COVID-19, COVID-19 Immunisation
Conditions
Keywords
2019-nCoV (mRNA-1273), COVID-19, Dose-escalation, Immunogenicity, novel coronavirus, Safety, SARS-CoV-2, vaccine
Brief summary
This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. Up to one hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms \[mcg\], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters \[mL\]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults. Optional Substudy: This is an optional third mRNA-1273 vaccination substudy, in subjects 18 years of age and older, who received both the first and second mRNA-1273 vaccinations in the main study and meet all other substudy eligibility criteria. This optional third mRNA-1273 vaccination substudy is designed to assess safety, reactogenicity, and immunogenicity through 12 months post third vaccination (Day 731). Subjects who receive the third mRNA-1273 vaccination will exit the Schedule of Activities for the main study and will enter the Schedule of Activities for the optional substudy. Up to one hundred and twenty subject will be enrolled into two cohorts (consisting of participating subjects who received 2 doses of 25 or 50 mcg and participating subjects who received 2 doses of 100 and 250 mcg). Subjects will receive an IM injection (0.5 mL) at a dosage of 100 mcg/0.5 mL. The primary objective is to evaluate the safety and reactogenicity of a third mRNA-1273 vaccination, at a dosage of 100 mcg.
Detailed description
This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. Up to one hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms \[mcg\], 25 mcg, 50 mcg, 100 mcg, or 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters \[mL\]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults. The secondary objective is to evaluate the immunogenicity as measured by Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 S (spike) protein following a 2-dose vaccination schedule of mRNA-1273 at Day 57. Optional Substudy: This is an optional third mRNA-1273 vaccination substudy, in subjects 18 years of age and older, who received both the first and second mRNA-1273 vaccinations in the main study and meet all other substudy eligibility criteria. This optional third mRNA-1273 vaccination substudy is designed to assess safety, reactogenicity, and immunogenicity through 12 months post third vaccination (Day 731). Subjects who receive the third mRNA-1273 vaccination will exit the Schedule of Activities for the main study and will enter the Schedule of Activities for the optional substudy. Up to one hundred and twenty subject will be enrolled into two cohorts (consisting of participating subjects who received 2 doses of 25 or 50 mcg and participating subjects who received 2 doses of 100 and 250 mcg). Subjects will receive an IM injection (0.5 mL) at a dosage of 100 mcg/0.5 mL. The primary objective is to evaluate the safety and reactogenicity of a third mRNA-1273 vaccination, at a dosage of 100 mcg. The secondary objective is to evaluate the immunogenicity as measured by IgG ELISA to the SARS-CoV-2 S protein following a third mRNA-1273 vaccination, at a dosage of 100 mcg, at all timepoints after the third mRNA-1273 vaccination.
Interventions
BIOLOGICALmRNA-1273
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. 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, DSPC, and PEG2000 DMG.
Sponsors
ModernaTX, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
A subject must meet all of the following criteria to be eligible to participate in this study: 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. Male or non-pregnant female, \>/= to 18 years of age at time of enrollment. 5. Body Mass Index (BMI) 18.0-35.0 kg/m\^2, inclusive (\< 56 years of age), at screening; BMI 18.0-30.0 kg/m\^2, inclusive (\>/= 56 years of age), at screening. 6. Women of childbearing potential\* must agree to use or have practiced true 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). * True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception). * 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. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination. 8. Male subjects of childbearing potential\*: use of condoms to ensure effective contraception with a female partner of childbearing potential from first vaccination until 60 days after the last vaccination. \*Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy. 9. Male subjects agree to refrain from sperm donation from the time of first vaccination until 60 days after the last vaccination. 10. 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 (ER), 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, as determined by the participating site principal investigator (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. 11. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius). 12. Pulse no greater than 100 beats per minute. 13. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive. 14. Clinical screening laboratory evaluations (white blood cell (WBC), hemoglobin (Hgb), platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), creatinine (Cr), alkaline phosphatase (ALP), total bilirubin (T. Bili), Lipase, prothrombin time (PT), and partial thromboplastin time (PTT)) are within acceptable normal reference ranges at the clinical laboratory being used. 15. Must agree to have samples stored for secondary research. 16. Agrees to adhere to Lifestyle Considerations throughout study duration. 17. Must agree to refrain from donating blood or plasma during the study (outside of this study). Leukapheresis Inclusion Criteria: A subject must meet all of the following criteria to be eligible for leukapheresis: 1. Written informed consent for leukapheresis is provided. 2. Weight \>/= 110 pounds. 3. Screening laboratory evaluations are within acceptable ranges at the site where the leukapheresis procedure will be performed. 4. Negative urine or serum pregnancy test within 48 hours of the leukapheresis procedure for women of childbearing potential. 5. Adequate bilateral antecubital venous access. 6. No use of blood thinners, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) at least 5 days before the leukapheresis procedure. 7. Enrolled in cohorts 2, 3, 5, 10, or 11, and possibly cohort 6, if enrolled, and completed the two-dose vaccination series. Optional Substudy Inclusion Criteria: 1. Enrolled in the main study and received both the first and second mRNA-1273 vaccinations. 2. Provides written informed consent for the third mRNA-1273 vaccination. 3. Agrees to the collection of venous blood per substudy. 4. Must agree to have samples stored for secondary research. 5. Women of childbearing potential have had a negative urine pregnancy test within 24 hours before the third mRNA-1273 vaccination. 6. Women of childbearing potential\* must agree to use or have practiced true abstinence\*\* or use at least one acceptable primary form of contraception.\*\*\*/\*\*\*\* * 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® placement). * True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception). * 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 third mRNA-1273 vaccination and for at least 30 days after the third mRNA-1273 vaccination.
Exclusion criteria
A subject who meets any of the following criteria will be excluded from participation in this study: 1. Positive pregnancy test either at screening or just prior to each vaccine administration. 2. Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination. 3. Has any medical disease or condition that, in the opinion of the participating site principal investigator (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. 4. 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. 5. 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. 6. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening. 7. Has participated in another investigational study involving any investigational product\* within 60 days, or 5 half-lives, whichever is longer, 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. \*\*13 months after the first vaccination. 9. Has previously participated in an investigational study involving lipid nanoparticles (LNPs) (a component of the investigational vaccine assessed in this trial). 10. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. 11. 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. 12. Anticipating the need for immunosuppressive treatment within the next 6 months. 13. 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. 14. Has any blood dyscrasias or significant disorder of coagulation. 15. Has any chronic liver disease, including fatty liver. 16. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first vaccine administration. 17. Has a positive test result for drugs of abuse at screening or before the first vaccine administration. If cannabis is the only detected drug, inclusion is permitted. 18. Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region). 19. Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. 20. Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. 21. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study. 22. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration. 23. History of COVID-19 diagnosis. 24. On current treatment with investigational agents for prophylaxis of COVID-19. 25. Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the investigator or necessary to manage a chronic condition. 26. Plan to travel outside the United States (US) (continental US, Hawaii, and Alaska) from enrollment through 28 days after the last vaccination. 27. Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. 28. Non-ambulatory. 29. For subjects \>/= 56 years of age, history of chronic smoking within the prior year. 30. For subjects \>/= 56 years of age, current smoking or vaping. 31. For subjects \>/= 56 years of age, individuals currently working with high risk of exposure to SARS-CoV-2 (e.g., active health care workers with direct patient contact, emergency response personnel). Optional Substudy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade of Solicited Reactogenicity Adverse Events (AEs) | Through 7 days post vaccination | 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. |
| Frequency of Any Medically-attended Adverse Events (MAAEs) | Day 1 to Day 394 | Number of participants that experienced any MAAEs from Day 1 to Day 394. |
| Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | Day 1 to Day 394 | Number of participants that experienced any NOCMCs from Day 1 to Day 394. |
| Frequency of Any Serious Adverse Events (SAEs) | Day 1 to Day 394 | The number of participants that experience any SAEs from Day 1 to Day 394. 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. |
| Frequency of Solicited Reactogenicity Adverse Events (AEs) | Through 7 days post-vaccination | 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. |
| Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Through 28 days post-vaccination | 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. |
| Grade of Any Unsolicited Adverse Events (AEs) | Through 28 days post-vaccination | Number of any unsolicited AEs through 28 days post vaccination by severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 1 to Day 394 | Geometric mean fold rise (GMFR) in IgG titer from baseline against S-2P (Wa-1). Fold-rise is calculated by dividing post-vaccination results by the baseline value. |
| Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 to Day 394 | Geometric mean titer (GMT) of antibody against RBD |
| Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 to Day 394 | Geometric mean titer (GMT) of antibody against S-2P (Wa-1) |
| Percentage of Participants Who Seroconverted Against RBD | Day 1 to Day 394 | Percentage of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against RBD |
| Percentage of Participants Who Seroconverted Against S-2P | Day 1 to Day 394 | Percentage of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against S-2P (Wa-1) |
| Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 1 to Day 394 | Geometric mean fold rise (GMFR) in IgG ELISA titer from baseline against RBD. Fold-rise is calculated by dividing post-vaccination results by the baseline value. |
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 and met all eligibility criteria. Participants were recruited from the community surrounding the clinical sites. Enrollment occurred between 16MAR2020 and 17JUNE2020.
Participants by arm
| Arm | Count |
|---|---|
| 25 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. | 15 |
| 50 mcg of mRNA-1273:18-55 Years 50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. | 15 |
| 100 mcg of mRNA-1273: 18-55 Years 100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. | 15 |
| 250 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. | 15 |
| 25 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age. | 10 |
| 50 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age. | 10 |
| 100 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age. | 10 |
| 25 mcg of mRNA-1273: 71+ Years 25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older. | 10 |
| 50 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older. | 10 |
| 100 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older. | 10 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Enrolled in separate trial | 0 | 0 | 8 | 13 | 12 | 0 | 0 | 8 | 0 | 0 | 0 | 7 | 0 |
Baseline characteristics
| Characteristic | 25 mcg of mRNA-1273: 18-55 Years | Total | 100 mcg of mRNA-1273: 71+ Years | 50 mcg of mRNA-1273: 71+ Years | 25 mcg of mRNA-1273: 71+ Years | 100 mcg of mRNA-1273: 56-70 Years | 50 mcg of mRNA-1273: 56-70 Years | 25 mcg of mRNA-1273: 56-70 Years | 250 mcg of mRNA-1273: 18-55 Years | 100 mcg of mRNA-1273: 18-55 Years | 50 mcg of mRNA-1273:18-55 Years |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 36.1 years STANDARD_DEVIATION 8 | 51.3 years STANDARD_DEVIATION 19 | 72.2 years STANDARD_DEVIATION 1.2 | 74.7 years STANDARD_DEVIATION 3.5 | 72.3 years STANDARD_DEVIATION 1.3 | 63.3 years STANDARD_DEVIATION 4.2 | 61.6 years STANDARD_DEVIATION 3.7 | 65.4 years STANDARD_DEVIATION 4.6 | 30.4 years STANDARD_DEVIATION 8 | 30.8 years STANDARD_DEVIATION 8.9 | 36.5 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 9 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 111 Participants | 10 Participants | 9 Participants | 9 Participants | 10 Participants | 10 Participants | 10 Participants | 13 Participants | 12 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 109 Participants | 10 Participants | 10 Participants | 9 Participants | 10 Participants | 7 Participants | 10 Participants | 14 Participants | 11 Participants | 13 Participants |
| Region of Enrollment United States | 15 participants | 120 participants | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 15 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 59 Participants | 7 Participants | 4 Participants | 2 Participants | 5 Participants | 5 Participants | 7 Participants | 9 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Male | 9 Participants | 61 Participants | 3 Participants | 6 Participants | 8 Participants | 5 Participants | 5 Participants | 3 Participants | 6 Participants | 7 Participants | 9 Participants |
Adverse events
| Event type | EG000 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 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 14 / 15 | 15 / 15 | 15 / 15 | 15 / 15 | 10 / 10 | 10 / 10 | 9 / 10 | 10 / 10 | 10 / 10 | 10 / 10 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 1 / 10 |
Outcome results
Primary
Frequency of Any Medically-attended Adverse Events (MAAEs)
Number of participants that experienced any MAAEs from Day 1 to Day 394.
Time frame: Day 1 to Day 394
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 7 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 6 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 5 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 7 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 2 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 6 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 2 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 5 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 4 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Any Medically-attended Adverse Events (MAAEs) | 8 Participants |
Primary
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Number of participants that experienced any NOCMCs from Day 1 to Day 394.
Time frame: Day 1 to Day 394
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 3 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
Primary
Frequency of Any Serious Adverse Events (SAEs)
The number of participants that experience any SAEs from Day 1 to Day 394. 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 Day 394
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Any Serious Adverse Events (SAEs) | 0 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Any Serious Adverse Events (SAEs) | 1 Participants |
Primary
Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity
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: Through 28 days post-vaccination
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 28 events |
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 0 events |
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 0 events |
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 1 events |
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 3 events |
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 4 events |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 7 events |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 1 events |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 0 events |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 22 events |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 5 events |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 0 events |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 15 events |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 0 events |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 6 events |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 3 events |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 10 events |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 0 events |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 11 events |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 1 events |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 3 events |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 16 events |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 14 events |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 7 events |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 7 events |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 9 events |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 0 events |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 2 events |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 2 events |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 0 events |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 1 events |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 4 events |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 0 events |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 6 events |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 1 events |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 0 events |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 1 events |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 1 events |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 7 events |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 0 events |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 5 events |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 0 events |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 12 events |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 0 events |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 0 events |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 0 events |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 18 events |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 5 events |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 8 events |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 0 events |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 0 events |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 6 events |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 2 events |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 0 events |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Mild | 3 events |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Moderate | 0 events |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Severe | 0 events |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Related : Severe | 0 events |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Mild | 26 events |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity | Not Related : Moderate | 4 events |
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: Through 7 days post-vaccination
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 11 participants |
| 25 mcg of mRNA-1273: 18-55 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 8 participants |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 14 participants |
| 50 mcg of mRNA-1273:18-55 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 13 participants |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 15 participants |
| 100 mcg of mRNA-1273: 18-55 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 15 participants |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 15 participants |
| 250 mcg of mRNA-1273: 18-55 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 15 participants |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 8 participants |
| 25 mcg of mRNA-1273: 56-70 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 8 participants |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 6 participants |
| 50 mcg of mRNA-1273: 56-70 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 9 participants |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 8 participants |
| 100 mcg of mRNA-1273: 56-70 Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 9 participants |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 8 participants |
| 25 mcg of mRNA-1273: 71+ Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 5 participants |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 7 participants |
| 50 mcg of mRNA-1273: 71+ Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 6 participants |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Local Events | 10 participants |
| 100 mcg of mRNA-1273: 71+ Years | Frequency of Solicited Reactogenicity Adverse Events (AEs) | Systemic Events | 7 participants |
Primary
Grade of Any Unsolicited Adverse Events (AEs)
Number of any unsolicited AEs through 28 days post vaccination by severity
Time frame: Through 28 days post-vaccination
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 4 events |
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 32 events |
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 0 events |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 27 events |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 0 events |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 8 events |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 0 events |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 25 events |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 9 events |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 4 events |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 27 events |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 21 events |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 0 events |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 11 events |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 9 events |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 1 events |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 5 events |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 6 events |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 7 events |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 6 events |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 1 events |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 5 events |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 30 events |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 0 events |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 6 events |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 10 events |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 0 events |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Any Unsolicited Adverse Events (AEs) | Mild | 29 events |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Any Unsolicited Adverse Events (AEs) | Moderate | 4 events |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Any Unsolicited Adverse Events (AEs) | Severe | 0 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: Through 7 days post vaccination
Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 2 Participants |
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 8 Participants |
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 5 Participants |
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 0 Participants |
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 3 Participants |
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 7 Participants |
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 3 Participants |
| 25 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 0 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 7 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 0 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 1 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 5 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 0 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 10 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 7 Participants |
| 50 mcg of mRNA-1273:18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 0 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 10 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 1 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 11 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 3 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 1 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 3 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 0 Participants |
| 100 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 1 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 8 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 0 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 9 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 4 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 0 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 2 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 1 Participants |
| 250 mcg of mRNA-1273: 18-55 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 5 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 1 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 5 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 2 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 3 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 2 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 0 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 0 Participants |
| 25 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 7 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 0 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 1 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 2 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 7 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 2 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 4 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 4 Participants |
| 50 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 0 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 0 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 6 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 0 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 1 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 9 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 0 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 1 Participants |
| 100 mcg of mRNA-1273: 56-70 Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 2 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 1 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 9 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 0 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 0 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 1 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 0 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 7 Participants |
| 25 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 2 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 1 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 0 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 6 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 1 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 2 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 7 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 3 Participants |
| 50 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 0 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Severe | 0 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | None | 0 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Moderate | 3 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Severe | 1 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 2 | Mild | 6 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Moderate | 0 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | Mild | 8 Participants |
| 100 mcg of mRNA-1273: 71+ Years | Grade of Solicited Reactogenicity Adverse Events (AEs) | Dose 1 | None | 2 Participants |
Secondary
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Geometric mean fold rise (GMFR) in IgG ELISA titer from baseline against RBD. Fold-rise is calculated by dividing post-vaccination results by the baseline value.
Time frame: Day 1 to 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 2621.803 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 326.688 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 118.232 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 2734.849 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 2427.728 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 1707.917 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 368.468 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 727.556 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 195.764 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 877.135 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 190.546 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 1122.191 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 46.423 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 113.292 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 40.957 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 1073.107 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 561.479 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 441.135 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 556.673 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 1416.229 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 3527.768 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 3007.923 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 2343.458 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 205.148 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 91.215 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 839.589 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 222.148 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 61.113 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 151.985 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 346.524 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 941.022 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 1086.092 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 79.878 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 23.779 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 100.000 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 14.358 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 975.663 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 989.692 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 383.266 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 223.100 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 701.940 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 114.078 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 303.529 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 154.917 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 578.229 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 24.082 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 38.967 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 285.832 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 183.781 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 181.844 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 4418.756 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 138.867 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 204.880 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 3071.850 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 1611.388 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 463.340 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 42.034 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 137.911 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 1443.444 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 2653.994 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 1962.908 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 285.957 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 593.198 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 201.187 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 475.445 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 657.204 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 187.845 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 407.474 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 11.013 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 42.530 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 626.325 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 451.648 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 43 | 1380.702 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 57 | 901.571 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 209 | 91.951 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 394 | 110.892 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 119 | 313.979 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 36 | 1414.165 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 29 | 112.047 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD | Day 15 | 51.027 Fold Rise |
Secondary
Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Geometric mean fold rise (GMFR) in IgG titer from baseline against S-2P (Wa-1). Fold-rise is calculated by dividing post-vaccination results by the baseline value.
Time frame: Day 1 to 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 2497.277 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 347.590 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 278.826 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 2425.121 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 1976.059 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 1964.265 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 532.926 Fold Rise |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 467.448 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 511.132 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 1588.791 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 426.170 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 2450.191 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 190.575 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 334.452 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 349.194 Fold Rise |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 2512.713 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 830.870 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 1079.124 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 639.244 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 3148.715 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 6380.536 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 5943.834 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 6157.842 Fold Rise |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 656.649 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 391.021 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 6479.378 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 1259.340 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 650.429 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 915.658 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 3190.558 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 5007.258 Fold Rise |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 6601.865 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 217.986 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 93.735 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 149.796 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 55.693 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 1662.647 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 2523.481 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 1715.932 Fold Rise |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 457.931 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 744.903 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 214.487 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 358.509 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 134.834 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 559.114 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 78.037 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 79.671 Fold Rise |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 127.513 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 258.048 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 131.644 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 4779.693 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 84.723 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 176.685 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 1548.460 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 1393.157 Fold Rise |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 385.745 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 133.721 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 522.637 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 4145.720 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 2737.159 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 10169.509 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 824.518 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 682.182 Fold Rise |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 374.024 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 193.464 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 774.819 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 184.289 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 297.577 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 20.706 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 49.900 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 483.727 Fold Rise |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 824.138 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 43 | 8483.987 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 57 | 3815.048 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 209 | 114.639 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 394 | 50.304 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 119 | 204.739 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 36 | 2765.031 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 29 | 213.206 Fold Rise |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2 | Day 15 | 109.977 Fold Rise |
Secondary
Geometric Mean Titer (GMT) of Antibody Against RBD
Geometric mean titer (GMT) of antibody against RBD
Time frame: Day 1 to 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 20464.446 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 18144.012 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 55.539 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 151891.452 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 94856.406 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 6566.491 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 134834.181 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 40407.936 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 145612.950 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 90573.260 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 588.031 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 659882.584 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 66619.290 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 27298.157 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 24084.261 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 515782.576 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 115115.375 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 572701.831 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 93239.514 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 371290.883 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 70794.578 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 34066.956 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 166.061 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 92441.432 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 499497.517 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 235179.791 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 558929.643 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 120088.107 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 199434.367 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 625076.733 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 541585.049 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 87471.519 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 35172.238 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 483207.129 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 575.528 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 52496.861 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 78036.898 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 45425.530 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 12844.414 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 20361.042 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 2923.479 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 201511.576 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 4841.724 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 198655.229 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 203.610 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 244962.722 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 348.980 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 8404.270 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 13598.782 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 105925.373 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 201790.167 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 54062.982 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 123784.614 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 39810.717 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 359418.146 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 40560.192 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 30974.193 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 103347.506 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 45698.295 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 985598.423 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 40992.084 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 223.049 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 685172.620 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 65978.130 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 111.224 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 160546.189 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 295188.885 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 31805.337 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 218323.256 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 15339.104 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 4675.198 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 22376.904 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 121394.777 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 2134.519 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 127379.635 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 87538.681 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 8243.279 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 36408.266 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 193.821 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 92150.989 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 78976.885 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 15 | 25668.471 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 57 | 453523.713 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 29 | 56363.766 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 119 | 157942.861 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 36 | 711377.295 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 209 | 49367.876 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 1 | 503.037 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 394 | 55782.760 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against RBD | Day 43 | 694544.378 Titer |
Secondary
Geometric Mean Titer (GMT) of Antibody Against S-2P
Geometric mean titer (GMT) of antibody against S-2P (Wa-1)
Time frame: Day 1 to 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 61659.500 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 40216.104 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 115.700 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 280586.432 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 227265.406 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 32260.171 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 228630.062 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 54083.734 Titer |
| 25 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 288934.898 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 115722.196 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 353.726 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 866695.749 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 118304.156 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 67411.398 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 123518.877 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 561996.141 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 180800.655 Titer |
| 50 mcg of mRNA-1273:18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 734030.804 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 109211.071 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 782785.653 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 151979.746 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 86311.103 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 131.442 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 84023.351 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 781267.935 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 413872.592 Titer |
| 100 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 811094.448 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 213515.089 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 569464.514 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 1178329.272 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 893716.961 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 163430.584 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 116091.387 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 1156467.236 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 178.484 Titer |
| 250 mcg of mRNA-1273: 18-55 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 69791.093 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 323817.265 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 86417.162 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 44800.794 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 28268.320 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 10509.934 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 476211.633 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 17688.866 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 313761.751 Titer |
| 25 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 188.712 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 419662.342 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 563.378 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 43964.284 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 44884.873 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 201976.108 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 314992.345 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 75962.631 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 74683.080 Titer |
| 50 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 120837.018 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 913271.700 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 86297.855 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 55539.249 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 252871.567 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 115824.384 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 3133285.724 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 169160.905 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 655.541 Titer |
| 100 mcg of mRNA-1273: 56-70 Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 1015079.367 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 75683.290 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 110.943 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 459938.749 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 303668.679 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 91474.491 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 1128236.122 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 57982.909 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 14835.425 Titer |
| 25 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 41495.404 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 157000.126 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 6720.475 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 251478.001 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 267485.349 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 16195.710 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 59813.608 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 324.564 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 62791.376 Titer |
| 50 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 96582.846 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 15 | 104881.768 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 57 | 3638312.512 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 29 | 203329.316 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 119 | 195254.027 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 36 | 2636938.493 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 209 | 112287.997 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 1 | 953.674 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 394 | 47973.345 Titer |
| 100 mcg of mRNA-1273: 71+ Years | Geometric Mean Titer (GMT) of Antibody Against S-2P | Day 43 | 8090958.992 Titer |
Secondary
Percentage of Participants Who Seroconverted Against RBD
Percentage of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against RBD
Time frame: Day 1 to 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 80 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 60 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 90 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 90 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 90 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 60 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 43 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 57 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 209 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 394 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 119 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 36 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 29 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against RBD | Day 15 | 90 percentage of participants |
Secondary
Percentage of Participants Who Seroconverted Against S-2P
Percentage of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against S-2P (Wa-1)
Time frame: Day 1 to 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 50 mcg of mRNA-1273:18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 250 mcg of mRNA-1273: 18-55 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 90 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 56-70 Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 25 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 90 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 90 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 50 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 43 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 57 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 209 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 394 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 119 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 36 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 29 | 100 percentage of participants |
| 100 mcg of mRNA-1273: 71+ Years | Percentage of Participants Who Seroconverted Against S-2P | Day 15 | 100 percentage of participants |