HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 X64_SR12 18JUN21:06:47:2118JUN21:06:47:21 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS TI SASDATA 9.4 X64_SR12 18JUN21:06:47:2118JUN21:06:47:21 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 ß TIVERS Protocol Criteria Versions è HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P201TIEXC01 Known history of SARS-CoV-2 infection or known exposure to someone with SARS-CoV-2 infection or COVID-19 EXCLUSIONAmendment 1mRNA-1273-P201TIEXC01A Pregnant or breastfeeding (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC01B1Pregnant or breastfeeding (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC01B2Pregnant or breastfeeding (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC02 Travel outside of the US in the 28 days prior to the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC02A Acutely ill or febrile 24 hours prior to or at Screening. Rescheduling allowed within relevant window. Afebrile participants with minor illnesses can be enrolled at investigator's discretion (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC02B1Acutely ill or febrile 24 hours prior to or at Screening. Rescheduling allowed within relevant window. Afebrile participants with minor illnesses can be enrolled at investigator's discretion (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC02B2Acutely ill or febrile 24 hours prior to or at Screening. Rescheduling allowed within relevant window. Afebrile participants with minor illnesses can be enrolled at investigator's discretion (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC03 Pregnant or breastfeeding EXCLUSIONAmendment 1mRNA-1273-P201TIEXC03A Current treatment with investigational agents for prophylaxis against COVID-19 (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC03B1Current treatment with investigational agents for prophylaxis against COVID-19 (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC03B2Current treatment with investigational agents for prophylaxis against COVID-19 (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC04 Acutely 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-P201TIEXC04A Has 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. (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC04B1Has 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. (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC04B2Has a medical/psychiatric/occupational condition that may pose risk, or that could interfere with safety assessments or interpretation of results by investigator's judgment. (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC05 Prior administration of an investigational CoV (eg, SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine EXCLUSIONAmendment 1mRNA-1273-P201TIEXC05A Is a healthcare worker or a member of an emergency response team. (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC05B1Is a healthcare worker or a member of an emergency response team. (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC05B2Is a healthcare worker or a member of an emergency response team. (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC06 Current treatment with investigational agents for prophylaxis against COVID-19 EXCLUSIONAmendment 1mRNA-1273-P201TIEXC06A Current use of any inhaled substance (eg, tobacco or cannabis smoke, nicotine vapors) (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC06B1Current use of any inhaled substance (eg, tobacco or cannabis smoke, nicotine vapors) (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC06B2Current use of any inhaled substance (eg, tobacco or cannabis smoke, nicotine vapors) (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC07 Has 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-P201TIEXC07A History of chronic smoking (>= 1 cigarette a day) within 1 year of the Screening Visit (Day 0) (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC07B1History of chronic smoking (>= 1 cigarette a day) within 1 year of the Screening Visit (Day 0) (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC07B2History of chronic smoking (>= 1 cigarette a day) within 1 year of the Screening Visit (Day 0) (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC08 Is a healthcare worker or a member of an emergency response team. EXCLUSIONAmendment 1mRNA-1273-P201TIEXC08A History of illegal substance use or alcohol abuse within the past 2 years. Not apply to historical cannabis use that was formerly illegal in participant's state but is legal at Screening. (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC08B1History of illegal substance use or alcohol abuse within the past 2 years. Not apply to historical cannabis use that was formerly illegal in participant's state but is legal at Screening. (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC08B2History of illegal substance use or alcohol abuse within the past 2 years. Not apply to historical cannabis use that was formerly illegal in participant's state but is legal at Screening. (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC09 Current use of any inhaled substance (eg, tobacco or cannabis smoke, nicotine vapors) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC09A Known 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) (A4)EXCLUSIONAmendment 4mRNA-1273-P201TIEXC09B1Known 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) (A5)EXCLUSIONAmendment 5mRNA-1273-P201TIEXC09B2Known 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 (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC10 History of chronic smoking (>= 1 cigarette a day) within 1 year of the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC10A Known history of hypotension or systolic blood pressure < 85 mm Hg at the Screening Visit (Day 0) (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC10B1Known history of hypotension or systolic blood pressure < 85 mm Hg at the Screening Visit (Day 0) (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC10B2Known history of hypotension or systolic blood pressure < 85 mm Hg at the Screening Visit (Day 0) (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC11 History 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-P201TIEXC11A Diabetes mellitus (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC11B1Diabetes mellitus (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC11B2Diabetes mellitus (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC12 Known 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-P201TIEXC12A Diagnosis of chronic pulmonary disease (eg, chronic obstructive pulmonary disease, asthma) (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC12B1Diagnosis of chronic pulmonary disease (eg, chronic obstructive pulmonary disease, asthma) (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC12B2Diagnosis of chronic pulmonary disease (eg, chronic obstructive pulmonary disease, asthma) (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC13 Known history of hypotension or systolic blood pressure < 85 mm Hg at the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC13A Chronic cardiovascular disease (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC13B1Chronic cardiovascular disease (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC13B2Chronic cardiovascular disease (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC14 Diabetes mellitus EXCLUSIONAmendment 1mRNA-1273-P201TIEXC14A Resides in a nursing home (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC14B1Resides in a nursing home (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC14B2Resides in a nursing home (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC15 Diagnosis of chronic pulmonary disease (eg, chronic obstructive pulmonary disease, asthma) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC15A Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0) (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC15B1Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0) (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC15B2Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0) (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC16 Chronic cardiovascular disease EXCLUSIONAmendment 1mRNA-1273-P201TIEXC16A Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC16B1Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC16B2Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC17 Resides in a nursing home EXCLUSIONAmendment 1mRNA-1273-P201TIEXC17A Received 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 (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC17B1Received 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 (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC17B2Received systemic immunosuppressants/immune-modifying drugs for >14 days in total within 6 months prior to Screening. Topical tacrolimus is allowed if not used <=14 days prior to Screening (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC18 Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC18A Anticipating the need for immunosuppressive treatment at any time during participation in the study (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC18B1Anticipating the need for immunosuppressive treatment at any time during participation in the study (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC18B2Anticipating the need for immunosuppressive treatment at any time during participation in the study (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC19 Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition EXCLUSIONAmendment 1mRNA-1273-P201TIEXC19A Positive 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) (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC19B1Positive 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) (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC19B2Positive 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) (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC20 Received 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-P201TIEXC20A History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC20B1History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC20B2History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC21 Anticipating the need for immunosuppressive treatment at any time during participation in the study EXCLUSIONAmendment 1mRNA-1273-P201TIEXC21A Bleeding disorder considered a contraindication to IM injection or phlebotomy (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC21B1Bleeding disorder considered a contraindication to IM injection or phlebotomy (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC21B2Bleeding disorder considered a contraindication to IM injection or phlebotomy (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC22 Positive 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-P201TIEXC22A Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer) (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC22B1Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer) (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC22B2Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer) (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC23 History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine EXCLUSIONAmendment 1mRNA-1273-P201TIEXC23A Has 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. (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC23B1Has 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. (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC23B2Has 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. (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC24 Bleeding disorder considered a contraindication to IM injection or phlebotomy EXCLUSIONAmendment 1mRNA-1273-P201TIEXC24A Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC24B1Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC24B2Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC25 Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer) EXCLUSIONAmendment 1mRNA-1273-P201TIEXC25A Has 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. (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC25B1Has 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. (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC25B2Has 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. (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC26 Has 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-P201TIEXC26A Participated 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. (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC26B1Participated 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. (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC26B2Participated 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. (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC27 Receipt 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-P201TIEXC27A Is an immediate family member or household member of study personnel. (A4) EXCLUSIONAmendment 4mRNA-1273-P201TIEXC27B1Is an immediate family member or household member of study personnel. (A5) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC27B2Is an immediate family member or household member of study personnel. (Part C) EXCLUSIONAmendment 5mRNA-1273-P201TIEXC28 Has 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-P201TIEXC29 Participated 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-P201TIEXC30 Is an immediate family member or household member of study personnel. EXCLUSIONAmendment 1mRNA-1273-P201TIINC01 Male or female, 18 years of age or older at the time of consent (Screening Visit, Day 0) INCLUSIONAmendment 1mRNA-1273-P201TIINC01A Male or female, 18 years of age or older at the time of consent (Screening Visit, Day 0). For Part B, participants must have been previously enrolled in the mRNA-1273 P201 study. (A4) INCLUSIONAmendment 4mRNA-1273-P201TIINC01B1Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. (A5) INCLUSIONAmendment 5mRNA-1273-P201TIINC01B2Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. (Part C) INCLUSIONAmendment 5mRNA-1273-P201TIINC02 Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONAmendment 1mRNA-1273-P201TIINC02 Understands and agrees to comply with the study procedures and provides written informed consent. INCLUSIONAmendment 4mRNA-1273-P201TIINC02B1Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. (A5) INCLUSIONAmendment 5mRNA-1273-P201TIINC02B2Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. (Part C) INCLUSIONAmendment 5mRNA-1273-P201TIINC03 According to the assessment of the investigator, is in good general health and can comply with study procedures. INCLUSIONAmendment 1mRNA-1273-P201TIINC03 According to the assessment of the investigator, is in good general health and can comply with study procedures. INCLUSIONAmendment 4mRNA-1273-P201TIINC03B1Male participants that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from 1st injection to 3m after last injection. (A5) INCLUSIONAmendment 5mRNA-1273-P201TIINC03B2Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. (Part C) INCLUSIONAmendment 5mRNA-1273-P201TIINC04 Body mass index (BMI) of 18 kg/m2 to 30 kg/m2 (inclusive) at the Screening Visit (Day 0) INCLUSIONAmendment 1mRNA-1273-P201TIINC04A Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. (A4) INCLUSIONAmendment 4mRNA-1273-P201TIINC04B2Male participants that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from 1st injection to 3m after last injection (Part C)INCLUSIONAmendment 5mRNA-1273-P201TIINC05 Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile or postmenopausal. INCLUSIONAmendment 1mRNA-1273-P201TIINC05A Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the criteria listed in the protocol. (A4) INCLUSIONAmendment 4mRNA-1273-P201TIINC05B2Healthy adults or adults with pre-existing medical conditions who are in stable condition. (Part C) INCLUSIONAmendment 5mRNA-1273-P201TIINC06 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-P201TIINC06B2For Part C, participants must have provided SARS-CoV 2 serology samples at Day 1, Day 29, Day 57, and at the Participant Decision Visit (OL-D1) in Moderna's COVE study (Part C) INCLUSIONAmendment 5mRNA-1273-P201TIINC07 Male 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 1mRNA-1273-P201TIINC07 Male 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 4