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    Clinical Trial Results:
    Timing and sequence of vaccination against COVID-19 and Influenza

    Summary
    EudraCT number
    		 2021-002186-17
    Trial protocol
    		 NL  
    Global end of trial date
    05 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2022
    First version publication date
    16 Dec 2022
    Other versions
    Summary report(s)
    		 TACTIC summary

    Trial information

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    Trial identification
    Sponsor protocol code
    112038
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands, 6525AG
    Public contact
    Elisabeth Dulfer, RadboudUMC, elisabeth.dulfer@radboudumc.nl
    Scientific contact
    Elisabeth Dulfer, RadboudUMC, 0031 642059042, elisabeth.dulfer@radboudumc.nl
    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
    05 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Aim 1. To study the impact of different sequences of combined influenza and SARS-CoV-2 vaccinations on immunological responses and side-effects. Aim 2. To understand the immunological mechanisms that mediate the potential interference between influenza and COVID-19 vaccines, and the long-term effects of this interaction.
    Protection of trial subjects
    Privacy protection: pseudonyms used, passwords for the key, adequate data management plan Medical protection: emergency medication set & MD were present during all study visits Comfort protection: study team was easily reachable by phone and mail, participants could decide on their own planning of study visits
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Sep 2021
    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
    Netherlands: 154
    Worldwide total number of subjects
    154
    EEA total number of subjects
    154
    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)
    57
    From 65 to 84 years
    95
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 On September 10 (2021), news items were published in local newspaper De Gelderlander and on the Radboudumc website, announcing the start of the TACTIC trial and inviting volunteers to participate. The same day, the first registrations entered the TACTIC mailbox. Planning of the participants was finalized two weeks later.

    Pre-assignment
    Screening details
    		 Interested volunteers received an email with the PIF and could decide if they wanted to join or not. If so, a phone call was set up with a study team member to explain the study in more detail, answer questions and check the inclusion/exclusion criteria using a checklist. If OK, the 1st study visit to discuss in person and sign the PIF was planned.

    Period 1
    Period 1 title
    Visit 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Participants received two injections with either one or two active vaccines. Placebo-vaccines and real vaccines were in the same type of syringe and had no name-label on them.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Influenza first
    Arm description
    		 Participants in this group received an influenza vaccine + palcebo during their first study visit, and a COVID-19 vaccine during the second.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vaxigrip Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1x 0,5ml administered IM in the deltoid

    Arm title
    		 Group 2: Booster first
    Arm description
    		 Participants in this group received a COVID-19 booster vaccine + placebo during their first study visit, and an influenza vaccine during the second.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Comirnaty
    Investigational medicinal product code
    Other name
    BNT162b2
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1x 0,3ml IM in the deltoid

    Arm title
    		 Group 3: Combination
    Arm description
    		 Participants in this group received both a COVID19 bosoter vaccine and an influenza vaccine during visit 1. At visit 2, they received a placebo.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vaxigrip Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1x 0,5ml administered IM in the deltoid

    Investigational medicinal product name
    Comirnaty
    Investigational medicinal product code
    Other name
    BNT162b2
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1x 0,3ml IM in the deltoid (in combination group: administration in the other arm)

    Arm title
    		 Group 4: Booster only (reference)
    Arm description
    		 Participants in this group received a COVID19 bosoter vaccine + placebo during the first study visit, and another placebo during the 2nd. After completing of the 3rd visit and therefore having essentially completed the study, the participants were offered an inluenza vaccine as a courtesy (so outside of the study scope).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Comirnaty
    Investigational medicinal product code
    Other name
    BNT162b2
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1x 0,3ml IM in the deltoid

    Number of subjects in period 1
    		Group 1: Influenza first Group 2: Booster first Group 3: Combination Group 4: Booster only (reference)
    Started
    39
    39
    38
    38
    Completed
    39
    39
    38
    38
    Period 2
    Period 2 title
    Visit 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Participants received one injection with either an active or placebo vaccine. Syringes were identical and were not name-labeled.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Influenza first
    Arm description
    		 Participants in this group received an influenza vaccine + palcebo during their first study visit, and a COVID-19 vaccine during the second.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Comirnaty
    Investigational medicinal product code
    Other name
    BNT162b2
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1x 0,3ml IM in the deltoid

    Arm title
    		 Group 2: Booster first
    Arm description
    		 Participants in this group received a COVID-19 booster vaccine + placebo during their first study visit, and an influenza vaccine during the second.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vaxigrip Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1x 0,5ml administered IM in the deltoid

    Arm title
    		 Group 3: Combination
    Arm description
    		 Participants in this group received both a COVID19 bosoter vaccine and an influenza vaccine during visit 1. At visit 2, they received a placebo.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NaCl 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Injection
    Dosage and administration details
    0.3ml placebo in the upper arm

    Arm title
    		 Group 4: Booster only (reference)
    Arm description
    		 Participants in this group received a COVID19 bosoter vaccine + placebo during the first study visit, and another placebo during the 2nd. After completing of the 3rd visit and therefore having essentially completed the study, the participants were offered an inluenza vaccine as a courtesy (so outside of the study scope).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NaCl 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Injection
    Dosage and administration details
    0.3ml placebo in the upper arm

    Number of subjects in period 2 [1]
    		Group 1: Influenza first Group 2: Booster first Group 3: Combination Group 4: Booster only (reference)
    Started
    39
    38
    37
    38
    Completed
    39
    38
    37
    38
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: After visit 1, one participant from Group 2 had surgery (non-SUSAR) and was not there for visit 2. The participant did take part in visit 3.
    Period 3
    Period 3 title
    Visit 3
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Participants were told about their vaccination schedule. To participants in group 4 (reference group), an influenza vaccine was offered (not-blinded).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Influenza first
    Arm description
    		 Participants in this group received an influenza vaccine + palcebo during their first study visit, and a COVID-19 vaccine during the second. Visit 3 consisted only of obtaining samples and discussing adverse events.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2: Booster first
    Arm description
    		 Participants in this group received a COVID-19 booster vaccine + placebo during their first study visit, and an influenza vaccine during the second. Visit 3 consisted only of obtaining samples and discussing adverse events.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3: Combination
    Arm description
    		 Participants in this group received both a COVID19 bosoter vaccine and an influenza vaccine during visit 1. At visit 2, they received a placebo. Visit 3 consisted only of obtaining samples and discussing adverse events.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4: Booster only (reference)
    Arm description
    		 Participants in this group received a COVID19 bosoter vaccine + placebo during the first study visit, and another placebo during the 2nd. After completing of the 3rd visit (obtaining samples & discussing adverse events) and therefore having essentially completed the study, the participants were offered an inluenza vaccine as a courtesy (so outside of the study scope).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vaxigrip Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1x 0,5ml administered IM in the deltoid

    Number of subjects in period 3
    		Group 1: Influenza first Group 2: Booster first Group 3: Combination Group 4: Booster only (reference)
    Started
    39
    38
    37
    38
    Completed
    39
    38
    37
    38

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Influenza first
    Reporting group description
    		 Participants in this group received an influenza vaccine + palcebo during their first study visit, and a COVID-19 vaccine during the second.

    Reporting group title
    Group 2: Booster first
    Reporting group description
    		 Participants in this group received a COVID-19 booster vaccine + placebo during their first study visit, and an influenza vaccine during the second.

    Reporting group title
    Group 3: Combination
    Reporting group description
    		 Participants in this group received both a COVID19 bosoter vaccine and an influenza vaccine during visit 1. At visit 2, they received a placebo.

    Reporting group title
    Group 4: Booster only (reference)
    Reporting group description
    		 Participants in this group received a COVID19 bosoter vaccine + placebo during the first study visit, and another placebo during the 2nd. After completing of the 3rd visit and therefore having essentially completed the study, the participants were offered an inluenza vaccine as a courtesy (so outside of the study scope).

    Reporting group values
    		 Group 1: Influenza first Group 2: Booster first Group 3: Combination Group 4: Booster only (reference) Total
    Number of subjects
    		 39 39 38 38 154
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 12 16 12 14 54
        From 65-84 years
    		 26 22 26 24 98
        85 years and over
    		 1 1 0 0 2
    Gender categorical
    Units: Subjects
        Female
    		 20 18 13 15 66
        Male
    		 19 21 25 23 88
    Actively smoking
    Units: Subjects
        Yes
    		 25 19 19 25 88
        No
    		 14 20 19 13 66
    History of COVID-19 infection
    Units: Subjects
        Yes
    		 1 0 0 2 3
        No
    		 38 39 38 36 151
    Previous COVID vaccination
    Units: Subjects
        mRNA (Pfizer)
    		 24 28 27 22 101
        vector (AstraZeneca)
    		 15 11 11 15 52
        mRNA (Modern)
    		 0 0 0 1 1
        Other
    		 0 0 0 0 0
    Previous pneumococcal vaccine
    Units: Subjects
        Yes
    		 5 0 7 5 17
        No
    		 34 39 31 33 137
    Previous BCG vaccine
    Units: Subjects
        Yes
    		 15 12 16 8 51
        No
    		 24 27 22 30 103
    Previous influenza vaccine (season 20/21)
    Units: Subjects
        Yes
    		 35 34 35 34 138
        No
    		 4 5 3 4 16
    BMI
    Body mass index
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 25.4 ± 4.0 25.9 ± 4.0 25.7 ± 3.5 26.4 ± 5.6 -
    Days since last COVID vaccine
    Units: day
        arithmetic mean (standard deviation)
    		 142 ± 33 154 ± 44 145 ± 32 143 ± 27 -

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Influenza first
    Reporting group description
    		 Participants in this group received an influenza vaccine + palcebo during their first study visit, and a COVID-19 vaccine during the second.

    Reporting group title
    Group 2: Booster first
    Reporting group description
    		 Participants in this group received a COVID-19 booster vaccine + placebo during their first study visit, and an influenza vaccine during the second.

    Reporting group title
    Group 3: Combination
    Reporting group description
    		 Participants in this group received both a COVID19 bosoter vaccine and an influenza vaccine during visit 1. At visit 2, they received a placebo.

    Reporting group title
    Group 4: Booster only (reference)
    Reporting group description
    		 Participants in this group received a COVID19 bosoter vaccine + placebo during the first study visit, and another placebo during the 2nd. After completing of the 3rd visit and therefore having essentially completed the study, the participants were offered an inluenza vaccine as a courtesy (so outside of the study scope).
    Reporting group title
    Group 1: Influenza first
    Reporting group description
    		 Participants in this group received an influenza vaccine + palcebo during their first study visit, and a COVID-19 vaccine during the second.

    Reporting group title
    Group 2: Booster first
    Reporting group description
    		 Participants in this group received a COVID-19 booster vaccine + placebo during their first study visit, and an influenza vaccine during the second.

    Reporting group title
    Group 3: Combination
    Reporting group description
    		 Participants in this group received both a COVID19 bosoter vaccine and an influenza vaccine during visit 1. At visit 2, they received a placebo.

    Reporting group title
    Group 4: Booster only (reference)
    Reporting group description
    		 Participants in this group received a COVID19 bosoter vaccine + placebo during the first study visit, and another placebo during the 2nd. After completing of the 3rd visit and therefore having essentially completed the study, the participants were offered an inluenza vaccine as a courtesy (so outside of the study scope).
    Reporting group title
    Group 1: Influenza first
    Reporting group description
    		 Participants in this group received an influenza vaccine + palcebo during their first study visit, and a COVID-19 vaccine during the second. Visit 3 consisted only of obtaining samples and discussing adverse events.

    Reporting group title
    Group 2: Booster first
    Reporting group description
    		 Participants in this group received a COVID-19 booster vaccine + placebo during their first study visit, and an influenza vaccine during the second. Visit 3 consisted only of obtaining samples and discussing adverse events.

    Reporting group title
    Group 3: Combination
    Reporting group description
    		 Participants in this group received both a COVID19 bosoter vaccine and an influenza vaccine during visit 1. At visit 2, they received a placebo. Visit 3 consisted only of obtaining samples and discussing adverse events.

    Reporting group title
    Group 4: Booster only (reference)
    Reporting group description
    		 Participants in this group received a COVID19 bosoter vaccine + placebo during the first study visit, and another placebo during the 2nd. After completing of the 3rd visit (obtaining samples & discussing adverse events) and therefore having essentially completed the study, the participants were offered an inluenza vaccine as a courtesy (so outside of the study scope).

    Primary: Concentration of anti-S IgG (and others) at 21 days after booster vaccination

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    End point title
    		 Concentration of anti-S IgG (and others) at 21 days after booster vaccination
    End point description
    Different antibodies and timepoints can be viewed in the graph attached
    End point type
    Primary
    End point timeframe
    21 days after booster vaccination For group 2-4: samples at day 21 For group 1: samples at day 42
    End point values
    		 Group 2: Booster first Group 3: Combination Group 4: Booster only (reference) Group 1: Influenza first
    Number of subjects analysed
    38
    37
    37
    37
    Units: Binding antibody units/ml
        geometric mean (confidence interval 95%)
    2137 (0 to 9999)
    1683 (0 to 9999)
    2543 (0 to 9999)
    2348 (0 to 9999)
    Statistical analysis title
    		 Non-inferiority analysis
    Statistical analysis description
    Non-inferiority analyses comparing anti-S IgG responses, each group compared to reference group ‘COVID-19 booster only’. If the lower limit of the 95% confidence interval lies above the non-inferiority margin of -0.3, the result is considered non-inferior.
    Comparison groups
    Group 3: Combination v Group 4: Booster only (reference)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 non-inf estimate
    Point estimate
    -0.1791
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3364
         upper limit
    		 -0.0217

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 days after initial vaccination round
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Group 1: Influenza first
    Reporting group description
    		 Participants in this group received an influenza vaccine + palcebo during their first study visit, and a COVID-19 vaccine during the second.

    Reporting group title
    Group 2: Booster first
    Reporting group description
    		 Participants in this group received a COVID-19 booster vaccine + placebo during their first study visit, and an influenza vaccine during the second.

    Reporting group title
    Group 3: Combination
    Reporting group description
    		 Participants in this group received both a COVID19 bosoter vaccine and an influenza vaccine during visit 1. At visit 2, they received a placebo.

    Reporting group title
    Group 4: Booster only (reference)
    Reporting group description
    		 Participants in this group received a COVID19 bosoter vaccine + placebo during the first study visit, and another placebo during the 2nd. After completing of the 3rd visit and therefore having essentially completed the study, the participants were offered an inluenza vaccine as a courtesy (so outside of the study scope).

    Serious adverse events
    		 Group 1: Influenza first Group 2: Booster first Group 3: Combination Group 4: Booster only (reference)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Gastrointestinal disorders
    Cholecystectomy
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Group 1: Influenza first Group 2: Booster first Group 3: Combination Group 4: Booster only (reference)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 38 (60.53%)
    33 / 38 (86.84%)
    33 / 38 (86.84%)
    33 / 38 (86.84%)
    Injury, poisoning and procedural complications
    Pain
    Additional description: at injection site
         subjects affected / exposed
    8 / 38 (21.05%)
    24 / 38 (63.16%)
    33 / 38 (86.84%)
    27 / 38 (71.05%)
         occurrences all number
    8
    24
    33
    27
    Rubor
    Additional description: Redness at injection site
         subjects affected / exposed
    3 / 38 (7.89%)
    5 / 38 (13.16%)
    5 / 38 (13.16%)
    3 / 38 (7.89%)
         occurrences all number
    3
    5
    5
    3
    Swollen
    Additional description: Swollen injection site
         subjects affected / exposed
    1 / 38 (2.63%)
    9 / 38 (23.68%)
    3 / 38 (7.89%)
    4 / 38 (10.53%)
         occurrences all number
    1
    9
    3
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 38 (21.05%)
    6 / 38 (15.79%)
    12 / 38 (31.58%)
    9 / 38 (23.68%)
         occurrences all number
    8
    6
    12
    9
    General disorders and administration site conditions
    Febrile infection
    Additional description: Simply meaning 'fever after vaccination', but cannot find that one.
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 38 (5.26%)
    1 / 38 (2.63%)
    3 / 38 (7.89%)
         occurrences all number
    0
    2
    1
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    3 / 38 (7.89%)
         occurrences all number
    0
    1
    0
    3
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    3 / 38 (7.89%)
    7 / 38 (18.42%)
    13 / 38 (34.21%)
    10 / 38 (26.32%)
         occurrences all number
    3
    7
    13
    10
    Joint stiffness
    Additional description: joint pain
         subjects affected / exposed
    4 / 38 (10.53%)
    3 / 38 (7.89%)
    7 / 38 (18.42%)
    3 / 38 (7.89%)
         occurrences all number
    4
    3
    7
    3
    Infections and infestations
    Chills
         subjects affected / exposed
    2 / 38 (5.26%)
    4 / 38 (10.53%)
    5 / 38 (13.16%)
    5 / 38 (13.16%)
         occurrences all number
    2
    4
    5
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jul 2021
    - Only Pfizer mRNA vaccines, no Janssen vaccines employed in the study - Influvac Tetra substituted with Vaxigip Tetra - Participants will be elderly adults, fully vaccinated against COVID-19 - Different planning (start in October) - Added: short questionnaire regarding underwent COVID-testing, per visit Participants Information & informed Consent forms are altered in accordance.

    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.
    Very summarized, more data available
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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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