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    Clinical Trial Results:
    Preventing meningitis in young people after infant immunisation: effect of a single meningococcal 4CMenB vaccine booster over 10 years of age

    Summary
    EudraCT number
    		 2017-004732-11
    Trial protocol
    		 GB  
    Global end of trial date
    28 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Mar 2022
    First version publication date
    24 Mar 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OVG2017/06
    Additional study identifiers
    ISRCTN number
    		 ISRCTN16774163
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford, Clinical Trials and Research Governance (CTRG)
    Sponsor organisation address
    Boundary Brook House, Oxford, United Kingdom, OX3 7GB
    Public contact
    Andrew Pollard, University of Oxford, 44 1865611400, andrew.pollard@paediatrics.ox.ac.uk
    Scientific contact
    Andrew Pollard, University of Oxford, 44 1865611400, andrew.pollard@paediatrics.ox.ac.uk
    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
    28 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if giving one booster dose of a licensed vaccine (4CMenB) to protect against meningococcal group B disease produces an antibody response that is protective in teenagers who were immunised as infants, as opposed to the two doses that are required for adolescents who have never been vaccinated before.
    Protection of trial subjects
    The main side effects of 4CMenB are local reactions, general malaise, and the possibility of fever (although it is more common in infants receiving 4CMenB). This is thoroughly explained in patient information booklets, and we also collect data on these side effects throughout the study to inform future decision-making. Children who have never received a meningococcal B vaccine before usually require at least 2 doses to become immune to the disease. Adolescent 1 group receive one does of 4CMenB at the first visit to act as a control for the groups receiving the vaccine once as a booster to their childhood immunisations. However, this single dose would not be enough to provide sufficient level of protection long term. For the participants in Adolescent 1 group not to be disadvantaged when compared with other groups, they are offered a second dose of 4CMenB at day 365. This should provide them with sufficient level of protection as the adolescent vaccine schedule for 4CMenB says that the two required doses should be separated by at least four weeks but does not stipulate an upper limit. The blood tests that are required to quantify how well the vaccine has induced immunity against meningococcus B can cause some distress to participants. This is mitigated with explanation and reassurance, use of anaesthetic cream or cold spray where necessary, and employment of staff skilled in paediatric venepuncture. The study staff will ensure that the participants' anonymity is maintained. The participants will be identified only by initials and a participants ID number on the source and any electronic CRF. All documents will be stored securely and only accessible by study staff and authorised personnel. The study will comply with the Data Protection Act which requires data to be anonymised as soon as it is practical to do so. Any data or samples that relate to participants and that leave the study site will be identified by study number and or code only.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 The 4CMenB vaccine was developed to protect all age groups against group B meningococcal disease. The vaccine was licensed in 2013 in Europe, North America and other jurisdictions, however only the UK has included it in a vaccination programme restricted to infants. The UK schedule consists of three doses administered at 2, 4 and 12 months of age. During clinical development, the vaccine was evaluated in adolescents, and was shown that two doses of 4CMenB induced robust immune responses. In the UK and in many other countries group B is responsible for the majority of invasive meningococcal disease. Although the number of these cases is currently low in adolescents, 4CmenB could offer protection to those adolescents against this devastating disease, and the vaccine is already licensed for that age group (as a two dose schedule). However, an adolescent program was not initiated in the UK because of the many uncertainties surrounding the vaccine efficacy, duration of protection in this age group and the estimation to not be cost-effective. In the future, all adolescents in the UK will have received their primary course of 4CMenB vaccination in infancy (currently three doses at 2, 4 +12 months). However no study has yet quantified the immune response in adolescents after a primary course of vaccination with 4CMenB given as babies. The infant 4CMenB vaccination program was only started in 2015 in the UK, and so these children have not yet reached adolescence. While the level of vaccine-induced protective antibody titres against MenB more than 10 years after the last vaccination is expected to be low, previously immunised adolescents may have a substantial level of vaccine-specific memory B-cells. This may in turn produce a strong antibody recall response to a new encounter with the antigen in the form of a booster vaccine. If this is the case, a single dose adolescent booster could be envisaged as an addition to the current vaccination schedule.
    Actual start date of recruitment
    24 Mar 2018
    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
    United Kingdom: 72
    Worldwide total number of subjects
    72
    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)
    49
    Adolescents (12-17 years)
    23
    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
    		 Between 24th March 2018 and 29th January 2019, the trial recruited 72 participants. Forty of the participants were vaccinated with with 4CMenB as part of previous studies in 2006-2009 at Oxford.

    Pre-assignment
    Screening details
    		 Healthy volunteers (received 4CMenB vaccine as infants as part of clinical trials in 2006 and 2009): 83 invited for screening, 53 responded, 40 enrolled. Naïve age-matched healthy volunteers: 62 invited for screening, 32 enrolled Exclusion criteria: previous meningococcal B disease, household contact of bacterial meningitis, immunodeficiency

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Follow up cohort
    Arm description
    		 Children, born between June and December 2006, who received either an infant 4CMenB schedule (infant group, 2-4-6 + 12 months or 6-8-12 months or just 12 months), or an infant schedule followed by a boost (at 40 months or 40 and 42 months), are given a booster dose of 4CMenB at approximately 11 years of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    4CMenB
    Investigational medicinal product code
    Other name
    Bexsero
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    supplied in pre-filled 1ml syringes that deliver a single dose of 0.5ml

    Arm title
    		 Adolescent 1 group
    Arm description
    		 Naïve age-matched controls who receive a single dose (day 0) of 4CMenB. For ethical reasons, they are offered a second dose at the end of study (day 365), so they would have received the full adolescent schedule.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    4CMenB
    Investigational medicinal product code
    Other name
    Bexsero
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    supplied in pre-filled 1ml syringes that deliver a single dose of 0.5ml

    Arm title
    		 Adolescent 2 group
    Arm description
    		 Naïve age-matched controls who receive two doses of 4CMenB at day 0 and 28.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    4CMenB
    Investigational medicinal product code
    Other name
    Bexsero
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    supplied in pre-filled 1ml syringes that deliver a single dose of 0.5ml

    Number of subjects in period 1
    		Follow up cohort Adolescent 1 group Adolescent 2 group
    Started
    40
    16
    16
    Completed
    37
    16
    14
    Not completed
    3
    0
    2
         Consent withdrawn by subject
    3
    -
    1
         failed to obtain blood
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Follow up cohort
    Reporting group description
    		 Children, born between June and December 2006, who received either an infant 4CMenB schedule (infant group, 2-4-6 + 12 months or 6-8-12 months or just 12 months), or an infant schedule followed by a boost (at 40 months or 40 and 42 months), are given a booster dose of 4CMenB at approximately 11 years of age.

    Reporting group title
    Adolescent 1 group
    Reporting group description
    		 Naïve age-matched controls who receive a single dose (day 0) of 4CMenB. For ethical reasons, they are offered a second dose at the end of study (day 365), so they would have received the full adolescent schedule.

    Reporting group title
    Adolescent 2 group
    Reporting group description
    		 Naïve age-matched controls who receive two doses of 4CMenB at day 0 and 28.

    Reporting group values
    		 Follow up cohort Adolescent 1 group Adolescent 2 group Total
    Number of subjects
    		 40 16 16 72
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age of the participants who received at least one 4CMenB dose.
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 11.7 (11.4 to 12.0) 12.1 (11.8 to 12.3) 12.1 (11.7 to 12.6) -
    Gender categorical
    Gender of the participants who received at least one 4CMenB dose.
    Units: Subjects
        Female
    		 23 11 6 40
        Male
    		 17 5 10 32
    Subject analysis sets

    Subject analysis set title
    infant group 1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule at 12 months of age (infant group 1), are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant group 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule at 6-8-12 months of age (infant group 2), are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant group 5
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received either an infant 4CMenB schedule at 2-4-6 + 12 months of age (infant group 5), are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant + preschool group 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule at 12 months of age followed by a boost at 40 and 42 months, are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant + preschool group 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule at 6-8-12 months of age followed by a boost at 40 months, are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant + preschool group 6
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule (at 2-4-6 + 12 months of age) followed by a boost at 40 months, are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    Adolescent 1 - group 7
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Naïve age-matched controls who receive a single dose (day 0) of 4CMenB. For ethical reasons, they are offered a second dose at the end of study (day 365), so they would have received the full adolescent schedule.

    Subject analysis set title
    Adolescent 2 - group 8
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Naïve age-matched controls who receive two doses of 4CMenB at day 0 and 28.

    Subject analysis sets values
    		 infant group 1 infant group 2 infant group 5 infant + preschool group 3 infant + preschool group 4 infant + preschool group 6 Adolescent 1 - group 7 Adolescent 2 - group 8
    Number of subjects
    4
    6
    6
    4
    9
    11
    16
    16
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Age of the participants who received at least one 4CMenB dose.
    Units: years
        median (inter-quartile range (Q1-Q3))
    11.6 (11.4 to 11.8)
    11.8 (11.4 to 12.0)
    11.5 (11.5 to 11.8)
    11.6 (11.4 to 11.7)
    11.7 (11.4 to 12.0)
    11.6 (11.4 to 11.9)
    12.1 (11.8 to 12.3)
    12.1 (11.7 to 12.6)
    Gender categorical
    Gender of the participants who received at least one 4CMenB dose.
    Units: Subjects
        Female
    1
    3
    4
    2
    7
    6
    11
    6
        Male
    3
    3
    2
    2
    2
    5
    5
    10

    End points

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    End points reporting groups
    Reporting group title
    Follow up cohort
    Reporting group description
    		 Children, born between June and December 2006, who received either an infant 4CMenB schedule (infant group, 2-4-6 + 12 months or 6-8-12 months or just 12 months), or an infant schedule followed by a boost (at 40 months or 40 and 42 months), are given a booster dose of 4CMenB at approximately 11 years of age.

    Reporting group title
    Adolescent 1 group
    Reporting group description
    		 Naïve age-matched controls who receive a single dose (day 0) of 4CMenB. For ethical reasons, they are offered a second dose at the end of study (day 365), so they would have received the full adolescent schedule.

    Reporting group title
    Adolescent 2 group
    Reporting group description
    		 Naïve age-matched controls who receive two doses of 4CMenB at day 0 and 28.

    Subject analysis set title
    infant group 1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule at 12 months of age (infant group 1), are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant group 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule at 6-8-12 months of age (infant group 2), are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant group 5
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received either an infant 4CMenB schedule at 2-4-6 + 12 months of age (infant group 5), are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant + preschool group 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule at 12 months of age followed by a boost at 40 and 42 months, are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant + preschool group 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule at 6-8-12 months of age followed by a boost at 40 months, are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    infant + preschool group 6
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children who received an infant 4CMenB schedule (at 2-4-6 + 12 months of age) followed by a boost at 40 months, are given a booster dose of 4CMenB at approximately 11 years of age.

    Subject analysis set title
    Adolescent 1 - group 7
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Naïve age-matched controls who receive a single dose (day 0) of 4CMenB. For ethical reasons, they are offered a second dose at the end of study (day 365), so they would have received the full adolescent schedule.

    Subject analysis set title
    Adolescent 2 - group 8
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Naïve age-matched controls who receive two doses of 4CMenB at day 0 and 28.

    Primary: Fold change in hSBA titre between Day 0 and Day 180

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    End point title
    		 Fold change in hSBA titre between Day 0 and Day 180 [1]
    End point description
    Calculation of the median of fold change in hSBA titre Day 180 value to Day 0 value. Results are reported as median of fold change with IQR, instead of geometric mean with 95% CI due to the small numbers.
    End point type
    Primary
    End point timeframe
    Fold change from Day 0 to Day 180
    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: This is a descriptive study and does not involve hypothesis testing for p-value.
    End point values
    		 infant group 1 infant group 2 infant group 5 infant + preschool group 3 infant + preschool group 4 infant + preschool group 6 Adolescent 1 - group 7 Adolescent 2 - group 8
    Number of subjects analysed
    4
    5
    6
    4
    9
    10
    15
    15
    Units: Fold change in hSBA
    median (inter-quartile range (Q1-Q3))
        strain 5/99
    72 (12 to 160)
    8 (4 to 128)
    24 (5 to 104)
    20 (6 to 56)
    32 (16 to 64)
    16 (4 to 112)
    2 (2 to 4)
    64 (64 to 128)
        strain NZ98/254
    1 (1 to 1)
    8 (1 to 8)
    2 (1 to 2)
    2 (2 to 2)
    4 (2 to 16)
    4 (2 to 4)
    1 (1 to 6)
    4 (2 to 12)
        strain 44/76-SL
    2 (1 to 5)
    1 (1 to 16)
    1 (1 to 1)
    4 (1 to 14)
    8 (4 to 32)
    4 (2 to 16)
    1 (1 to 1)
    4 (1 to 8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For the first 7days after immunisation at visit 1 (all study groups), visit 2 (group 8 only) and visit 4 (group 7 only) all AEs observed by the study team or reported by the participant’s parent/legal guardian, are recorded in the eDiary.
    Adverse event reporting additional description
    Description, onset and end date, severity, assessment of relatedness to study vaccine and action taken are recorder. Any medication taken to treat an AE is recorded. Reactions occurring in the first 7 days after immunisation are divided into solicited and unsolicited. Non-serous AE are not part of the study objectives and are not reported here.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Protocol
    Dictionary version
    v4.0
    Reporting groups
    Reporting group title
    Follow up cohort
    Reporting group description
    		 Children, born between June and December 2006, who received either an infant 4CMenB schedule (infant group, 2-4-6 + 12 months or 6-8-12 months or just 12 months), or an infant schedule followed by a boost (at 40 months or 40 and 42 months), are given a booster dose of 4CMenB at approximately 11 years of age. Follow up cohort consists of protocol groups 1-6.

    Reporting group title
    Adolescent 1 group
    Reporting group description
    		 Naïve age-matched controls who receive a single dose (day 0) of 4CMenB. For ethical reasons, they are offered a second dose at the end of study (day 365), so they would have received the full adolescent schedule.

    Reporting group title
    Adolescent 2 group
    Reporting group description
    		 Naïve age-matched controls who receive two doses of 4CMenB at day 0 and 28.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non-serous adverse events are not part of the study objectives and are not reported here. Full details of non-serious adverse events will be provided in the study publication.
    Serious adverse events
    		 Follow up cohort Adolescent 1 group Adolescent 2 group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Surgical and medical procedures
    Phimosis
    Additional description: Mild, not related to study vaccine, pre-existing condition
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (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
    Gastrointestinal disorders
    Acute appendicitis
    Additional description: Moderate, not related to study vaccine
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 16 (0.00%)
    0 / 16 (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
    Appendicitis
    Additional description: Moderate, not related to study vaccine
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Unexplained lower limb weakness
    Additional description: Severe, not related to study vaccine
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 16 (0.00%)
    0 / 16 (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
    Broken left wrist and green stick fracture
    Additional description: Moderate, not related to study vaccine
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Follow up cohort Adolescent 1 group Adolescent 2 group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2018
    .Addition of an option to return a reply slip for previously vaccinated participants when indicating whether they would like to take part in this study. .Changing the randomisation of patients in the naïve group from a computer-based system (Sortition) to a paper envelope based system to avoid issues with internet access on site.
    19 Mar 2018
    .Amended the protocol and parent and assenting information booklets to change the use of the continuous temperature monitoring device to being optional. .Added reply slips for GP and CHIS letters so they can let us know if they have managed to forward the invitation pack on to the family. Amended typographical errors in group card 7&8, Study labels and the assenting information booklet for non-naives.
    21 Jun 2018
    .Changing of the statistical analysis section to include a descriptive analysis of immunogenicity at 180 days, and changes to the wording of the how the analysis will be done. .Changing the wording of the exclusion criteria (changed “bacterial” meningitis to “meningococcal” meningitis). .Updating the PIL to change the details of where to opt-out of receiving study mail and to update GDPR details.

    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.
    Publication of results is in draft and will be published soon and distributed to participants. It will include the secondary objectives and non-serious adverse events, which are not reported here.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31340842
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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
    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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