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Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04785144
Enrollment
135
Registered
2021-03-05
Start date
2021-03-31
Completion date
2022-07-05
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BIOLOGICALmRNA-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.

BIOLOGICALmRNA-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.

Sponsors

ModernaTX, Inc.
CollaboratorINDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

1. Provides written informed consent prior to initiation of any study procedures. 2. Be able to understand and agrees to comply with planned study procedures and be available for all study visits. 3. Agrees to the collection of venous blood per protocol. 4. Cohort 1: previously received 2 doses of mRNA-1273 intramuscular (IM) as part of DMID 20-0003. 5. 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. 6. 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. 7. 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. 8. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius). 9. Must agree to have samples stored for secondary research. 10. Agrees to adhere to Lifestyle Considerations throughout study duration. 11. Must agree to refrain from donating blood or plasma during the study (outside of this study).

Exclusion criteria

1. Positive pregnancy test prior to each vaccine administration. 2. BMI \> 40.0 kg / m\^2. 3. Female subject who is breastfeeding. 4. 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. 5. 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. Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease). 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. 6. 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. 7. Has participated in another investigational study involving any investigational product\* within 5 half-lives before the first vaccine administration. \* study drug, biologic or device. 8. 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. 9. 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. 10. 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. 11. Anticipating the need for immunosuppressive treatment within the next 6 months. 12. 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. 13. Has any blood dyscrasias or significant disorder of coagulation. 14. Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. 15. Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. 16. 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. 17. Close contact of anyone known to have SARS-CoV-2 infection within 14 days prior to vaccine administration. 18. History of COVID-19 diagnosis, positive SARS-CoV-2 PCR test, or, for Cohort 2 only, a known positive SARS-CoV-2 serologic test. 19. On current treatment with investigational agents for prophylaxis of COVID-19.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Any Serious Adverse Events (SAEs)Day 1 to study completion, up to 1 year post last doseThe 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.
Number of Participants With Any Medically-attended Adverse Events (MAAEs)Day 1 to study completion, up to 1 year post last doseNumber of participants that experienced MAAEs during the course of the study.
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)Day 1 to study completion, up to 1 year post last doseNumber of participants that experienced any NOCMCs during the course of the study.
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)Day 1 to study completion, up to 1 year post last doseNumber 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.
Frequency of Solicited Reactogenicity Adverse Events (AEs)Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2BThe 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.
Grade of Solicited Reactogenicity Adverse Events (AEs)Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2BNumber 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.
Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductDay 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-2BNumber 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.
Grade of Any Unsolicited Adverse Events (AEs)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-2BNumber of any unsolicited AEs through 28 days post vaccination by severity.

Secondary

MeasureTime frameDescription
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 15, Day 29, Day 91, Day 181, Day 366Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422Geometric Mean (GM) of Pseudovirus Neutralization Against D614G
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Geometric 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.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Geometric 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.
Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 15, Day 29, Day 91, Day 181, Day 366Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G.
Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 29, Day 57, Day 85, Day 147, Day 237, Day 422Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G.
Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 29, Day 43, Day 57, Day 119, Day 209, Day 394Number 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.
Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 15, Day 29, Day 91, Day 181, Day 366Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351.
Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 29, Day 57, Day 85, Day 147, Day 237, Day 422Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351.
Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 29, Day 43, Day 57, Day 119, Day 209, Day 394Number 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.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 15, Day 29, Day 91, Day 181, Day 366Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.

Countries

United States

Participant flow

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.

Participants by arm

ArmCount
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.
25
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.
23
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.
5
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.
6
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.
12
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.
13
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.
13
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.
12
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.
13
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.
13
Total135

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009
Overall StudyLost to Follow-up1000121241
Overall StudyPhysician Decision0000000001
Overall StudyProtocol Violation0000001000
Overall StudyUnable to continue due to work schedule0000000001
Overall StudyWithdrawal by Subject4100022010

Baseline characteristics

CharacteristicArm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351TotalArm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Arm 1A: 50 mcg of mRNA-1273.351Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
Age, Continuous39.2 years
STANDARD_DEVIATION 14
40.3 years
STANDARD_DEVIATION 11.9
39.1 years
STANDARD_DEVIATION 11.5
35.8 years
STANDARD_DEVIATION 13
32.7 years
STANDARD_DEVIATION 9.8
39.2 years
STANDARD_DEVIATION 14.4
36.1 years
STANDARD_DEVIATION 10.8
43.7 years
STANDARD_DEVIATION 17
45.0 years
STANDARD_DEVIATION 19
34.9 years
STANDARD_DEVIATION 11.4
36.7 years
STANDARD_DEVIATION 10
BMI27.30 kg/m^2
STANDARD_DEVIATION 8.13
23.47 kg/m^2
STANDARD_DEVIATION 2.97
25.77 kg/m^2
STANDARD_DEVIATION 4.73
26.76 kg/m^2
STANDARD_DEVIATION 4.56
24.34 kg/m^2
STANDARD_DEVIATION 4.8
26.23 kg/m^2
STANDARD_DEVIATION 4.74
29.09 kg/m^2
STANDARD_DEVIATION 5.78
25.53 kg/m^2
STANDARD_DEVIATION 3.12
24.86 kg/m^2
STANDARD_DEVIATION 3.27
27.47 kg/m^2
STANDARD_DEVIATION 4.54
28.85 kg/m^2
STANDARD_DEVIATION 6.28
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants1 Participants0 Participants2 Participants9 Participants0 Participants1 Participants4 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants6 Participants11 Participants12 Participants11 Participants125 Participants12 Participants22 Participants21 Participants12 Participants13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Height170.44 centimeters
STANDARD_DEVIATION 8.96
175.10 centimeters
STANDARD_DEVIATION 10.27
177.44 centimeters
STANDARD_DEVIATION 10.13
175.30 centimeters
STANDARD_DEVIATION 13.25
173.22 centimeters
STANDARD_DEVIATION 11.16
173.75 centimeters
STANDARD_DEVIATION 10.17
169.83 centimeters
STANDARD_DEVIATION 10.44
172.70 centimeters
STANDARD_DEVIATION 11.39
171.62 centimeters
STANDARD_DEVIATION 7.6
178.17 centimeters
STANDARD_DEVIATION 9.88
175.08 centimeters
STANDARD_DEVIATION 8.14
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants2 Participants0 Participants2 Participants6 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants2 Participants2 Participants1 Participants19 Participants3 Participants1 Participants1 Participants3 Participants2 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants0 Participants0 Participants1 Participants2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
White
2 Participants4 Participants7 Participants11 Participants9 Participants105 Participants9 Participants22 Participants21 Participants10 Participants10 Participants
Region of Enrollment
United States
5 participants6 participants12 participants13 participants13 participants135 participants12 participants23 participants25 participants13 participants13 participants
Sex: Female, Male
Female
3 Participants3 Participants3 Participants5 Participants6 Participants63 Participants8 Participants12 Participants11 Participants6 Participants6 Participants
Sex: Female, Male
Male
2 Participants3 Participants9 Participants8 Participants7 Participants72 Participants4 Participants11 Participants14 Participants7 Participants7 Participants
Time Between Previous Trial Dose and Dose 1—————320.5 Days
STANDARD_DEVIATION 25
—319.4 Days
STANDARD_DEVIATION 25.7
321.4 Days
STANDARD_DEVIATION 24.8
——
Weight78.44 kilograms
STANDARD_DEVIATION 19.6
72.13 kilograms
STANDARD_DEVIATION 12.53
81.43 kilograms
STANDARD_DEVIATION 17.92
83.19 kilograms
STANDARD_DEVIATION 21.04
74.53 kilograms
STANDARD_DEVIATION 21.89
79.66 kilograms
STANDARD_DEVIATION 17.82
84.59 kilograms
STANDARD_DEVIATION 21.19
76.40 kilograms
STANDARD_DEVIATION 13.1
73.68 kilograms
STANDARD_DEVIATION 13.68
87.53 kilograms
STANDARD_DEVIATION 17.54
88.42 kilograms
STANDARD_DEVIATION 19.65

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 230 / 50 / 60 / 120 / 130 / 130 / 120 / 130 / 13
other
Total, other adverse events
24 / 2523 / 235 / 56 / 612 / 1212 / 1313 / 1311 / 1213 / 1313 / 13
serious
Total, serious adverse events
0 / 251 / 230 / 50 / 60 / 120 / 130 / 130 / 120 / 130 / 13

Outcome results

Primary

Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)

Number of participants that experienced any NOCMCs during the course of the study.

Time frame: Day 1 to study completion, up to 1 year post last dose

Population: The Safety Analysis Population includes all participants who received one dose of vaccine.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)1 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)1 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)1 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)0 Participants
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.

Time frame: Day 1 to study completion, up to 1 year post last dose

Population: The Safety Analysis Population includes all participants who received one dose of vaccine.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)1 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)1 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)1 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)0 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)0 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)0 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)0 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)0 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)1 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)0 Participants
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.

Time frame: Day 1 to study completion, up to 1 year post last dose

Population: The Safety Analysis Population includes all participants who received one dose of vaccine.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)0 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)1 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)0 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)0 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)0 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)0 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)0 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)0 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)0 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Any Serious Adverse Events (SAEs)0 Participants
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.

Time frame: 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

Population: The Safety Analysis Population includes all participants who received one dose of vaccine.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events24 Participants
Arm 1A: 50 mcg of mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events22 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events20 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events20 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events5 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events5 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events6 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events6 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events12 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events10 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events11 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events12 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events12 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events13 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events11 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events11 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events12 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events12 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Local Events13 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Solicited Reactogenicity Adverse Events (AEs)Systemic Events12 Participants
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.

Time frame: 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

Population: The Safety Analysis population includes all participants who received one dose of vaccine.

ArmMeasureGroupValue (NUMBER)
Arm 1A: 50 mcg of mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related10 Events
Arm 1A: 50 mcg of mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated12 Events
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related11 Events
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated3 Events
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related4 Events
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated3 Events
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related5 Events
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated1 Events
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated5 Events
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related6 Events
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated16 Events
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related0 Events
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated4 Events
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related3 Events
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related6 Events
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated2 Events
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related7 Events
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated13 Events
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductNot Related8 Events
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study ProductRelated10 Events
Primary

Grade of Any Unsolicited Adverse Events (AEs)

Number of any unsolicited AEs through 28 days post vaccination by severity.

Time frame: 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

Population: The Safety Analysis Population includes all participants who received one dose of vaccine.

ArmMeasureGroupValue (NUMBER)
Arm 1A: 50 mcg of mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate6 Events
Arm 1A: 50 mcg of mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe2 Events
Arm 1A: 50 mcg of mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild14 Events
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate6 Events
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild7 Events
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe1 Events
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild4 Events
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe0 Events
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate3 Events
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate2 Events
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild4 Events
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe0 Events
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe1 Events
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild9 Events
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate1 Events
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate5 Events
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild11 Events
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe0 Events
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild4 Events
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe0 Events
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate3 Events
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate3 Events
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild4 Events
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe1 Events
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate5 Events
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild15 Events
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe0 Events
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Mild5 Events
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Severe3 Events
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Any Unsolicited Adverse Events (AEs)Moderate10 Events
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.

Time frame: 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

Population: The Safety Analysis Population includes all participants who received one dose of vaccine.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None1 Participants
Arm 1A: 50 mcg of mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild4 Participants
Arm 1A: 50 mcg of mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate18 Participants
Arm 1A: 50 mcg of mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe2 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild6 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None1 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe3 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate13 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild0 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None0 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate2 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe3 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None0 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild2 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate4 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe0 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate6 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild2 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe4 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None0 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate7 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild3 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None1 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe2 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild1 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate8 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe4 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None0 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None1 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe2 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild2 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate7 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe3 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None0 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate9 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild1 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Moderate6 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)None0 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Severe3 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Grade of Solicited Reactogenicity Adverse Events (AEs)Mild4 Participants
Primary

Number of Participants With Any Medically-attended Adverse Events (MAAEs)

Number of participants that experienced MAAEs during the course of the study.

Time frame: Day 1 to study completion, up to 1 year post last dose

Population: The Safety Analysis Population includes all participants who received one dose of vaccine.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)1 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)1 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)0 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)0 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)0 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)0 Participants
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)0 Participants
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)0 Participants
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)0 Participants
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants With Any Medically-attended Adverse Events (MAAEs)0 Participants
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.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 1, Pre-Booster Dose23.2 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 151100.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 291773.8 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 911150.2 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 181482.0 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 366291.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 181367.7 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 1, Pre-Booster Dose24.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 91792.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 15864.6 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 366301.0 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1BDay 291326.1 Titer
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

Time frame: Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 57518.4 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 147298.3 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 29129.9 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 237106.3 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 85670.9 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 422275.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 1, Pre-Dose12.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 422382.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 1, Pre-Dose5.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 2918.0 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 57163.9 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 85298.6 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 147105.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2BDay 23730.6 Titer
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.

Time frame: Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 3941281.6 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 57918.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 431711.4 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 209164.0 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 119386.2 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 1, Pre-Dose10.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 2940.7 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 1, Pre-Dose6.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 394341.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 2925.4 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 57916.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 119404.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 209138.4 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 1, Pre-Dose7.7 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 209137.9 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 119348.9 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 2951.9 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 3941006.9 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 57589.8 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 2944.9 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 20975.4 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 57338.3 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 1, Pre-Dose7.4 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 119214.7 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 394671.1 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 57946.7 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 119479.0 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 209133.1 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 2951.6 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 3941609.1 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 1, Pre-Dose7.0 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 3942349.3 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 1, Pre-Dose14.5 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 29132.5 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 571435.4 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 119643.1 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-HDay 209170.6 Titer
Secondary

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 152111.4 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 913175.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 1, Pre-Booster Dose127.0 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 1811623.6 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 366749.6 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 292544.6 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 366653.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 1, Pre-Booster Dose114.9 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 152460.4 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 292829.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 913572.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1BDay 1811794.5 Titer
Secondary

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G

Time frame: Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 573759.4 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 1471855.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 291587.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 237484.8 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 853046.9 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 422604.0 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 1, Pre-Dose37.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 4221372.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 1, Pre-Dose9.4 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 29135.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 572600.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 851875.4 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 147705.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2BDay 237120.9 Titer
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.

Time frame: Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 394863.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 57280.8 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 43316.9 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 209113.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 119178.6 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 1, Pre-Dose10.8 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 2924.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 1, Pre-Dose5.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 394179.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 2916.0 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 57313.6 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 119147.6 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 20985.2 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 571914.4 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 209497.5 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 3941793.5 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 1191042.3 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 29357.3 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 1, Pre-Dose12.5 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 29366.9 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 209183.2 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 57939.9 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 1, Pre-Dose12.1 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 119476.1 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 3941091.6 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 1, Pre-Dose6.8 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 431926.4 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 209272.2 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 3942265.8 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 2989.9 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 571316.6 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 119749.9 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 3942958.7 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 1, Pre-Dose12.7 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 29102.7 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 572017.1 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 119938.9 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-HDay 209315.0 Titer
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.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 1, Pre-Booster Dose16714.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 15598971.7 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 29633384.7 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 91334468.3 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 181158501.6 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 366131964.9 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 181136205.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 1, Pre-Booster Dose14513.9 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 91279134.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 15465312.9 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 366119198.6 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1BDay 29495722.6 Titer
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.

Time frame: Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 1, Pre-Dose733.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 15244620.3 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 29192969.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 43402295.2 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 57277548.7 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 71310800.9 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 85264416.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 147115520.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 23737901.7 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 42246726.0 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 14756873.6 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 1, Pre-Dose328.9 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 71192337.7 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 1554497.0 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 422113969.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 2939611.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 85152131.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 43195404.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 23717270.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2BDay 57142696.8 Titer
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.

Time frame: Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 2926830.7 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1526421.7 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1, Pre-Dose197.8 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 43307328.7 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 57224236.3 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 119107644.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 20953366.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 394208767.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 43344899.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 39483893.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1, Pre-Dose47.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 20951958.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 119127871.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 2923453.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1519904.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 57251732.7 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1596043.2 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 2970695.1 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 43291453.2 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 394259147.4 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 57209943.5 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 119105382.0 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 20947486.8 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1, Pre-Dose229.3 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 20928167.4 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 11980663.9 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 57161775.1 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1, Pre-Dose267.5 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 2945830.5 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 43212624.2 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 394135964.4 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1537894.4 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 394266166.9 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1, Pre-Dose63.8 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 57252862.2 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 119115540.1 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 20939447.9 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1544484.5 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 2942977.0 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 43357231.6 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 394331123.7 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 57257459.9 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 2950232.1 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 43255274.4 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 119104319.3 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1544725.5 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 20932817.3 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-HDay 1, Pre-Dose104.4 Titer
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.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 1, Pre-Booster Dose40555.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 151065642.8 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 291276347.8 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 91660179.8 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 181335476.6 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 366287835.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 181320314.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 1, Pre-Booster Dose35988.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 91623572.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 15993561.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 366268030.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1BDay 291169728.7 Titer
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.

Time frame: Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 1, Pre-Dose1687.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 15408309.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 29348738.5 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 431028488.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 57689051.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 71687273.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 85565917.9 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 147254433.8 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 23766652.9 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 42286226.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 147144121.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 1, Pre-Dose601.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 71485649.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 15103325.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 422254786.0 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 2985622.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 85373198.2 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 43622864.8 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 23737379.9 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2BDay 57440293.4 Titer
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

Time frame: Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 2928662.2 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1530368.1 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1, Pre-Dose271.4 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 43225186.6 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 57171256.0 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 11978575.3 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 20933582.4 Titer
Arm 1A: 50 mcg of mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 394234021.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 43258723.7 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 39477061.1 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1, Pre-Dose92.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 20932839.3 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 11986821.0 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 2925301.5 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1521710.7 Titer
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 57184762.6 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 15156640.9 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 29125557.3 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 43550894.5 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 394399456.3 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 57380485.7 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 119176619.9 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 20971377.9 Titer
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1, Pre-Dose346.7 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 20943724.8 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 119142765.3 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 57320340.2 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1, Pre-Dose645.6 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 29118461.4 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 43427940.0 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 394218022.7 Titer
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1591564.4 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 394347444.1 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1, Pre-Dose159.8 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 57301884.2 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 119142664.0 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 20944229.8 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1567811.1 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 2963247.3 Titer
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 43433732.7 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 394499494.9 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 57321259.8 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 2973048.1 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 43313325.4 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 119134238.4 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1562111.1 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 20940884.3 Titer
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-HDay 1, Pre-Dose192.7 Titer
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.

Time frame: Day 15, Day 29, Day 91, Day 181, Day 366

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 2925 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 18122 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 9125 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 36618 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 1525 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 36615 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 1523 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 2923 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 9123 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1BDay 18120 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.

Time frame: Day 29, Day 57, Day 85, Day 147, Day 237, Day 422

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 575 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 1475 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 2374 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 294 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 4224 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 855 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 4225 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 292 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 575 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 856 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 2375 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2BDay 1476 Participants
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.

Time frame: Day 29, Day 43, Day 57, Day 119, Day 209, Day 394

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 294 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 11911 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 39411 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 4310 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 5711 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 20911 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 11912 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 5712 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 3948 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 295 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 20912 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 11911 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 295 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 5712 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 20911 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 3948 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 1199 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 2097 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 579 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 296 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 39410 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 5712 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 1199 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 3948 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 2098 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 296 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 2099 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 3948 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 298 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 5711 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-HDay 11911 Participants
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.

Time frame: Day 15, Day 29, Day 91, Day 181, Day 366

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 2925 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 18120 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 9125 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 36618 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 1525 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 36615 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 1523 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 2923 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 9123 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1BDay 18118 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.

Time frame: Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 294 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 854 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 574 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 1474 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 434 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 2373 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 714 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 4223 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 154 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 4225 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 156 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 296 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 436 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 576 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 716 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 856 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 1475 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2BDay 2375 Participants
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.

Time frame: Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 1511 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 11911 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 2911 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 39411 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 4311 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 20911 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 5711 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 2913 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 5712 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 4312 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 11912 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 1513 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 3949 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 20912 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 4312 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 2913 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 1513 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 11911 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 20912 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 5712 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 3948 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 5710 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 1512 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 2911 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 4311 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 11910 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 2099 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 39410 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 4312 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 2912 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 3948 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 1513 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 2099 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 5712 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 1199 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 3949 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 11912 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 4312 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 2912 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 20911 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 1512 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-HDay 5712 Participants
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.

Time frame: Day 15, Day 29, Day 91, Day 181, Day 366

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 2924 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 18119 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 9125 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 36612 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 1524 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 36612 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 1523 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 2923 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 9123 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 1A and 1BDay 18121 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.

Time frame: Day 29, Day 57, Day 85, Day 147, Day 237, Day 422

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 295 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 575 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 855 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 1475 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 2374 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 4223 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 2375 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 294 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 1476 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 576 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 4225 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2A and 2BDay 856 Participants
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.

Time frame: Day 29, Day 43, Day 57, Day 119, Day 209, Day 394

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 5711 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 4310 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 20910 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 11911 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 293 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 39411 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 3948 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 20911 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 293 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 5712 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 11912 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 5712 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 2912 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 3947 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 20911 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 11911 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 39410 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 5710 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 2911 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 11910 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 2099 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 3948 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 2911 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 4312 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 5712 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 1199 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 2098 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 20910 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 11912 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 5712 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 297 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against D614G for Arms 2C-HDay 3948 Participants
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.

Time frame: Day 15, Day 29, Day 91, Day 181, Day 366

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 2925 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 18119 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 9124 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 36616 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 1525 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 36613 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 1523 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 2923 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 9122 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1BDay 18118 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.

Time frame: Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 294 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 854 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 574 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 1474 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 434 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 2373 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 714 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 4223 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 154 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 4225 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 156 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 296 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 436 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 576 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 716 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 856 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 1476 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2BDay 2375 Participants
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.

Time frame: Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 1511 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 11911 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 2911 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 39411 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 4311 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 20911 Participants
Arm 1A: 50 mcg of mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 5711 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 2913 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 5712 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 4312 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 11912 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 1513 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 3949 Participants
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 20912 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 4312 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 2913 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 1513 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 11911 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 20912 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 5712 Participants
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 3948 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 5710 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 1512 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 2911 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 4311 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 11910 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 2099 Participants
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 39410 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 4312 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 2912 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 3948 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 1513 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 2099 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 5712 Participants
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 1199 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 3949 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 11912 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 4312 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 2912 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 20911 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 1512 Participants
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-HDay 5712 Participants

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026