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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Clinical Trial Results:
    Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines with AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (two Monovalent and one Bivalent)

    Summary
    EudraCT number
    2020-003370-41
    Trial protocol
    ES  
    Global end of trial date
    29 Jun 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Feb 2025
    First version publication date
    27 Feb 2025
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    VAT00002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04762680
    WHO universal trial number (UTN)
    U1111-1251-4616
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc
    Sponsor organisation address
    Discovery Drive, Swiftwater, Pennsylvania, United States, 18370-0187
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    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
    06 Sep 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To assess the safety profile of all participants in each age group and in each study Intervention group. - To assess the neutralizing antibody profile after primary series vaccination in severe acute respiratory syndrome coronavirus (SARS-CoV-2) naïve participants. - To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to participants previously vaccinated with an authorized/approved coronavirus disease (COVID-19) vaccine induces an immune response that is non-inferior to the response induced by a 2-dose priming series with the monovalent vaccine, and superior to that observed immediately before booster. CoV2 preS dTM= SARS-CoV2 prefusion Spike delta TM, PBP= Pfizer/BioNTech Primed, MP= Moderna Primed, OUAP= Oxford University/AstraZeneca Primed, JJJP= J&J/Janssen Primed and PP= Protein Primed.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Participants with allergy to any of the vaccine components were not vaccinated. After vaccination, participants were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Feb 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
    Australia: 363
    Country: Number of subjects enrolled
    France: 375
    Country: Number of subjects enrolled
    Honduras: 220
    Country: Number of subjects enrolled
    New Zealand: 30
    Country: Number of subjects enrolled
    Spain: 83
    Country: Number of subjects enrolled
    United Kingdom: 307
    Country: Number of subjects enrolled
    United States: 1991
    Worldwide total number of subjects
    3369
    EEA total number of subjects
    458
    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)
    2924
    From 65 to 84 years
    430
    85 years and over
    15

    Subject disposition

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    Recruitment
    Recruitment details
    The Phase 2 of study was conducted at 20 centers in Honduras and the United States between 24 February 2021 and 01 May 2021. The Phase 3 of study was conducted at 110 centers in Australia, France, Honduras, New Zealand, Spain, United Kingdom, and the United States between 29 July 2021 and 06 January 2023.

    Pre-assignment
    Screening details
    722 participants were enrolled in Phase 2 and 2647 participants (supplemental Phase 3=2617 and exploratory Phase 3=30) were enrolled in Phase 3 of the study. A total of 3159 unique participants were enrolled in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Carer, Data analyst, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
    Arm description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant intermuscular (IM) injection once daily on Days 1 and 22.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Arm description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Arm description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
    Arm description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
    Arm description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Arm description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Bivalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM bivalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
    Arm description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
    Arm description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Arm description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Bivalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM bivalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
    Arm description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
    Arm description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Arm description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Bivalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM bivalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
    Arm description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
    Arm description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Arm description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Bivalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM bivalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
    Arm description
    Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
    Arm description
    Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Arm description
    SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
    Arm type
    Active comparator

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
    Arm description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
    Arm description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
    Arm description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Arm title
    Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
    Arm description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 prefusion Spike delta TM protein, recombinant
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant was administered to deltoid muscle in the upper arm by IM injection.

    Number of subjects in period 1
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
    Started
    241
    239
    242
    329
    378
    378
    113
    112
    108
    127
    101
    101
    105
    38
    38
    132
    78
    479
    4
    8
    9
    9
    Completed
    199
    204
    204
    302
    338
    337
    102
    105
    100
    119
    95
    98
    94
    32
    31
    126
    71
    368
    4
    7
    9
    8
    Not completed
    42
    35
    38
    27
    40
    41
    11
    7
    8
    8
    6
    3
    11
    6
    7
    6
    7
    111
    0
    1
    0
    1
         Consent withdrawn by subject
    23
    21
    28
    13
    17
    12
    8
    3
    2
    4
    3
    1
    3
    2
    1
    4
    6
    32
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    1
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    3
    -
    -
    -
    -
         Lost to follow-up
    14
    8
    9
    9
    22
    24
    2
    4
    6
    4
    3
    -
    5
    4
    6
    1
    1
    66
    -
    1
    -
    -
         Protocol deviation
    5
    5
    1
    4
    1
    5
    1
    -
    -
    -
    -
    2
    3
    -
    -
    1
    -
    10
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
    Reporting group description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant intermuscular (IM) injection once daily on Days 1 and 22.

    Reporting group title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Reporting group description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Reporting group description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Reporting group description
    SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351) Total
    Number of subjects
    241 239 242 329 378 378 113 112 108 127 101 101 105 38 38 132 78 479 4 8 9 9 3369
    Age Categorical
    Units: participants
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    53.8 ( 15.3 ) 53.5 ( 14.9 ) 53.1 ( 15.9 ) 49.0 ( 15.5 ) 40.6 ( 14.0 ) 40.5 ( 13.9 ) 47.7 ( 16.4 ) 44.4 ( 15.8 ) 46.6 ( 13.9 ) 54.5 ( 12.2 ) 51.6 ( 11.7 ) 51.1 ( 13.2 ) 46.8 ( 13.2 ) 47.1 ( 12.0 ) 47.4 ( 12.6 ) 54.9 ( 14.8 ) 65.9 ( 11.5 ) 37.6 ( 11.3 ) 33.8 ( 9.50 ) 35.5 ( 14.9 ) 42.7 ( 12.5 ) 44.6 ( 16.9 ) -
    Gender Categorical
    Units: participants
        Female
    123 114 122 181 208 199 68 60 64 59 42 48 63 19 20 64 38 215 3 3 8 6 1727
        Male
    118 125 120 148 170 179 45 52 44 68 59 53 42 19 18 68 40 264 1 5 1 3 1642
    Race
    Units: Subjects
        American Indian or Alaska Native
    22 24 20 5 5 6 2 6 2 0 0 0 1 4 2 20 14 15 0 0 0 0 148
        Asian
    13 10 10 19 12 13 7 1 3 11 4 7 0 2 2 2 2 18 0 0 0 0 136
        Black or African American
    14 23 20 15 54 61 3 16 32 2 3 2 5 16 10 7 2 52 0 0 0 0 337
        Multiple
    5 2 4 1 6 6 1 3 1 0 0 1 0 0 0 0 1 8 0 0 0 0 39
        Native Hawaiian or Other Pacific Islander
    2 1 2 0 2 1 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 10
        White
    156 149 156 252 247 240 100 79 61 104 92 87 99 15 21 80 37 372 0 0 0 0 2347
        Not Reported
    4 4 2 33 44 49 0 1 6 10 1 2 0 0 2 0 0 3 4 7 8 9 189
        Unknown
    25 26 28 4 8 2 0 6 3 0 1 2 0 0 1 23 22 10 0 1 1 0 163

    End points

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    End points reporting groups
    Reporting group title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
    Reporting group description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant intermuscular (IM) injection once daily on Days 1 and 22.

    Reporting group title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Reporting group description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Reporting group description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Reporting group description
    SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.

    Subject analysis set title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Primary: Number of Participants With Immediate Unsolicited Adverse Events (AEs)

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    End point title
    Number of Participants With Immediate Unsolicited Adverse Events (AEs) [1] [2]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants.
    End point type
    Primary
    End point timeframe
    Up to 30 minutes after each vaccination
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [2] - 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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Number of subjects analysed
    240
    241
    328
    378
    375
    113
    111
    108
    127
    100
    100
    103
    38
    38
    132
    78
    473
    240
    Units: participants
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    9
    1
    No statistical analyses for this end point

    Primary: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

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    End point title
    Number of Participants With Solicited Injection Site Reactions and Systemic Reactions [3] [4]
    End point description
    A solicited reaction was an “expected” adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF, and were considered to be related to the study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. Systemic AR were all ARs that were not injection site reactions. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants.
    End point type
    Primary
    End point timeframe
    Up to 7 days after each vaccination
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [4] - 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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Number of subjects analysed
    238
    239
    326
    367
    370
    113
    110
    108
    127
    100
    100
    102
    38
    38
    132
    78
    460
    237
    Units: participants
        Injection site reaction
    201
    200
    262
    300
    303
    90
    82
    74
    104
    87
    87
    81
    19
    19
    98
    46
    375
    196
        Systemic reaction
    191
    185
    198
    238
    242
    67
    67
    65
    75
    61
    75
    62
    14
    17
    88
    36
    359
    191
    No statistical analyses for this end point

    Primary: Number of Participants With Unsolicited Adverse Events

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    End point title
    Number of Participants With Unsolicited Adverse Events [5] [6]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants.
    End point type
    Primary
    End point timeframe
    Up to 21 days after each vaccination
    Notes
    [5] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [6] - 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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Number of subjects analysed
    240
    241
    328
    378
    375
    113
    111
    108
    127
    100
    100
    103
    38
    38
    132
    78
    473
    240
    Units: participants
    88
    91
    76
    106
    96
    29
    18
    22
    34
    27
    35
    16
    7
    7
    25
    11
    199
    81
    No statistical analyses for this end point

    Primary: Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

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    End point title
    Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) [7] [8]
    End point description
    An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor’s study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant’s parent/guardian to seek unplanned medical advice at a physician’s office or Emergency Department. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants.
    End point type
    Primary
    End point timeframe
    Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.
    Notes
    [7] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Number of subjects analysed
    240
    241
    328
    378
    375
    113
    111
    108
    127
    100
    100
    103
    38
    38
    132
    78
    473
    240
    Units: participants
        SAE
    2
    4
    8
    9
    11
    3
    1
    4
    3
    4
    0
    1
    2
    3
    3
    3
    14
    6
        AESI
    0
    0
    2
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
        MAAE
    42
    59
    80
    106
    117
    28
    25
    19
    31
    24
    29
    19
    7
    7
    42
    32
    110
    48
    No statistical analyses for this end point

    Primary: Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1

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    End point title
    Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1 [9] [10]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The per-protocol analysis set (PPAS) Naïve-D01+D22 is a subset of the FAS. Here, -99999 and 99999= The upper and lower limits of 95% confidence interval was not calculable.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1
    Notes
    [9] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    167
    170
    171
    Units: titers
        geometric mean (confidence interval 95%)
    20.0 (-99999 to 99999)
    20.0 (-99999 to 99999)
    20.0 (-99999 to 99999)
    No statistical analyses for this end point

    Primary: Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36

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    End point title
    Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36 [11] [12]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The PPAS Naïve-D01+D22 is a subset of the FAS.
    End point type
    Primary
    End point timeframe
    Day 36
    Notes
    [11] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    162
    163
    167
    Units: titers
        geometric mean (confidence interval 95%)
    2132 (1690 to 2688)
    2376 (1873 to 3015)
    2903 (2289 to 3683)
    No statistical analyses for this end point

    Primary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

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    End point title
    Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36 [13] [14]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS Naïve-D01+D22 is a subset of the FAS.
    End point type
    Primary
    End point timeframe
    Day 1 (pre-vaccination) and Day 36
    Notes
    [13] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [14] - 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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    159
    158
    161
    Units: participants
        >=2-fold rise
    155
    156
    158
        >=4-fold rise
    154
    154
    157
    No statistical analyses for this end point

    Primary: Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

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    End point title
    Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36 [15] [16]
    End point description
    Responders were participants who had baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. The PPAS Naïve-D01+D22 is a subset of the FAS.
    End point type
    Primary
    End point timeframe
    Day 36
    Notes
    [15] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [16] - 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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    159
    158
    161
    Units: participants
    155
    156
    158
    No statistical analyses for this end point

    Primary: Phase 3: Cohorts 1 and 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 1

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    End point title
    Phase 3: Cohorts 1 and 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 1 [17] [18]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1
    Notes
    [17] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [18] - 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: Only participants treated in Phase 3 Cohorts 1 and 2 reporting groups were analyzed in this endpoint.
    End point values
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
    Number of subjects analysed
    301 [19]
    348 [20]
    345 [21]
    107 [22]
    107 [23]
    101 [24]
    120 [25]
    90 [26]
    97 [27]
    89 [28]
    36 [29]
    36 [30]
    108 [31]
    68 [32]
    Units: titers
    geometric mean (confidence interval 95%)
        D614G
    320 (275 to 373)
    678 (558 to 824)
    579 (478 to 701)
    668 (537 to 830)
    1107 (816 to 1503)
    1347 (977 to 1858)
    265 (190 to 369)
    137 (98.0 to 193)
    134 (95.7 to 186)
    222 (155 to 318)
    1188 (567 to 2490)
    447 (217 to 921)
    274 (182 to 413)
    159 (97.4 to 260)
        B.1.351
    70.1 (60.3 to 81.4)
    176 (142 to 217)
    149 (120 to 184)
    122 (95.4 to 157)
    258 (182 to 364)
    296 (207 to 424)
    54.1 (41.4 to 70.7)
    43.3 (32.0 to 58.5)
    36.8 (28.8 to 47.1)
    42.6 (32.5 to 55.7)
    345 (167 to 714)
    122 (55.3 to 268)
    97.7 (68.0 to 140)
    70.3 (47.9 to 103)
    Notes
    [19] - D614G (n=301) B.1.351 (n=290)
    [20] - D614G (n=348) B.1.351 (n=336)
    [21] - D614G (n=345) B.1.351 (n=324)
    [22] - D614G (n=107) B.1.351 (n=88)
    [23] - D614G (n=107) B.1.351 (n=97)
    [24] - D614G (n=101) B.1.351 (n=94)
    [25] - D614G (n=107) B.1.351 (n=120)
    [26] - D614G (n=89) B.1.351 (n=90)
    [27] - D614G (n=93) B.1.351 (n=97)
    [28] - D614G (n=82) B.1.351 (n=89)
    [29] - D614G (n=36) B.1.351 (n=36)
    [30] - D614G (n=36) B.1.351 (n=34)
    [31] - D614G (n=107) B.1.351 (n=108)
    [32] - D614G (n=67) B.1.351 (n=68)
    No statistical analyses for this end point

    Primary: Phase 3: Cohorts 1, 2 and Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination

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    End point title
    Phase 3: Cohorts 1, 2 and Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination [33] [34]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter.
    End point type
    Primary
    End point timeframe
    Cohorts 1 and 2: 14 days post-vaccination on Day 1, Day 15; Comparator: 14 days post-vaccination on Day 22, Day 36
    Notes
    [33] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [34] - 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: Only participants treated in Phase 3 Cohorts 1, 2 and comparator reporting groups were analyzed in this endpoint.
    End point values
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    301 [35]
    325 [36]
    334 [37]
    101 [38]
    93 [39]
    96 [40]
    118 [41]
    94 [42]
    93 [43]
    91 [44]
    31 [45]
    34 [46]
    119 [47]
    72 [48]
    307 [49]
    Units: titers
    geometric mean (confidence interval 95%)
        D614G
    6964 (6268 to 7737)
    9995 (8976 to 11129)
    8430 (7572 to 9386)
    6347 (5207 to 7736)
    14240 (11257 to 18013)
    12522 (10368 to 15123)
    6257 (5313 to 7369)
    5536 (4436 to 6910)
    5855 (4669 to 7344)
    6875 (5587 to 8460)
    11005 (7533 to 16078)
    11624 (8086 to 16710)
    22457 (19123 to 26374)
    25002 (18441 to 33897)
    3611 (3086 to 4224)
        B.1.351
    2610 (2316 to 2942)
    7021 (6262 to 7873)
    4900 (4370 to 5494)
    2222 (1754 to 2814)
    9449 (7376 to 12104)
    6581 (5340 to 8111)
    2062 (1708 to 2489)
    4610 (3689 to 5760)
    3099 (2386 to 4026)
    2054 (1642 to 2568)
    6872 (4482 to 10537)
    5057 (3416 to 7488)
    7452 (6212 to 8939)
    13300 (9817 to 18018)
    413 (346 to 493)
    Notes
    [35] - D614G (n=301) B.1.351 (n=299)
    [36] - D614G (n=325) B.1.351 (n=325)
    [37] - D614G (n=334) B.1.351 (n=334)
    [38] - D614G (n=101) B.1.351 (n=98)
    [39] - D614G (n=93) B.1.351 (n=93)
    [40] - D614G (n=96) B.1.351 (n=95)
    [41] - D614G (n=118) B.1.351 (n=118)
    [42] - D614G (n=94) B.1.351 (n=94)
    [43] - D614G (n=93) B.1.351 (n=93)
    [44] - D614G (n=91) B.1.351 (n=89)
    [45] - D614G (n=31) B.1.351 (n=30)
    [46] - D614G (n=34) B.1.351 (n=34)
    [47] - D614G (n=119) B.1.351 (n=119)
    [48] - D614G (n=72) B.1.351 (n=72)
    [49] - D614G (n=307) B.1.351 (n=296)
    No statistical analyses for this end point

    Primary: Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36

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    End point title
    Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36 [50] [51]
    End point description
    Responders were participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter. Percentages are rounded off to the tenth decimal place.
    End point type
    Primary
    End point timeframe
    Day 36
    Notes
    [50] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [51] - 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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.
    End point values
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    301
    Units: percentage of participants
    number (confidence interval 95%)
        D614G (n=301)
    99.3 (97.6 to 99.9)
        B.1.351 (n=290)
    91.0 (87.1 to 94.1)
    No statistical analyses for this end point

    Secondary: Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

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    End point title
    Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 [52]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Post-vaccination on Days 22, 78, 134, 202, 292, and 387
    Notes
    [52] - 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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    159 [53]
    160 [54]
    160 [55]
    Units: titers
    geometric mean (confidence interval 95%)
        Day 22
    36.0 (29.4 to 44.2)
    39.6 (32.3 to 48.6)
    47.3 (37.8 to 59.1)
        Day 78
    467 (361 to 606)
    558 (438 to 711)
    569 (458 to 707)
        Day 134
    225 (160 to 318)
    249 (182 to 340)
    260 (190 to 358)
        Day 202
    254 (158 to 408)
    344 (208 to 570)
    259 (159 to 421)
        Day 292
    12145 (3643 to 40491)
    2518 (335 to 18928)
    804 (108 to 6014)
        Day 387
    17837 (9491 to 33522)
    46305 (24179 to 88677)
    8353 (1414 to 49336)
    Notes
    [53] - Day 22 (n=159) Day 78 (n=118) Day 134 (n=99) Day 202 (n=73) Day 292 (n=11) Day 387 (n=11)
    [54] - Day 22 (n=160) Day 78 (n=124) Day 134 (n=103) Day 202 (n=76) Day 292 (n=11) Day 387 (n=9)
    [55] - Day 22 (n=160) Day 78 (n=121) Day 134 (n=94) Day 202 (n=77) Day 292 (n=13) Day 387 (n=12)
    No statistical analyses for this end point

    Secondary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

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    End point title
    Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 [56]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and Post-vaccination on Days 22, 78, 134, 202, 292, and 387
    Notes
    [56] - 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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    159 [57]
    160 [58]
    159 [59]
    Units: participants
        Day 22: >=2-fold rise
    35
    44
    53
        Day 22: >=4-fold rise
    28
    36
    44
        Day 78: >=2-fold rise
    108
    116
    113
        Day 78: >=4-fold rise
    105
    115
    110
        Day 134: >=2-fold rise
    85
    87
    82
        Day 134: >=4-fold rise
    75
    83
    76
        Day 202: >=2-fold rise
    57
    62
    62
        Day 202: >=4-fold rise
    53
    57
    60
        Day 292: >=2-fold rise
    10
    10
    11
        Day 292: >=4-fold rise
    10
    9
    8
        Day 387: >=2-fold rise
    10
    9
    11
        Day 387: >=4-fold rise
    10
    9
    11
    Notes
    [57] - Day 22 (n=159) Day 78 (n=116) Day 134 (n=98) Day 202 (n=72) Day 292 (n=10) Day 387 (n=10)
    [58] - Day 22 (n=160) Day 78 (n=123) Day 134 (n=102) Day 202 (n=75) Day 292 (n=11) Day 387 (n=9)
    [59] - Day 22 (n=159) Day 78 (n=117) Day 134 (n=93) Day 202 (n=77) Day 292 (n=13) Day 387 (n=12)
    No statistical analyses for this end point

    Secondary: Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

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    End point title
    Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 [60]
    End point description
    Responders were participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Post-vaccination on Days 22, 78, 134, 202, 292, and 387
    Notes
    [60] - 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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    159 [61]
    160 [62]
    159 [63]
    Units: participants
        Day 22
    35
    44
    53
        Day 78
    108
    116
    113
        Day 134
    85
    87
    82
        Day 202
    57
    62
    62
        Day 292
    10
    10
    11
        Day 387
    10
    9
    11
    Notes
    [61] - Day 22 (n=159) Day 78 (n=116) Day 134 (n=98) Day 202 (n=72) Day 292 (n=10) Day 387 (n=10)
    [62] - Day 22 (n=160) Day 78 (n=123) Day 134 (n=102) Day 202 (n=75) Day 292 (n=11) Day 387 (n=9)
    [63] - Day 22 (n=159) Day 78 (n=117) Day 134 (n=93) Day 202 (n=77) Day 292 (n=13) Day 387 (n=12)
    No statistical analyses for this end point

    Secondary: Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387

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    End point title
    Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387 [64]
    End point description
    Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-enzyme-linked immunosorbent assay (ELISA) and the results were expressed as geometric mean concentrations. The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
    Notes
    [64] - 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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    169
    172
    176
    Units: titers
    geometric mean (confidence interval 95%)
        Day 1 (n=166,170,175)
    10.3 (9.54 to 11.1)
    9.99 (9.52 to 10.5)
    10.2 (9.77 to 10.7)
        Day 22 (n=169,172,176)
    103 (80.6 to 131)
    149 (119 to 187)
    228 (182 to 285)
        Day 36 (n=165,167,171)
    15533 (13000 to 18560)
    17176 (14468 to 20390)
    18003 (15039 to 21550)
        Day 78 (n=126,127,127)
    6572 (5469 to 7897)
    7526 (6112 to 9267)
    7133 (5848 to 8700)
        Day 134 (n=105,111,100)
    2750 (2104 to 3594)
    2977 (2305 to 3846)
    2696 (2064 to 3521)
        Day 202 (n=87,93,87)
    1414 (983 to 2033)
    1961 (1369 to 2809)
    1438 (978 to 2113)
        Day 292 (n=12,12,14)
    40589 (10633 to 155000)
    9247 (1625 to 52615)
    5557 (1183 to 26116)
        Day 387 (n=11,10,13)
    61087 (40242 to 92728)
    58674 (12370 to 278000)
    16234 (3146 to 83760)
    No statistical analyses for this end point

    Secondary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387

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    End point title
    Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387 [65]
    End point description
    Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. Participants with binding antibodies concentration >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
    Notes
    [65] - 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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    166 [66]
    170 [67]
    175 [68]
    Units: participants
        Day 22: >=2-fold rise
    141
    155
    161
        Day 22: >=4-fold rise
    117
    136
    156
        Day 36: >=2-fold rise
    159
    160
    165
        Day 36: >=4-fold rise
    158
    160
    165
        Day 78: >=2-fold rise
    121
    124
    124
        Day 78: >=4-fold rise
    121
    124
    124
        Day 134: >=2-fold rise
    101
    109
    100
        Day 134: >=4-fold rise
    101
    109
    100
        Day 202: >=2-fold rise
    85
    91
    86
        Day 202: >=4-fold rise
    85
    91
    85
        Day 292: >=2-fold rise
    11
    12
    14
        Day 292: >=4-fold rise
    11
    12
    14
        Day 387: >=2-fold rise
    10
    10
    13
        Day 387: >=4-fold rise
    10
    10
    13
    Notes
    [66] - Day 22(n=166) Day 36(n=159) Day 78(n=121) Day 134(n=101) Day 202(n=85) Day 292(n=11) Day 387(n=10)
    [67] - Day 22(n=170) Day 36(n=161) Day 78(n=125) Day 134(n=110) Day 202(n=92) Day 292(n=12) Day 387(n=10)
    [68] - Day 22(n=175) Day 36(n=166) Day 78(n=124) Day 134(n=100) Day 202(n=87) Day 292(n=14) Day 387(n=13)
    No statistical analyses for this end point

    Secondary: Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387

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    End point title
    Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387 [69]
    End point description
    Responders were participants who had baseline values below LLOQ with detectable antibody concentration above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
    Notes
    [69] - 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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Number of subjects analysed
    166 [70]
    170 [71]
    175 [72]
    Units: participants
        Day 22
    139
    154
    161
        Day 36
    159
    160
    165
        Day 78
    121
    124
    124
        Day 134
    101
    109
    100
        Day 202
    85
    91
    86
        Day 292
    11
    12
    14
        Day 387
    10
    10
    13
    Notes
    [70] - Day 22(n=166) Day 36(n=159) Day 78(n=121) Day 134(n=101) Day 202(n=85) Day 292(n=11) Day 387(n=10)
    [71] - Day 22(n=170) Day 36(n=161) Day 78(n=125) Day 134(n=110) Day 202(n=92) Day 292(n=12) Day 387(n=10)
    [72] - Day 22(n=175) Day 36(n=166) Day 78(n=124) Day 134(n=100) Day 202(n=87) Day 292(n=14) Day 387(n=13)
    No statistical analyses for this end point

    Secondary: Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366

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    End point title
    Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366 [73]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Post-vaccination on Days 29, 91, 181, and 366
    Notes
    [73] - 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: Only participants treated in Phase 3 Cohort 1 reporting groups were analyzed in this endpoint.
    End point values
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    311
    106
    117
    96
    Units: titers
    geometric mean (confidence interval 95%)
        Day 29: D614G (n=311,106,117,96)
    5795 (5222 to 6432)
    5743 (4668 to 7065)
    4869 (4113 to 5764)
    4400 (3566 to 5430)
        Day 29: B.1.351 (n=307,104,117,96)
    2078 (1844 to 2342)
    1726 (1355 to 2198)
    1790 (1452 to 2207)
    1390 (1095 to 1764)
        Day 91: D614G (n=249,91,86,84)
    4623 (4037 to 5295)
    4879 (3774 to 6308)
    2704 (2065 to 3541)
    2509 (1954 to 3223)
        Day 91: B.1.351 (n=248,90,83,83)
    1522 (1304 to 1776)
    1254 (920 to 1711)
    949 (702 to 1281)
    711 (540 to 936)
        Day 181: D614G (n=197,59,74,66)
    7502 (6161 to 9135)
    10068 (6940 to 14605)
    2658 (1834 to 3852)
    5649 (3695 to 8635)
        Day 181: B.1.351 (n=196,56,70,64)
    2328 (1827 to 2966)
    3217 (2073 to 4992)
    1035 (650 to 1648)
    1853 (1095 to 3134)
        Day 366: D614G (n=161,47,46,42)
    10224 (8101 to 12903)
    10567 (6608 to 16898)
    2940 (1779 to 4858)
    6314 (3847 to 10361)
        Day 366: B.1.351 (n=162,47,46,41)
    3419 (2572 to 4545)
    3349 (1929 to 5812)
    942 (533 to 1664)
    2233 (1267 to 3937)
    No statistical analyses for this end point

    Secondary: Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366

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    End point title
    Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366 [74]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366
    Notes
    [74] - 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: Only participants treated in Phase 3 Cohort 1 reporting groups were analyzed in this endpoint.
    End point values
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    290
    104
    114
    87
    Units: participants
        D614G; Day 15: >=2-fold rise (n=278,98,101,75)
    263
    86
    95
    70
        D614G; Day 15: >=4-fold rise (n=278,98,101,75)
    252
    70
    87
    66
        D614G; Day 29: >=2-fold rise (n=290,104,102,80)
    266
    91
    97
    73
        D614G; Day 29: >=4-fold rise (n=290,104,102,80)
    250
    79
    87
    68
        D614G; Day 91: >=2-fold rise (n=233,89,74,72)
    208
    74
    67
    62
        D614G; Day 91: >=4-fold rise (n=233,89,74,72)
    187
    57
    58
    56
        D614G; Day 181: >=2-fold rise (n=182,58,63,55)
    167
    50
    54
    51
        D614G; Day 181: >=4-fold rise (n=182,58,63,55)
    149
    44
    42
    41
        D614G; Day 366: >=2-fold rise (n=152,45,37,37)
    141
    38
    33
    31
        D614G; Day 366: >=4-fold rise (n=152,45,37,37)
    129
    34
    28
    31
        B.1.351; Day 15: >=2-fold rise (n=266,79,114,81)
    258
    76
    109
    78
        B.1.351; Day 15: >=4-fold rise (n=266,79,114,81)
    246
    67
    103
    76
        B.1.351; Day 29: >=2-fold rise (n=273,85,113,87)
    261
    79
    109
    83
        B.1.351; Day 29: >=4-fold rise (n=273,85,113,87)
    245
    70
    103
    80
        B.1.351; Day 91: >=2-fold rise (n=224,74,79,75)
    203
    64
    75
    68
        B.1.351; Day 91: >=4-fold rise (n=224,74,79,75)
    189
    54
    67
    66
        B.1.351; Day 181: >=2-fold rise (n=173,44,68,58)
    162
    38
    59
    54
        B.1.351; Day 181: >=4-fold rise (n=173,44,68,58)
    145
    38
    51
    46
        B.1.351; Day 366: >=2-fold rise (n=147,35,43,36)
    137
    32
    36
    34
        B.1.351; Day 366: >=4-fold rise (n=147,35,43,36)
    127
    30
    34
    30
    No statistical analyses for this end point

    Secondary: Phase 3: Cohorts 1, 2 and Comparator: Percentage of Participants With Seroresponse Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination

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    End point title
    Phase 3: Cohorts 1, 2 and Comparator: Percentage of Participants With Seroresponse Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination [75]
    End point description
    Seroresponse was defined as a >=4-fold rise in serum neutralization titer against SARS-CoV-2 D614G strain and B.1.351 variant (post/pre) at Day 15 or Day 36 relative to Day 0 or Day 22. Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint. Percentages are rounded off to the tenth decimal place.
    End point type
    Secondary
    End point timeframe
    Cohorts 1 and 2: 14 days post-vaccination on Day 1 (Day 15); Comparator: 14 days post-vaccination on Day 22 (Day 36)
    Notes
    [75] - 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: Only participants treated in Phase 3 Cohorts 1, 2 and comparator reporting groups were analyzed in this endpoint.
    End point values
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    278 [76]
    315 [77]
    320 [78]
    98 [79]
    92 [80]
    91 [81]
    114 [82]
    87 [83]
    91 [84]
    81 [85]
    31 [86]
    33 [87]
    99 [88]
    64 [89]
    301 [90]
    Units: percentage of participants
    number (confidence interval 95%)
        D614G
    90.6 (86.6 to 93.8)
    73.7 (68.4 to 78.4)
    75.6 (70.5 to 80.2)
    71.4 (61.4 to 80.1)
    72.8 (62.6 to 81.6)
    63.7 (53.0 to 73.6)
    86.1 (77.8 to 92.2)
    89.7 (81.3 to 95.2)
    89.8 (81.5 to 95.2)
    88.0 (78.4 to 94.4)
    58.1 (39.1 to 75.5)
    78.8 (61.1 to 91.0)
    84.8 (76.2 to 91.3)
    90.6 (80.7 to 96.5)
    99.0 (97.1 to 99.8)
        B.1.351
    92.5 (88.6 to 95.3)
    83.3 (78.6 to 87.3)
    82.9 (78.1 to 87.0)
    84.8 (75.0 to 91.9)
    83.3 (73.6 to 90.6)
    80.0 (69.9 to 87.9)
    90.4 (83.4 to 95.1)
    95.4 (88.6 to 98.7)
    96.7 (90.7 to 99.3)
    93.8 (86.2 to 98.0)
    75.9 (56.5 to 89.7)
    77.4 (58.9 to 90.4)
    85.9 (77.4 to 92.0)
    90.6 (80.7 to 96.5)
    86.6 (82.1 to 90.3)
    Notes
    [76] - D614G (n=278) B.1.351 (n=266)
    [77] - D614G (n=315) B.1.351 (n=299)
    [78] - D614G (n=320) B.1.351 (n=298)
    [79] - D614G (n=98) B.1.351 (n=79)
    [80] - D614G (n=92) B.1.351 (n=84)
    [81] - D614G (n=91) B.1.351 (n=85)
    [82] - D614G (n=101) B.1.351 (n=114)
    [83] - D614G (n=87) B.1.351 (n=87)
    [84] - D614G (n=88) B.1.351 (n=91)
    [85] - D614G (n=75) B.1.351 (n=81)
    [86] - D614G (n=31) B.1.351 (n=29)
    [87] - D614G (n=33) B.1.351 (n=31)
    [88] - D614G (n=99) B.1.351 (n=99)
    [89] - D614G (n=64) B.1.351 (n=64)
    [90] - D614G (n=301) B.1.351 (n=290)
    No statistical analyses for this end point

    Secondary: Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366

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    End point title
    Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366 [91]
    End point description
    Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA and the results were expressed as geometric mean concentrations. The PPAS is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint and 99999= no participants were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, 91, 181, and 366
    Notes
    [91] - 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: Only participants treated in Phase 3 Cohorts 1 and 2 reporting groups were analyzed in this endpoint.
    End point values
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
    Number of subjects analysed
    326 [92]
    362 [93]
    361 [94]
    110 [95]
    108 [96]
    107 [97]
    125 [98]
    97 [99]
    99 [100]
    99 [101]
    37 [102]
    37 [103]
    130 [104]
    77 [105]
    Units: titers
    geometric mean (confidence interval 95%)
        Day 1
    1888 (1687 to 2114)
    3032 (2621 to 3507)
    2580 (2228 to 2987)
    3236 (2729 to 3839)
    3285 (2534 to 4259)
    3505 (2747 to 4471)
    993 (781 to 1262)
    564 (427 to 747)
    537 (420 to 687)
    608 (457 to 809)
    2290 (1068 to 4908)
    996 (491 to 2021)
    1357 (1004 to 1834)
    969 (688 to 1365)
        Day 15
    26710 (24337 to 29314)
    36428 (33227 to 39938)
    30892 (27925 to 34174)
    27390 (23220 to 32309)
    43611 (35852 to 53049)
    34704 (29398 to 40968)
    21654 (18927 to 24775)
    23775 (19137 to 29537)
    28783 (24417 to 33930)
    21758 (18254 to 25935)
    31067 (24221 to 39849)
    34534 (26146 to 45614)
    65824 (57576 to 75254)
    77057 (61772 to 96125)
        Day 29
    20212 (18487 to 22097)
    33416 (30407 to 36723)
    27083 (24480 to 29964)
    23079 (19417 to 27431)
    48428 (39336 to 59623)
    41018 (34290 to 49065)
    13305 (11657 to 15186)
    16401 (13253 to 20296)
    17729 (14944 to 21034)
    14014 (11798 to 16647)
    29315 (22236 to 38647)
    24388 (17369 to 34243)
    60707 (52764 to 69845)
    65974 (53800 to 80902)
        Day 91
    18845 (16780 to 21165)
    29384 (25972 to 33244)
    23908 (20860 to 27402)
    20758 (16506 to 26107)
    37791 (29062 to 49140)
    35363 (28656 to 43639)
    9792 (8093 to 11849)
    10365 (8105 to 13255)
    13189 (10078 to 17261)
    9032 (7387 to 11043)
    18463 (13497 to 25255)
    16236 (9684 to 27219)
    41282 (34967 to 48736)
    40566 (32032 to 51373)
        Day 181
    20073 (17076 to 23596)
    20450 (18029 to 23195)
    18628 (16117 to 21530)
    25701 (17854 to 36998)
    25615 (20346 to 32248)
    24500 (19714 to 30448)
    7281 (5366 to 9880)
    8665 (6100 to 12311)
    10649 (7312 to 15510)
    12342 (8420 to 18092)
    11275 (7727 to 16451)
    19231 (12448 to 29712)
    21387 (17825 to 25661)
    20803 (16151 to 26794)
        Day 366
    41232 (28233 to 60218)
    19545 (17037 to 22422)
    19989 (17351 to 23028)
    32368 (16026 to 65374)
    25800 (20031 to 33232)
    19848 (15543 to 25345)
    99999 (99999 to 99999)
    10382 (6531 to 16505)
    10937 (6565 to 18220)
    14545 (4542 to 46582)
    12176 (8897 to 16664)
    12002 (8266 to 17425)
    32168 (25602 to 40417)
    33194 (24774 to 44476)
    Notes
    [92] - Day 1 (n=326) Day 15 (n=302) Day 29 (n=312) Day 91 (n=251) Day 181 (n=198) Day 366 (n=28)
    [93] - Day 1 (n=362) Day 15 (n=323) Day 29 (n=334) Day 91 (n=267) Day 181 (n=257) Day 366 (n=234)
    [94] - Day 1 (n=361) Day 15 (n=335) Day 29 (n=341) Day 91 (n=280) Day 181 (n=269) Day 366 (n=241)
    [95] - Day 1 (n=110) Day 15 (n=102) Day 29 (n=107) Day 91 (n=92) Day 181 (n=59) Day 366 (n=20)
    [96] - Day 1 (n=108) Day 15 (n=93) Day 29 (n=98) Day 91 (n=84) Day 181 (n=85) Day 366 (n=81)
    [97] - Day 1 (n=107) Day 15 (n=98) Day 29 (n=101) Day 91 (n=91) Day 181 (n=83) Day 366 (n=72)
    [98] - Day 1 (n=125) Day 15 (n=119) Day 29 (n=118) Day 91 (n=87) Day 181 (n=74) Day 366 (n=0)
    [99] - Day 1 (n=97) Day 15 (n=94) Day 29 (n=94) Day 91 (n=61) Day 181 (n=57) Day 366 (n=30)
    [100] - Day 1 (n=99) Day 15 (n=93) Day 29 (n=92) Day 91 (n=60) Day 181 (n=51) Day 366 (n=32)
    [101] - Day 1 (n=99) Day 15 (n=92) Day 29 (n=97) Day 91 (n=87) Day 181 (n=66) Day 366 (n=10)
    [102] - Day 1 (n=37) Day 15 (n=31) Day 29 (n=34) Day 91 (n=29) Day 181 (n=25) Day 366 (n=22)
    [103] - Day 1 (n=37) Day 15 (n=34) Day 29 (n=31) Day 91 (n=26) Day 181 (n=25) Day 366 (n=22)
    [104] - Day 1 (n=130) Day 15 (n=120) Day 29 (n=124) Day 91 (n=114) Day 181 (n=116) Day 366 (n=99)
    [105] - Day 1 (n=77) Day 15 (n=72) Day 29 (n=71) Day 91 (n=69) Day 181 (n=68) Day 366 (n=57)
    No statistical analyses for this end point

    Secondary: Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366

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    End point title
    Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366 [106]
    End point description
    Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. Participants with binding antibodies concentration >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint and 99999= no participants were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366
    Notes
    [106] - 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: Only participants treated in Phase 3 Cohorts 1 and 2 reporting groups were analyzed in this endpoint.
    End point values
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
    Number of subjects analysed
    312 [107]
    332 [108]
    340 [109]
    106 [110]
    98 [111]
    101 [112]
    119 [113]
    94 [114]
    93 [115]
    96 [116]
    34 [117]
    34 [118]
    124 [119]
    72 [120]
    Units: participants
        Day 15: >=2-fold rise
    287
    276
    292
    94
    84
    87
    114
    92
    92
    88
    24
    29
    108
    69
        Day 15: >=4-fold rise
    265
    234
    265
    72
    73
    69
    106
    85
    90
    84
    19
    28
    103
    67
        Day 29: >=2-fold rise
    285
    278
    285
    93
    87
    87
    111
    92
    90
    91
    24
    27
    115
    69
        Day 29: >=4-fold rise
    253
    243
    254
    71
    75
    74
    96
    85
    86
    84
    19
    27
    109
    66
        Day 91: >=2-fold rise
    227
    210
    217
    73
    70
    76
    82
    61
    59
    79
    17
    23
    105
    65
        Day 91: >=4-fold rise
    197
    183
    184
    60
    62
    58
    69
    57
    56
    72
    14
    22
    98
    62
        Day 181: >=2-fold rise
    175
    189
    193
    43
    63
    59
    59
    53
    49
    56
    14
    20
    98
    62
        Day 181: >=4-fold rise
    146
    160
    167
    38
    55
    48
    45
    45
    40
    51
    11
    17
    89
    59
        Day 366: >=2-fold rise
    27
    174
    184
    15
    62
    49
    99999
    26
    27
    9
    12
    17
    83
    53
        Day 366: >=4-fold rise
    26
    147
    165
    13
    56
    37
    99999
    23
    23
    7
    11
    14
    77
    52
    Notes
    [107] - Day 15 (n=302) Day 29 (n=312) Day 91 (n=251) Day 181 (n=198) Day 366 (n=28)
    [108] - Day 15 (n=322) Day 29 (n=332) Day 91 (n=266) Day 181 (n=255) Day 366 (n=232)
    [109] - Day 15 (n=334) Day 29 (n=340) Day 91 (n=279) Day 181 (n=269) Day 366 (n=240)
    [110] - Day 15 (n=101) Day 29 (n=106) Day 91 (n=91) Day 181 (n=59) Day 366 (n=19)
    [111] - Day 15 (n=93) Day 29 (n=98) Day 91 (n=84) Day 181 (n=85) Day 366 (n=81)
    [112] - Day 15 (n=98) Day 29 (n=101) Day 91 (n=91) Day 181 (n=83) Day 366 (n=72)
    [113] - Day 15 (n=119) Day 29 (n=118) Day 91 (n=87) Day 181 (n=74) Day 366 (n=0)
    [114] - Day 15 (n=94) Day 29 (n=94) Day 91 (n=61) Day 181 (n=57) Day 366 (n=30)
    [115] - Day 15 (n=93) Day 29 (n=92) Day 91 (n=60) Day 181 (n=51) Day 366 (n=32)
    [116] - Day 15 (n=91) Day 29 (n=96) Day 91 (n=86) Day 181 (n=65) Day 366 (n=10)
    [117] - Day 15 (n=31) Day 29 (n=34) Day 91 (n=29) Day 181 (n=25) Day 366 (n=22)
    [118] - Day 15 (n=34) Day 29 (n=31) Day 91 (n=26) Day 181 (n=25) Day 366 (n=22)
    [119] - Day 15 (n=120) Day 29 (n=124) Day 91 (n=114) Day 181 (n=116) Day 366 (n=99)
    [120] - Day 15 (n=72) Day 29 (n=71) Day 91 (n=69) Day 181 (n=68) Day 366 (n=57)
    No statistical analyses for this end point

    Secondary: Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, 91, 181, and 366

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    End point title
    Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, 91, 181, and 366 [121]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint and 99999= no participants were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, 91, 181, and 366
    Notes
    [121] - 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: Only participants treated in Phase 3 Cohort 2 reporting groups were analyzed in this endpoint.
    End point values
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
    Number of subjects analysed
    348
    345
    107
    101
    94
    97
    36
    36
    123
    72
    Units: titers
    geometric mean (confidence interval 95%)
        Day 1: D614G(n=348,345,107,101,89,93,36,36,107,67)
    678 (558 to 824)
    579 (478 to 701)
    1107 (816 to 1503)
    1347 (977 to 1858)
    137 (98.0 to 193)
    134 (95.7 to 186)
    1188 (567 to 2490)
    447 (217 to 921)
    274 (182 to 413)
    159 (97.4 to 260)
        Day 1: B.1.351(n=336,324,97,94,90,97,36,34,108,68)
    176 (142 to 217)
    149 (120 to 184)
    258 (182 to 364)
    296 (207 to 424)
    43.3 (32.0 to 58.5)
    36.8 (28.8 to 47.1)
    345 (167 to 714)
    122 (55.3 to 268)
    97.7 (68.0 to 140)
    70.3 (47.9 to 103)
        Day 15: D614G (n=325,334,93,96,94,93,31,34,119,72)
    9995 (8976 to 11129)
    8430 (7572 to 9386)
    14240 (11257 to 18013)
    12522 (10368 to 15123)
    5536 (4436 to 6910)
    5855 (4669 to 7344)
    11005 (7533 to 16078)
    11624 (8086 to 16710)
    22457 (19123 to 26374)
    25002 (18441 to 33897)
        Day 15:B.1.351(n=325,334,93,95,94,93,30,34,119,72)
    7021 (6262 to 7873)
    4900 (4370 to 5494)
    9449 (7376 to 12104)
    6581 (5340 to 8111)
    4610 (3689 to 5760)
    3099 (2386 to 4026)
    6872 (4482 to 10537)
    5057 (3416 to 7488)
    7452 (6212 to 8939)
    13300 (9817 to 18018)
        Day 29: D614G(n=333,341,99,100,93,92,34,31,123,71)
    14065 (12399 to 15954)
    10885 (9664 to 12261)
    16286 (12808 to 20710)
    16874 (13763 to 20688)
    6320 (4941 to 8083)
    6370 (5014 to 8093)
    9711 (6526 to 14450)
    9521 (6555 to 13828)
    16032 (13535 to 18989)
    16425 (12103 to 22291)
        Day 29:B.1.351(n=333,340,99,98,93,92,34,31,123,71)
    8947 (7845 to 10203)
    6045 (5307 to 6886)
    10264 (7924 to 13296)
    8139 (6470 to 10239)
    4736 (3680 to 6096)
    3103 (2340 to 4115)
    6028 (3889 to 9342)
    4007 (2553 to 6290)
    7185 (5841 to 8838)
    12712 (9376 to 17234)
        Day 91: D614G (n=264,279,84,89,61,60,29,26,112,69)
    11037 (9530 to 12782)
    8523 (7284 to 9973)
    13701 (10206 to 18392)
    12424 (9586 to 16103)
    3620 (2680 to 4891)
    3981 (2812 to 5637)
    5797 (3725 to 9024)
    5880 (3125 to 11064)
    14498 (11931 to 17618)
    13641 (9766 to 19055)
        Day 91:B.1.351(n=264,279,84,89,61,60,29,26,112,69)
    6557 (5617 to 7654)
    4359 (3673 to 5172)
    8141 (5982 to 11080)
    5474 (4176 to 7175)
    2456 (1792 to 3364)
    2029 (1376 to 2993)
    3374 (2161 to 5269)
    2405 (1093 to 5295)
    6455 (5117 to 8143)
    8990 (6284 to 12861)
        Day 181: D614G (n=0,0,0,0,0,0,0,0,0,0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        Day 181: B.1.351 (n=0,0,0,0,0,0,0,0,0,0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        Day 366: D614G (n=0,0,0,0,0,0,0,0,0,0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        Day 366: B.1.351 (n=0,0,0,0,0,0,0,0,0,0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366

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    End point title
    Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366 [122]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint, 99999= no participants were analyzed, and D=Day.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366
    Notes
    [122] - 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: Only participants treated in Phase 3 Cohort 2 reporting groups were analyzed in this endpoint.
    End point values
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
    Number of subjects analysed
    318 [123]
    324 [124]
    99 [125]
    95 [126]
    87 [127]
    91 [128]
    33 [129]
    33 [130]
    103 [131]
    64 [132]
    Units: participants
        D614G; Day 15: >=2-fold rise
    267
    269
    79
    77
    85
    84
    26
    30
    86
    60
        D614G; Day 15: >=4-fold rise
    232
    242
    67
    58
    78
    79
    18
    26
    84
    58
        D614G; Day 29: >=2-fold rise
    272
    283
    83
    76
    84
    83
    22
    28
    89
    58
        D614G; Day 29: >=4-fold rise
    240
    251
    74
    67
    80
    80
    15
    23
    85
    56
        D614G; Day 91: >=2-fold rise
    199
    208
    69
    70
    57
    51
    16
    20
    81
    57
        D614G; Day 91: >=4-fold rise
    175
    187
    57
    54
    55
    48
    12
    16
    78
    53
        D614G; Day 181: >=2-fold rise
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
        D614G; Day 181: >=4-fold rise
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
        D614G; Day 366: >=2-fold rise
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
        D614G; Day 366: >=4-fold rise
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
        B.1.351; Day 15: >=2-fold rise
    275
    269
    77
    79
    85
    88
    28
    28
    88
    62
        B.1.351; Day 15: >=4-fold rise
    249
    247
    70
    68
    83
    88
    22
    24
    85
    58
        B.1.351; Day 29: >=2-fold rise
    278
    277
    81
    79
    86
    87
    28
    26
    95
    62
        B.1.351; Day 29: >=4-fold rise
    258
    261
    75
    70
    84
    87
    20
    25
    92
    58
        B.1.351; Day 91: >=2-fold rise
    212
    207
    69
    68
    56
    56
    22
    21
    87
    58
        B.1.351; Day 91: >=4-fold rise
    195
    197
    62
    60
    56
    53
    16
    17
    80
    55
        B.1.351; Day 181: >=2-fold rise
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
        B.1.351; Day 181: >=4-fold rise
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
        B.1.351; Day 366: >=2-fold rise
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
        B.1.351; Day 366: >=4-fold rise
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    Notes
    [123] - D614G:D15(n=315),D29(n=318),D91(n=251);B.1.351:D15(n=299),D29(n=306),D91(n=246);D181:(n=0),D366:(n=0
    [124] - D614G:D15(n=320),D29(n=324),D91(n=265);B.1.351:D15(n=298),D29(n=304),D91(n=252);D181:(n=0),D366:(n=0
    [125] - D614G:D15(n=92),D29(n=99),D91(n=84);B.1.351:D15(n=84),D29(n=90),D91(n=76);D181:(n=0),D366:(n=0)
    [126] - D614G:D15(n=91),D29(n=95),D91(n=86);B.1.351:D15(n=85),D29(n=88),D91(n=82);D181:(n=0),D366:(n=0)
    [127] - D614G:D15(n=87),D29(n=86),D91(n=58);B.1.351:D15(n=87),D29(n=87),D91(n=56);D181:(n=0),D366:(n=0)
    [128] - D614G:D15(n=88),D29(n=86),D91(n=55);B.1.351:D15(n=91),D29(n=90),D91(n=58);D181:(n=0),D366:(n=0)
    [129] - D614G:D15(n=31),D29(n=33),D91(n=28);B.1.351:D15(n=29),D29(n=33),D91(n=29);D181:(n=0),D366:(n=0)
    [130] - D614G:D15(n=33),D29(n=30),D91(n=25);B.1.351:D15(n=31),D29(n=28),D91(n=25);D181:(n=0),D366:(n=0)
    [131] - D614G:D15(n=99),D29(n=101),D91(n=93);B.1.351:D15(n=99),D29(n=103),D91(n=94);D181:(n=0),D366:(n=0)
    [132] - D614G:D15(n=64),D29(n=62),D91(n=61);B.1.351:D15(n=64),D29(n=64),D91(n=62);D181:(n=0),D366:(n=0)
    No statistical analyses for this end point

    Secondary: Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387

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    End point title
    Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387 [133]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387
    Notes
    [133] - 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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.
    End point values
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    330
    Units: titers
    geometric mean (confidence interval 95%)
        D614G: Day 1 (n=330)
    20.3 (19.7 to 21.0)
        D614G: Day 22 (n=281)
    53.3 (44.6 to 63.8)
        D614G: Day 36 (n=302)
    3658 (3123 to 4286)
        D614G: Day 134 (n=143)
    1050 (743 to 1486)
        D614G: Day 202 (n=128)
    1685 (1142 to 2487)
        D614G: Day 292 (n=117)
    1943 (1294 to 2918)
        D614G: Day 387 (n=112)
    1973 (1344 to 2897)
        B.1.351: Day 1 (n=329)
    20.3 (19.7 to 20.8)
        B.1.351: Day 22 (n=326)
    29.4 (25.7 to 33.5)
        B.1.351: Day 36 (n=291)
    413 (346 to 493)
        B.1.351: Day 134 (n=113)
    496 (330 to 745)
        B.1.351: Day 202 (n=123)
    671 (441 to 1022)
        B.1.351: Day 292 (n=120)
    867 (560 to 1342)
        B.1.351: Day 387 (n=112)
    1033 (686 to 1555)
    No statistical analyses for this end point

    Secondary: Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387

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    End point title
    Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387 [134]
    End point description
    Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387
    Notes
    [134] - 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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.
    End point values
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    325
    Units: participants
        D614G; Day 22: >=2-fold rise (n=281)
    99
        D614G; Day 22: >=4-fold rise (n=281)
    88
        D614G; Day 36: >=2-fold rise (n=301)
    299
        D614G; Day 36: >=4-fold rise (n=301)
    298
        D614G; Day 134: >=2-fold rise (n=143)
    134
        D614G; Day 134: >=4-fold rise (n=143)
    131
        D614G; Day 202: >=2-fold rise (n=127)
    120
        D614G; Day 202: >=4-fold rise (n=127)
    119
        D614G; Day 292: >=2-fold rise (n=117)
    108
        D614G; Day 292: >=4-fold rise (n=117)
    105
        D614G; Day 387: >=2-fold rise (n=111)
    105
        D614G; Day 387: >=4-fold rise (n=111)
    101
        B.1.351; Day 22: >=2-fold rise (n=325)
    39
        B.1.351; Day 22: >=4-fold rise (n=325)
    32
        B.1.351; Day 36: >=2-fold rise (n=290)
    264
        B.1.351; Day 36: >=4-fold rise (n=290)
    251
        B.1.351; Day 134: >=2-fold rise (n=112)
    99
        B.1.351; Day 134: >=4-fold rise (n=112)
    89
        B.1.351; Day 202: >=2-fold rise (n=122)
    100
        B.1.351; Day 202: >=4-fold rise (n=122)
    97
        B.1.351; Day 292: >=2-fold rise (n=119)
    98
        B.1.351; Day 292: >=4-fold rise (n=119)
    91
        B.1.351; Day 387: >=2-fold rise (n=111)
    96
        B.1.351; Day 387: >=4-fold rise (n=111)
    94
    No statistical analyses for this end point

    Secondary: Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387

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    End point title
    Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387 [135]
    End point description
    Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA and the results were expressed as geometric mean concentrations. The PPAS is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387
    Notes
    [135] - 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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.
    End point values
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    330
    Units: titers
    geometric mean (confidence interval 95%)
        Day 1 (n=326)
    10.7 (9.91 to 11.6)
        Day 22 (n=330)
    212 (183 to 246)
        Day 36 (n=303)
    24278 (21681 to 27185)
        Day 134 (n=147)
    6593 (4952 to 8779)
        Day 202 (n=132)
    6667 (4833 to 9197)
        Day 292 (n=122)
    6868 (4919 to 9587)
        Day 387 (n=115)
    7112 (5216 to 9697)
    No statistical analyses for this end point

    Secondary: Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387

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    End point title
    Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387 [136]
    End point description
    Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. Participants with binding antibodies concentration >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387
    Notes
    [136] - 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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.
    End point values
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    331
    Units: participants
        Day 22: >=2-fold rise (n=331)
    312
        Day 22: >=4-fold rise (n=331)
    290
        Day 36: >=2-fold rise (n=303)
    302
        Day 36: >=4-fold rise (n=303)
    302
        Day 134: >=2-fold rise (n=150)
    149
        Day 134: >=4-fold rise (n=150)
    148
        Day 202: >=2-fold rise (n=134)
    133
        Day 202: >=4-fold rise (n=134)
    133
        Day 292: >=2-fold rise (n=124)
    123
        Day 292: >=4-fold rise (n=124)
    123
        Day 387: >=2-fold rise (n=118)
    117
        Day 387: >=4-fold rise (n=118)
    117
    No statistical analyses for this end point

    Secondary: Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387

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    End point title
    Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387 [137]
    End point description
    Responders were participants who had baseline values below LLOQ with detectable antibody concentration above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA. The PPAS is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint. Percentages are rounded off to the tenth decimal place.
    End point type
    Secondary
    End point timeframe
    Post-vaccination on Days 22, 36, 134, 202, 292, and 387
    Notes
    [137] - 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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.
    End point values
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Number of subjects analysed
    331
    Units: percentage of participants
    number (confidence interval 95%)
        Day 22 (n=331)
    94.3 (91.2 to 96.5)
        Day 36 (n=325)
    99.7 (98.3 to 100)
        Day 134 (n=159)
    98.7 (95.5 to 99.8)
        Day 202 (n=141)
    99.3 (96.1 to 100)
        Day 292 (n=134)
    99.3 (95.9 to 100)
        Day 387 (n=127)
    99.2 (95.7 to 100)
    No statistical analyses for this end point

    Secondary: Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection

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    End point title
    Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection [138]
    End point description
    Blood samples collected from participants were used for serological assessments in the study. Serologically-confirmed SARS-CoV-2 infection was defined as a positive result in a serum sample for antibodies specific to the nucleocapsid of SARS-CoV-2 detected by electrochemiluminescence immunoassay. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Percentages are rounded off to the tenth decimal place.
    End point type
    Secondary
    End point timeframe
    From first dose of study vaccine administration (Day 1) up to 387 days
    Notes
    [138] - 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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Number of subjects analysed
    240
    241
    240
    Units: percentage of participants
        number (confidence interval 95%)
    12.1 (8.2 to 16.9)
    14.1 (10.0 to 19.2)
    10.8 (7.2 to 15.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19

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    End point title
    Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 [139]
    End point description
    Laboratory-confirmed SARS-CoV-2 infection was defined as a positive result for SARS-CoV-2 by nucleic acid amplification test (done by the central laboratory or locally) on at least 1 respiratory sample. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants. Percentages are rounded off to the tenth decimal place.
    End point type
    Secondary
    End point timeframe
    Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.
    Notes
    [139] - 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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Number of subjects analysed
    240
    241
    328
    378
    375
    113
    111
    108
    127
    100
    100
    103
    38
    38
    132
    78
    473
    240
    Units: percentage of participants
        number (confidence interval 95%)
    3.3 (1.4 to 6.5)
    5.4 (2.9 to 9.0)
    14.0 (10.5 to 18.3)
    20.9 (16.9 to 25.4)
    23.5 (19.3 to 28.1)
    12.4 (6.9 to 19.9)
    10.8 (5.7 to 18.1)
    10.2 (5.2 to 17.5)
    24.4 (17.2 to 32.8)
    25.0 (16.9 to 34.7)
    29.0 (20.4 to 38.9)
    9.7 (4.8 to 17.1)
    0 (0 to 9.3)
    18.4 (7.7 to 34.3)
    18.9 (12.6 to 26.7)
    19.2 (11.2 to 29.7)
    8.2 (5.9 to 11.1)
    1.7 (0.5 to 4.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization

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    End point title
    Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization [140]
    End point description
    Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants. Percentages are rounded off to the tenth decimal place.
    End point type
    Secondary
    End point timeframe
    Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.
    Notes
    [140] - 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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Number of subjects analysed
    240
    241
    328
    378
    375
    113
    111
    108
    127
    100
    100
    103
    38
    38
    132
    78
    473
    240
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 1.5)
    0 (0 to 1.5)
    0 (0 to 1.1)
    0 (0 to 1.0)
    0.3 (0 to 1.5)
    0 (0 to 3.2)
    0 (0 to 3.3)
    0 (0 to 3.4)
    0.8 (0 to 4.3)
    0 (0 to 3.6)
    0 (0 to 3.6)
    0 (0 to 3.5)
    0 (0 to 9.3)
    0 (0 to 9.3)
    0 (0 to 2.8)
    0 (0 to 4.6)
    0 (0 to 0.8)
    0 (0 to 1.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Severe Symptomatic COVID-19

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    End point title
    Percentage of Participants With Severe Symptomatic COVID-19 [141]
    End point description
    Severe COVID-19 was defined as COVID-19 with any 1: Any clinical signs of severe illness measured at least on 2 occasions separated by 30 minutes, supplemental oxygen administration for >1 hour, use of invasive or non-invasive ventilation or Extracorporeal Membrane Oxygenation, clinical diagnosis of respiratory failure, significant acute renal, hepatic, or neurologic dysfunction, shock (defined by systolic blood pressure ˂ 90 mm Hg, or diastolic blood pressure ˂ 60 mm Hg or requiring vasopressors), admission to an intensive care unit, or death. Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants. Percentages are rounded off to the tenth decimal place.
    End point type
    Secondary
    End point timeframe
    Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.
    Notes
    [141] - 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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Number of subjects analysed
    240
    241
    328
    378
    375
    113
    111
    108
    127
    100
    100
    103
    38
    38
    132
    78
    473
    240
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 1.5)
    0 (0 to 1.5)
    0 (0 to 1.1)
    0 (0 to 1.0)
    0.3 (0 to 1.5)
    0 (0 to 3.2)
    0 (0 to 3.3)
    0 (0 to 3.4)
    0 (0 to 2.9)
    0 (0 to 3.6)
    0 (0 to 3.6)
    0 (0 to 3.5)
    0 (0 to 9.3)
    0 (0 to 9.3)
    0.8 (0 to 4.1)
    0 (0 to 4.6)
    0 (0 to 0.8)
    0 (0 to 1.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Death Associated With Symptomatic COVID-19

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    End point title
    Percentage of Participants With Death Associated With Symptomatic COVID-19 [142]
    End point description
    Death associated with COVID-19 was defined as death in a participant with COVID-19 who died within 28 days of the first positive specimen date OR died more than 28 days after the first specimen date and COVID-19 was mentioned as an immediate or underlying cause of death on the death certificate. Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants. Percentages are rounded off to the tenth decimal place.
    End point type
    Secondary
    End point timeframe
    Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.
    Notes
    [142] - 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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.
    End point values
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Number of subjects analysed
    240
    241
    328
    378
    375
    113
    111
    108
    127
    100
    100
    103
    38
    38
    132
    78
    473
    240
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 1.5)
    0 (0 to 1.5)
    0 (0 to 1.1)
    0 (0 to 1.0)
    0 (0 to 1.0)
    0 (0 to 3.2)
    0 (0 to 3.3)
    0 (0 to 3.4)
    0 (0 to 2.9)
    0 (0 to 3.6)
    0 (0 to 3.6)
    0 (0 to 3.5)
    0 (0 to 9.3)
    0 (0 to 9.3)
    0 (0 to 2.8)
    0 (0 to 4.6)
    0 (0 to 0.8)
    0 (0 to 1.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
    Adverse event reporting additional description
    Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
    Reporting group description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
    Reporting group description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
    Reporting group description
    Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
    Reporting group description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
    Reporting group description
    Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
    Reporting group description
    Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
    Reporting group description
    SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

    Reporting group title
    Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

    Reporting group title
    Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
    Reporting group description
    Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.

    Serious adverse events
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 240 (0.83%)
    8 / 328 (2.44%)
    4 / 241 (1.66%)
    6 / 240 (2.50%)
    9 / 378 (2.38%)
    11 / 375 (2.93%)
    3 / 127 (2.36%)
    4 / 108 (3.70%)
    1 / 111 (0.90%)
    3 / 113 (2.65%)
    4 / 100 (4.00%)
    3 / 78 (3.85%)
    3 / 132 (2.27%)
    3 / 38 (7.89%)
    2 / 38 (5.26%)
    0 / 100 (0.00%)
    1 / 103 (0.97%)
    2 / 4 (50.00%)
    14 / 473 (2.96%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    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 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    1 / 127 (0.79%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    1 / 100 (1.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    1 / 100 (1.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal Neoplasm
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive Breast Carcinoma
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic Pregnancy
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Antidepressant Discontinuation Syndrome
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Serum Sickness-Like Reaction
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Loss Of Personal Independence In Daily Activities
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional State
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    1 / 127 (0.79%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Animal Bite
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Stoma Complication
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand Fracture
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    1 / 127 (0.79%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stoma Site Pain
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 113 (0.88%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    1 / 100 (1.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 113 (0.88%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Alcoholic Seizure
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    1 / 378 (0.26%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial Syndrome
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss Of Consciousness
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    1 / 100 (1.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Motor Neurone Disease
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trigeminal Neuralgia
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    1 / 78 (1.28%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    1 / 241 (0.41%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blindness Unilateral
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 113 (0.88%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 113 (0.88%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    1 / 241 (0.41%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    1 / 103 (0.97%)
    1 / 4 (25.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    1 / 241 (0.41%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus Urinary
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Inappropriate Antidiuretic Hormone Secretion
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    1 / 78 (1.28%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    2 / 378 (0.53%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral Disc Disorder
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral Disc Degeneration
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    1 / 4 (25.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    1 / 127 (0.79%)
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    1 / 78 (1.28%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising Fasciitis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Abscess
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurological Infection
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian Abscess
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periumbilical Abscess
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal Disease
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 113 (0.88%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    1 / 241 (0.41%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    1 / 111 (0.90%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte Imbalance
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351) Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351) Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    217 / 240 (90.42%)
    281 / 328 (85.67%)
    219 / 241 (90.87%)
    215 / 240 (89.58%)
    328 / 378 (86.77%)
    331 / 375 (88.27%)
    115 / 127 (90.55%)
    83 / 108 (76.85%)
    88 / 111 (79.28%)
    97 / 113 (85.84%)
    92 / 100 (92.00%)
    59 / 78 (75.64%)
    112 / 132 (84.85%)
    24 / 38 (63.16%)
    21 / 38 (55.26%)
    97 / 100 (97.00%)
    89 / 103 (86.41%)
    4 / 4 (100.00%)
    421 / 473 (89.01%)
    8 / 9 (88.89%)
    7 / 8 (87.50%)
    6 / 9 (66.67%)
    General disorders and administration site conditions
    Injection Site Pain
         subjects affected / exposed
    199 / 240 (82.92%)
    259 / 328 (78.96%)
    200 / 241 (82.99%)
    194 / 240 (80.83%)
    297 / 378 (78.57%)
    301 / 375 (80.27%)
    100 / 127 (78.74%)
    75 / 108 (69.44%)
    81 / 111 (72.97%)
    89 / 113 (78.76%)
    86 / 100 (86.00%)
    46 / 78 (58.97%)
    96 / 132 (72.73%)
    19 / 38 (50.00%)
    18 / 38 (47.37%)
    85 / 100 (85.00%)
    80 / 103 (77.67%)
    4 / 4 (100.00%)
    372 / 473 (78.65%)
    7 / 9 (77.78%)
    5 / 8 (62.50%)
    3 / 9 (33.33%)
         occurrences all number
    336
    260
    339
    331
    298
    302
    100
    75
    81
    89
    86
    46
    96
    19
    18
    85
    80
    4
    590
    7
    5
    3
    Injection Site Erythema
         subjects affected / exposed
    28 / 240 (11.67%)
    32 / 328 (9.76%)
    26 / 241 (10.79%)
    41 / 240 (17.08%)
    23 / 378 (6.08%)
    19 / 375 (5.07%)
    22 / 127 (17.32%)
    4 / 108 (3.70%)
    7 / 111 (6.31%)
    8 / 113 (7.08%)
    8 / 100 (8.00%)
    2 / 78 (2.56%)
    9 / 132 (6.82%)
    3 / 38 (7.89%)
    1 / 38 (2.63%)
    9 / 100 (9.00%)
    5 / 103 (4.85%)
    0 / 4 (0.00%)
    77 / 473 (16.28%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    31
    32
    29
    46
    23
    19
    22
    4
    7
    8
    8
    2
    9
    3
    1
    9
    5
    0
    92
    0
    0
    0
    Fatigue
         subjects affected / exposed
    22 / 240 (9.17%)
    9 / 328 (2.74%)
    17 / 241 (7.05%)
    9 / 240 (3.75%)
    17 / 378 (4.50%)
    13 / 375 (3.47%)
    4 / 127 (3.15%)
    3 / 108 (2.78%)
    3 / 111 (2.70%)
    2 / 113 (1.77%)
    1 / 100 (1.00%)
    0 / 78 (0.00%)
    4 / 132 (3.03%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    6 / 100 (6.00%)
    4 / 103 (3.88%)
    0 / 4 (0.00%)
    40 / 473 (8.46%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    25
    9
    19
    11
    18
    13
    4
    3
    3
    2
    1
    0
    4
    0
    1
    6
    4
    0
    46
    0
    0
    0
    Injection Site Swelling
         subjects affected / exposed
    40 / 240 (16.67%)
    32 / 328 (9.76%)
    37 / 241 (15.35%)
    39 / 240 (16.25%)
    37 / 378 (9.79%)
    25 / 375 (6.67%)
    24 / 127 (18.90%)
    4 / 108 (3.70%)
    7 / 111 (6.31%)
    10 / 113 (8.85%)
    8 / 100 (8.00%)
    3 / 78 (3.85%)
    11 / 132 (8.33%)
    3 / 38 (7.89%)
    0 / 38 (0.00%)
    5 / 100 (5.00%)
    6 / 103 (5.83%)
    0 / 4 (0.00%)
    72 / 473 (15.22%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    42
    33
    41
    46
    37
    25
    24
    4
    7
    10
    8
    3
    11
    3
    0
    5
    6
    0
    86
    0
    1
    0
    Chills
         subjects affected / exposed
    97 / 240 (40.42%)
    50 / 328 (15.24%)
    77 / 241 (31.95%)
    93 / 240 (38.75%)
    74 / 378 (19.58%)
    77 / 375 (20.53%)
    23 / 127 (18.11%)
    23 / 108 (21.30%)
    23 / 111 (20.72%)
    16 / 113 (14.16%)
    23 / 100 (23.00%)
    15 / 78 (19.23%)
    38 / 132 (28.79%)
    5 / 38 (13.16%)
    5 / 38 (13.16%)
    31 / 100 (31.00%)
    10 / 103 (9.71%)
    0 / 4 (0.00%)
    160 / 473 (33.83%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
         occurrences all number
    113
    50
    90
    103
    75
    77
    23
    23
    23
    16
    23
    15
    38
    5
    5
    31
    10
    0
    193
    1
    1
    1
    Malaise
         subjects affected / exposed
    138 / 240 (57.50%)
    101 / 328 (30.79%)
    146 / 241 (60.58%)
    142 / 240 (59.17%)
    122 / 378 (32.28%)
    122 / 375 (32.53%)
    40 / 127 (31.50%)
    33 / 108 (30.56%)
    39 / 111 (35.14%)
    42 / 113 (37.17%)
    35 / 100 (35.00%)
    25 / 78 (32.05%)
    61 / 132 (46.21%)
    7 / 38 (18.42%)
    8 / 38 (21.05%)
    43 / 100 (43.00%)
    31 / 103 (30.10%)
    1 / 4 (25.00%)
    241 / 473 (50.95%)
    2 / 9 (22.22%)
    3 / 8 (37.50%)
    3 / 9 (33.33%)
         occurrences all number
    189
    101
    190
    183
    124
    126
    40
    33
    39
    43
    38
    25
    61
    7
    8
    43
    31
    1
    331
    2
    4
    3
    Pyrexia
         subjects affected / exposed
    34 / 240 (14.17%)
    15 / 328 (4.57%)
    29 / 241 (12.03%)
    35 / 240 (14.58%)
    12 / 378 (3.17%)
    18 / 375 (4.80%)
    3 / 127 (2.36%)
    6 / 108 (5.56%)
    5 / 111 (4.50%)
    1 / 113 (0.88%)
    4 / 100 (4.00%)
    3 / 78 (3.85%)
    11 / 132 (8.33%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    7 / 100 (7.00%)
    2 / 103 (1.94%)
    0 / 4 (0.00%)
    42 / 473 (8.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    35
    16
    29
    36
    12
    19
    3
    6
    5
    1
    4
    3
    11
    1
    0
    7
    2
    0
    44
    0
    0
    1
    Injection Site Pruritus
         subjects affected / exposed
    7 / 240 (2.92%)
    4 / 328 (1.22%)
    6 / 241 (2.49%)
    14 / 240 (5.83%)
    4 / 378 (1.06%)
    2 / 375 (0.53%)
    1 / 127 (0.79%)
    3 / 108 (2.78%)
    1 / 111 (0.90%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    1 / 78 (1.28%)
    3 / 132 (2.27%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    13 / 473 (2.75%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    7
    4
    8
    15
    4
    2
    1
    3
    1
    0
    0
    1
    3
    1
    0
    0
    0
    0
    15
    0
    0
    0
    Immune system disorders
    Dust Allergy
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    2 / 375 (0.53%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    1 / 111 (0.90%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 100 (1.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    3 / 473 (0.63%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 240 (1.67%)
    8 / 328 (2.44%)
    2 / 241 (0.83%)
    3 / 240 (1.25%)
    13 / 378 (3.44%)
    12 / 375 (3.20%)
    7 / 127 (5.51%)
    4 / 108 (3.70%)
    3 / 111 (2.70%)
    4 / 113 (3.54%)
    4 / 100 (4.00%)
    1 / 78 (1.28%)
    4 / 132 (3.03%)
    2 / 38 (5.26%)
    1 / 38 (2.63%)
    4 / 100 (4.00%)
    1 / 103 (0.97%)
    0 / 4 (0.00%)
    33 / 473 (6.98%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    4
    8
    2
    4
    14
    12
    7
    4
    3
    4
    4
    1
    4
    2
    1
    4
    1
    0
    36
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 240 (0.42%)
    2 / 328 (0.61%)
    0 / 241 (0.00%)
    2 / 240 (0.83%)
    3 / 378 (0.79%)
    1 / 375 (0.27%)
    1 / 127 (0.79%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    1 / 100 (1.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    2 / 100 (2.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    7 / 473 (1.48%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    1
    2
    0
    2
    3
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    7
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    4 / 240 (1.67%)
    6 / 328 (1.83%)
    1 / 241 (0.41%)
    4 / 240 (1.67%)
    9 / 378 (2.38%)
    11 / 375 (2.93%)
    2 / 127 (1.57%)
    3 / 108 (2.78%)
    3 / 111 (2.70%)
    4 / 113 (3.54%)
    5 / 100 (5.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    2 / 100 (2.00%)
    1 / 103 (0.97%)
    0 / 4 (0.00%)
    22 / 473 (4.65%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    4
    6
    1
    4
    10
    11
    2
    3
    3
    4
    5
    0
    1
    0
    0
    2
    1
    0
    24
    0
    1
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 240 (0.00%)
    4 / 328 (1.22%)
    4 / 241 (1.66%)
    2 / 240 (0.83%)
    6 / 378 (1.59%)
    5 / 375 (1.33%)
    2 / 127 (1.57%)
    2 / 108 (1.85%)
    1 / 111 (0.90%)
    1 / 113 (0.88%)
    3 / 100 (3.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    4 / 100 (4.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    13 / 473 (2.75%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    4
    4
    2
    6
    5
    2
    2
    1
    1
    3
    0
    0
    0
    0
    4
    0
    0
    14
    0
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 328 (0.30%)
    1 / 241 (0.41%)
    0 / 240 (0.00%)
    3 / 378 (0.79%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 100 (1.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    1
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    Injury, poisoning and procedural complications
    Foot Fracture
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Muscle Strain
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    2 / 378 (0.53%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 113 (0.88%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin Laceration
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    2 / 378 (0.53%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 113 (0.88%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    2 / 473 (0.42%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    141 / 240 (58.75%)
    130 / 328 (39.63%)
    134 / 241 (55.60%)
    134 / 240 (55.83%)
    167 / 378 (44.18%)
    165 / 375 (44.00%)
    45 / 127 (35.43%)
    39 / 108 (36.11%)
    50 / 111 (45.05%)
    47 / 113 (41.59%)
    48 / 100 (48.00%)
    20 / 78 (25.64%)
    51 / 132 (38.64%)
    10 / 38 (26.32%)
    10 / 38 (26.32%)
    55 / 100 (55.00%)
    37 / 103 (35.92%)
    2 / 4 (50.00%)
    278 / 473 (58.77%)
    6 / 9 (66.67%)
    3 / 8 (37.50%)
    3 / 9 (33.33%)
         occurrences all number
    195
    133
    198
    187
    176
    179
    46
    39
    51
    49
    51
    20
    52
    10
    10
    56
    37
    2
    406
    6
    3
    3
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    2 / 240 (0.83%)
    2 / 328 (0.61%)
    3 / 241 (1.24%)
    1 / 240 (0.42%)
    5 / 378 (1.32%)
    4 / 375 (1.07%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    1 / 38 (2.63%)
    1 / 38 (2.63%)
    1 / 100 (1.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    5 / 473 (1.06%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    3
    2
    3
    1
    5
    5
    0
    0
    0
    0
    0
    0
    1
    1
    1
    1
    0
    0
    6
    0
    0
    1
    Gastrointestinal disorders
    Dental Caries
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 328 (0.30%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    1 / 378 (0.26%)
    2 / 375 (0.53%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    2 / 132 (1.52%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    2 / 473 (0.42%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    Nausea
         subjects affected / exposed
    11 / 240 (4.58%)
    2 / 328 (0.61%)
    8 / 241 (3.32%)
    7 / 240 (2.92%)
    9 / 378 (2.38%)
    8 / 375 (2.13%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    1 / 111 (0.90%)
    1 / 113 (0.88%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    3 / 38 (7.89%)
    2 / 100 (2.00%)
    1 / 103 (0.97%)
    0 / 4 (0.00%)
    26 / 473 (5.50%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    11
    2
    9
    8
    9
    8
    0
    0
    1
    1
    0
    0
    1
    0
    3
    2
    1
    0
    30
    0
    0
    0
    Tooth Impacted
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hepatobiliary disorders
    Biliary Colic
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    1 / 375 (0.27%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    1 / 4 (25.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Skin Reaction
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    107 / 240 (44.58%)
    91 / 328 (27.74%)
    104 / 241 (43.15%)
    102 / 240 (42.50%)
    110 / 378 (29.10%)
    114 / 375 (30.40%)
    22 / 127 (17.32%)
    31 / 108 (28.70%)
    39 / 111 (35.14%)
    31 / 113 (27.43%)
    30 / 100 (30.00%)
    18 / 78 (23.08%)
    42 / 132 (31.82%)
    7 / 38 (18.42%)
    6 / 38 (15.79%)
    35 / 100 (35.00%)
    24 / 103 (23.30%)
    0 / 4 (0.00%)
    228 / 473 (48.20%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
         occurrences all number
    132
    94
    131
    134
    113
    115
    22
    31
    40
    32
    30
    18
    42
    7
    6
    36
    24
    0
    308
    1
    1
    1
    Myalgia
         subjects affected / exposed
    143 / 240 (59.58%)
    123 / 328 (37.50%)
    123 / 241 (51.04%)
    135 / 240 (56.25%)
    145 / 378 (38.36%)
    153 / 375 (40.80%)
    40 / 127 (31.50%)
    43 / 108 (39.81%)
    48 / 111 (43.24%)
    41 / 113 (36.28%)
    36 / 100 (36.00%)
    27 / 78 (34.62%)
    61 / 132 (46.21%)
    11 / 38 (28.95%)
    9 / 38 (23.68%)
    54 / 100 (54.00%)
    33 / 103 (32.04%)
    2 / 4 (50.00%)
    275 / 473 (58.14%)
    4 / 9 (44.44%)
    2 / 8 (25.00%)
    4 / 9 (44.44%)
         occurrences all number
    196
    124
    166
    176
    148
    153
    41
    43
    51
    41
    38
    27
    61
    11
    9
    54
    33
    2
    371
    4
    2
    4
    Infections and infestations
    Breast Abscess
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Covid-19
         subjects affected / exposed
    5 / 240 (2.08%)
    16 / 328 (4.88%)
    7 / 241 (2.90%)
    3 / 240 (1.25%)
    34 / 378 (8.99%)
    37 / 375 (9.87%)
    2 / 127 (1.57%)
    9 / 108 (8.33%)
    4 / 111 (3.60%)
    6 / 113 (5.31%)
    9 / 100 (9.00%)
    13 / 78 (16.67%)
    20 / 132 (15.15%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    6 / 100 (6.00%)
    5 / 103 (4.85%)
    0 / 4 (0.00%)
    21 / 473 (4.44%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    5
    16
    7
    3
    35
    38
    2
    9
    4
    6
    9
    13
    20
    1
    0
    6
    5
    0
    21
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 240 (0.83%)
    3 / 328 (0.91%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    7 / 378 (1.85%)
    2 / 375 (0.53%)
    5 / 127 (3.94%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    1 / 100 (1.00%)
    6 / 78 (7.69%)
    3 / 132 (2.27%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    2 / 100 (2.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    2 / 473 (0.42%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    3
    0
    1
    9
    2
    5
    0
    0
    0
    1
    6
    4
    0
    0
    2
    0
    0
    2
    0
    0
    0
    Otitis Externa
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 240 (0.42%)
    2 / 328 (0.61%)
    3 / 241 (1.24%)
    3 / 240 (1.25%)
    7 / 378 (1.85%)
    4 / 375 (1.07%)
    2 / 127 (1.57%)
    1 / 108 (0.93%)
    3 / 111 (2.70%)
    2 / 113 (1.77%)
    2 / 100 (2.00%)
    0 / 78 (0.00%)
    2 / 132 (1.52%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    2 / 100 (2.00%)
    1 / 103 (0.97%)
    0 / 4 (0.00%)
    7 / 473 (1.48%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    1
    2
    3
    3
    7
    4
    2
    1
    3
    2
    2
    0
    2
    1
    0
    2
    1
    0
    7
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    2 / 240 (0.83%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    4 / 378 (1.06%)
    7 / 375 (1.87%)
    1 / 127 (0.79%)
    0 / 108 (0.00%)
    3 / 111 (2.70%)
    3 / 113 (2.65%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 100 (0.00%)
    2 / 103 (1.94%)
    0 / 4 (0.00%)
    3 / 473 (0.63%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    1
    4
    8
    1
    0
    3
    3
    0
    0
    1
    0
    1
    0
    2
    0
    3
    2
    0
    0
    Post-Acute Covid-19 Syndrome
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    1 / 240 (0.42%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 100 (1.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Suspected Covid-19
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    2 / 378 (0.53%)
    3 / 375 (0.80%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    2 / 100 (2.00%)
    2 / 78 (2.56%)
    4 / 132 (3.03%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    1 / 473 (0.21%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    3
    0
    0
    0
    0
    2
    2
    4
    2
    0
    0
    0
    0
    1
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    1 / 378 (0.26%)
    3 / 375 (0.80%)
    0 / 127 (0.00%)
    0 / 108 (0.00%)
    1 / 111 (0.90%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    4 / 473 (0.85%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    0
    0
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 240 (0.00%)
    0 / 328 (0.00%)
    0 / 241 (0.00%)
    0 / 240 (0.00%)
    0 / 378 (0.00%)
    0 / 375 (0.00%)
    0 / 127 (0.00%)
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 113 (0.00%)
    0 / 100 (0.00%)
    0 / 78 (0.00%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
    0 / 4 (0.00%)
    0 / 473 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urinary Tract Infection
         subjects affected / exposed
    4 / 240 (1.67%)
    2 / 328 (0.61%)
    2 / 241 (0.83%)
    3 / 240 (1.25%)
    6 / 378 (1.59%)
    5 / 375 (1.33%)
    3 / 127 (2.36%)
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 113 (0.88%)
    1 / 100 (1.00%)
    1 / 78 (1.28%)
    0 / 132 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 100 (1.00%)
    1 / 103 (0.97%)
    0 / 4 (0.00%)
    5 / 473 (1.06%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    4
    2
    2
    3
    6
    6
    3
    0
    0
    1
    1
    1
    0
    0
    0
    1
    2
    0
    5
    0
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 240 (0.00%)
    3 / 328 (0.91%)
    3 / 241 (1.24%)
    1 / 240 (0.42%)
    5 / 378 (1.32%)
    2 / 375 (0.53%)
    0 / 127 (0.00%)
    4 / 108 (3.70%)
    1 / 111 (0.90%)
    2 / 113 (1.77%)
    0 / 100 (0.00%)
    2 / 78 (2.56%)
    1 / 132 (0.76%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 100 (1.00%)
    3 / 103 (2.91%)
    0 / 4 (0.00%)
    4 / 473 (0.85%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
         occurrences all number
    0
    4
    3
    1
    5
    2
    0
    4
    1
    2
    0
    3
    1
    0
    0
    1
    3
    0
    4
    0
    1
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2021
    Amended to clarify that safety, reactogenicity, and immunogenicity data from the Phase 2 study used to determine progression to a Phase 3 and inform dose selection. Revised text to clarify the onset of COVID-like-illness. Halting rule added per Center for Biologics Evaluation and Research non-hold comment.
    10 Jun 2021
    The study design changed to add a Supplemental Phase 3 Cohorts (Booster Study 1). Study phase changed. Study name changed to add Supplemental Phase 3 Cohorts. Titles changed to add Supplemental Phase 3 Cohorts. New formulations added for the Supplemental Phase 3 Cohorts. Study Design changed to add the Supplemental Phase 3 Cohorts. Objectives and Endpoints added for the Supplemental Phase 3 Cohorts. Schemas added for the Supplemental Phase 3 Cohorts. Schedule of Activities added for the Supplemental Phase 3 Cohorts.
    31 Aug 2021
    Shortened names of vaccine candidates changed. Greek letter names for the virus variants was added, that is Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617). Text added to replace pandemic scope text in previous versions. Nonclinical studies text added for monovalent and bivalent vaccine data. Additional objectives for Supplemental Cohorts 1 and 2 added. Modified participant numbers for Cohort 3 subset to 87. Dose formulation text updated. Updated inclusion and exclusion criteria. Removed text for SARS-CoV-2 Virus Neutralization Assays.
    12 Oct 2021
    Clarification added to protein-primed dosing groups only. Seroresponse included as conditional secondary endpoint for powered comparisons. New subsection "A Pooled Primary Series Cohort as Supplemental Cohorts 1 and 2 Comparator Group" was added.
    19 Nov 2021
    Removed bivalent vaccine candidate arm from Variant Prime Cohort 3. Participants numbers changed in monovalent arms. Total participant numbers changed due to no bivalent arm in Variant Prime Cohort 3. Definition of COVID-19 was changed. Updated the Section "Variant Prime Cohort 3 statistical analysis".
    20 Jan 2022
    Removed Supplemental Variant Prime Cohort 3. Total participant numbers changed for removal of Variant Prime Cohort 3 participants. Updated the Section "List of potential immune-mediated diseases".

    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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