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    Clinical Trial Results:
    A multi-site, Phase I/II, 2-part, dose escalation trial investigating the safety and immunogenicity of a prophylactic SARS-CoV-2 RNA vaccine (BNT162b3) against COVID-19 using different dosing regimens in healthy adults

    Summary
    EudraCT number
    		 2020-003267-26
    Trial protocol
    		 DE  
    Global end of trial date
    07 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Feb 2023
    First version publication date
    22 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BNT162-04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04537949
    WHO universal trial number (UTN)
    		 U1111-1254-4840
    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 6131 90840, patients@biontech.de
    Scientific contact
    BioNTech clinical trials patient information, BioNTech SE, 0049 6131 90840, 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
    22 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety and tolerability profiles of a prophylactic BNT162b3 in healthy adults after prime/boost (P/B) immunization.
    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
    09 Sep 2020
    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: 96
    Worldwide total number of subjects
    96
    EEA total number of subjects
    96
    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)
    70
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were selected from the volunteer panel at the clinical CRO, who responded to either generic or study-specific advertisements in social media, or who contacted the clinical CRO via a web-based study participant recruitment portal. Participants were selected from this pool of volunteers according to inclusion and exclusion criteria.

    Pre-assignment
    Screening details
    		 All enrolled participants were allocated to treatment.

    Period 1
    Period 1 title
    Treatment Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A Participants Aged 18 to 55 Years - 3 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 18 to 55 Years - 10 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 18 to 55 Years - 20 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 18 to 55 Years - 30 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee).
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 56 to 85 Years - 3 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 56 to 85 Years - 10 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 56 to 85 Years - 20 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 56 to 85 Years - 30 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Number of subjects in period 1
    		Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Started
    12
    12
    12
    12
    12
    12
    12
    12
    Completed
    11
    12
    12
    12
    12
    12
    12
    12
    Not completed
    1
    0
    0
    0
    0
    0
    0
    0
         Personal reasons not related to the IMP
    1
    -
    -
    -
    -
    -
    -
    -
    Period 2
    Period 2 title
    Follow-up Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A Participants Aged 18 to 55 Years - 3 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 18 to 55 Years - 10 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 18 to 55 Years - 20 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 18 to 55 Years - 30 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee).
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 56 to 85 Years - 3 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 56 to 85 Years - 10 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 56 to 85 Years - 20 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Arm title
    		 Part A Participants Aged 56 to 85 Years - 30 μg
    Arm description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two injections administered intramuscularly (upper arm, musculus deltoideus) approximately 21 days apart. Injection volumes were up to 1.5 mL.

    Number of subjects in period 2
    		Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Started
    11
    12
    12
    12
    12
    12
    12
    12
    Completed
    8
    8
    12
    9
    9
    11
    7
    6
    Not completed
    3
    4
    0
    3
    3
    1
    5
    6
         Personal reasons
    -
    -
    -
    1
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    -
    -
    1
    -
    -
    -
         Roll-over into trial BNT162-14
    3
    1
    -
    2
    1
    1
    5
    6
         Lost to follow-up
    -
    3
    -
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee).

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 3 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg Total
    Number of subjects
    		 12 12 12 12 12 12 12 12 96
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.32 ± 9.79 31.20 ± 9.11 31.89 ± 13.51 37.28 ± 6.40 66.08 ± 7.16 69.32 ± 8.74 64.93 ± 6.63 66.42 ± 6.82 -
    Gender categorical
    Units: Subjects
        Female
    		 3 4 7 8 9 8 9 6 54
        Male
    		 9 8 5 4 3 4 3 6 42
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0 0 0 0 0
        Not Hispanic or Latino
    		 12 12 12 12 12 12 12 12 96
        Unknown or Not Reported
    		 0 0 0 0 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 0
        Asian
    		 0 0 1 0 0 0 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0 0 0 0
        White
    		 12 12 11 12 12 12 12 12 95
        More than one race
    		 0 0 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0 0 0 0 0
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 72.74 ± 11.43 71.68 ± 11.67 71.40 ± 14.40 71.20 ± 13.80 76.05 ± 11.88 70.90 ± 10.69 69.06 ± 14.25 84.43 ± 17.53 -
    Body mass index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 23.89 ± 2.92 24.23 ± 3.68 23.80 ± 2.74 23.69 ± 2.03 25.92 ± 1.66 24.69 ± 3.09 24.03 ± 3.17 26.73 ± 2.75 -

    End points

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    End points reporting groups
    Reporting group title
    Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee).

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 3 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
    Reporting group title
    Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee).

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 3 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Primary: Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose

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    End point title
    		 Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose [1]
    End point description
    Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and 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 reporting of local reactions was based on the participant’s assessments via daily solicited reports in the participant diaries. Safety Set - all participants who received at least one dose of the IMP. 9999 indicates data not available as the boost immunization was withheld for 30 μg younger cohort following Safety Review Committee decision.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization
    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 end point.
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Participants
        Prime up to Day 7: any local reaction
    9
    9
    12
    12
    4
    10
    10
    9
        Prime up to Day 7: any grade ≥3 local reaction
    0
    0
    2
    2
    0
    0
    0
    0
        Boost up to Day 7: any local reaction
    9
    9
    12
    9999
    2
    9
    8
    11
        Boost up to Day 7: any grade ≥3 local reaction
    0
    0
    1
    9999
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose

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    End point title
    		 Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose [2]
    End point description
    Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and 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 reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Safety Set - all participants who received at least one dose of the IMP. 9999 indicates data not available as the boost immunization was withheld for 30 μg younger cohort following Safety Review Committee decision.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization
    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 end point.
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Participants
        Prime up to Day 7: any systemic reaction
    4
    10
    12
    12
    3
    9
    9
    10
        Prime up to Day 7: any grade ≥3 systemic reaction
    0
    0
    1
    3
    0
    3
    0
    2
        Boost up to Day 7: any systemic reaction
    10
    9
    12
    9999
    2
    10
    9
    12
        Boost up to Day 7: any grade ≥3 systemic reaction
    0
    2
    4
    9999
    0
    2
    2
    2
    No statistical analyses for this end point

    Primary: The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Prime Immunization up to Boost Immunization or 28 Days After Prime Immunization

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    End point title
    		 The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Prime Immunization up to Boost Immunization or 28 Days After Prime Immunization [3]
    End point description
    Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The number and percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade ≥3 TEAE) using the Safety Set. Safety Set - all participants who received at least one dose of the IMP.
    End point type
    Primary
    End point timeframe
    28 days following first IMP dose or up to second IMP dose (whichever was first)
    Notes
    [3] - 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 end point.
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Percentage of participants
    number (not applicable)
        Any TEAE
    42
    25
    25
    50
    17
    17
    25
    42
        Any grade ≥3 TEAE
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring up to 28 Days After Boost Immunization or After Prime Immunization (if no Boost Immunization)

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    End point title
    		 The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring up to 28 Days After Boost Immunization or After Prime Immunization (if no Boost Immunization) [4]
    End point description
    Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade ≥3 TEAE) using the Safety Set. Safety Set - all participants who received at least one dose of the IMP.
    End point type
    Primary
    End point timeframe
    28 days following second IMP dose or first IMP dose (if no second IMP dose as given)
    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 end point.
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Percentage of participants
    number (not applicable)
        Any TEAE
    50
    33
    42
    50
    58
    25
    42
    50
        Any grade ≥3 TEAE
    0
    0
    0
    0
    0
    0
    0
    8
    No statistical analyses for this end point

    Secondary: Functional Antibody Responses

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    End point title
    		 Functional Antibody Responses
    End point description
    At 7 and 21 days after primary immunization and at 7, 14, 21, 28 days after boost immunization. Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. 9999 indicates missing Day 36 data of 10 μg and 20 μg younger cohort as they have only re-consented to Clinical Trial Protocol 7.0 (introducing visit 5a/Day 36) on/after their Day 43.
    End point type
    Secondary
    End point timeframe
    Up to 50 days following first IMP dose
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Titer
    geometric mean (confidence interval 95%)
        7 days after Prime Immunization (Day 8)
    5.0 (5.0 to 5.0)
    5.1 (4.8 to 5.5)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    7.3 (3.2 to 16.6)
    5.0 (5.0 to 5.0)
        21 days after Prime Immunization (Day 22)
    6.1 (4.5 to 8.4)
    25.9 (13.8 to 48.7)
    8.9 (6.0 to 13.3)
    12.2 (7.5 to 20.0)
    6.3 (4.8 to 8.3)
    5.3 (4.9 to 5.8)
    15.0 (5.9 to 37.9)
    9.4 (5.4 to 16.4)
        7 days after Boost Immunization (Day 29)
    51.5 (26.4 to 100.3)
    479.5 (300.3 to 765.5)
    106.8 (58.2 to 196.0)
    10.0 (6.5 to 15.4)
    53.4 (25.1 to 113.7)
    51.9 (25.0 to 107.4)
    320.0 (189.7 to 539.7)
    207.5 (118.0 to 364.8)
        14 days after Boost Immunization (Day 36)
    60.6 (33.5 to 109.8)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    10.3 (6.9 to 15.4)
    77.7 (40.4 to 149.4)
    219.8 (148.5 to 325.4)
    320.0 (169.3 to 604.9)
    359.2 (204.0 to 632.6)
        21 days after Boost Immunization (Day 43)
    36.4 (20.0 to 66.2)
    116.5 (79.6 to 170.4)
    201.6 (104.9 to 387.2)
    9.7 (5.7 to 16.5)
    53.4 (27.5 to 103.6)
    155.4 (105.0 to 230.1)
    285.1 (152.6 to 532.7)
    261.4 (136.0 to 502.6)
        28 days after Boost Immunization (Day 50)
    31.7 (18.5 to 54.6)
    80.0 (49.1 to 130.4)
    219.8 (117.5 to 411.1)
    7.9 (5.0 to 12.5)
    41.2 (20.5 to 82.8)
    138.5 (87.9 to 218.2)
    232.9 (131.1 to 413.8)
    195.8 (109.4 to 350.6)
    No statistical analyses for this end point

    Secondary: Fold Increase in Functional Antibody Titers

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    End point title
    		 Fold Increase in Functional Antibody Titers
    End point description
    At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization. Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision.
    End point type
    Secondary
    End point timeframe
    Up to 50 days following first IMP dose
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Fold rise
    geometric mean (confidence interval 95%)
        7 days after Prime Immunization (Day 8)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.1)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.3 (0.8 to 2.1)
    1.0 (1.0 to 1.0)
        21 days after Prime Immunization (Day 22)
    1.2 (0.9 to 1.7)
    5.2 (2.8 to 9.7)
    1.8 (1.2 to 2.7)
    2.4 (1.5 to 4.0)
    1.3 (1.0 to 1.7)
    1.1 (1.0 to 1.2)
    2.6 (1.3 to 5.0)
    1.9 (1.1 to 3.3)
        7 days after Boost Immunization (Day 29)
    10.3 (5.3 to 20.1)
    95.6 (60.1 to 153.1)
    21.4 (11.6 to 39.2)
    2.0 (1.3 to 3.1)
    10.7 (5.0 to 22.7)
    10.4 (5.0 to 21.5)
    55.4 (35.5 to 86.4)
    41.5 (23.6 to 73.0)
        14 days after Boost Immunization (Day 36)
    12.1 (6.7 to 22.0)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    2.1 (1.4 to 3.1)
    15.5 (8.1 to 29.9)
    44.0 (29.7 to 65.1)
    55.4 (31.2 to 98.4)
    71.8 (40.8 to 126.5)
        21 days after Boost Immunization (Day 43)
    7.3 (4.0 to 13.2)
    23.3 (15.9 to 34.1)
    40.3 (21.0 to 77.4)
    1.9 (1.1 to 3.3)
    10.7 (5.5 to 20.7)
    31.1 (21.0 to 46.0)
    49.4 (29.7 to 81.9)
    52.3 (27.2 to 100.5)
        28 days after Boost Immunization (Day 50)
    6.3 (3.7 to 10.9)
    16.0 (9.8 to 26.1)
    44.0 (23.5 to 82.2)
    1.6 (1.0 to 2.5)
    8.2 (4.1 to 16.6)
    27.7 (17.6 to 43.6)
    40.3 (26.7 to 60.9)
    39.2 (21.9 to 70.1)
    No statistical analyses for this end point

    Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline

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    End point title
    		 Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
    End point description
    At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization. Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. 9999 indicates missing Day 36 data of 10 μg and 20 μg younger cohort as they have only re-consented to Clinical Trial Protocol 7.0 (introducing visit 5a/Day 36) on/after their Day 43.
    End point type
    Secondary
    End point timeframe
    Up to 50 days following first IMP dose
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Participants
        7 days after Prime Immunization (Day 8)
    0
    0
    0
    0
    0
    0
    1
    0
        21 days after Prime Immunization (Day 22)
    1
    9
    2
    5
    1
    0
    4
    2
        7 days after Boost Immunization (Day 29)
    9
    12
    12
    3
    10
    10
    12
    12
        14 days after Boost Immunization (Day 36)
    9
    9999
    9999
    4
    11
    12
    12
    12
        21 days after Boost Immunization (Day 43)
    8
    12
    12
    3
    9
    12
    12
    12
        28 days after Boost Immunization (Day 50)
    8
    11
    12
    1
    9
    12
    12
    12
    No statistical analyses for this end point

    Secondary: Functional Antibody Responses

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    End point title
    		 Functional Antibody Responses
    End point description
    At 63, 162, 365 days after boost immunization. Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. 9999 indicates Day 387 data is either missing due to exclusion because of non-study vaccination or due to premature discontinuation. 99999 indicates value not evaluable, confidence intervals were only calculated if values of at least 3 participants were available.
    End point type
    Secondary
    End point timeframe
    From 51 to up to 387 days following first IMP dose
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Titer
    geometric mean (confidence interval 95%)
        63 days after Boost Immunization (Day 85)
    40.0 (22.4 to 71.4)
    51.9 (39.1 to 68.9)
    116.5 (51.0 to 266.1)
    13.0 (7.8 to 21.5)
    34.6 (18.1 to 66.1)
    85.2 (48.7 to 149.0)
    142.5 (77.9 to 260.7)
    75.5 (45.6 to 125.0)
        162 days after Boost Immunization (Day 184)
    11.7 (5.8 to 23.8)
    51.5 (33.9 to 78.1)
    119.9 (62.6 to 229.5)
    11.0 (4.7 to 25.8)
    9.6 (6.1 to 15.0)
    28.3 (11.2 to 71.6)
    44.9 (22.0 to 91.8)
    107.7 (42.3 to 273.8)
        365 days after Boost Immunization (Day 387)
    197.0 (14.2 to 2727.9)
    452.5 (47.4 to 4322.3)
    513.3 (215.8 to 1221.2)
    5.0 (-99999 to 99999)
    1280.0 (-99999 to 99999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: Fold Increase in Functional Antibody Titers

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    End point title
    		 Fold Increase in Functional Antibody Titers
    End point description
    At 63, 162, 365 days after boost immunization. Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. 9999 indicates Day 387 data is either missing due to exclusion because of non-study vaccination or due to premature discontinuation. 99999 indicates value not evaluable, confidence intervals were only calculated if values of at least 3 participants were available.
    End point type
    Secondary
    End point timeframe
    From 51 to up to 387 days following first IMP dose
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Fold rise
    geometric mean (confidence interval 95%)
        63 days after Boost Immunization (Day 85)
    8.0 (4.5 to 14.3)
    10.4 (7.8 to 13.8)
    23.3 (10.2 to 53.2)
    2.6 (1.6 to 4.3)
    6.9 (3.6 to 13.2)
    17.0 (9.7 to 29.8)
    24.7 (15.3 to 39.9)
    15.1 (9.1 to 25.0)
        162 days after Boost Immunization (Day 184)
    2.3 (1.2 to 4.8)
    10.3 (6.8 to 15.6)
    24.0 (12.5 to 45.9)
    2.2 (0.9 to 5.2)
    1.9 (1.2 to 3.0)
    5.7 (2.2 to 14.3)
    9.0 (4.4 to 18.4)
    21.5 (8.5 to 54.8)
        365 days after Boost Immunization (Day 387)
    39.4 (2.8 to 545.6)
    90.5 (9.5 to 864.5)
    102.7 (43.2 to 244.2)
    1.0 (-99999 to 99999)
    256.0 (-99999 to 99999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline

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    End point title
    		 Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
    End point description
    At 63, 162, 365 days after boost immunization. Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. 9999 indicates Day 387 data is either missing due to exclusion because of non-study vaccination or due to premature discontinuation.
    End point type
    Secondary
    End point timeframe
    From 51 to up to 387 days following first IMP dose
    End point values
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    12
    12
    Units: Participants
        63 days after Boost Immunization (Day 85)
    9
    12
    11
    3
    8
    11
    12
    12
        162 days after Boost Immunization (Day 184)
    4
    11
    12
    2
    2
    6
    6
    6
        365 days after Boost Immunization (Day 387)
    4
    5
    11
    0
    1
    9999
    9999
    9999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 (Prime Immunization) up to Day 50 (with or without Boost Immunization). Adverse events with an onset date more than 28 days after the last administration of IMP are reported only if assessed as related to IMP by the investigator.
    Adverse event reporting additional description
    Treatment emergent adverse events (TEAEs) are reported, i.e., adverse events (AEs) with an onset date on or after the first administration of IMP (if the AE was absent before the first administration of IMP) or worsened after the first administration of IMP (if the AE was present before the first administration of IMP).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Part A Participants Aged 18 to 55 Years - 3 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 10 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 20 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 18 to 55 Years - 30 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee).

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 3 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 10 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 20 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Reporting group title
    Part A Participants Aged 56 to 85 Years - 30 μg
    Reporting group description
    		 BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)

    Serious adverse events
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 12 (58.33%)
    4 / 12 (33.33%)
    5 / 12 (41.67%)
    6 / 12 (50.00%)
    7 / 12 (58.33%)
    5 / 12 (41.67%)
    5 / 12 (41.67%)
    6 / 12 (50.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Surgical and medical procedures
    Dental care
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Malaise
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Tenderness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    4
    Nasal discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Lipase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    0
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    2
    3
    1
    0
    0
    0
    Hyperaesthesia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Vertigo
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Eye disorders
    Meibomian gland dysfunction
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Toothache
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    1
    2
    0
    0
    0
    Myalgia
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Myofascial pain syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Sep 2020
    This amendment described changes made to clarify potential inconsistencies, to align trial reporting with other ongoing BNT162 trials, and to enhance assessments for immunogenicity.
    02 Dec 2020
    This update implemented: a change in sponsor name; the addition of two additional dosing cohorts in older adults; measures to avoid under reporting of mild COVID-19 related events revealed within the trial; terminology alignment with other ongoing trials; correction to some errors. The rational for the addition of two older adult cohorts was based on the available immunogenicity and cell-mediated immune response data after dosing with BNT162b1 and BNT162b2 in younger and elderly adults in the BNT162-01 (2020-001038-36) and BNT162-02 (2020-002641-42) trials elicited measurable but lower responses in elderly adults than in younger adults. Therefore, the additional older adult cohorts were to be used to investigate BNT162b3 doses above the already tested 20 μg BNT162b3 dose, to support any future Phase III program planned to support marketing approval.
    25 Mar 2021
    This update implemented the removal of Part B, changes to the primary objective endpoints, and a change to concomitant medication reporting during study follow-up to allow capture of vaccinations, e.g., SARS-CoV-2 vaccinations.
    12 May 2021
    This update implemented corrections to time points in the exploratory objectives and a deletion within Section 4.4 (End of Treatment and end of trial definition) in order to allow subjects to participate in other clinical trials investigating COVID-19 vaccines and treatments.

    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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