HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 X64_SR12 19MAY21:19:09:3119MAY21:19:09:31 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS TI SASDATA 9.4 X64_SR12 19MAY21:19:09:3119MAY21:19:09:31 Trial Inclusion/Exclusion Criteria HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000000600000000000000000000 STUDYID Study Identifier DOMAIN Domain Abbreviation IETESTCDInclusion/Exclusion Criterion Short Name ÇIETEST Inclusion/Exclusion Criterion  IECAT Inclusion/Exclusion Category Ý TIVERS Protocol Criteria Versions æ HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P301TIEXC01 Participants who are acutely ill or febrile 72 hours prior to or at Screening may be rescheduled. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC01 Participants who are acutely ill or febrile 72 hours prior to or at Screening may be rescheduled. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC01 Participants who are acutely ill or febrile 72 hours prior to or at Screening may be rescheduled. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC01 Participants who are acutely ill or febrile 72 hours prior to or at Screening may be rescheduled. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC01 Participants who are acutely ill or febrile 72 hours prior to or at Screening may be rescheduled. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC01 Participants who are acutely ill or febrile 72 hours prior to or at Screening may be rescheduled. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC01 Participants who are acutely ill or febrile 72 hours prior to or at Screening may be rescheduled. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. EXCLUSIONOriginal mRNA-1273-P301TIEXC02 Is pregnant or breastfeeding. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC02 Is pregnant or breastfeeding. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC02 Is pregnant or breastfeeding. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC02 Is pregnant or breastfeeding. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC02 Is pregnant or breastfeeding. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC02 Is pregnant or breastfeeding. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC02 Is pregnant or breastfeeding. EXCLUSIONOriginal mRNA-1273-P301TIEXC03 Known history of SARS-CoV-2 infection. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC03 Known history of SARS-CoV-2 infection. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC03 Known history of SARS-CoV-2 infection. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC03 Known history of SARS-CoV-2 infection. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC03 Known history of SARS-CoV-2 infection. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC03 Known history of SARS-CoV-2 infection. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC03 Known history of SARS-CoV-2 infection. EXCLUSIONOriginal mRNA-1273-P301TIEXC04 Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC04 Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC04 Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC04 Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC04 Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC04 Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC04 Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19. EXCLUSIONOriginal mRNA-1273-P301TIEXC05 Demonstrated inability to comply with the study procedures. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC05 Demonstrated inability to comply with the study procedures. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC05 Demonstrated inability to comply with the study procedures. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC05 Demonstrated inability to comply with the study procedures. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC05 Demonstrated inability to comply with the study procedures. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC05 Demonstrated inability to comply with the study procedures. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC05 Demonstrated inability to comply with the study procedures. EXCLUSIONOriginal mRNA-1273-P301TIEXC06 An immediate family member or household member of this study's personnel. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC06 An immediate family member or household member of this study's personnel. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC06 An immediate family member or household member of this study's personnel. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC06 An immediate family member or household member of this study's personnel. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC06 An immediate family member or household member of this study's personnel. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC06 An immediate family member or household member of this study's personnel. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC06 An immediate family member or household member of this study's personnel. EXCLUSIONOriginal mRNA-1273-P301TIEXC07 History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC07 History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. EXCLUSIONOriginal mRNA-1273-P301TIEXC07AKnown or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC07AKnown or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC07AKnown or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC07AKnown or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC07AKnown or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC08 Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC08 Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC08 Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC08 Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC08 Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC08 Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC08 Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. EXCLUSIONOriginal mRNA-1273-P301TIEXC09 Has received or plans to receive a vaccine within 28 days prior to the first dose or plans to receive a non-study vaccine within 28 days prior to or after any dose of IP. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC09 Has received or plans to receive a vaccine within 28 days prior to the first dose or plans to receive a non-study vaccine within 28 days prior to or after any dose of IP. EXCLUSIONOriginal mRNA-1273-P301TIEXC09AHas received or plans to receive a non-study vaccine within 28 days before/after any dose of IP (except for seasonal influenza vaccine which not permitted within 14 days before/after any dose of IP).EXCLUSIONAmendment 2mRNA-1273-P301TIEXC09AHas received or plans to receive a non-study vaccine within 28 days before/after any dose of IP (except for seasonal influenza vaccine which not permitted within 14 days before/after any dose of IP).EXCLUSIONAmendment 3mRNA-1273-P301TIEXC09AHas received or plans to receive a non-study vaccine within 28 days before/after any dose of IP (except for seasonal influenza vaccine which not permitted within 14 days before/after any dose of IP).EXCLUSIONAmendment 4mRNA-1273-P301TIEXC09AHas received or plans to receive a non-study vaccine within 28 days before/after any dose of IP (except for seasonal influenza vaccine which not permitted within 14 days before/after any dose of IP).EXCLUSIONAmendment 5mRNA-1273-P301TIEXC09AHas received or plans to receive a non-study vaccine within 28 days before/after any dose of IP (except for seasonal influenza vaccine which not permitted within 14 days before/after any dose of IP).EXCLUSIONAmendment 6mRNA-1273-P301TIEXC10 Has participated in an interventional clinical study within 28 days prior to the day of enrollment. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC10 Has participated in an interventional clinical study within 28 days prior to the day of enrollment. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC10 Has participated in an interventional clinical study within 28 days prior to the day of enrollment. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC10 Has participated in an interventional clinical study within 28 days prior to the day of enrollment. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC10 Has participated in an interventional clinical study within 28 days prior to the day of enrollment. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC10 Has participated in an interventional clinical study within 28 days prior to the day of enrollment. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC10 Has participated in an interventional clinical study within 28 days prior to the day of enrollment. EXCLUSIONOriginal mRNA-1273-P301TIEXC11 Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition. EXCLUSIONOriginal mRNA-1273-P301TIEXC11AImmunosuppressive or immunodeficient state, including HIV infection, asplenia, recurrent severe infections. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC11BImmunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIVpositive participants on stable antiretroviral therapy are not excluded). EXCLUSIONAmendment 2mRNA-1273-P301TIEXC11CImmunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIVpositive participants with CD4 count =350 cells/mm3 and an undetectable HIV viral load within the past year). EXCLUSIONAmendment 3mRNA-1273-P301TIEXC11CImmunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIVpositive participants with CD4 count =350 cells/mm3 and an undetectable HIV viral load within the past year). EXCLUSIONAmendment 4mRNA-1273-P301TIEXC11CImmunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIVpositive participants with CD4 count =350 cells/mm3 and an undetectable HIV viral load within the past year). EXCLUSIONAmendment 5mRNA-1273-P301TIEXC11CImmunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIVpositive participants with CD4 count =350 cells/mm3 and an undetectable HIV viral load within the past year). EXCLUSIONAmendment 6mRNA-1273-P301TIEXC12 Has received systemic immunosuppressants/immune-modifying drugs for >14 days in total within 6 months prior to Screening. Topical tacrolimus is allowed if not used within 14 days prior to Screening. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC12 Has received systemic immunosuppressants/immune-modifying drugs for >14 days in total within 6 months prior to Screening. Topical tacrolimus is allowed if not used within 14 days prior to Screening. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC12 Has received systemic immunosuppressants/immune-modifying drugs for >14 days in total within 6 months prior to Screening. Topical tacrolimus is allowed if not used within 14 days prior to Screening. EXCLUSIONOriginal mRNA-1273-P301TIEXC12AHas received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids = 20 mg/day of prednisone equivalent). EXCLUSIONAmendment 3mRNA-1273-P301TIEXC12AHas received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids = 20 mg/day of prednisone equivalent). EXCLUSIONAmendment 4mRNA-1273-P301TIEXC12AHas received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids = 20 mg/day of prednisone equivalent). EXCLUSIONAmendment 5mRNA-1273-P301TIEXC12AHas received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids = 20 mg/day of prednisone equivalent). EXCLUSIONAmendment 6mRNA-1273-P301TIEXC13 Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC13 Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC13 Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC13 Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC13 Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC13 Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC13 Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. EXCLUSIONOriginal mRNA-1273-P301TIEXC14 Has donated >= 450 mL of blood products within 28 days prior to Screening. EXCLUSIONAmendment 1mRNA-1273-P301TIEXC14 Has donated >= 450 mL of blood products within 28 days prior to Screening. EXCLUSIONAmendment 2mRNA-1273-P301TIEXC14 Has donated >= 450 mL of blood products within 28 days prior to Screening. EXCLUSIONAmendment 3mRNA-1273-P301TIEXC14 Has donated >= 450 mL of blood products within 28 days prior to Screening. EXCLUSIONAmendment 4mRNA-1273-P301TIEXC14 Has donated >= 450 mL of blood products within 28 days prior to Screening. EXCLUSIONAmendment 5mRNA-1273-P301TIEXC14 Has donated >= 450 mL of blood products within 28 days prior to Screening. EXCLUSIONAmendment 6mRNA-1273-P301TIEXC14 Has donated >= 450 mL of blood products within 28 days prior to Screening. EXCLUSIONOriginal mRNA-1273-P301TIINC01 Adults, >= 18 years of age at time of consent, who are at high risk of SARS-CoV-2 infection. INCLUSIONAmendment 1mRNA-1273-P301TIINC01 Adults, >= 18 years of age at time of consent, who are at high risk of SARS-CoV-2 infection. INCLUSIONAmendment 2mRNA-1273-P301TIINC01 Adults, >= 18 years of age at time of consent, who are at high risk of SARS-CoV-2 infection. INCLUSIONAmendment 3mRNA-1273-P301TIINC01 Adults, >= 18 years of age at time of consent, who are at high risk of SARS-CoV-2 infection. INCLUSIONAmendment 4mRNA-1273-P301TIINC01 Adults, >= 18 years of age at time of consent, who are at high risk of SARS-CoV-2 infection. INCLUSIONAmendment 5mRNA-1273-P301TIINC01 Adults, >= 18 years of age at time of consent, who are at high risk of SARS-CoV-2 infection. INCLUSIONAmendment 6mRNA-1273-P301TIINC01 Adults, >= 18 years of age at time of consent, who are at high risk of SARS-CoV-2 infection. INCLUSIONOriginal mRNA-1273-P301TIINC02 Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONAmendment 1mRNA-1273-P301TIINC02 Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONAmendment 2mRNA-1273-P301TIINC02 Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONAmendment 3mRNA-1273-P301TIINC02 Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONAmendment 4mRNA-1273-P301TIINC02 Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONAmendment 5mRNA-1273-P301TIINC02 Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONAmendment 6mRNA-1273-P301TIINC02 Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONOriginal mRNA-1273-P301TIINC03 Able to comply with study procedures based on the assessment of the Investigator. INCLUSIONAmendment 1mRNA-1273-P301TIINC03 Able to comply with study procedures based on the assessment of the Investigator. INCLUSIONAmendment 2mRNA-1273-P301TIINC03 Able to comply with study procedures based on the assessment of the Investigator. INCLUSIONAmendment 3mRNA-1273-P301TIINC03 Able to comply with study procedures based on the assessment of the Investigator. INCLUSIONAmendment 4mRNA-1273-P301TIINC03 Able to comply with study procedures based on the assessment of the Investigator. INCLUSIONAmendment 5mRNA-1273-P301TIINC03 Able to comply with study procedures based on the assessment of the Investigator. INCLUSIONAmendment 6mRNA-1273-P301TIINC03 Able to comply with study procedures based on the assessment of the Investigator. INCLUSIONOriginal mRNA-1273-P301TIINC04 Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. INCLUSIONAmendment 1mRNA-1273-P301TIINC04 Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. INCLUSIONAmendment 2mRNA-1273-P301TIINC04 Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. INCLUSIONAmendment 3mRNA-1273-P301TIINC04 Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. INCLUSIONAmendment 4mRNA-1273-P301TIINC04 Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. INCLUSIONAmendment 5mRNA-1273-P301TIINC04 Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. INCLUSIONAmendment 6mRNA-1273-P301TIINC04 Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. INCLUSIONOriginal mRNA-1273-P301TIINC05 Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. INCLUSIONAmendment 1mRNA-1273-P301TIINC05 Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. INCLUSIONAmendment 2mRNA-1273-P301TIINC05 Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. INCLUSIONAmendment 3mRNA-1273-P301TIINC05 Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. INCLUSIONAmendment 4mRNA-1273-P301TIINC05 Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. INCLUSIONAmendment 5mRNA-1273-P301TIINC05 Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. INCLUSIONAmendment 6mRNA-1273-P301TIINC05 Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. INCLUSIONOriginal mRNA-1273-P301TIINC06 Male participants that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the 1st dose to 3 months after the second dose. INCLUSIONAmendment 1mRNA-1273-P301TIINC06 Male participants that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the 1st dose to 3 months after the second dose. INCLUSIONOriginal mRNA-1273-P301TIINC07 Healthy adults or adults with pre-existing medical conditions who are in stable condition. INCLUSIONAmendment 1mRNA-1273-P301TIINC07 Healthy adults or adults with pre-existing medical conditions who are in stable condition. INCLUSIONAmendment 2mRNA-1273-P301TIINC07 Healthy adults or adults with pre-existing medical conditions who are in stable condition. INCLUSIONAmendment 3mRNA-1273-P301TIINC07 Healthy adults or adults with pre-existing medical conditions who are in stable condition. INCLUSIONAmendment 4mRNA-1273-P301TIINC07 Healthy adults or adults with pre-existing medical conditions who are in stable condition. INCLUSIONAmendment 5mRNA-1273-P301TIINC07 Healthy adults or adults with pre-existing medical conditions who are in stable condition. INCLUSIONAmendment 6mRNA-1273-P301TIINC07 Healthy adults or adults with pre-existing medical conditions who are in stable condition. INCLUSIONOriginal