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    Clinical Trial Results:
    Towards improved meningococcal vaccines: a randomised, descriptive, open label study exploring the relationship between gene expression signatures with reactogenicity and immunogenicity following vaccination with serogroup B meningococcal vaccine(4CMenB)

    Summary
    EudraCT number
    		 2014-000126-38
    Trial protocol
    		 GB  
    Global end of trial date
    27 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jan 2019
    First version publication date
    18 Jan 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OVG2012/05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02080559
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Oxford Vaccine Group, CCVTM, Churchill Hospital, Oxford, United Kingdom, OX3 7LE
    Public contact
    Oxford Vaccine Group, University of Oxford, andrew.pollard@paediatrics.ox.ac.uk
    Scientific contact
    Oxford Vaccine Group, University of Oxford, 01865 611400, 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
    20 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the kinetics of global gene expression (i.e. the pattern of which genes are switched on/off) in whole blood, following vaccination with 4CMenB vaccine in healthy infants.
    Protection of trial subjects
    Ethical, Legal and Management Protection: Every effort was made to ensure that parents or guardians giving informed consent were able to understand fully the nature of the study including the risks,burdens, benefits and implications that taking part had for their child. The study involved the collection of blood samples that would not normally be part of routine care. In order to minimise any discomfort, local anaesthetic cream was offered to numb the skin prior to the sample being collected. The members of the study team undertaking venepuncture had specific training and experience in this technique. With the parent/guardians agreement two attempts at blood sampling were made and if unsuccessful a further visit was arranged by the study team. Strict inclusion and exclusion criteria applied to the enrolment of each study participant. The study complied with the Data Protection Act which requires data to be anonymised as soon as it is practical to do so ensuring that the participant's anonymity was maintained throughout the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Apr 2014
    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: 187
    Worldwide total number of subjects
    187
    EEA total number of subjects
    187
    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)
    187
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Healthy 8-12 week old Caucasian infants born between 37 and 42 weeks of gestation were recruited in the UK between 21st July 2014 and 27th May 2015.

    Pre-assignment
    Screening details
    		 Eligible participants were identified through the Child Health Database, GP surgeries, the OVG website, and antenatal clinics or classes and the Oxford Spires Midwifery-led unit of the John Radcliffe Hospital, Oxford. Interested parents were telephone screened against the eligibility criteria.

    Period 1
    Period 1 title
    Visit 1 Enrolment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Test group, subgroup 1 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 2
    Arm description
    		 Test group, subgroup 2 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 3
    Arm description
    		 Test group, subgroup 3 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 4
    Arm description
    		 Test group, subgroup 4 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 5
    Arm description
    		 Control group, subgroup 5 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1).
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6
    Arm description
    		 Control group, subgroup 6 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1).
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 7
    Arm description
    		 Control group, subgroup 7 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1).
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 8
    Arm description
    		 Control group, subgroup 8 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1).
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8
    Started
    20
    22
    24
    28
    21
    23
    21
    28
    Completed
    20
    22
    24
    28
    21
    23
    21
    28
    Period 2
    Period 2 title
    Study visit 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Test group, subgroup 1: Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 2
    Arm description
    		 Test group, subgroup 2: Vaccinated with Pediacel, MenC and Rotarix at 3 months of age
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 3
    Arm description
    		 Test group, subgroup 3 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 4
    Arm description
    		 Test group, subgroup 4 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 5
    Arm description
    		 Control group, subgroup 5 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6
    Arm description
    		 Control group, subgroup 6 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 7
    Arm description
    		 Control group, subgroup 7 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 8
    Arm description
    		 Control group, subgroup 8 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [1]
    		Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8
    Started
    20
    22
    24
    28
    21
    22
    20
    26
    Completed
    20
    22
    24
    28
    21
    22
    20
    26
    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: Four participants withdrew between time periods 1 and 2.
    Period 3
    Period 3 title
    Visit 3 and 4: Primary Endpoint Baseline
    Is this the baseline period?
    		 Yes [2]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Test group, subgroup 1 Baseline blood collected at V3. Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 2
    Arm description
    		 Test group, subgroup 2 Baseline blood at visit 3 Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 3
    Arm description
    		 Test group, subgroup 3 Baseline blood at visit 4 Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 4
    Arm description
    		 Test group, subgroup 4 Baseline blood at visit 4 Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 5
    Arm description
    		 Control group, subgroup 5 Baseline blood at visit 3 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6
    Arm description
    		 Control group, subgroup 6 Baseline blood at visit 3 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 7
    Arm description
    		 Control group, subgroup 7 Baseline blood at visit 4 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 8
    Arm description
    		 Control group, subgroup 8 Baseline blood at visit 4 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: For this trial, the primary objective compared gene expression pre and post immunisation with the 2nd and 3rd dose of IMP.
    Number of subjects in period 3 [3] [4]
    		Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8
    Started
    19
    22
    24
    28
    21
    22
    20
    26
    Completed
    19
    22
    24
    28
    21
    22
    20
    26
    Notes
    [3] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The baseline for this trial was visit not the first visit. Five participants withdrew prior to the baseline visit.
    [4] - 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: One participant withdrew between time periods 2 and 3.
    Period 4
    Period 4 title
    Visit 5: Primary Endpoint
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Test group, subrgoup 1 Primary endpoint blood collected at V5 (V4+ 4 hours).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 2
    Arm description
    		 Test group, subgroup 2 Blood taken at V5=V4+24 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 3
    Arm description
    		 Test group, subgroup 3 Blood taken at V5=V4+72 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 4
    Arm description
    		 Test group, subgroup 4 Blood taken at V5=V4+7 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 5
    Arm description
    		 Control group, subgroup 5 Blood taken at V5=V4+4 hours
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6
    Arm description
    		 Control group, subgroup 6 Blood taken at V5=V4+24 hours
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 7
    Arm description
    		 Control group, subgroup 7 Blood taken at V5=V4+72 hours
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 8
    Arm description
    		 Control group, subgroup 8 Blood taken at V5=V4+7 days
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8
    Started
    19
    22
    24
    28
    21
    22
    20
    26
    Completed
    19
    22
    24
    28
    21
    22
    20
    26
    Period 5
    Period 5 title
    Follow up visits (6-12)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Test group, subgroup 1 Blood collected at visits 6, 9, 11 (V10 + 4 hours) and 12 Vaccination with Bexsero, Hib-MenC and PCV13 at visit 10 Vaccination with MMR at visit 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 2
    Arm description
    		 Test group, subgroup 2 Blood collected at visits 6, 9, 11 (V10 + 24 hours) and 12 Vaccination with Bexsero, Hib-MenC and PCV13 at visit 10 Vaccination with MMR at visit 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 3
    Arm description
    		 Test group, subgroup 3 Blood collected at visits 6, 10, 11 (V10 + 72 hours) and 12 Vaccination with Bexsero, Hib-MenC and PCV13 at visit 10 Vaccination with MMR at visit 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 4
    Arm description
    		 Test group, subgroup 4 Blood collected at visits 6, 10, 11 (V10 + 7 days) and 12 Vaccination with Bexsero, Hib-MenC and PCV13 at visit 10 Vaccination with MMR at visit 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml 4CMenB by intra-muscular injection into the upper antero-lateral aspect of the right thigh

    Arm title
    		 Group 5
    Arm description
    		 Control group, subgroup 5 Blood collected at visits 7, 9, 11 (V10 + 4 hours) and 12 Vaccination with Bexsero at visits 7 and 8 Vaccination with Hib-MenC and PCV13 at visit 10 Vaccination with MMR and Bexsero at visit 12
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6
    Arm description
    		 Control group, subgroup 6 Blood collected at visits 7, 9, 11 (V10 + 24 hours) and 12 Vaccination with Bexsero at visits 7 and 8 Vaccination with Hib-MenC and PCV13 at visit 10 Vaccination with MMR and Bexsero at visit 12
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 7
    Arm description
    		 Control group, subgroup 7 Blood collected at visits 7, 10, 11 (V10 + 72 hours) and 12 Vaccination with Bexsero at visits 7 and 8 Vaccination with Hib-MenC and PCV13 at visit 10 Vaccination with MMR and Bexsero at visit 12
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 8
    Arm description
    		 Control group, subgroup 8 Blood collected at visits 7, 10, 11 (V10 + 7 days) and 12 Vaccination with Bexsero at visits 7 and 8 Vaccination with Hib-MenC and PCV13 at visit 10 Vaccination with MMR and Bexsero at visit 12
    Arm type
    		 Routine immunisation schedule only, no IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 5
    		Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8
    Started
    19
    22
    24
    28
    21
    22
    20
    26
    Completed
    18
    22
    24
    28
    21
    22
    20
    26
    Not completed
    1
    0
    0
    0
    0
    0
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Test group, subgroup 1 Baseline blood collected at V3. Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 2
    Reporting group description
    		 Test group, subgroup 2 Baseline blood at visit 3 Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 3
    Reporting group description
    		 Test group, subgroup 3 Baseline blood at visit 4 Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 4
    Reporting group description
    		 Test group, subgroup 4 Baseline blood at visit 4 Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 5
    Reporting group description
    		 Control group, subgroup 5 Baseline blood at visit 3 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 6
    Reporting group description
    		 Control group, subgroup 6 Baseline blood at visit 3 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 7
    Reporting group description
    		 Control group, subgroup 7 Baseline blood at visit 4 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 8
    Reporting group description
    		 Control group, subgroup 8 Baseline blood at visit 4 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8 Total
    Number of subjects
    		 19 22 24 28 21 22 20 26 182
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 19 22 24 28 21 22 20 26 182
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 13 10 14 7 12 11 9 83
        Male
    		 12 9 14 14 14 10 9 17 99

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Test group, subgroup 1 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1).

    Reporting group title
    Group 2
    Reporting group description
    		 Test group, subgroup 2 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1).

    Reporting group title
    Group 3
    Reporting group description
    		 Test group, subgroup 3 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1).

    Reporting group title
    Group 4
    Reporting group description
    		 Test group, subgroup 4 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1).

    Reporting group title
    Group 5
    Reporting group description
    		 Control group, subgroup 5 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1).

    Reporting group title
    Group 6
    Reporting group description
    		 Control group, subgroup 6 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1).

    Reporting group title
    Group 7
    Reporting group description
    		 Control group, subgroup 7 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1).

    Reporting group title
    Group 8
    Reporting group description
    		 Control group, subgroup 8 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1).
    Reporting group title
    Group 1
    Reporting group description
    		 Test group, subgroup 1: Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2).

    Reporting group title
    Group 2
    Reporting group description
    		 Test group, subgroup 2: Vaccinated with Pediacel, MenC and Rotarix at 3 months of age

    Reporting group title
    Group 3
    Reporting group description
    		 Test group, subgroup 3 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age

    Reporting group title
    Group 4
    Reporting group description
    		 Test group, subgroup 4 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2)

    Reporting group title
    Group 5
    Reporting group description
    		 Control group, subgroup 5 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age

    Reporting group title
    Group 6
    Reporting group description
    		 Control group, subgroup 6 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age

    Reporting group title
    Group 7
    Reporting group description
    		 Control group, subgroup 7 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age

    Reporting group title
    Group 8
    Reporting group description
    		 Control group, subgroup 8 Vaccinated with Pediacel, MenC and Rotarix at 3 months of age
    Reporting group title
    Group 1
    Reporting group description
    		 Test group, subgroup 1 Baseline blood collected at V3. Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 2
    Reporting group description
    		 Test group, subgroup 2 Baseline blood at visit 3 Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 3
    Reporting group description
    		 Test group, subgroup 3 Baseline blood at visit 4 Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 4
    Reporting group description
    		 Test group, subgroup 4 Baseline blood at visit 4 Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 5
    Reporting group description
    		 Control group, subgroup 5 Baseline blood at visit 3 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 6
    Reporting group description
    		 Control group, subgroup 6 Baseline blood at visit 3 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 7
    Reporting group description
    		 Control group, subgroup 7 Baseline blood at visit 4 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4

    Reporting group title
    Group 8
    Reporting group description
    		 Control group, subgroup 8 Baseline blood at visit 4 Vaccinated with Pediacel, PCV13 at 4 months of age at visit 4
    Reporting group title
    Group 1
    Reporting group description
    		 Test group, subrgoup 1 Primary endpoint blood collected at V5 (V4+ 4 hours).

    Reporting group title
    Group 2
    Reporting group description
    		 Test group, subgroup 2 Blood taken at V5=V4+24 hours

    Reporting group title
    Group 3
    Reporting group description
    		 Test group, subgroup 3 Blood taken at V5=V4+72 hours

    Reporting group title
    Group 4
    Reporting group description
    		 Test group, subgroup 4 Blood taken at V5=V4+7 days

    Reporting group title
    Group 5
    Reporting group description
    		 Control group, subgroup 5 Blood taken at V5=V4+4 hours

    Reporting group title
    Group 6
    Reporting group description
    		 Control group, subgroup 6 Blood taken at V5=V4+24 hours

    Reporting group title
    Group 7
    Reporting group description
    		 Control group, subgroup 7 Blood taken at V5=V4+72 hours

    Reporting group title
    Group 8
    Reporting group description
    		 Control group, subgroup 8 Blood taken at V5=V4+7 days
    Reporting group title
    Group 1
    Reporting group description
    		 Test group, subgroup 1 Blood collected at visits 6, 9, 11 (V10 + 4 hours) and 12 Vaccination with Bexsero, Hib-MenC and PCV13 at visit 10 Vaccination with MMR at visit 12

    Reporting group title
    Group 2
    Reporting group description
    		 Test group, subgroup 2 Blood collected at visits 6, 9, 11 (V10 + 24 hours) and 12 Vaccination with Bexsero, Hib-MenC and PCV13 at visit 10 Vaccination with MMR at visit 12

    Reporting group title
    Group 3
    Reporting group description
    		 Test group, subgroup 3 Blood collected at visits 6, 10, 11 (V10 + 72 hours) and 12 Vaccination with Bexsero, Hib-MenC and PCV13 at visit 10 Vaccination with MMR at visit 12

    Reporting group title
    Group 4
    Reporting group description
    		 Test group, subgroup 4 Blood collected at visits 6, 10, 11 (V10 + 7 days) and 12 Vaccination with Bexsero, Hib-MenC and PCV13 at visit 10 Vaccination with MMR at visit 12

    Reporting group title
    Group 5
    Reporting group description
    		 Control group, subgroup 5 Blood collected at visits 7, 9, 11 (V10 + 4 hours) and 12 Vaccination with Bexsero at visits 7 and 8 Vaccination with Hib-MenC and PCV13 at visit 10 Vaccination with MMR and Bexsero at visit 12

    Reporting group title
    Group 6
    Reporting group description
    		 Control group, subgroup 6 Blood collected at visits 7, 9, 11 (V10 + 24 hours) and 12 Vaccination with Bexsero at visits 7 and 8 Vaccination with Hib-MenC and PCV13 at visit 10 Vaccination with MMR and Bexsero at visit 12

    Reporting group title
    Group 7
    Reporting group description
    		 Control group, subgroup 7 Blood collected at visits 7, 10, 11 (V10 + 72 hours) and 12 Vaccination with Bexsero at visits 7 and 8 Vaccination with Hib-MenC and PCV13 at visit 10 Vaccination with MMR and Bexsero at visit 12

    Reporting group title
    Group 8
    Reporting group description
    		 Control group, subgroup 8 Blood collected at visits 7, 10, 11 (V10 + 7 days) and 12 Vaccination with Bexsero at visits 7 and 8 Vaccination with Hib-MenC and PCV13 at visit 10 Vaccination with MMR and Bexsero at visit 12

    Primary: Gene expression post immunisation

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    End point title
    		 Gene expression post immunisation [1]
    End point description
    Analysis of differentially expressed genes in whole blood at 4hr, 24hr, 3d and 7d time points following the 2nd and 3rd doses of 4CMenB vaccine when given at 2, 4 and 12 months of age together with routine immunisations, or following routine immunisations alone given at equivalent time points
    End point type
    Primary
    End point timeframe
    Gene expression 4, 24, 72 hours or 7 days post immunisation with a second dose of Bexsero was compared to expression at baseline.
    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: Details of the statistical analyses performed will be available in the trial publication.
    End point values
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8
    Number of subjects analysed
    19
    22
    24
    28
    21
    22
    20
    26
    Units: Gene counts per million
        number (not applicable)
    19
    22
    24
    28
    21
    22
    20
    26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    7 days following the 2, 4, and 12 month vaccinations (V1, V4 & V10) Prescription medications given in the 28 days that follow these time points
    Adverse event reporting additional description
    The parents of participants were asked to maintain an electronic diary card detailing all (solicited and unsolicited) reactions in the 7 days following the 2, 4, and 12 month vaccinations (V1, V4 & V10), as well as prescription medications that are given in the 28 days that follow these time points.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Protocol
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Test group (routine immunisation schedule plus Bexsero). Baseline blood collected at V3. Primary endpoint blood collected at V5 (V4+ 4 hours).

    Reporting group title
    Group 2
    Reporting group description
    		 Test group, subgroup 2 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1). Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2). Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age (V4). Blood taken at V5=V4+24 hours

    Reporting group title
    Group 3
    Reporting group description
    		 Test group, subgroup 3 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1). Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2). Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age (V4). Blood taken at V5=V4+72 hours

    Reporting group title
    Group 4
    Reporting group description
    		 Test group, subgroup 4 Vaccinated with 4CMenB, Pediacel, PCV13 and Rotarix at 2 months of age (V1). Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2). Vaccinated with 4CMenB, Pediacel, PCV13 at 4 months of age (V4). Blood taken at V5=V4+7 days

    Reporting group title
    Group 5
    Reporting group description
    		 Control group, subgroup 5 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1). Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2). Vaccinated with Pediacel, PCV13 at 4 months of age (V4). Blood taken at V5=V4+4 hours

    Reporting group title
    Group 6
    Reporting group description
    		 Control group, subgroup 6 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1). Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2). Vaccinated with Pediacel, PCV13 at 4 months of age (V4). Blood taken at V5=V4+24 hours

    Reporting group title
    Group 7
    Reporting group description
    		 Control group, subgroup 7 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1). Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2). Vaccinated with Pediacel, PCV13 at 4 months of age (V4). Blood taken at V5=V4+72 hours

    Reporting group title
    Group 8
    Reporting group description
    		 Control group, subgroup 8 Vaccinated with Pediacel, PCV13 and Rotarix at 2 months of age (V1). Vaccinated with Pediacel, MenC and Rotarix at 3 months of age (V2). Vaccinated with Pediacel, PCV13 at 4 months of age (V4). Blood taken at V5=V4+7 days

    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: Adverse event data for this trial only form part of the exploratory analysis and are therefore not included in this report.
    Serious adverse events
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 22 (0.00%)
    2 / 24 (8.33%)
    2 / 28 (7.14%)
    0 / 21 (0.00%)
    3 / 23 (13.04%)
    1 / 21 (4.76%)
    3 / 28 (10.71%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Sepsis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 24 (0.00%)
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hypothermia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 24 (4.17%)
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to animal
    Additional description: Cow's milk intolerance
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 24 (0.00%)
    1 / 28 (3.57%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchiolitis
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 22 (0.00%)
    0 / 24 (0.00%)
    1 / 28 (3.57%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wheezing
    Additional description: Respiratory distress/wheeze
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 24 (0.00%)
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Abscess
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 24 (0.00%)
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 24 (4.17%)
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 24 (0.00%)
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 28 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2015
    This amendment updated the protocol as follows: 1. Addition of exploratory objective to evaluate the effect of maternal pertussis vaccine receipt on infant immunisation responses and addition of exploratory endpoint of concentration of infant pertussis antigens – in order to evaluate the effect of maternal pertussis vaccine receipt on infant immunisation responses 2. Temperature recording to be performed at 4 and 8 hours to better reflect time of maximum fever as identified on continuous monitoring on ibutton 3. Sample size adjusted due to being unable to collect enough blood samples at key time points to achieve the primary objective at the original sample size 4. Planed trial duration extended to 2 years in order to complete all analyses
    21 Mar 2018
    This amendment updated the protocol in relation to secondary and exploratory endpoints.

    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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