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    Clinical Trial Results:
    A Phase II, open-label, rollover trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 in BNT162-01 trial subjects, or two boosting doses of Comirnaty in BNT162-04 trial subjects

    Summary
    EudraCT number
    2021-002387-50
    Trial protocol
    DE  
    Global end of trial date
    16 Sep 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Oct 2023
    First version publication date
    01 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BNT162-14
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04949490
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    BioNTech SE
    Sponsor organisation address
    An der Goldgrube 12, Mainz, Germany, 55131
    Public contact
    BioNTech clinical trials patient information, BioNTech SE, 0049 613190840, patients@biontech.de
    Scientific contact
    BioNTech clinical trials patient information, BioNTech SE, 0049 613190840, patients@biontech.de
    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
    04 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the safety and tolerability of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 in BNT162-01 trial subjects, or two boosting doses of Comirnaty in BNT162-04 trial subjects.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Jul 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
    Germany: 137
    Worldwide total number of subjects
    137
    EEA total number of subjects
    137
    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)
    106
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This rollover study (BNT162-14) has enrolled BNT162-01 (EudraCT number 2020-001038-36) or BNT162-04 (EudraCT number 2020-003267-26) study participants meeting all inclusion/exclusion criteria defined in the study protocol. The first participant was enrolled on 26 JUL 2021. The last visit of the last participant was on 16 SEP 2022.

    Pre-assignment
    Screening details
    All enrolled participants were allocated to treatment. Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants)

    Period 1
    Period 1 title
    Group A and B
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Group A Comirnaty
    Arm description
    Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1. BNT162b2: intramuscular (IM) injection
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM); upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    Group A BNT162b2s01
    Arm description
    Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1. BNT162b2s01: IM injection
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2s01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    Group A Total
    Arm description
    All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1. BNT162b2s01 and BNT162b2: IM injection
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM); upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Investigational medicinal product name
    BNT162b2s01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM; upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    Group B Non-transplant Participants
    Arm description
    Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM); upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    Group B Transplant Participants
    Arm description
    Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). BNT162b2: IM injection
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM); upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    Group B Total
    Arm description
    All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM); upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Number of subjects in period 1
    Group A Comirnaty Group A BNT162b2s01 Group A Total Group B Non-transplant Participants Group B Transplant Participants Group B Total
    Started
    21
    44
    65
    61
    11
    72
    Completed
    21
    44
    65
    60
    9
    69
    Not completed
    0
    0
    0
    1
    2
    3
         Consent withdrawn by subject
    -
    -
    -
    1
    -
    1
         Non-study SARS-COV-2 vaccination
    -
    -
    -
    -
    2
    2
    Period 2
    Period 2 title
    Subset Group B Immunogenicity Evaluation
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group B Immunology Subset Non-transplant Participants
    Arm description
    Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM); upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    Group B Immunology Subset Transplant Participants
    Arm description
    Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). BNT162b2: IM injection
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM); upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Arm title
    Group B Immunology Subset Total
    Arm description
    All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection
    Arm type
    Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM); upper arm, musculus deltoideus. The non-dominant arm was preferred.

    Number of subjects in period 2
    Group B Immunology Subset Non-transplant Participants Group B Immunology Subset Transplant Participants Group B Immunology Subset Total
    Started
    22
    11
    33
    Completed
    21
    9
    30
    Not completed
    1
    2
    3
         Consent withdrawn by subject
    1
    -
    1
         Non-study SARS-COV-2 vaccination
    -
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A Comirnaty
    Reporting group description
    Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1. BNT162b2: intramuscular (IM) injection

    Reporting group title
    Group A BNT162b2s01
    Reporting group description
    Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1. BNT162b2s01: IM injection

    Reporting group title
    Group A Total
    Reporting group description
    All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1. BNT162b2s01 and BNT162b2: IM injection

    Reporting group title
    Group B Non-transplant Participants
    Reporting group description
    Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Reporting group title
    Group B Transplant Participants
    Reporting group description
    Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). BNT162b2: IM injection

    Reporting group title
    Group B Total
    Reporting group description
    All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Reporting group values
    Group A Comirnaty Group A BNT162b2s01 Group A Total Group B Non-transplant Participants Group B Transplant Participants Group B Total Total
    Number of subjects
    21 44 65 61 11 72 137
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0
        Adults (18-64 years)
    17 28 45 50 11 61 106
        From 65-84 years
    4 16 20 11 0 11 31
        85 years and over
    0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    53.91 ( 15.13 ) 55.81 ( 15.20 ) 55.19 ( 15.09 ) 49.17 ( 16.72 ) 50.88 ( 11.92 ) 49.43 ( 16.02 ) -
    Gender categorical
    Units: Subjects
        Female
    9 20 29 29 5 34 63
        Male
    12 24 36 32 6 38 74
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    1 0 1 0 0 0 1
        Not Hispanic or Latino
    20 44 64 61 11 72 136
    Race
    Units: Subjects
        Asian
    0 1 1 0 0 0 1
        Black or African American
    0 1 1 0 0 0 1
        White
    21 42 63 61 11 72 135
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    76.76 ( 10.80 ) 76.73 ( 13.45 ) 76.74 ( 12.57 ) 76.79 ( 13.86 ) 74.14 ( 10.93 ) 76.38 ( 13.42 ) -
    Subject analysis sets

    Subject analysis set title
    Group B Immunology Subset Non-transplant Participants
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Subject analysis set title
    Group B Immunology Subset Transplant Participants
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). BNT162b2: IM injection

    Subject analysis set title
    Group B Immunology Subset Total
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Subject analysis sets values
    Group B Immunology Subset Non-transplant Participants Group B Immunology Subset Transplant Participants Group B Immunology Subset Total
    Number of subjects
    22
    11
    33
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    21
    11
    32
        From 65-84 years
    1
    0
    1
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.09 ( 15.00 )
    50.88 ( 11.92 )
    45.02 ( 14.48 )
    Gender categorical
    Units: Subjects
        Female
    6
    5
    11
        Male
    16
    6
    22
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
    0
    0
        Not Hispanic or Latino
    22
    11
    33
    Race
    Units: Subjects
        Asian
    0
    0
    0
        Black or African American
    0
    0
    0
        White
    22
    11
    33
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    79.08 ( 14.39 )
    74.14 ( 10.93 )
    77.43 ( 13.37 )

    End points

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    End points reporting groups
    Reporting group title
    Group A Comirnaty
    Reporting group description
    Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1. BNT162b2: intramuscular (IM) injection

    Reporting group title
    Group A BNT162b2s01
    Reporting group description
    Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1. BNT162b2s01: IM injection

    Reporting group title
    Group A Total
    Reporting group description
    All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1. BNT162b2s01 and BNT162b2: IM injection

    Reporting group title
    Group B Non-transplant Participants
    Reporting group description
    Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Reporting group title
    Group B Transplant Participants
    Reporting group description
    Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). BNT162b2: IM injection

    Reporting group title
    Group B Total
    Reporting group description
    All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection
    Reporting group title
    Group B Immunology Subset Non-transplant Participants
    Reporting group description
    Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Reporting group title
    Group B Immunology Subset Transplant Participants
    Reporting group description
    Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). BNT162b2: IM injection

    Reporting group title
    Group B Immunology Subset Total
    Reporting group description
    All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Subject analysis set title
    Group B Immunology Subset Non-transplant Participants
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Subject analysis set title
    Group B Immunology Subset Transplant Participants
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). BNT162b2: IM injection

    Subject analysis set title
    Group B Immunology Subset Total
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Primary: The Number of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)

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    End point title
    The Number of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs) [1]
    End point description
    For treatment-emergent SAEs and AESIs (TESAEs, TEAESIs), the data refers to the interval “Dose 1 up to 28 days after Dose 1”. For other SAEs and AESIs, the data refers to the interval “Dose 1 up to 26 weeks after Dose 1”. A TESAE/TEAESI is defined as any SAE/AESI with an onset after the first IMP dose or worsened after the first IMP dose (if the SAE/AESI was present before the first administration of IMP). SAEs/AESIs with an onset date more than 28 days after the last administration of IMP will be considered as TESAE/TEAESI only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
    End point type
    Primary
    End point timeframe
    Up to 26 weeks after the first IMP injection
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this primary endpoint.
    End point values
    Group A Comirnaty Group A BNT162b2s01 Group A Total Group B Non-transplant Participants Group B Transplant Participants Group B Total Group B Immunology Subset Non-transplant Participants Group B Immunology Subset Transplant Participants Group B Immunology Subset Total
    Number of subjects analysed
    21
    44
    65
    61
    11
    72
    22
    11
    33
    Units: Participants
        Any SAE
    0
    2
    2
    1
    4
    5
    0
    4
    4
        Any related SAE
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Any TESAE
    0
    1
    1
    0
    1
    1
    0
    0
    0
        Any related TESAE
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Any AESI
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Any related AESI
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Any TEAESI
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: The Number of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants

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    End point title
    The Number of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants [2] [3]
    End point description
    Local reactions (pain, tenderness, erythema/redness, induration/swelling) were graded using criteria based on the guidance given in US FDA Guidance for Industry “Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials”; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of local reactions was based on the participant’s assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented. 99999 indicates not applicable since Group A only received 1 dose.
    End point type
    Primary
    End point timeframe
    Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this primary endpoint.
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per protocol, the results for Group B Immunology Subset participants are presented and not for all Group B participants.
    End point values
    Group A Comirnaty Group A BNT162b2s01 Group A Total Group B Immunology Subset Non-transplant Participants Group B Immunology Subset Transplant Participants Group B Immunology Subset Total
    Number of subjects analysed
    21
    44
    65
    22
    11
    33
    Units: Participants
        Dose 1 up to Day 8: any local reaction
    20
    41
    61
    21
    10
    31
        Dose 1 up to Day 8: any grade >=3 local reaction
    1
    2
    3
    3
    1
    4
        Dose 2 up to Day 8: any local reaction
    99999
    99999
    99999
    20
    5
    25
        Dose 2 up to Day 8: any grade >=3 local reaction
    99999
    99999
    99999
    4
    0
    4
    No statistical analyses for this end point

    Primary: The Number of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants

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    End point title
    The Number of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants [4] [5]
    End point description
    Systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) were graded using criteria based on the guidance given in US FDA Guidance for Industry “Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials”; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of systemic reactions was based on the participant’s assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented. 99999 indicates not applicable since Group A only received 1 dose.
    End point type
    Primary
    End point timeframe
    Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this primary endpoint.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per protocol, the results for Group B Immunology Subset participants are presented and not for all Group B participants.
    End point values
    Group A Comirnaty Group A BNT162b2s01 Group A Total Group B Immunology Subset Non-transplant Participants Group B Immunology Subset Transplant Participants Group B Immunology Subset Total
    Number of subjects analysed
    21
    44
    65
    22
    11
    33
    Units: Participants
    number (not applicable)
        Dose 1 to Day 8: any systemic reaction
    18
    33
    51
    20
    8
    28
        Dose 1 to Day 8: any grade >=3 systemic reaction
    4
    9
    13
    2
    0
    2
        Dose 2 to Day 8: any systemic reaction
    99999
    99999
    99999
    17
    4
    21
        Dose 2 to Day 8: any grade >=3 systemic reaction
    99999
    99999
    99999
    7
    0
    7
    No statistical analyses for this end point

    Primary: The Number of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants

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    End point title
    The Number of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants [6] [7]
    End point description
    A TEAE is defined as any AE with an onset after the first IMP injection or worsened after the first IMP injection (if the AE was present before the first administration of IMP). AEs with an onset date more than 28 days after the last administration of IMP will be considered as treatment-emergent only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented. 99999 indicates not applicable since Group A only received 1 dose.
    End point type
    Primary
    End point timeframe
    Up to 28 days after Dose 1 and up to 28 days after Dose 2
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this primary endpoint.
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per protocol, the results for Group B Immunology Subset participants are presented and not for all Group B participants.
    End point values
    Group A Comirnaty Group A BNT162b2s01 Group A Total Group B Immunology Subset Non-transplant Participants Group B Immunology Subset Transplant Participants Group B Immunology Subset Total
    Number of subjects analysed
    21
    44
    65
    22
    11
    33
    Units: Participants
        Dose 1 up to Day 29: any TEAE
    8
    14
    22
    5
    6
    11
        Dose 1 up to Day 29: any grade >=3 TEAE
    1
    1
    2
    0
    0
    0
        Dose 2 up to Day 29: any TEAE
    99999
    99999
    99999
    5
    2
    7
        Dose 2 up to Day 29: any grade >=3 TEAE
    99999
    99999
    99999
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351

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    End point title
    Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351 [8]
    End point description
    For Group A participants and Group B participants (except transplant subjects). Non-transplant participants of the Group B immunology subset are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A includes all participants from the Group A arms/groups. Response neutralizing antibody titers from reference (ref.) strain and SARS-CoV-2 variant B.1.351 (variant). 9999 indicates data not collected per protocol. 99999 indicates titers were below lower limit of detection and confidence intervals were not computable.
    End point type
    Secondary
    End point timeframe
    Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per planned analyses data is only presented for the Group B immunology subset.
    End point values
    Group A Comirnaty Group A BNT162b2s01 Group A Total Group B Non-transplant Participants Group B Immunology Subset Non-transplant Participants
    Number of subjects analysed
    21
    44
    65
    61
    22
    Units: Titer
    geometric mean (confidence interval 95%)
        Neutralizing antibody titers ref. strain - Day 1
    21.4 (13.2 to 34.5)
    21.3 (15.3 to 29.6)
    21.3 (16.4 to 27.7)
    15.6 (11.5 to 21.0)
    13.3 (8.3 to 21.3)
        Neutralizing antibody titers variant - Day 1
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Neutralizing antibody titers ref. strain - Day 8
    640.0 (376.6 to 1087.7)
    349.0 (254.5 to 478.6)
    424.5 (322.5 to 558.8)
    729.3 (485.4 to 1095.8)
    1093.4 (719.8 to 1661.0)
        Neutralizing antibody titers variant - Day 8
    285.1 (164.2 to 495.0)
    330.2 (232.3 to 469.5)
    314.9 (235.8 to 420.6)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Neutralizing antibody titers ref. strain - Day 22
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    1085.6 (775.5 to 1519.5)
    1183.0 (738.2 to 1896.0)
        Neutralizing antibody titers ref. strain - Day 29
    570.2 (309.3 to 1051.1)
    509.3 (372.4 to 696.6)
    528.2 (399.1 to 699.2)
    1789.7 (1367.3 to 2342.6)
    1868.1 (1278.7 to 2729.3)
        Neutralizing antibody titers variant - Day 29
    271.3 (157.9 to 466.1)
    325.1 (233.2 to 453.3)
    306.6 (232.4 to 404.6)
    9999 (9999 to 9999)
    9999 (-9999 to 9999)
        Neutralizing antibody titers ref. strain - Day 50
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    1386.0 (1054.5 to 1821.6)
    1429.2 (864.5 to 2362.8)
        Neutralizing antibody titers ref. strain - Day 85
    371.2 (202.5 to 680.5)
    282.1 (181.0 to 439.8)
    313.9 (221.5 to 444.9)
    1348.3 (992.8 to 1831.1)
    1301.3 (795.2 to 2129.5)
        Neutralizing antibody titers variant - Day 85
    122.9 (65.3 to 231.4)
    259.4 (162.6 to 413.7)
    194.0 (133.0 to 282.9)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Neutralizing antibody titers ref. strain - Day 182
    336.2 (159.6 to 708.6)
    132.0 (64.6 to 269.7)
    218.4 (130.0 to 366.8)
    659.8 (469.5 to 927.1)
    710.1 (439.5 to 1147.3)
        Neutralizing antibody titers variant - Day 182
    140.2 (60.4 to 325.2)
    129.5 (63.8 to 262.6)
    135.1 (79.3 to 230.3)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351

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    End point title
    Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351 [9]
    End point description
    For Group A participants and Group B participants (except transplant subjects); immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment. Response antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference Ref.) strain and SARS-CoV-2 Variant B.1.351 (variant). Non-transplant participants in the Group B immunology subset arm are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A includes all participants from the Group A arms/groups. 9999 indicates data not collected per protocol. 99999 indicates titers were above upper limit of detection and confidence intervals were not computable.
    End point type
    Secondary
    End point timeframe
    Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per planned analyses data is only presented for the Group B immunology subset.
    End point values
    Group A Comirnaty Group A BNT162b2s01 Group A Total Group B Non-transplant Participants Group B Immunology Subset Non-transplant Participants
    Number of subjects analysed
    21
    44
    65
    61
    22
    Units: Titers
    geometric mean (confidence interval 95%)
        Antibody titers IgG RBD ref. strain - Day 1
    2216.1 (1507.6 to 3257.7)
    2161.4 (1634.7 to 2857.8)
    2178.9 (1748.0 to 2716.1)
    2135.4 (1303.7 to 3497.5)
    2056.4 (1297.3 to 3259.6)
        Antibody titers IgG RBD variant - Day 1
    566.5 (370.9 to 865.3)
    588.7 (438.4 to 790.6)
    581.5 (459.5 to 735.8)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Antibody titers IgG S protein ref. strain - Day 1
    3209.0 (2045.6 to 5033.9)
    2594.7 (1977.5 to 3404.4)
    2779.1 (2210.9 to 3493.2)
    1634.4 (1025.5 to 2605.0)
    1636.2 (885.2 to 3024.5)
        Antibody titers IgG S protein variant - Day 1
    7164.8 (4231.7 to 12130.9)
    9267.9 (6837.3 to 12562.5)
    8528.4 (6572.5 to 11066.5)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Antibody titers IgG RBD ref. strain - Day 8
    99999 (-99999 to 99999)
    48945.7 (35518.9 to 67447.9)
    99999 (-99999 to 99999)
    48805.7 (29759.0 to 80043.1)
    99999 (-99999 to 99999)
        Antibody titers IgG RBD variant - Day 8
    22903.0 (11936.4 to 43945.2)
    21244.0 (15712.2 to 28723.3)
    21766.4 (16403.7 to 28882.2)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Antibody titers IgG S protein ref. strain - Day 8
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    45270.4 (27269.8 to 75153.2)
    99999 (-99999 to 99999)
        Antibody titers IgG S protein variant - Day 8
    520744.5 (258322.6 to 1049752.6)
    480042.7 (319790.9 to 720599.2)
    492832.1 (348924.0 to 696092.7)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Antibody titers IgG RBD ref. strain - Day 22
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Antibody titers IgG S protein ref. strain - Day 22
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Antibody titers IgG RBD ref. strain - Day 29
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Antibody titers IgG RBD variant - Day 29
    18959.7 (11062.8 to 32493.5)
    21082.1 (16052.9 to 27686.8)
    20371.6 (15940.0 to 26035.3)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Antibody titers IgG S protein ref. strain - Day 29
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Antibody titers IgG S protein variant - Day 29
    394493.5 (198914.7 to 782371.2)
    362296.9 (259569.0 to 505680.9)
    372400.7 (274455.6 to 505299.6)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Antibody titers IgG RBD ref. strain - Day 50
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Antibody titers IgG S protein ref. strain - Day 50
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Antibody titers IgG RBD ref. strain - Day 85
    23883.9 (15193.4 to 37545.2)
    28535.3 (20676.5 to 39381.0)
    26627.5 (20616.5 to 34391.0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Antibody titers IgG RBD variant - Day 85
    11106.8 (6446.7 to 19135.5)
    14367.3 (9798.4 to 21066.5)
    12998.8 (9570.3 to 17655.4)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Antibody titers IgG S protein ref. strain - Day 85
    50709.2 (33710.6 to 76279.3)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Antibody titers IgG S protein variant - Day 85
    178167.5 (95710.4 to 331663.8)
    305041.0 (196223.1 to 474205.2)
    247480.6 (173229.4 to 353558.0)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Antibody titers IgG RBD ref. strain - Day 182
    14309.8 (7900.1 to 25920.0)
    8670.5 (5238.9 to 14349.9)
    11355.5 (7717.3 to 16709.0)
    34032.7 (25327.8 to 45729.3)
    38865.2 (23611.8 to 63972.6)
        Antibody titers IgG RBD variant - Day 182
    9829.9 (4948.4 to 19526.7)
    6967.7 (4124.5 to 11770.9)
    8386.3 (5479.1 to 12835.9)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        Antibody titers IgG S protein ref. strain - Day182
    27732.0 (15894.6 to 48385.3)
    17049.8 (10185.6 to 28539.8)
    22155.2 (15250.2 to 32186.6)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Antibody titers IgG S protein variant - Day 182
    142683.7 (67849.2 to 300057.1)
    91825.4 (50843.9 to 165838.9)
    116420.8 (72901.4 to 185919.5)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain

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    End point title
    SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain [10]
    End point description
    For Group A only. The geometric mean titer (GMT) ratio is calculated as the GMT of reference divided by the GMT of variant B.1.351. The 'Total' arm for Group A includes all participants from the two Group A arms/groups.
    End point type
    Secondary
    End point timeframe
    Up to 26 weeks after the first IMP injection (Dose 1)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per planned analyses data is only presented for Group A.
    End point values
    Group A Comirnaty Group A BNT162b2s01 Group A Total
    Number of subjects analysed
    21
    44
    65
    Units: GMT ratio
    number (not applicable)
        GMT ratio neutralizing antibody titers - Day 1
    3.1
    3.0
    3.0
        GMT ratio antibody titers IgG RBD Domain - Day 1
    3.9
    3.7
    3.7
        GMT ratio antibody titers IgG S Protein - Day 1
    0.4
    0.3
    0.3
        GMT ratio neutralizing antibody titers - Day 8
    2.2
    1.1
    1.3
        GMT ratio antibody titers IgG RBD Domain - Day 8
    2.9
    2.3
    2.5
        GMT ratio antibody titers IgG S Protein - Day 8
    0.2
    0.2
    0.2
        GMT ratio neutralizing antibody titers - Day 29
    2.1
    1.6
    1.7
        GMT ratio antibody titers IgG RBD Domain - Day 29
    3.1
    2.6
    2.8
        GMT ratio antibody titers IgG S Protein - Day 29
    0.2
    0.2
    0.2
        GMT ratio neutralizing antibody titers - Day 85
    3.0
    1.1
    1.6
        GMT ratio antibody titers IgG RBD Domain - Day 85
    2.2
    2.0
    2.0
        GMT ratio antibody titers IgG S Protein - Day 85
    0.3
    0.2
    0.2
        GMT ratio neutralizing antibody titers - Day 182
    2.4
    1.0
    1.6
        MT ratio antibody titers IgG RBD Domain - Day 182
    1.5
    1.2
    1.4
        GMT ratio antibody titers IgG S Protein - Day 182
    0.2
    0.2
    0.2
    No statistical analyses for this end point

    Secondary: Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2

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    End point title
    Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2 [11]
    End point description
    For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2. Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data. 99999 indicates that titers were below lower limit of detection and confidence intervals were not computable.
    End point type
    Secondary
    End point timeframe
    From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2.
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per protocol, the results for Group B Transplant Participants are presented.
    End point values
    Group B Transplant Participants
    Number of subjects analysed
    11
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 1 of Dose 1
    99999 (-99999 to 99999)
        Day 8 of Dose 1
    48.3 (13.0 to 179.2)
        Day 29 of Dose 1
    124.4 (25.4 to 609.6)
        Day 85 of Dose 1
    80.0 (17.1 to 374.8)
        Day 182 of Dose 1
    108.9 (23.1 to 513.0)
        Day 1 pre Dose 2
    47.6 (7.3 to 311.5)
        Day 8 post Dose 2
    142.5 (9.4 to 2160.6)
        Day 29 post Dose 2
    452.5 (61.7 to 3317.6)
        Day 85 post Dose 2
    142.5 (21.5 to 945.6)
        Day 182 post Dose 2
    127.0 (19.7 to 819.1)
    No statistical analyses for this end point

    Secondary: Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2

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    End point title
    Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2 [12]
    End point description
    For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2. Response antibody titers for IgG RBD Domain (RBD) and IgG S Protein of the reference strain measured by enzyme-linked immunosorbent assay (ELISA) are presented. Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.
    End point type
    Secondary
    End point timeframe
    From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2.
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per protocol, the results for Group B Transplant Participants are presented.
    End point values
    Group B Transplant Participants
    Number of subjects analysed
    11
    Units: Titer
    geometric mean (confidence interval 95%)
        Antibody titers RBD Domain - Day 1 of Dose 1
    730.5 (157.1 to 3397.0)
        Antibody titers S Protein - Day 1 of Dose 1
    599.1 (117.1 to 3064.9)
        Antibody titers RBD Domain - Day 8 of Dose 1
    4328.8 (512.9 to 36532.1)
        Antibody titers S Protein - Day 8 of Dose 1
    5078.0 (528.0 to 48838.3)
        Antibody titers RBD Domain - Day 29 of Dose 1
    6616.9 (987.7 to 44327.3)
        Antibody titers S Protein - Day 29 of Dose 1
    7937.6 (1179.2 to 53431.0)
        Antibody titers RBD Domain - Day 85 of Dose 1
    5065.9 (791.0 to 32443.1)
        Antibody titers S Protein - Day 85 of Dose 1
    11988.6 (1607.4 to 89413.3)
        Antibody titers RBD Domain - Day 182 of Dose 1
    10602.6 (2076.7 to 54130.4)
        Antibody titers S Protein - Day 182 of Dose 1
    19644.7 (5085.2 to 75890.1)
        Antibody titers RBD Domain - Day 1 pre Dose 2
    3633.0 (506.1 to 26078.1)
        Antibody titers S Protein - Day 1 pre Dose 2
    5822.9 (894.5 to 37904.8)
        Antibody titers RBD Domain - Day 8 post Dose 2
    12441.7 (1398.3 to 110702.9)
        Antibody titers S Protein - Day 8 post Dose 2
    22067.6 (2752.2 to 176945.0)
        Antibody titers RBD Domain - Day 29 post Dose 2
    13625.0 (2884.8 to 64350.9)
        Antibody titers S Protein - Day 29 post Dose 2
    34242.9 (7476.0 to 156845.8)
        Antibody titers RBD Domain - Day 85 post Dose 2
    12265.4 (1706.1 to 88179.1)
        Antibody titers S Protein - Day 85 post Dose 2
    24015.7 (3852.9 to 149692.4)
        Antibody titers RBD Domain - Day 182 post Dose 2
    13468.1 (2320.5 to 78167.7)
        Antibody titers S Protein - Day 182 post Dose 2
    10833.5 (1763.7 to 66543.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Time frame of other AEs see in section 'Adverse event reporting additional description'.
    Adverse event reporting additional description
    Other AEs in Group B: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in Group A: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182. Events reported in the Group B immunology subset are also included in Group B.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Group A Comirnaty
    Reporting group description
    Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1. BNT162b2: intramuscular (IM) injection

    Reporting group title
    Group A BNT162b2s01
    Reporting group description
    Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1. BNT162b2s01: IM injection

    Reporting group title
    Group A Total
    Reporting group description
    All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1. BNT162b2s01 and BNT162b2: IM injection

    Reporting group title
    Group B Non-transplant Participants
    Reporting group description
    Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Reporting group title
    Group B Transplant Participants
    Reporting group description
    Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). BNT162b2: IM injection

    Reporting group title
    Group B Total
    Reporting group description
    All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21. BNT162b2: IM injection

    Reporting group title
    Group B Immunology Subset Non-transplant Participants
    Reporting group description
    Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. BNT162b2: IM injection

    Reporting group title
    Group B Immunology Subset Transplant Participants
    Reporting group description
    Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. BNT162b2: IM injection

    Reporting group title
    Group B Immunology Subset Total
    Reporting group description
    All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21. Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. BNT162b2: IM injection

    Serious adverse events
    Group A Comirnaty Group A BNT162b2s01 Group A Total Group B Non-transplant Participants Group B Transplant Participants Group B Total Group B Immunology Subset Non-transplant Participants Group B Immunology Subset Transplant Participants Group B Immunology Subset Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 44 (4.55%)
    2 / 65 (3.08%)
    1 / 61 (1.64%)
    4 / 11 (36.36%)
    5 / 72 (6.94%)
    0 / 22 (0.00%)
    4 / 11 (36.36%)
    4 / 33 (12.12%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Shunt blood flow excessive
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 44 (2.27%)
    1 / 65 (1.54%)
    0 / 61 (0.00%)
    0 / 11 (0.00%)
    0 / 72 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    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
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 44 (2.27%)
    1 / 65 (1.54%)
    0 / 61 (0.00%)
    0 / 11 (0.00%)
    0 / 72 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    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
    0 / 0
    Infections and infestations
    Chronic sinusitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    1 / 61 (1.64%)
    0 / 11 (0.00%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    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
    0 / 0
    Hepatitis E
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    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 A Comirnaty Group A BNT162b2s01 Group A Total Group B Non-transplant Participants Group B Transplant Participants Group B Total Group B Immunology Subset Non-transplant Participants Group B Immunology Subset Transplant Participants Group B Immunology Subset Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 21 (14.29%)
    7 / 44 (15.91%)
    10 / 65 (15.38%)
    4 / 61 (6.56%)
    7 / 11 (63.64%)
    11 / 72 (15.28%)
    4 / 22 (18.18%)
    7 / 11 (63.64%)
    11 / 33 (33.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 44 (2.27%)
    1 / 65 (1.54%)
    2 / 61 (3.28%)
    0 / 11 (0.00%)
    2 / 72 (2.78%)
    2 / 22 (9.09%)
    0 / 11 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    1
    1
    2
    0
    2
    2
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 44 (4.55%)
    2 / 65 (3.08%)
    1 / 61 (1.64%)
    1 / 11 (9.09%)
    2 / 72 (2.78%)
    1 / 22 (4.55%)
    1 / 11 (9.09%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    2
    1
    1
    2
    1
    1
    2
    Pyrexia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 44 (2.27%)
    3 / 65 (4.62%)
    0 / 61 (0.00%)
    0 / 11 (0.00%)
    0 / 72 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    1
    3
    0
    0
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    1
    Muscle tightness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 44 (6.82%)
    4 / 65 (6.15%)
    1 / 61 (1.64%)
    3 / 11 (27.27%)
    4 / 72 (5.56%)
    1 / 22 (4.55%)
    3 / 11 (27.27%)
    4 / 33 (12.12%)
         occurrences all number
    1
    3
    4
    1
    3
    4
    1
    3
    4
    Urinary tract infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 44 (0.00%)
    0 / 65 (0.00%)
    0 / 61 (0.00%)
    1 / 11 (9.09%)
    1 / 72 (1.39%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jul 2021
    The protocol amendment 01 describes changes made in response to feedback from the German Paul-Ehrlich-Institute (PEI), i.e., update of risk assessment section to include myocarditis and pericarditis, considering any events of myocarditis or pericarditis as AESIs regardless of grade, and add treatment recommendations for participants reporting symptoms that could represent myocarditis or pericarditis. This update was issued before any trial participants were enrolled into the trial and had no impact on the planned trial objectives or trial conduct.
    12 Aug 2021
    The protocol amendment 2 includes changes made in response to requests for clarification, i.e., to clarify overall timing of screening and rescreening, update the schedule of activities, update the risk assessment to reflect more recent information, revise the in- and exclusion criteria for clarity and rescreening of subjects based on site feedback, include instructions to the site related to safety assessments, modify AESIs definition for clarity and AESIs reporting, and add guidance related to contraception. This amendment had no impact on the planned trial objectives.
    20 Jan 2022
    The protocol amendment 3 includes changes made to allow administration of Dose 2 to Group B transplant subjects (Cohort 13 of the BNT162-01 trial) based on an Safety Review Committee recommendation and for a reduction of the recruitment period. In addition, details to accommodate subjects receiving non-trial SARS-CoV-2 vaccinations and clarifications of AE and TEAEs definitions were added. Further it was clarified that any case of proven COVID-19 disease occurring until the last follow-up visit should be reported as an SAE/AE.

    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
    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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