HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 Linux 31MAR21:12:06:0931MAR21:12:06:09 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS TI SASDATA 9.4 Linux 31MAR21:12:06:0931MAR21:12:06:09 Trial Inclusion/Exclusion Criteria HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000000600000000000000000000 STUDYID Study Identifier DOMAIN Domain Abbreviation IETESTCDInclusion/Exclusion Criterion Short Name ÈIETEST Inclusion/Exclusion Criterion IECAT Inclusion/Exclusion Category ÙTIVERS Protocol Criteria Versions â HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 C4591001TIEX01A00Other medical or psychiatric condition incl. recent (within past year) or active suicidal ideation/behavior/lab abnormality that may increase the risk of study participation EXCLUSION1.0C4591001TIEX01A00Other medical or psychiatric condition incl. recent (within past year) or active suicidal ideation/behavior/lab abnormality that may increase the risk of study participation EXCLUSION2.0C4591001TIEX01A00Other medical or psychiatric condition incl. recent (within past year) or active suicidal ideation/behavior/lab abnormality that may increase the risk of study participation EXCLUSION5.0C4591001TIEX01A00Other medical or psychiatric condition incl. recent (within past year) or active suicidal ideation/behavior/lab abnormality that may increase the risk of study participation EXCLUSION6.0C4591001TIEX01A00Other medical or psychiatric condition incl. recent (within past year) or active suicidal ideation/behavior/lab abnormality that may increase the risk of study participation EXCLUSION7.0C4591001TIEX01A00Other medical or psychiatric condition incl. recent (within past year) or active suicidal ideation/behavior/lab abnormality that may increase the risk of study participation EXCLUSION8.0C4591001TIEX02A00Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) EXCLUSION1.0C4591001TIEX02A00Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) EXCLUSION2.0C4591001TIEX02A00Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) EXCLUSION5.0C4591001TIEX02A00Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) EXCLUSION6.0C4591001TIEX02A06Phase 1 & 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) EXCLUSION7.0C4591001TIEX02A06Phase 1 & 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) EXCLUSION8.0C4591001TIEX03A00History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) EXCLUSION1.0C4591001TIEX03A00History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) EXCLUSION2.0C4591001TIEX03A00History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) EXCLUSION5.0C4591001TIEX03A00History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) EXCLUSION6.0C4591001TIEX03A00History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) EXCLUSION7.0C4591001TIEX03A00History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) EXCLUSION8.0C4591001TIEX04A00Receipt of medications intended to prevent COVID-19 EXCLUSION1.0C4591001TIEX04A00Receipt of medications intended to prevent COVID-19 EXCLUSION2.0C4591001TIEX04A00Receipt of medications intended to prevent COVID-19 EXCLUSION5.0C4591001TIEX04A00Receipt of medications intended to prevent COVID-19 EXCLUSION6.0C4591001TIEX04A00Receipt of medications intended to prevent COVID-19 EXCLUSION7.0C4591001TIEX04A00Receipt of medications intended to prevent COVID-19 EXCLUSION8.0C4591001TIEX05A00Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID-19 EXCLUSION1.0C4591001TIEX05A00Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID-19 EXCLUSION2.0C4591001TIEX05A00Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID-19 EXCLUSION5.0C4591001TIEX05A05Previous clinical or microbiological diagnosis of COVID-19 EXCLUSION6.0C4591001TIEX05A05Previous clinical or microbiological diagnosis of COVID-19 EXCLUSION7.0C4591001TIEX05A07Previous clinical (based on COVID-19 symptoms/signs alone if no SARS-CoV-2 NAAT result) or microbiological (based on COVID-19 symptoms/signs and positive SARS-CoV-2 NAAT result) diagnosis of COVID-19 EXCLUSION8.0C4591001TIEX06A00Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 EXCLUSION1.0C4591001TIEX06A01Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 (full details in protocol) EXCLUSION2.0C4591001TIEX06A01Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 (full details in protocol) EXCLUSION5.0C4591001TIEX06A05Phase 1 only: Individuals at high risk for severe COVID-19 (full details in protocol) EXCLUSION6.0C4591001TIEX06A05Phase 1 only: Individuals at high risk for severe COVID-19 (full details in protocol) EXCLUSION7.0C4591001TIEX06A05Phase 1 only: Individuals at high risk for severe COVID-19 (full details in protocol) EXCLUSION8.0C4591001TIEX07A00Sentinel participants in Stage 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel) EXCLUSION1.0C4591001TIEX07A00Sentinel participants in Stage 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel) EXCLUSION2.0C4591001TIEX07A00Sentinel participants in Stage 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel) EXCLUSION5.0C4591001TIEX07A05Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel) EXCLUSION6.0C4591001TIEX07A05Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel) EXCLUSION7.0C4591001TIEX07A05Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel) EXCLUSION8.0C4591001TIEX08A00Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination EXCLUSION1.0C4591001TIEX08A00Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination EXCLUSION2.0C4591001TIEX08A00Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination EXCLUSION5.0C4591001TIEX08A00Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination EXCLUSION6.0C4591001TIEX08A00Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination EXCLUSION7.0C4591001TIEX08A00Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination EXCLUSION8.0C4591001TIEX09A00Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention EXCLUSION1.0C4591001TIEX09A00Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention EXCLUSION2.0C4591001TIEX09A04Sentinel participants in Stage 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention EXCLUSION5.0C4591001TIEX09A05Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention EXCLUSION6.0C4591001TIEX09A05Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention EXCLUSION7.0C4591001TIEX09A05Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention EXCLUSION8.0C4591001TIEX10A00Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection EXCLUSION1.0C4591001TIEX10A00Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection EXCLUSION2.0C4591001TIEX10A00Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection EXCLUSION5.0C4591001TIEX10A00Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection EXCLUSION6.0C4591001TIEX10A00Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection EXCLUSION7.0C4591001TIEX10A00Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection EXCLUSION8.0C4591001TIEX11A00Women who are pregnant or breastfeeding EXCLUSION1.0C4591001TIEX11A00Women who are pregnant or breastfeeding EXCLUSION2.0C4591001TIEX11A00Women who are pregnant or breastfeeding EXCLUSION5.0C4591001TIEX11A00Women who are pregnant or breastfeeding EXCLUSION6.0C4591001TIEX11A00Women who are pregnant or breastfeeding EXCLUSION7.0C4591001TIEX11A00Women who are pregnant or breastfeeding EXCLUSION8.0C4591001TIEX12A00Previous vaccination with any coronavirus vaccine EXCLUSION1.0C4591001TIEX12A00Previous vaccination with any coronavirus vaccine EXCLUSION2.0C4591001TIEX12A00Previous vaccination with any coronavirus vaccine EXCLUSION5.0C4591001TIEX12A00Previous vaccination with any coronavirus vaccine EXCLUSION6.0C4591001TIEX12A00Previous vaccination with any coronavirus vaccine EXCLUSION7.0C4591001TIEX12A00Previous vaccination with any coronavirus vaccine EXCLUSION8.0C4591001TIEX13A00Individuals who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids. Inhaled/nebulized, Intra-articular, intrabursal, or topical corticosteroids are permitted EXCLUSION1.0C4591001TIEX13A01Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids EXCLUSION2.0C4591001TIEX13A01Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids EXCLUSION5.0C4591001TIEX13A01Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids EXCLUSION6.0C4591001TIEX13A01Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids EXCLUSION7.0C4591001TIEX13A01Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids EXCLUSION8.0C4591001TIEX14A00Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study EXCLUSION1.0C4591001TIEX14A00Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study EXCLUSION2.0C4591001TIEX14A00Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study EXCLUSION5.0C4591001TIEX14A00Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study EXCLUSION6.0C4591001TIEX14A00Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study EXCLUSION7.0C4591001TIEX14A00Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study EXCLUSION8.0C4591001TIEX15A00Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation EXCLUSION1.0C4591001TIEX15A00Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation EXCLUSION2.0C4591001TIEX15A00Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation EXCLUSION5.0C4591001TIEX15A00Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation EXCLUSION6.0C4591001TIEX15A00Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation EXCLUSION7.0C4591001TIEX15A00Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation EXCLUSION8.0C4591001TIEX16A00Previous participation in other studies involving study intervention containing lipid nanoparticles EXCLUSION1.0C4591001TIEX16A00Previous participation in other studies involving study intervention containing lipid nanoparticles EXCLUSION2.0C4591001TIEX16A00Previous participation in other studies involving study intervention containing lipid nanoparticles EXCLUSION5.0C4591001TIEX16A00Previous participation in other studies involving study intervention containing lipid nanoparticles EXCLUSION6.0C4591001TIEX16A00Previous participation in other studies involving study intervention containing lipid nanoparticles EXCLUSION7.0C4591001TIEX16A00Previous participation in other studies involving study intervention containing lipid nanoparticles EXCLUSION8.0C4591001TIEX17A00Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit EXCLUSION1.0C4591001TIEX17A00Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit EXCLUSION2.0C4591001TIEX17A00Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit EXCLUSION5.0C4591001TIEX17A05Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit EXCLUSION6.0C4591001TIEX17A05Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit EXCLUSION7.0C4591001TIEX17A05Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit EXCLUSION8.0C4591001TIEX18A00Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator EXCLUSION1.0C4591001TIEX18A00Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator EXCLUSION2.0C4591001TIEX18A00Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator EXCLUSION5.0C4591001TIEX18A05Phase 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator EXCLUSION6.0C4591001TIEX18A05Phase 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator EXCLUSION7.0C4591001TIEX18A05Phase 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator EXCLUSION8.0C4591001TIEX19A00Sentinel participants in Stage 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at screening visit EXCLUSION1.0C4591001TIEX19A00Sentinel participants in Stage 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at screening visit EXCLUSION2.0C4591001TIEX19A00Sentinel participants in Stage 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at screening visit EXCLUSION5.0C4591001TIEX19A05Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at screening visit EXCLUSION6.0C4591001TIEX19A05Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at screening visit EXCLUSION7.0C4591001TIEX19A05Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at screening visit EXCLUSION8.0C4591001TIEX20A00Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention EXCLUSION1.0C4591001TIEX20A00Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention EXCLUSION2.0C4591001TIEX20A00Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention EXCLUSION5.0C4591001TIEX20A05Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention EXCLUSION6.0C4591001TIEX20A05Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention EXCLUSION7.0C4591001TIEX20A05Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention EXCLUSION8.0C4591001TIEX21A00Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members EXCLUSION1.0C4591001TIEX21A00Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members EXCLUSION2.0C4591001TIEX21A00Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members EXCLUSION5.0C4591001TIEX21A00Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members EXCLUSION6.0C4591001TIEX21A06Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members EXCLUSION7.0C4591001TIEX21A06Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members EXCLUSION8.0C4591001TIEX22A01Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized corticosteroids EXCLUSION2.0C4591001TIEX22A01Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized corticosteroids EXCLUSION5.0C4591001TIEX22A05Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids EXCLUSION6.0C4591001TIEX22A05Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids EXCLUSION7.0C4591001TIEX22A05Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids EXCLUSION8.0C4591001TIIN01A00Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study stage) INCLUSION1.0C4591001TIIN01A00Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study stage) INCLUSION2.0C4591001TIIN01A00Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study stage) INCLUSION5.0C4591001TIIN01A05Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study phase) INCLUSION6.0C4591001TIIN01A06Male or female participants between the ages of 18 and 55 years, inclusive, and 65 and 85 years, inclusive (Phase 1), or >= 16 years (Phase 2/3), at randomization INCLUSION7.0C4591001TIIN01A07Male or female participants between 18 and 55 years inclusive and 65 and 85 years inclusive (Phase 1) or >= 12 years (Phase 2/3) at randomization. Participants <18 years cannot be enrolled in EU INCLUSION8.0C4591001TIIN02A00Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures INCLUSION1.0C4591001TIIN02A00Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures INCLUSION2.0C4591001TIIN02A00Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures INCLUSION5.0C4591001TIIN02A00Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures INCLUSION6.0C4591001TIIN02A00Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures INCLUSION7.0C4591001TIIN02A00Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures INCLUSION8.0C4591001TIIN03A00Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study INCLUSION1.0C4591001TIIN03A00Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study INCLUSION2.0C4591001TIIN03A00Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study INCLUSION5.0C4591001TIIN03A05Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study INCLUSION6.0C4591001TIIN03A06Healthy participants, determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for the study. Specific criteria apply for HIV/HCV/HBVINCLUSION7.0C4591001TIIN03A06Healthy participants, determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for the study. Specific criteria apply for HIV/HCV/HBVINCLUSION8.0C4591001TIIN04A00Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol INCLUSION1.0C4591001TIIN04A00Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol INCLUSION2.0C4591001TIIN04A00Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol INCLUSION5.0C4591001TIIN04A00Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol INCLUSION6.0C4591001TIIN04A00Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol INCLUSION7.0C4591001TIIN04A07Capable of giving personal signed informed consent/have parent/legal guardian capable of giving signed informed consent, which includes compliance with requirements, restrictions in ICD and protocol INCLUSION8.0C4591001TIIN05A05Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19 INCLUSION6.0C4591001TIIN05A06Phase 2/3 only: Participants who, in the judgment of the investigator, are at higher risk for acquiring COVID-19 INCLUSION7.0C4591001TIIN05A06Phase 2/3 only: Participants who, in the judgment of the investigator, are at higher risk for acquiring COVID-19 INCLUSION8.0