HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 X64_SR12 10NOV20:19:51:1910NOV20:19:51:19 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS TI SASDATA 9.4 X64_SR12 10NOV20:19:51:1910NOV20:19:51:19 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 Ý TIVERS Protocol Criteria Versions æ HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P201TIEXC01Known history of SARS-CoV-2 infection or known exposure to someone with SARS-CoV-2 infection or COVID-19 EXCLUSIONAmendment 1mRNA-1273-P201TIEXC02Travel outside of the US in the 28 days prior to the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC03Pregnant or breastfeeding EXCLUSIONAmendment 1mRNA-1273-P201TIEXC04Acutely ill or febrile 24 hours prior to or at the Screening Visit. Rescheduling allowed within relevant window. Afebrile participants with minor illnesses can be enrolled at investigator's discretionEXCLUSIONAmendment 1mRNA-1273-P201TIEXC05Prior administration of an investigational CoV (eg, SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine EXCLUSIONAmendment 1mRNA-1273-P201TIEXC06Current treatment with investigational agents for prophylaxis against COVID-19 EXCLUSIONAmendment 1mRNA-1273-P201TIEXC07Has a medical/psychiatric/occupational condition that may pose risk due to participation, or that could interfere with safety assessments or interpretation of results by investigator's judgment. EXCLUSIONAmendment 1mRNA-1273-P201TIEXC08Is a healthcare worker or a member of an emergency response team. EXCLUSIONAmendment 1mRNA-1273-P201TIEXC09Current use of any inhaled substance (eg, tobacco or cannabis smoke, nicotine vapors) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC10History of chronic smoking (>= 1 cigarette a day) within 1 year of the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC11History of illegal substance use or alcohol abuse within the past 2 years. This does not apply to historical cannabis use that was formerly illegal in participant's state but is legal at Screening. EXCLUSIONAmendment 1mRNA-1273-P201TIEXC12Known history of hypertension, or systolic blood pressure > 150 mm Hg in participants in Cohort 1 or systolic blood pressure > 160 mm Hg in participants in Cohort 2 at the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC13Known history of hypotension or systolic blood pressure < 85 mm Hg at the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC14Diabetes mellitus EXCLUSIONAmendment 1mRNA-1273-P201TIEXC15Diagnosis of chronic pulmonary disease (eg, chronic obstructive pulmonary disease, asthma) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC16Chronic cardiovascular disease EXCLUSIONAmendment 1mRNA-1273-P201TIEXC17Resides in a nursing home EXCLUSIONAmendment 1mRNA-1273-P201TIEXC18Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC19Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition EXCLUSIONAmendment 1mRNA-1273-P201TIEXC20Received systemic immunosuppressants/immune-modifying drugs for >14 days in total within 6 months prior to Screening Visit. Topical tacrolimus is allowed if not used <=14 days prior to Screening VisitEXCLUSIONAmendment 1mRNA-1273-P201TIEXC21Anticipating the need for immunosuppressive treatment at any time during participation in the study EXCLUSIONAmendment 1mRNA-1273-P201TIEXC22Positive serology for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibodies identified at the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC23History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine EXCLUSIONAmendment 1mRNA-1273-P201TIEXC24Bleeding disorder considered a contraindication to IM injection or phlebotomy EXCLUSIONAmendment 1mRNA-1273-P201TIEXC25Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC26Has received or plan to receive licensed vaccine <= 28 days before or after any study injection. Licensed influenza vaccines may be received > 14 days before or after any study injection. EXCLUSIONAmendment 1mRNA-1273-P201TIEXC27Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study EXCLUSIONAmendment 1mRNA-1273-P201TIEXC28Has donated >= 450 mL of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study. EXCLUSIONAmendment 1mRNA-1273-P201TIEXC29Participated in an interventional clinical study within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study. EXCLUSIONAmendment 1mRNA-1273-P201TIEXC30Is an immediate family member or household member of study personnel. EXCLUSIONAmendment 1mRNA-1273-P201TIINC01Male or female, 18 years of age or older at the time of consent (Screening Visit, Day 0) INCLUSIONAmendment 1mRNA-1273-P201TIINC02Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONAmendment 1mRNA-1273-P201TIINC03According to the assessment of the investigator, is in good general health and can comply with study procedures. INCLUSIONAmendment 1mRNA-1273-P201TIINC04Body mass index (BMI) of 18 kg/m2 to 30 kg/m2 (inclusive) at the Screening Visit (Day 0) INCLUSIONAmendment 1mRNA-1273-P201TIINC05Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. INCLUSIONAmendment 1mRNA-1273-P201TIINC06Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. INCLUSIONAmendment 1mRNA-1273-P201TIINC07Male participants that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from 1st injection to 3 months after last injection. INCLUSIONAmendment 1