         occurrences all number
    35
    32
    9
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 150 (12.67%)
    21 / 150 (14.00%)
    6 / 75 (8.00%)
         occurrences all number
    19
    21
    6
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 150 (8.67%)
    16 / 150 (10.67%)
    6 / 75 (8.00%)
         occurrences all number
    13
    16
    6
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 150 (4.67%)
    7 / 150 (4.67%)
    4 / 75 (5.33%)
         occurrences all number
    7
    7
    4
    Diarrhea infectious
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 150 (3.33%)
    9 / 150 (6.00%)
    2 / 75 (2.67%)
         occurrences all number
    5
    9
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jan 2007
    It was decided to offer all subjects complementary vaccination against Haemophilus influenzae type b (Hib) disease with GSK Biologicals’ Hiberix vaccine after the study end. The protocol was amended to reflect this change.

    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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    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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