A Study to Evaluate the Safety, Reactogenicity, and Effec... | NCT04649151

ID	Type	Description	Link
2023-000382-14	EudraCT Number

Name	Class
Biomedical Advanced Research and Development Authority	FED

Description Module

Label	Type	Description	Intervention Names
mRNA-1273	Experimental	Part 1A (Blinded Phase): Participants will receive 2 intramuscular (IM) injections of mRNA-1273 (100 microgram [ug] each), 28 days apart, on Day 1 and Day 29. Part 1B (Open-Label Phase): Participants who cross over from placebo in Part 1A to Part 1B will receive 2 IM injections of mRNA-1273 (100 ug each), 28 days apart on Open Label Day 1 and Open Label Day 29. Part 2 (Open-Label): Participants will receive 2 IM injections of mRNA-1273 (50 ug each), 28 days apart, on Day 1 and Day 29 and may receive a booster dose on Day 149.	Biological: mRNA-1273
Placebo	Placebo Comparator	Part 1A (Blinded Phase): Participants will receive 2 IM injections of mRNA-1273 matching placebo, 28 days apart, on Day 1 and Day 29.	Biological: Placebo
mRNA-1273 BD	Experimental	Part 1C-1 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, 5 months after the last dose of Part 1A and 1B. Part 1C-2 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, at least 3 months post-last dose.	Biological: mRNA-1273
mRNA-1273.222	Experimental	Part 3 (Open-Label): Participants will receive up to 2 IM injections of mRNA-1273.222 (50 ug each), 6 months apart, on Day 1 and Day 181.	Biological: mRNA-1273.222

Name	Type	Description	Arm Group Labels	Other Names
mRNA-1273	Biological	Sterile liquid for injection	mRNA-1273 mRNA-1273 BD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)	Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Solicited ARs considered causally related to injection were graded 1-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicated lower severity, and higher score indicated greater severity. Investigator reviewed if the solicited AR was recorded as an adverse event (AE) as detailed in the AE section. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the AE section.	7 days post-vaccination
Number of Participants With Unsolicited AEs	An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (onset after Day 7 of dosing). An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result or other safety assessment, including one that worsened from baseline and was considered clinically significant by the Investigator was recorded as an AE. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part1/2 but were considered clinical events for efficacy in Part 3 and not AEs. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the AE section.	Up to 28 days post-vaccination
Part 1A Geometric Mean Value of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers From Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Secondary Outcomes

Measure	Description	Time Frame
Part 1A Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)	SARS-CoV-2 infection was defined in participants with negative SARS-CoV-2 status at baseline: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1, that became positive postbaseline; or positive postbaseline.	Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection

Other Outcomes

Measure	Description	Time Frame
Number of Deaths Related to Study Drug	A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable and/or the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For Part 1A, Part 2 and Part 3:

Participants 12 to <18 years of age at the time of consent (Screening Visit, Day 0) who, in the opinion of the Investigator, are in good general health based on review of medical history and screening physical examination.
Investigator assessment that the participant, in the case of an emancipated minor, or parent(s)/legally acceptable representative(s) (LAR[s]) understand and is willing and physically able to comply with protocol-mandated follow up, including all procedures and provides written informed consent/assent.
Body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit (Day 0)
Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as premenarche or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy).
Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test at Screening (Day 0), on the day of the first injection (Day 1), on the day of the second injection (Day 29 in Parts 1A and Part 2, and Day 181 in Part 3); has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1); and has agreed to continue adequate contraception or abstinence through 3 months following the second injection (Day 29 in Part 1A and Part 2, and Day 181 in Part 3).

For Part 1B:

Participants must have been previously enrolled in mRNA-1273-P203 study.
Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (Open-Label-Day 1) and on the day of the second injection (Open-Label-Day 29).

For Part 1C-1 Homologous Booster Dose:

Participants must have been previously enrolled in the mRNA-1273-P203 study, are actively participating in Part 1A or Part 1B and are least 5 months from the last dose.
Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (BD-Day 1).

Part 1C-2 Heterologous Booster Dose:

Male or female, 12 to < 18 years of age at the time of consent who, in the opinion of the investigator, is in good general health based on review of medical history and screening physical examination AND has completed non-Moderna primary COVID-19 vaccination series under EUA (for example, Pfizer) at least 3 months from consent.

Exclusion Criteria:

For Part 1A, Part 2, and Part 3:

Has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of investigational product (IP) or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection of COVID-19 within 2 weeks prior to administration of IP (Part 2 participants only). For Part 3 participants, known history of SARS-CoV-2 infection within 90 days prior to administration of IP or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 90 days prior to administration of IP.
Travel outside of the United States or home country (Part 2 and Part 3 only) in the 28 days prior to the Screening Visit (Day 0).
Pregnant or breastfeeding
Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥38.0°Celsius (C)/≥100.4°Farenheit (F). Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator.
Prior administration of an investigational coronavirus (for example, SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]) vaccine
Current treatment with investigational agents for prophylaxis against COVID-19
Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment
Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors)
History of chronic smoking (≥1 cigarette a day) within 1 year of the Screening Visit (Day 0)
History of illegal substance use or alcohol abuse within the past 2 years. This exclusion does not apply to historical cannabis use that was formerly illegal in the participant's state but is legal at the time of screening.
History of a diagnosis or condition that, in the judgment of the Investigator, may affect study endpoint assessment or compromise participant safety, specifically:
- Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection
- Suspected active hepatitis
- Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
- Dermatologic conditions that could affect local solicited AR assessments
- History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine
- Diagnosis of malignancy within the previous 10 years (excluding nonmelanoma skin cancer)
- Febrile seizures
Receipt of:
- Any licensed vaccine within 28 days before the first dose of IP or plans for receipt of any licensed vaccine within 28 days before and/or after each dose of IP.
- Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥20 mg/day prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids are allowed.
- Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment
Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study
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
Is an immediate family member or has a household contact who is an employee of the research center or otherwise involved with the conduct of the study

For Part 1C-1 and Part 1C-2:

Pregnant or breastfeeding.
Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥ 38.0°C/≥ 100.4°F. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
History of a diagnosis or condition (after enrolment in Part 1A) that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety:
- Suspected active hepatitis
- Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
- Dermatologic conditions that could affect local solicited AR assessments
- History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine
- Diagnosis of malignancy (excluding nonmelanoma skin cancer)
Receipt of:

• Any authorized or licensed vaccine within 28 days before the first dose of IP or plans for receipt of any licensed vaccine through 28 days following the last dose of IP or any seasonal influenza vaccine within 14 days before the first dose of IP or plans for receipt of any seasonal influenza vaccine 14 days following the last dose of IP.
Participated in an interventional clinical study, other than mRNA-1273-P203 study, within 28 days prior to the Screening Visit (Day 0 [for Part 1C-1], BD-Day 0 [for Part 1C-2]) or plans to do so while participating in this study.

Part 1C-2 Heterologous Booster Dose:

Has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of IP or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID 19 within 2 weeks prior to administration of IP.

Facility	Status	City	State	ZIP	Country	Contacts
Velocity Clinical Research - Banning		Banning	California	92220	United States
Paradigm Clinical Research

PubMed Identifier	Type	Citation	Retractions
39332418	Derived	Figueroa AL, Torres D, Reyes-Acuna C, Matherne P, Yeakey A, Deng W, Xu W, Sigal Y, Chambers G, Olsen M, Girard B, Miller JM, Das R, Priddy F. Safety and immunogenicity of a single-dose omicron-containing COVID-19 vaccination in adolescents: an open-label, single-arm, phase 2/3 trial. Lancet Infect Dis. 2025 Feb;25(2):208-217. doi: 10.1016/S1473-3099(24)00501-2. Epub 2024 Sep 24.
34379915

Label	URL
Click here to access the website, http://TeenCoveStudy.com, for additional information for the study, such as Study Overview, Participation, Site Locations, along with contact numbers for each location for the study.	View source

ID	Title	Description
FG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 micrograms (μg) mRNA-1273 by intramuscular (IM) injection (Day 1 and Day 29).
FG001	Part 1A: Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 19, 2023	Jun 9, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Solicited ARs considered causally related to injection were graded 1-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicated lower severity, and higher score indicated greater severity. Investigator reviewed if the solicited AR was recorded as an adverse event (AE) as detailed in the AE section. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the AE section.

Solicited Safety Set included participants who received at least 1 dose of study drug and contributed any solicited AR data.

Posted

Count of Participants

Participants

7 days post-vaccination

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).
OG001	Part 1A: Placebo	Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).
OG002	Part 1C-1: mRNA-1273 50 µg BD	Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.
OG003	Part 1C-2: mRNA-1273 50 μg BD	Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.
OG004	Part 2: mRNA-1273 50 μg First Injection	Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).
OG005	Part 2: mRNA-1273 50 μg Second Injection	Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).
OG006	Part 2: mRNA-1273 50 μg BD	Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.
OG007	Part 3: mRNA-1273.222 50 μg 1 Dose	Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).

Units	Counts
Participants	OG0002485 OG0011240 OG0021351 OG003

Title

Denominators

Categories

Grade 1

Title	Measurements
	OG000586 OG001585 OG002627 OG003

Primary

Number of Participants With Unsolicited AEs

An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (onset after Day 7 of dosing). An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result or other safety assessment, including one that worsened from baseline and was considered clinically significant by the Investigator was recorded as an AE.

Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part1/2 but were considered clinical events for efficacy in Part 3 and not AEs.

A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the AE section.

Safety Set: participants who received at least 1 dose of study drug. As prespecified in the protocol, Part 1B was not assessed for this outcome measure. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Posted

Count of Participants

Participants

Up to 28 days post-vaccination

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).
OG001	Part 1A: Placebo

Primary

Part 1A Geometric Mean Value of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers From Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Pseudovirus nAb ID50 titers were measured using pseudovirus neutralization assay (PsVNA) assay. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available (LLOQ: 18.5 arbitrary units (AU)/milliliter (mL), ULOQ: 45118 AU/mL). Antibody levels were analyzed using an analysis of covariance (ANCOVA) model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.

Part 1A PPIS: randomized participants who were selected for the Immunogenicity Subset, received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. Participants who were seropositive at baseline were excluded from the PPIS. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Posted

Geometric Mean

95% Confidence Interval

titer

Day 57 Study P203/Day 57 Study P301

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).

Primary

Part 1A Seroresponse Rate (SRR) for Serum Pseudovirus nAb ID50 in Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Percentage of participants with seroresponse for pseudovirus nAb ID50 measured using PsVNA assay are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4*LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ (LLOQ: 18.5 AU/mL), ULOQ: 45118 AU/mL).

PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.

Posted

Number

95% Confidence Interval

percentage of participants

Day 57 Study P203/Day 57 Study P301

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).
OG001	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg	Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).

Primary

Part 1C-1 Geometric Mean Concentration (GMC) of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Pseudovirus nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10, ULOQ: 281600). PPIS P301: randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.

Part 1C-1 PPIS-Neg: participants were baseline (pre-dose 1 of part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, received BD, and were pre-booster SARS-CoV2 negative. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Posted

Geometric Mean

95% Confidence Interval

arbitrary units (AU)/mL

BD Day 29 Study P203/Day 57 Study P301

ID	Title	Description
OG000	Part 1C-1: mRNA-1273 50 µg BD	Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.
OG001	Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg

Primary

Part 1C-1 SRR of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse relative to pre-Dose 1 (baseline) at a participant level was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold-rise if baseline was equal to or above LLOQ (LLOQ: 10 AU/mL, ULOQ: 281600 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.

Posted

Number

95% Confidence Interval

percentage of participants

BD Day 29 Study P203/Day 57 Study P301

ID	Title	Description
OG000	Part 1C-1: mRNA-1273 50 µg BD	Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.
OG001	Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg

Primary

Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 103 AU/mL, ULOQ: 28571 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.

Part 3 PPIS-Pos: participants received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, SARS-CoV-2 positive at Baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint.

Posted

Geometric Mean

95% Confidence Interval

AU/mL

Day 29 Study P203/Day 57 Study P301

ID	Title	Description
OG000	Part 3: mRNA-1273.222 50 µg	Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).
OG001	Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg	Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).

Primary

Part 1C-2 GMC of Post-booster Pseudovirus nAb Against Ancestral Strain at BD Day 29

Part 1C-2 PPIS: all randomized participants who received BD in Part 1C-2, had BD-Day 29 Ab assessment, had no major protocol deviations that impacted key or critical data, and did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Posted

Geometric Mean

95% Confidence Interval

AU/mL

BD Day 29

ID	Title	Description
OG000	Part 1C-2: mRNA-1273 50 μg BD	Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.

Units	Counts
Participants	OG000

Primary

Part 2 GMC of the Pseudovirus nAb Against Ancestral Strain at Day 57

Part 2 PPIS: all randomized participants who received at least 1 dose of the planned study drug, had Ab assessment for the analysis endpoint, and had no major protocol deviations that could impact key or critical data.

Posted

Geometric Mean

95% Confidence Interval

AU/mL

Day 57

ID	Title	Description
OG000	Part 2: mRNA-1273 50 μg	Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).

Units	Counts
Participants	OG000

Primary

Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against SARS-CoV-2 Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.

Posted

Geometric Mean

95% Confidence Interval

AU/mL

Day 29 Study P203/Day 57 Study P301

ID	Title	Description
OG000	Part 3: mRNA-1273.222 50 µg	Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).
OG001	Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg	Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).

Primary

Part 2 SRR of Pseudovirus nAb Against Ancestral Strain

Posted

Number

95% Confidence Interval

percentage of participants

Day 57

ID	Title	Description
OG000	Part 2: mRNA-1273 50 μg	Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).

Units	Counts
Participants	OG000

Primary

Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation

SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. MAAE was an AE that led to an unscheduled visit to a healthcare practitioner, included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and visits to healthcare practitioners external to the study site [for example, urgent care, primary care physician]). Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were defined as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.

Participants who received at least 1 dose of mRNA-1273 were included in the analysis. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Note: Part 3 is presented for overall study for this assessment (AE section presents AEs separately for 1 dose and second dose).

Posted

Count of Participants

Participants

Day 1 up to Day 751

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).

Secondary

Part 1A Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)

SARS-CoV-2 infection was defined in participants with negative SARS-CoV-2 status at baseline: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1, that became positive postbaseline; or positive postbaseline.

Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data.

Posted

Count of Participants

Participants

Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).
OG001	Part 1A: Placebo	Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).

Units	Counts
Participants

Secondary

Part 1A Number of Participants With Asymptomatic SARS-CoV-2 Infection

Asymptomatic SARS-CoV-2 infection was defined as absence of symptoms and a positive RT-PCR or serology test (bAb levels against SARS-CoV-2 nucleocapsid protein) post dosing in participants who did not have an infection at baseline or pre-Dose 1.

Posted

Count of Participants

Participants

Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).
OG001	Part 1A: Placebo	Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).

Units	Counts
Participants

Secondary

Part 1A Number of Participants With a First Occurrence of Symptomatic COVID-19

COVID-19 was defined as symptomatic disease based on the following criteria: participants experienced at least 2 of the following systemic symptoms: fever (≥ 38ºC/≥ 100.4ºF), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s); or experienced at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia; and had at least 1 nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2.

Posted

Count of Participants

Participants

Day 43 (14 days after second injection) up to 2.5 months after second injection

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).
OG001	Part 1A: Placebo	Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).

Secondary

Part 1A Number of Participants With Secondary Case Definition of COVID-19 (Center for Disease Control and Prevention [CDC] Case Definition)

Secondary case definition of COVID-19 was defined by the following criteria: 1 systemic or respiratory symptoms: fever (temperature > 38ºC/≥ 100.4ºF), or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches, or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, or vomiting or diarrhea, and at least one positive test for SARS-CoV-2.

Posted

Count of Participants

Participants

Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).
OG001	Part 1A: Placebo	Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).

Secondary

Part 1C-1 SRR of the Post-booster Serum Binding Antibody (bAb) Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD

Percentage of participants with seroresponse for bAb measured using (MesoScale Discovery) MSD are reported. Seroresponse from baseline (pre-Dose 1) at a participant level was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold-rise if baseline (pre-Dose 1) is equal to or above the LLOQ.

Part 1C-1 PPIS: participants were baseline (pre-dose 1 of Part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, and received BD. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

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Number

95% Confidence Interval

Percentage of participants

BD Day 29

ID	Title	Description
OG000	Part 1C-1: mRNA-1273 50 µg BD	Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.

Units	Counts
Participants

Secondary

Part 1C-1 GMC of Post-booster Pseudovirus nAb Against Variant Strain (B.1.1.529)

Post-booster Pseudovirus nAb against B.1.1.529 (LLOQ: 8 AU/mL, ULOQ: 24503 AU/mL). Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available.

Part 1C-1 PPIS: participants were baseline (pre-dose 1 of Part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, and received BD. Overall number of participants analyzed' = participants evaluable for this endpoint.

Posted

Geometric Mean

95% Confidence Interval

AU/mL

BD Day 29

ID	Title	Description
OG000	Part 1C-1: mRNA-1273 50 µg BD	Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.

Units	Counts
Participants	OG000

Secondary

Part 3 SRR of Serum Pseudovirus nAb Post Dose 1 of mRNA-1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Seroresponse from pre Dose 1 Baseline at a participant level was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold rise if Baseline was equal to or above the LLOQ (LLOQ: 103 AU/mL, ULOQ:

28571 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.

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Number

95% Confidence Interval

percentage of participants

Day 29 Study P203/Day 57 Study P301

ID	Title	Description
OG000	Part 3: mRNA-1273.222 50 µg	Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).
OG001	Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg	Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).

Secondary

Part 3 Pseudovirus nAb SRR of Post Dose 1 of mRNA-1273.222 Against Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse from pre Dose 1 Baseline at a participant level was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold rise if Baseline was equal to or above the LLOQ. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.

Part 3 PPIS-Pos: participants who received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, and were SARS-CoV-2 positive at baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint.

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Number

95% Confidence Interval

percentage of participants

Day 29 P203/Day 57 P301

ID	Title	Description
OG000	Part 3: mRNA-1273.222 50 µg	Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).
OG001	Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg	Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).

Secondary

Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest

mRNA-1273.222 bAb was measured using a S-binding IgG immunoassay. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 397 AU/ml, ULOQ: 2200000 AU/mL).

Part 3 PPIS: all participants who received Dose 1 of mRNA-1273.222 and had both Baseline (pre Dose 1) and Day 29 antibody assessment, had no major protocol deviations that impacted key or critical data; and had not received off-study COVID-19 vaccination prior to Day 29. 'Overall number of participants analyzed' = participants evaluable for the endpoint.

Posted

Geometric Mean

95% Confidence Interval

AU/mL

Day 29

ID	Title	Description
OG000	Part 3: mRNA-1273.222 50 µg	Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).

Units	Counts
Participants	OG000

Secondary

Part 1C-2 GM Value of mRNA-1273 Booster Against Variants of Interest at Day 29

As a result of emergence of a more divergent variant of concern (Omicron), Part 1C-2 enrollment and booster dosing were discontinued. Therefore, data were collected for Part 1C-2 Primary Outcome Measure but after Part 1C-2 was discontinued, per Sponsor, it was decided that data would not be collected for this Part 1C-2 Secondary Outcome Measure and instead collect data for the more updated variant containing vaccine (Part 3: mRNA-1273.222).

Posted

Day 29

ID	Title	Description
OG000	Part 1C-2: mRNA-1273 50 μg BD	Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.

Units	Counts
Participants	OG000

Secondary

Part 1A GM Level of SARS-CoV-2 Spike Protein-specific bAb at Days 1, 57, 209, 394

SARS-CoV-2 Spike Protein-specific bAb were measured using MSD electrochemiluminescence multiplex assay. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 69 AU/mL, ULOQ: 14400000 AU/mL).

Part 1A PPIS for long term analysis included all randomized participants who had a negative SARS-CoV-2 status at baseline (pre-Dose 1), received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Posted

Geometric Mean

95% Confidence Interval

AU/mL

Days 1, 57, 209, 394

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).

Units	Counts
Participants	OG000

Secondary

Part 1A GM Value of SARS-CoV-2-Specific nAb at Days 1, 57, 209, 394

SARS-CoV-2-Specific nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 10 AU/mL, ULOQ: 281600 AU/mL).

Posted

Geometric Mean

95% Confidence Interval

AU/mL

Days 1, 57, 209, 394

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).

Units	Counts
Participants	OG000

Secondary

Part 1C-1 GM Value of Post-booster Dose Serum bAb Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD

Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. B.1.1.7 (LLOQ: 52, ULOQ: 8800000), B.1.351 (LLOQ: 111, ULOQ: 5000000), B.1.617.2 (LLOQ: 49, ULOQ: 7400000), P.1 (LLOQ: 143, ULOQ: 5800000).

Posted

Geometric Mean

95% Confidence Interval

AU/mL

BD Day 29

ID	Title	Description
OG000	Part 1C-1: mRNA-1273 50 µg BD	Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Deaths Related to Study Drug

A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable and/or the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.

Safety Set: participants who received at least 1 dose of study drug.

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Count of Participants

Participants

Day 1 up to Day 751

ID	Title	Description
OG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).
OG001	Part 1A: Placebo	Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1A: mRNA-1273 100 μg	Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).	0	2,486	21	2,486	943	2,486
EG001	Part 1A: Placebo	Participants received at least 1 of 2 doses of placebo by IM injection (Day 1 and Day 29).	0	1,240	4	1,240	155	1,240
EG002	Part 1B: mRNA-1273 100 µg	Participants previously received 2 doses of placebo in the blinded phase and then received crossover vaccination with 100 μg of mRNA-1273.	0	96	2	96	22	96
EG003	Part 1C-1: mRNA-1273 50 µg BD	Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.	0	1,408	9	1,408	429	1,408
EG004	Part 1C-2: mRNA-1273 50 μg BD	Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single booster of 50 μg mRNA-1273 IM injection on BD Day 1.	0	155	3	155	28	155
EG005	Part 2: mRNA-1273 50 μg	Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).	0	52	0	52	12	52
EG006	Part 2: mRNA-1273 50 ug BD	Participants received open-label mRNA-1273 50 µg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.	0	19	0	19	7	19
EG007	Part 3: mRNA1273.222 50 µg 1 Dose	Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1).	0	388	12	388	77	388
EG008	Part 3: mRNA-1273.222 50 ug Second Dose	Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).	1	335	4	335	51	335

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pectus excavatum	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG0030 events0 affected1,408 at risk EG004
Syringomyelia	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Arnold-Chiari malformation	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Hyperbilirubinaemia neonatal	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	Investigator and Sponsor assessment of drug-induced liver injury was not related to study drug.	EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 23.0	Systematic Assessment	Investigator and Sponsor assessment of anaphylactic reaction was not related to study drug due to long time to onset (171 days).	EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Amoebic dysentery	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Murine typhus	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Dengue fever	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Appendicitis	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0002 events2 affected2,486 at risk EG0011 events1 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Peritonitis	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	AE of gunshot wound resulted in death. Investigator assessment was not related to study drug.	EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0021 events1 affected96 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Splenic injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Vulvovaginal injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Status migrainosus	Nervous system disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Idiopathic generalised epilepsy	Nervous system disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0011 events1 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Depression suicidal	Psychiatric disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Emotional distress	Psychiatric disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Major depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment		EG0002 events2 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment		EG0005 events5 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0021 events1 affected96 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 23.0	Systematic Assessment		EG0003 events3 affected2,486 at risk EG0011 events1 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Obstructive nephropathy	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0011 events1 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Vaginal haematoma	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment		EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Hypercoagulation	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	Sponsor assessment of AE of hypercoagulation was not related to study drug based on medical history, results of the heart biopsy, including findings of long-standing pre-existing heart failure and long time to onset (256 days).	EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 23.0	Systematic Assessment	Sponsor assessment of AE of cardiogenic shock was not related to study drug based on medical history, results of the heart biopsy, including findings of long-standing pre-existing heart failure and long time to onset (256 days).	EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0009 events8 affected2,486 at risk EG0013 events3 affected1,240 at risk EG0020 events0 affected96 at risk EG0036 events6 affected1,408 at risk EG0040 events0 affected155 at risk EG0050 events0 affected52 at risk EG0061 events1 affected19 at risk EG0071 events1 affected388 at risk EG0081 events1 affected335 at risk
Injection site lymphadenopathy	General disorders	MedDRA 23.0	Systematic Assessment	EG000146 events137 affected2,486 at risk EG0016 events6 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00012 events11 affected2,486 at risk EG0014 events4 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0021 events1 affected96 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00064 events60 affected2,486 at risk EG0016 events6 affected1,240 at risk EG0024 events4 affected96 at risk EG003
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00020 events19 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0021 events1 affected96 at risk EG003
COVID-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG000383 events382 affected2,486 at risk EG00135 events34 affected1,240 at risk EG00211 events11 affected96 at risk EG003
Asymptomatic COVID-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00082 events81 affected2,486 at risk EG00125 events25 affected1,240 at risk EG0026 events6 affected96 at risk EG003
Mechanical urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Attention deficit hyperactivity disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00041 events41 affected2,486 at risk EG0016 events6 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00060 events58 affected2,486 at risk EG0013 events3 affected1,240 at risk EG0021 events1 affected96 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG000129 events117 affected2,486 at risk EG00157 events51 affected1,240 at risk EG0021 events1 affected96 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG000293 events257 affected2,486 at risk EG00132 events28 affected1,240 at risk EG0023 events3 affected96 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003
Parapsoriasis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,486 at risk EG0010 events0 affected1,240 at risk EG0020 events0 affected96 at risk EG003

ID	Term
D018352	Coronavirus Infections
D014777	Virus Diseases
D000086382	COVID-19

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D007239	Infections
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D000087503	mRNA Vaccines
D000087504	Nucleic Acid-Based Vaccines
D014614	Vaccines, Synthetic
D011994	Recombinant Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D000086663	COVID-19 Vaccines
D014765	Viral Vaccines
D000941	Antigens
D001685	Biological Factors

ID	Title	Description
BG000	Part 1A: mRNA-1273 100 μg	Participants were randomized to receive 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).
BG001	Part 1A: Placebo	Participants were randomized to receive 2 doses of placebo by IM injection (Day 1 and Day 29). Participants had the option to receive crossover vaccination with 100 μg mRNA-1273 in Part 1B.
BG002	Part 1C-2: mRNA-1273 50 μg BD	Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single booster of 50 μg mRNA-1273 IM injection on BD Day 1.
BG003	Part 2: mRNA-1273 50 μg	Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).
BG004	Part 3: mRNA-1273.222 50 µg	Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Participants may have received a second dose of mRNA-1273.222 50 µg at approximately month 6 after the first dose (Day 181).
BG005	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg	Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).
BG006	Total	Total of all reporting groups