Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
Official Title
Phase 1, Open-Label, Randomized Study of the Safety and Immunogenicity of a SARS-CoV-2 Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Apr 6, 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 31, 2021Actual
Primary Completion Date
Jul 5, 2022Actual
Completion Date
Jul 5, 2022Actual
First Submitted Date
Mar 4, 2021
First Submission Date that Met QC Criteria
Mar 4, 2021
First Posted Date
Mar 5, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jun 22, 2023
Results First Submitted that Met QC Criteria
Aug 31, 2023
Results First Posted Date
Sep 13, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 14, 2024
Last Update Posted Date
Mar 18, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Name
Class
ModernaTX, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a phase 1, open-label, randomized clinical trial in males and non-pregnant females, 18 years of age and older, who are in good health, have no known history of COVID-19 or SARS-CoV-2 infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273.351 manufactured by ModernaTX, Inc, given in vaccination schedules alone, sequentially, or coadministered with mRNA-1273. mRNA-1273.351 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized S protein of the SARS-CoV-2 B.1.351 variant. Enrollment will occur at approximately five domestic clinical research sites.
This study includes two cohorts. Cohort 1 will provide rapid information about the immunogenicity of mRNA-1273.351 in a previously vaccinated group. This cohort can inform near term public health decisions if the variant virus becomes more widespread. Cohort 2 will evaluate different strategies for generation of cross protective immune responses in a naïve population. This cohort will take longer to provide information on the immunogenicity of mRNA-1273.351, but is important to inform future public health strategies. Cohort 1 will include approximately 60 subjects 18 years of age and older who received two vaccinations of mRNA-1273 at dosages of 50 mcg, 100 mcg, or 250 mcg in the Phase 1 clinical trial (DMID 20-0003). Subjects in Cohort 1 will receive a single intramuscular (IM) injection of the designated vaccine and will be followed through 12 months after vaccination. Follow-up visits will occur on Days 8, 15, and 29, as well as 3, 6, and 12 months after the vaccination. Cohort 2 will include approximately 150 participants 18 through 55 years of age who have not received a COVID-19 vaccine, have no known history of COVID-19 or SARS-CoV-2 infection, and do not have underlying conditions that are associated with an increased risk of severe illness from SARS-CoV-2 infection. Enrollment may close before the full 150 participants based on estimates on the timing of immunogenicity results and the need to inform public health decisions. They will be randomly assigned to one of 8 treatment arms and will receive 2 or 3 IM injections of the vaccine and followed through 12 months after the last vaccination. Follow-up visits will occur 7, 14, and 28 days after each vaccination, as well as 3, 6 and 12 months post the last vaccination.
The primary objective is to evaluate the safety and reactogenicity of mRNA-1273 and mRNA-1273.351 vaccines, in naïve and previously vaccinated individuals.
Detailed Description
This is a phase 1, open-label, randomized clinical trial in males and non-pregnant females, 18 years of age and older, who are in good health, have no known history of COVID-19 or SARS-CoV-2 infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273.351 manufactured by ModernaTX, Inc, given in vaccination schedules alone, sequentially, or coadministered with mRNA-1273. mRNA-1273.351 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized S protein of the SARS-CoV-2 B.1.351 variant. Enrollment will occur at approximately five domestic clinical research sites.
This study includes two cohorts. Cohort 1 will provide rapid information about the immunogenicity of mRNA-1273.351 in a previously vaccinated group. This cohort can inform near term public health decisions if the variant virus becomes more widespread. Cohort 2 will evaluate different strategies for generation of cross protective immune responses in a naïve population. This cohort will take longer to provide information on the immunogenicity of mRNA-1273.351, but is important to inform future public health strategies. Cohort 1 will include approximately 60 subjects 18 years of age and older who received two vaccinations of mRNA-1273 at dosages of 50 mcg, 100 mcg, or 250 mcg in the Phase 1 clinical trial (DMID 20-0003). Subjects in Cohort 1 will receive a single intramuscular (IM) injection of the designated vaccine and will be followed through 12 months after vaccination. Follow-up visits will occur on Days 8, 15, and 29, as well as 3, 6, and 12 months after the vaccination. Cohort 2 will include approximately 150 participants 18 through 55 years of age who have not received a COVID-19 vaccine, have no known history of COVID-19 or SARS-CoV-2 infection, and do not have underlying conditions that are associated with an increased risk of severe illness from SARS-CoV-2 infection. Enrollment may close before the full 150 participants based on estimates on the timing of immunogenicity results and the need to inform public health decisions. They will be randomly assigned to one of 8 treatment arms and will receive 2 or 3 IM injections of the vaccine and followed through 12 months after the last vaccination. Follow-up visits will occur 7, 14, and 28 days after each vaccination, as well as 3, 6 and 12 months post the last vaccination.
The primary objective is to evaluate the safety and reactogenicity of mRNA-1273 and mRNA-1273.351 vaccines, in naïve and previously vaccinated individuals. The secondary objective is to assess humoral immunogenicity of mRNA-1273 and mRNA-1273.351 vaccines, in naïve and previously vaccinated individuals.
Conditions Module
Conditions
COVID-19
COVID-19 Immunisation
Keywords
Coronavirus
COVID-19
Immunogenicity
mRNA-1273
mRNA-1273.351
SARS-CoV-2
SARS-CoV-2 B.1.351
vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
135Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1A
Experimental
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273 in DMID Protocol 20-0003 (NCT04283461). N=30.
Biological: mRNA-1273.351
Arm 1B
Experimental
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273 in DMID Protocol 20-0003 (NCT04283461). N=30.
Biological: mRNA-1273
Biological: mRNA-1273.351
Arm 2A
Experimental
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57 in COVID-19 naïve participants. N=15
Biological: mRNA-1273
Biological: mRNA-1273.351
Arm 2B
Experimental
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57 in COVID-19 naïve participants. N=15
Biological: mRNA-1273
Biological: mRNA-1273.351
Arm 2C
Interventions
Name
Type
Description
Arm Group Labels
Other Names
mRNA-1273
Biological
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Any Medically-attended Adverse Events (MAAEs)
Number of participants that experienced MAAEs during the course of the study.
Day 1 to study completion, up to 1 year post last dose
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Number of participants that experienced any NOCMCs during the course of the study.
Day 1 to study completion, up to 1 year post last dose
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)
Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem inflammatory disorders, thrombocytopenia, acute aseptic arthritis, new onset of or worsening of neurologic disease, anaphylaxis, and other syndromes.
Day 1 to study completion, up to 1 year post last dose
Frequency of Any Serious Adverse Events (SAEs)
The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Day 1 to study completion, up to 1 year post last dose
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B
Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provides written informed consent prior to initiation of any study procedures.
Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
Agrees to the collection of venous blood per protocol.
Cohort 1: previously received 2 doses of mRNA-1273 intramuscular (IM) as part of DMID 20-0003.
Cohort 1: Male or non-pregnant female, >/= 18 years of age at time of enrollment. Cohort 2: Male or non-pregnant female, 18 through 55 years of age at time of enrollment.
Women of childbearing potential* must agree to practice abstinence or use at least one acceptable primary form of contraception.**, *** Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the criteria do not apply to subjects in a same sex relationship).
* Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement).
** Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products.
*** Must use at least one acceptable primary form of contraception for at least 30 days prior to the first vaccination and at least one acceptable primary form of contraception for 60 days after the last vaccination.
In good health.*
* As determined by medical history and physical examination to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of safety of subjects. Chronic medical diagnoses/conditions should be stable for the last 60 days (no hospitalizations, emergency room, or urgent care for condition or need for supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 60 days before enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome or for dose optimization, as determined by the participating site PI or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to study vaccination.
Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
Must agree to have samples stored for secondary research.
Agrees to adhere to Lifestyle Considerations throughout study duration.
Must agree to refrain from donating blood or plasma during the study (outside of this study).
Exclusion Criteria:
Positive pregnancy test prior to each vaccine administration.
BMI > 40.0 kg / m^2.
Female subject who is breastfeeding.
Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation.*
* Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
Presence of self-reported or medically documented significant medical or psychiatric condition(s).*
* Significant medical or psychiatric conditions include but are not limited to: Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.
Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), history of myocarditis or pericarditis as an adult, myocardial infarction (MI) within past 6 months, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia.
Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
An autoimmune disease, including hypothyroidism without a defined non-autoimmune cause, localized or history of psoriasis.
An immunodeficiency of any cause. Chronic kidney disease, estimated glomerular filtration rate (eGFR) < 60 mL / min / 1.73m^2.
Type 2 diabetes mellitus, not including prediabetes.
Has an acute illness*, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature >/= 38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior to each vaccination.
* An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
Has participated in another investigational study involving any investigational product* within 5 half-lives before the first vaccine administration.
* study drug, biologic or device.
Currently enrolled in or plans to participate in another clinical trial with an investigational agent* that will be received during the study-reporting period.**
* Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.
** Up to 15 months after the first vaccination.
Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to drugs or any previous licensed or unlicensed vaccines or to polyethylene glycol (PEG) or a PEG-containing product.
Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.*
* Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
Anticipating the need for immunosuppressive treatment within the next 6 months.
Received immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study.
Has any blood dyscrasias or significant disorder of coagulation.
Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination.
Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination.
Receipt of any other SARS-CoV-2 vaccine or any experimental coronavirus vaccine at any time prior to or during the study, except Cohort 1 subjects who received mRNA-1273 in DMID 20-0003.
Close contact of anyone known to have SARS-CoV-2 infection within 14 days prior to vaccine administration.
History of COVID-19 diagnosis, positive SARS-CoV-2 PCR test, or, for Cohort 2 only, a known positive SARS-CoV-2 serologic test.
On current treatment with investigational agents for prophylaxis of COVID-19.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
99 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Hope Clinic of Emory University
Decatur
Georgia
30030-1705
United States
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Anderson E, Jackson L, Rouphael N, Widge A, Montefiori D, Doria-Rose N, Suthar M, Cohen K, O'Connell S, Makowski M, Makhene M, Buchanan W, Spearman P, Creech CB, O'Dell S, Schmidt S, Leav B, Bennett H, Pajon R, Posavad C, Hural J, Beigel J, Albert J, Abebe K, Eaton A, Rostad C, Rebolledo P, Kamidani S, Graciaa D, Coler R, McDermott A, Ledgerwood J, Mascola J, DeRosa S, Neuzil K, McElrath MJ, Roberts P. Safety and Immunogenicity of a Third Dose of SARS-CoV-2 mRNA Vaccine - An Interim Analysis. Res Sq [Preprint]. 2022 May 3:rs.3.rs-1222037. doi: 10.21203/rs.3.rs-1222037/v1.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Participants recruited for this study include males and non-pregnant females of 18 or more years of age, who were in good health, had no known history of COVID-19 or SARS-CoV-2 infection, and met all other eligibility criteria. Participants were recruited from the Phase 1 clinical trial (NCT04283461) and from the community surrounding the clinical sites. Enrollment occurred between 31MAR2021 and 27MAY2021.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from a Phase 1 clinical trial (NCT04283461).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 30, 2021
Apr 3, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Biological: mRNA-1273.351
Arm 2D
Experimental
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Biological: mRNA-1273.351
Arm 2E
Experimental
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29 in COVID-19 naïve participants. N=20
Biological: mRNA-1273
Biological: mRNA-1273.351
Arm 2F
Experimental
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29 in COVID-19 naïve participants. N=20
Biological: mRNA-1273
Biological: mRNA-1273.351
Arm 2G
Experimental
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Biological: mRNA-1273
Biological: mRNA-1273.351
Arm 2H
Experimental
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Biological: mRNA-1273
Biological: mRNA-1273.351
Arm 1B
Arm 2A
Arm 2B
Arm 2E
Arm 2F
Arm 2G
Arm 2H
mRNA-1273.351
Biological
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Arm 1A
Arm 1B
Arm 2A
Arm 2B
Arm 2C
Arm 2D
Arm 2E
Arm 2F
Arm 2G
Arm 2H
Frequency of Solicited Reactogenicity Adverse Events (AEs)
The number of participants that experienced at least one solicited (local and systemic) AE through 7 days post vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.
Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2B
Grade of Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any solicited (local and systemic) AEs through 7 days post vaccination by grade. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.
Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2B
Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product
Number of events of any unsolicited AE through 28 days post vaccination by relationship to study product and severity, experienced by participants in the Safety Analysis population. Unsolicited AEs were events that were spontaneously reported by the subject, or revealed by observation, physical examination or other diagnostic procedures.
Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2B
Grade of Any Unsolicited Adverse Events (AEs)
Number of any unsolicited AEs through 28 days post vaccination by severity.
Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2B
Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.
Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay
Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1B
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
Day 15, Day 29, Day 91, Day 181, Day 366
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1B
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
Day 15, Day 29, Day 91, Day 181, Day 366
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G
Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351
Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
Number of Participants Who Seroconverted Against D614G for Arms 1A and 1B
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G.
Day 15, Day 29, Day 91, Day 181, Day 366
Number of Participants Who Seroconverted Against D614G for Arms 2A and 2B
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G.
Day 29, Day 57, Day 85, Day 147, Day 237, Day 422
Number of Participants Who Seroconverted Against D614G for Arms 2C-H
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1B
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351.
Day 15, Day 29, Day 91, Day 181, Day 366
Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2B
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351.
Day 29, Day 57, Day 85, Day 147, Day 237, Day 422
Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-H
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
Cincinnati
Ohio
45229-3039
United States
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville
Tennessee
37232-0004
United States
Kaiser Permanente Washington Health Research Institute
Seattle
Washington
98101-1466
United States
FG001
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from a Phase 1 clinical trial (NCT04283461).
FG002
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
FG003
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
FG004
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
FG005
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
FG006
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
FG007
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
FG008
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
FG009
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
FG00025 subjects
FG00123 subjects
FG0025 subjects
FG0036 subjects
FG00412 subjects
FG00513 subjects
FG00613 subjects
FG00712 subjects
FG00813 subjects
FG00913 subjects
COMPLETED
FG00020 subjects
FG00122 subjects
FG0025 subjects
FG0036 subjects
FG00411 subjects
FG0059 subjects
FG0069 subjects
FG00710 subjects
FG0088 subjects
FG00910 subjects
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0054 subjects
FG0064 subjects
FG0072 subjects
FG0085 subjects
FG0093 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Unable to continue due to work schedule
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
BG001
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
BG002
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
BG003
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
BG004
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
BG005
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
BG006
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
BG007
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
BG008
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
BG009
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00123
BG0025
BG0036
BG00412
BG00513
BG00613
BG00712
BG00813
BG00913
BG010135
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00123
ParticipantsBG0025
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00123
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00123
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00123
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
ParticipantsBG00025
ParticipantsBG00123
ParticipantsBG002
Height
Mean
Standard Deviation
centimeters
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00123
ParticipantsBG002
Weight
Mean
Standard Deviation
kilograms
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00123
ParticipantsBG002
BMI
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00123
ParticipantsBG002
Time Between Previous Trial Dose and Dose 1
Participants in Arms 1A-B were recruited from a previous trial (NCT04283461) and were administered a booster dose in this trial. Thus, they had varying times between the previous trial dose and dose 1 administration. Arms 2A-H were naïve participants and had a set schedule between doses.
Mean
Standard Deviation
Days
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00123
ParticipantsBG002
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 Any Medically-attended Adverse Events (MAAEs)
Number of participants that experienced MAAEs during the course of the study.
The Safety Analysis Population includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
Day 1 to study completion, up to 1 year post last dose
ID
Title
Description
OG000
Arm 1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG002
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG003
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG004
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG006
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG007
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG008
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG009
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00025
OG00123
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0020
OG003
Primary
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Number of participants that experienced any NOCMCs during the course of the study.
The Safety Analysis Population includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
Day 1 to study completion, up to 1 year post last dose
ID
Title
Description
OG000
Arm 1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG002
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Primary
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)
Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem inflammatory disorders, thrombocytopenia, acute aseptic arthritis, new onset of or worsening of neurologic disease, anaphylaxis, and other syndromes.
The Safety Analysis Population includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
Day 1 to study completion, up to 1 year post last dose
ID
Title
Description
OG000
Arm 1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
Primary
Frequency of Any Serious Adverse Events (SAEs)
The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
The Safety Analysis Population includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
Day 1 to study completion, up to 1 year post last dose
ID
Title
Description
OG000
Arm 1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG002
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
Primary
Frequency of Solicited Reactogenicity Adverse Events (AEs)
The number of participants that experienced at least one solicited (local and systemic) AE through 7 days post vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.
The Safety Analysis Population includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2B
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG002
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Primary
Grade of Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any solicited (local and systemic) AEs through 7 days post vaccination by grade. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.
The Safety Analysis Population includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2B
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG002
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Primary
Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product
Number of events of any unsolicited AE through 28 days post vaccination by relationship to study product and severity, experienced by participants in the Safety Analysis population. Unsolicited AEs were events that were spontaneously reported by the subject, or revealed by observation, physical examination or other diagnostic procedures.
The Safety Analysis population includes all participants who received one dose of vaccine.
Posted
Number
Events
Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2B
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG002
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Primary
Grade of Any Unsolicited Adverse Events (AEs)
Number of any unsolicited AEs through 28 days post vaccination by severity.
The Safety Analysis Population includes all participants who received one dose of vaccine.
Posted
Number
Events
Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2B
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG002
2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Secondary
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B
Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
Units
Counts
Participants
Secondary
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422
ID
Title
Description
OG000
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG001
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Units
Counts
Secondary
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
ID
Title
Description
OG000
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG001
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG002
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
Secondary
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
Units
Counts
Participants
Secondary
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422
ID
Title
Description
OG000
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG001
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Units
Counts
Secondary
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
ID
Title
Description
OG000
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG001
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG002
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
Secondary
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1B
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 15, Day 29, Day 91, Day 181, Day 366
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
Units
Counts
Participants
Secondary
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422
ID
Title
Description
OG000
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG001
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Units
Counts
Secondary
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
ID
Title
Description
OG000
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG001
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG002
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
Secondary
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1B
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 15, Day 29, Day 91, Day 181, Day 366
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
Units
Counts
Participants
Secondary
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422
ID
Title
Description
OG000
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG001
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Units
Counts
Secondary
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
ID
Title
Description
OG000
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG001
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG002
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
Secondary
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
Units
Counts
Participants
Secondary
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422
ID
Title
Description
OG000
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG001
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Units
Counts
Secondary
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
ID
Title
Description
OG000
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG001
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG002
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
Secondary
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
Units
Counts
Participants
Secondary
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422
ID
Title
Description
OG000
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG001
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Units
Counts
Secondary
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
ID
Title
Description
OG000
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG001
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG002
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
Secondary
Number of Participants Who Seroconverted Against D614G for Arms 1A and 1B
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 15, Day 29, Day 91, Day 181, Day 366
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
Units
Counts
Participants
Secondary
Number of Participants Who Seroconverted Against D614G for Arms 2A and 2B
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 29, Day 57, Day 85, Day 147, Day 237, Day 422
ID
Title
Description
OG000
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG001
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Units
Counts
Secondary
Number of Participants Who Seroconverted Against D614G for Arms 2C-H
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
ID
Title
Description
OG000
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG001
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG002
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
Secondary
Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1B
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 15, Day 29, Day 91, Day 181, Day 366
ID
Title
Description
OG000
1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
OG001
1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
Units
Counts
Participants
Secondary
Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2B
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 29, Day 57, Day 85, Day 147, Day 237, Day 422
ID
Title
Description
OG000
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG001
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
Units
Counts
Secondary
Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-H
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Posted
Count of Participants
Participants
Day 29, Day 43, Day 57, Day 119, Day 209, Day 394
ID
Title
Description
OG000
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG001
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG002
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
Time Frame
Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Description
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
All-Cause Mortality Comment
Not provided
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
Arm 1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
0
25
0
25
24
25
EG001
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
0
23
1
23
23
23
EG002
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
0
5
0
5
5
5
EG003
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
0
6
0
6
6
6
EG004
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
0
12
0
12
12
12
EG005
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
0
13
0
13
12
13
EG006
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
0
13
0
13
13
13
EG007
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
0
12
0
12
11
12
EG008
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
0
13
0
13
13
13
EG009
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG004
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG006
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG007
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG008
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG009
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00025
OG00123
OG0025
OG0036
OG00412
OG00513
OG00613
OG00712
OG00813
OG00913
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
OG002
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG003
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG004
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG006
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG007
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG008
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG009
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00025
OG00123
OG0025
OG0036
OG00412
OG00513
OG00613
OG00712
OG00813
OG00913
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG003
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG004
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG006
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG007
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG008
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG009
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00025
OG00123
OG0025
OG0036
OG00412
OG00513
OG00613
OG00712
OG00813
OG00913
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG003
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG004
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG006
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG007
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG008
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG009
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00025
OG00123
OG0025
OG0036
OG00412
OG00513
OG00613
OG00712
OG00813
OG00913
Title
Denominators
Categories
Local Events
Title
Measurements
OG00024
OG00120
OG0025
OG0036
OG00410
OG00512
OG00613
OG00711
OG00812
OG00913
Systemic Events
Title
Measurements
OG00022
OG00120
OG0025
OG003
OG003
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG004
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG006
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG007
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG008
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG009
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00025
OG00123
OG0025
OG0036
OG00412
OG00513
OG00613
OG00712
OG00813
OG00913
Title
Denominators
Categories
Title
Measurements
None
OG0001
OG0011
OG0020
OG0030
OG0040
OG0051
OG0060
OG0071
OG0080
OG0090
Mild
OG0004
OG0016
OG0020
OG0032
OG004
Moderate
OG00018
OG00113
OG0022
OG0034
OG004
Severe
OG0002
OG0013
OG0023
OG0030
OG004
OG003
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG004
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG006
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG007
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG008
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG009
2F: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00025
OG00123
OG0025
OG0036
OG00412
OG00513
OG00613
OG00712
OG00813
OG00913
Title
Denominators
Categories
Not Related
Title
Measurements
OG00010
OG00111
OG0024
OG0035
OG0046
OG0050
OG0063
OG0076
OG0087
OG0098
Related
Title
Measurements
OG00012
OG0013
OG0023
OG003
OG003
2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
OG004
2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG006
2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG007
2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG008
2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG009
2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00025
OG00123
OG0025
OG0036
OG00412
OG00513
OG00613
OG00712
OG00813
OG00913
Title
Denominators
Categories
Mild
Title
Measurements
OG00014
OG0017
OG0024
OG0034
OG0049
OG00511
OG0064
OG0074
OG00815
OG0095
Moderate
Title
Measurements
OG0006
OG0016
OG0023
OG003
Severe
Title
Measurements
OG0002
OG0011
OG0020
OG003
OG00025
OG00123
Title
Denominators
Categories
Day 1, Pre-Booster Dose
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00040555.5(29458.3 to 55833.2)
OG00135988.3(28423.6 to 45566.3)
Day 15
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG0001065642.8(831651.5 to 1365469.3)
OG001
Day 29
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG0001276347.8(996652.8 to 1634534.8)
OG001
Day 91
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG000660179.8(482539.5 to 903216.0)
OG001
Day 181
ParticipantsOG00022
ParticipantsOG00123
Title
Measurements
OG000335476.6(225669.7 to 498713.5)
OG001
Day 366
ParticipantsOG00020
ParticipantsOG00122
Title
Measurements
OG000287835.1(175517.5 to 472027.2)
OG001
Participants
OG0005
OG0016
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0001687.1(7.1 to 399625.2)
OG001601.5(35.0 to 10335.2)
Day 15
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000408309.5(42298.5 to 3941435.8)
OG001
Day 29
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000348738.5(58387.7 to 2082947.7)
OG001
Day 43
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0001028488.1(427257.0 to 2475764.6)
OG001
Day 57
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000689051.1(311987.0 to 1521830.7)
OG001
Day 71
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000687273.1(354218.2 to 1333484.0)
OG001
Day 85
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000565917.9(329154.7 to 972986.3)
OG001
Day 147
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000254433.8(141392.1 to 457851.2)
OG001
Day 237
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG00066652.9(32372.9 to 137232.1)
OG001
Day 422
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG00086226.1(13571.1 to 547849.5)
OG001
OG003
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG004
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00012
OG00113
OG00213
OG00312
OG00413
OG00512
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00512
Title
Measurements
OG000271.4(56.6 to 1301.5)
OG00192.3(44.2 to 193.1)
OG002346.7(106.4 to 1129.4)
OG003
Day 15
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00312
Day 29
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00311
Day 43
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Day 57
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
Day 119
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
Day 209
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG0039
Day 394
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG00310
OG00025
OG00123
Title
Denominators
Categories
Day 1, Pre-Booster Dose
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00016714.5(12487.0 to 22373.1)
OG00114513.9(11417.0 to 18451.0)
Day 15
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG000598971.7(463182.5 to 774569.7)
OG001
Day 29
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG000633384.7(495342.5 to 809896.5)
OG001
Day 91
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG000334468.3(248187.1 to 450744.8)
OG001
Day 181
ParticipantsOG00022
ParticipantsOG00123
Title
Measurements
OG000158501.6(109437.9 to 229561.9)
OG001
Day 366
ParticipantsOG00020
ParticipantsOG00122
Title
Measurements
OG000131964.9(82509.5 to 211063.5)
OG001
Participants
OG0005
OG0016
Title
Denominators
Categories
Day 1, Pre-Dose
Title
Measurements
OG000733.5(2.4 to 225877.7)
OG001328.9(22.3 to 4844.4)
Day 15
Title
Measurements
OG000244620.3(19555.8 to 3059912.2)
OG00154497.0(8122.1 to 365658.8)
Day 29
Title
Measurements
OG000192969.1(27809.7 to 1338997.0)
OG00139611.5(6922.0 to 226679.9)
Day 43
Title
Measurements
OG000402295.2(143809.2 to 1125389.9)
OG001195404.8(103020.2 to 370636.7)
Day 57
Title
Measurements
OG000277548.7(108735.7 to 708445.2)
OG001142696.8(72199.7 to 282028.5)
Day 71
Title
Measurements
OG000310800.9(148772.2 to 649295.8)
OG001192337.7(117452.4 to 314968.3)
Day 85
Title
Measurements
OG000264416.1(141960.4 to 492502.6)
OG001152131.5(102734.3 to 225280.1)
Day 147
Title
Measurements
OG000115520.5(54985.1 to 242702.0)
OG00156873.6(41022.8 to 78849.1)
Day 237
Title
Measurements
OG00037901.7(14721.7 to 97579.8)
OG00117270.3(13122.3 to 22729.4)
Day 422
Title
Measurements
OG00046726.0(8400.5 to 259904.3)
OG001113969.3(32167.4 to 403794.5)
OG003
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG004
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00012
OG00113
OG00213
OG00312
OG00413
OG00512
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00512
Title
Measurements
OG000197.8(46.2 to 846.0)
OG00147.3(15.8 to 141.8)
OG002229.3(71.9 to 731.7)
OG003
Day 15
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00312
Day 29
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00311
Day 43
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Day 57
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
Day 119
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
Day 209
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG0039
Day 394
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG00310
OG00025
OG00123
Title
Denominators
Categories
Day 15
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00025
OG00123
Day 29
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00025
OG001
Day 91
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00024
OG001
Day 181
ParticipantsOG00022
ParticipantsOG00123
Title
Measurements
OG00019
OG001
Day 366
ParticipantsOG00020
ParticipantsOG00122
Title
Measurements
OG00016
OG001
Participants
OG0005
OG0016
Title
Denominators
Categories
Day 15
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG0016
Day 29
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 43
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 57
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 71
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 85
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 147
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 237
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0003
OG001
Day 422
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG0003
OG001
OG003
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG004
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00012
OG00113
OG00213
OG00312
OG00413
OG00512
Title
Denominators
Categories
Day 15
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00512
Title
Measurements
OG00011
OG00113
OG00213
OG003
Day 29
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00311
Day 43
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Day 57
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
Day 119
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
Day 209
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG0039
Day 394
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG00310
OG00025
OG00123
Title
Denominators
Categories
Day 15
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00025
OG00123
Day 29
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00025
OG001
Day 91
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00025
OG001
Day 181
ParticipantsOG00022
ParticipantsOG00123
Title
Measurements
OG00020
OG001
Day 366
ParticipantsOG00020
ParticipantsOG00122
Title
Measurements
OG00018
OG001
Participants
OG0005
OG0016
Title
Denominators
Categories
Day 15
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG0016
Day 29
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 43
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 57
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 71
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 85
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 147
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 237
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0003
OG001
Day 422
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG0003
OG001
OG003
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG004
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00012
OG00113
OG00213
OG00312
OG00413
OG00512
Title
Denominators
Categories
Day 15
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00512
Title
Measurements
OG00011
OG00113
OG00213
OG003
Day 29
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00311
Day 43
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
Day 57
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
Day 119
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
Day 209
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG0039
Day 394
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG00310
OG00025
OG00123
Title
Denominators
Categories
Day 1, Pre-Booster Dose
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG000127.0(96.1 to 167.8)
OG001114.9(87.9 to 150.3)
Day 15
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG0002111.4(1615.0 to 2760.3)
OG001
Day 29
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG0002544.6(1872.3 to 3458.3)
OG001
Day 91
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG0003175.5(2124.4 to 4746.6)
OG001
Day 181
ParticipantsOG00022
ParticipantsOG00123
Title
Measurements
OG0001623.6(1045.0 to 2522.6)
OG001
Day 366
ParticipantsOG00020
ParticipantsOG00122
Title
Measurements
OG000749.6(422.1 to 1331.1)
OG001
Participants
OG0005
OG0016
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG00037.2(4.3 to 318.7)
OG0019.4(4.0 to 21.7)
Day 29
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0001587.5(72.4 to 34798.3)
OG001
Day 57
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0003759.4(1566.5 to 9022.1)
OG001
Day 85
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0003046.9(1732.8 to 5357.7)
OG001
Day 147
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0001855.5(931.1 to 3697.7)
OG001
Day 237
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000484.8(200.0 to 1175.2)
OG001
Day 422
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG000604.0(77.6 to 4700.2)
OG001
OG003
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG004
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00012
OG00113
OG00213
OG00312
OG00413
OG00512
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00512
Title
Measurements
OG00010.8(3.2 to 36.5)
OG0015.3(4.6 to 6.2)
OG00212.5(5.9 to 26.6)
OG003
Day 29
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00311
Day 43
ParticipantsOG00010
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 57
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
Day 119
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
Day 209
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG0039
Day 394
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG00310
OG00025
OG00123
Title
Denominators
Categories
Day 1, Pre-Booster Dose
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00023.2(16.4 to 32.6)
OG00124.2(17.3 to 33.7)
Day 15
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG0001100.1(867.3 to 1395.5)
OG001
Day 29
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG0001773.8(1306.2 to 2408.8)
OG001
Day 91
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG0001150.2(761.5 to 1737.5)
OG001
Day 181
ParticipantsOG00022
ParticipantsOG00123
Title
Measurements
OG000482.0(295.0 to 787.5)
OG001
Day 366
ParticipantsOG00020
ParticipantsOG00121
Title
Measurements
OG000291.8(149.2 to 570.4)
OG001
Participants
OG0005
OG0016
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG00012.1(4.1 to 35.7)
OG0015.8(4.0 to 8.4)
Day 29
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000129.9(5.5 to 3085.5)
OG001
Day 57
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000518.4(147.9 to 1817.0)
OG001
Day 85
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000670.9(321.2 to 1401.5)
OG001
Day 147
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000298.3(144.1 to 617.7)
OG001
Day 237
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000106.3(32.2 to 351.0)
OG001
Day 422
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG000275.5(28.6 to 2650.4)
OG001
OG003
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG004
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00012
OG00113
OG00213
OG00312
OG00413
OG00512
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00512
Title
Measurements
OG00010.1(3.4 to 30.3)
OG0016.3(4.7 to 8.4)
OG0027.7(5.4 to 10.9)
OG003
Day 29
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00311
Day 43
ParticipantsOG00010
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 57
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
Day 119
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
Day 209
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG0039
Day 394
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG00310
OG00025
OG00123
Title
Denominators
Categories
Day 15
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00024
OG00123
Day 29
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00024
OG001
Day 91
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00025
OG001
Day 181
ParticipantsOG00022
ParticipantsOG00123
Title
Measurements
OG00019
OG001
Day 366
ParticipantsOG00020
ParticipantsOG00122
Title
Measurements
OG00012
OG001
Participants
OG0005
OG0016
Title
Denominators
Categories
Day 29
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0005
OG0014
Day 57
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0005
OG001
Day 85
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0005
OG001
Day 147
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0005
OG001
Day 237
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 422
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG0003
OG001
OG003
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG004
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
Units
Counts
Participants
OG00012
OG00113
OG00213
OG00312
OG00413
OG00512
Title
Denominators
Categories
Day 29
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00311
ParticipantsOG00412
ParticipantsOG00512
Title
Measurements
OG0003
OG0013
OG00212
OG003
Day 43
ParticipantsOG00010
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 57
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
Day 119
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
Day 209
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG0039
Day 394
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG00310
OG00025
OG00123
Title
Denominators
Categories
Day 15
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00025
OG00123
Day 29
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00025
OG001
Day 91
ParticipantsOG00025
ParticipantsOG00123
Title
Measurements
OG00025
OG001
Day 181
ParticipantsOG00022
ParticipantsOG00123
Title
Measurements
OG00022
OG001
Day 366
ParticipantsOG00020
ParticipantsOG00121
Title
Measurements
OG00018
OG001
Participants
OG0005
OG0016
Title
Denominators
Categories
Day 29
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG0012
Day 57
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0005
OG001
Day 85
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0005
OG001
Day 147
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0005
OG001
Day 237
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG0004
OG001
Day 422
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG0004
OG001
OG003
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
OG004
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
OG005
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.