The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283461
Recruitment Status : Completed
First Posted : February 25, 2020
Results First Posted : May 9, 2023
Last Update Posted : March 18, 2024
Sponsor:
Collaborator:
ModernaTX, Inc.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions COVID-19
COVID-19 Immunisation
Intervention Biological: mRNA-1273
Enrollment 120
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.
Pre-assignment Details  
Arm/Group Title 10 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 250 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years 250 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description

10 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.

mRNA-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.

25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.

mRNA-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.

50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.

mRNA-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.

100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.

mRNA-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.

250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age.

mRNA-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.

25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.

mRNA-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.

50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.

mRNA-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.

100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.

mRNA-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.

250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age.

mRNA-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.

25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.

mRNA-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.

50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.

mRNA-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.

100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.

mRNA-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.

250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older.

mRNA-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.
Period Title: Overall Study
Started 0 15 15 15 15 10 10 10 0 10 10 10 0
Completed 0 15 7 2 3 10 10 2 0 10 10 3 0
Not Completed 0 0 8 13 12 0 0 8 0 0 0 7 0
Reason Not Completed
Enrolled in separate trial             0             0             8             13             12             0             0             8             0             0             0             7             0
Arm/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years Total
Hide Arm/Group Description 25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. 50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. 100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. 250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. 25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age. 50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age. 100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age. 25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older. 50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older. 100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older. Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 15 10 10 10 10 10 10 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants 120 participants
36.1  (8.0) 36.5  (9.9) 30.8  (8.9) 30.4  (8.0) 65.4  (4.6) 61.6  (3.7) 63.3  (4.2) 72.3  (1.3) 74.7  (3.5) 72.2  (1.2) 51.3  (19.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants 120 participants
Female
6
  40.0%
6
  40.0%
8
  53.3%
9
  60.0%
7
  70.0%
5
  50.0%
5
  50.0%
2
  20.0%
4
  40.0%
7
  70.0%
59
  49.2%
Male
9
  60.0%
9
  60.0%
7
  46.7%
6
  40.0%
3
  30.0%
5
  50.0%
5
  50.0%
8
  80.0%
6
  60.0%
3
  30.0%
61
  50.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants 120 participants
Hispanic or Latino
1
   6.7%
1
   6.7%
3
  20.0%
2
  13.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
1
  10.0%
0
   0.0%
9
   7.5%
Not Hispanic or Latino
14
  93.3%
14
  93.3%
12
  80.0%
13
  86.7%
10
 100.0%
10
 100.0%
10
 100.0%
9
  90.0%
9
  90.0%
10
 100.0%
111
  92.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants 120 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Asian
0
   0.0%
2
  13.3%
0
   0.0%
1
   6.7%
0
   0.0%
1
  10.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
5
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
  13.3%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   2.5%
White
15
 100.0%
13
  86.7%
11
  73.3%
14
  93.3%
10
 100.0%
7
  70.0%
10
 100.0%
9
  90.0%
10
 100.0%
10
 100.0%
109
  90.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants 120 participants
15 15 15 15 10 10 10 10 10 10 120
1.Primary Outcome
Title Frequency of Any Medically-attended Adverse Events (MAAEs)
Hide Description Number of participants that experienced any MAAEs from Day 1 to Day 394.
Time Frame Day 1 to Day 394
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Arm/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
7
  46.7%
6
  40.0%
5
  33.3%
7
  46.7%
2
  20.0%
6
  60.0%
2
  20.0%
5
  50.0%
4
  40.0%
8
  80.0%
2.Primary Outcome
Title Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Hide Description Number of participants that experienced any NOCMCs from Day 1 to Day 394.
Time Frame Day 1 to Day 394
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Arm/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2
  13.3%
2
  13.3%
1
  10.0%
3
  30.0%
0
   0.0%
0
   0.0%
1
  10.0%
1
  10.0%
3.Primary Outcome
Title Frequency of Any Serious Adverse Events (SAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Arm/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
4.Primary Outcome
Title Frequency of Solicited Reactogenicity Adverse Events (AEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Arm/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Measure Type: Number
Unit of Measure: participants
Local Events 11 14 15 15 8 9 9 8 7 10
Systemic Events 8 13 15 15 8 6 8 5 6 7
5.Primary Outcome
Title Frequency of Any Unsolicited Adverse Events (AEs) by Relationship to Study Product and Severity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Arm/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Measure Type: Number
Unit of Measure: events
Not Related : Mild 28 22 15 16 9 6 5 18 8 26
Not Related : Moderate 3 7 6 14 7 4 7 5 6 4
Not Related : Severe 0 0 0 1 0 1 1 0 0 0
Related : Mild 4 5 10 11 2 0 1 12 2 3
Related : Moderate 1 1 3 7 2 1 0 0 0 0
Related : Severe 0 0 0 3 0 0 0 0 0 0
6.Primary Outcome
Title Grade of Any Unsolicited Adverse Events (AEs)
Hide Description Number of any unsolicited AEs through 28 days post vaccination by severity
Time Frame Through 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Arm/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Measure Type: Number
Unit of Measure: events
Mild 32 27 25 27 11 6 6 30 10 29
Moderate 4 8 9 21 9 5 7 5 6 4
Severe 0 0 0 4 0 1 1 0 0 0
7.Primary Outcome
Title Grade of Solicited Reactogenicity Adverse Events (AEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Arm/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
Dose 1 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
None
5
  33.3%
0
   0.0%
1
   6.7%
0
   0.0%
3
  30.0%
4
  40.0%
1
  10.0%
1
  10.0%
2
  20.0%
2
  20.0%
Mild
8
  53.3%
10
  66.7%
10
  66.7%
9
  60.0%
5
  50.0%
4
  40.0%
9
  90.0%
9
  90.0%
7
  70.0%
8
  80.0%
Moderate
2
  13.3%
5
  33.3%
3
  20.0%
5
  33.3%
2
  20.0%
2
  20.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
1
   6.7%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Dose 2 Number Analyzed 13 participants 15 participants 15 participants 14 participants 10 participants 10 participants 9 participants 10 participants 10 participants 10 participants
None
3
  23.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
1
  11.1%
1
  10.0%
3
  30.0%
0
   0.0%
Mild
7
  53.8%
7
  46.7%
3
  20.0%
2
  14.3%
7
  70.0%
7
  70.0%
2
  22.2%
7
  70.0%
6
  60.0%
6
  60.0%
Moderate
3
  23.1%
7
  46.7%
11
  73.3%
8
  57.1%
2
  20.0%
0
   0.0%
6
  66.7%
2
  20.0%
1
  10.0%
3
  30.0%
Severe
0
   0.0%
1
   6.7%
1
   6.7%
4
  28.6%
1
  10.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
8.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against RBD
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Mean (95% Confidence Interval)
Unit of Measure: Fold Rise
Day 15 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
118.232
(60.888 to 229.579)
46.423
(24.502 to 87.956)
205.148
(105.848 to 397.603)
151.985
(74.288 to 310.944)
14.358
(2.731 to 75.481)
24.082
(12.174 to 47.639)
138.867
(47.290 to 407.785)
42.034
(14.335 to 123.258)
11.013
(2.664 to 45.534)
51.027
(17.037 to 152.833)
Day 29 Number Analyzed 15 participants 15 participants 15 participants 14 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
326.688
(194.477 to 548.780)
113.292
(51.591 to 248.785)
561.479
(264.946 to 1189.896)
222.148
(107.069 to 460.915)
23.779
(5.816 to 97.219)
38.967
(19.884 to 76.363)
204.880
(54.672 to 767.772)
137.911
(37.221 to 510.994)
42.530
(11.332 to 159.622)
112.047
(39.432 to 318.385)
Day 36 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
2621.803
(1355.412 to 5071.410)
1122.191
(669.513 to 1880.939)
3007.923
(1610.324 to 5618.496)
1086.092
(554.012 to 2129.187)
975.663
(330.190 to 2882.945)
303.529
(136.134 to 676.756)
4418.756
(1818.818 to 10735.216)
1443.444
(386.453 to 5391.417)
407.474
(109.921 to 1510.502)
1414.165
(487.854 to 4099.307)
Day 43 Number Analyzed 15 participants 14 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
2734.849
(1338.670 to 5587.186)
1073.107
(726.428 to 1585.232)
3527.768
(1637.665 to 7599.321)
941.022
(437.492 to 2024.092)
989.692
(411.218 to 2381.921)
701.940
(272.166 to 1810.366)
3071.850
(1480.126 to 6375.312)
2653.994
(759.931 to 9268.852)
657.204
(173.073 to 2495.569)
1380.702
(475.775 to 4006.810)
Day 57 Number Analyzed 15 participants 15 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
2427.728
(1238.979 to 4757.030)
877.135
(557.842 to 1379.184)
2343.458
(963.830 to 5697.890)
839.589
(364.917 to 1931.696)
383.266
(156.920 to 936.101)
578.229
(249.207 to 1341.649)
1611.388
(367.006 to 7075.003)
1962.908
(480.835 to 8013.154)
626.325
(180.467 to 2173.714)
901.571
(270.733 to 3002.336)
Day 119 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
1707.917
(793.649 to 3675.400)
195.764
(117.352 to 326.571)
1416.229
(684.896 to 2928.480)
346.524
(164.750 to 728.856)
223.100
(82.918 to 600.274)
154.917
(61.416 to 390.765)
463.340
(141.681 to 1515.262)
593.198
(150.885 to 2332.137)
187.845
(59.459 to 593.450)
313.979
(88.410 to 1115.058)
Day 209 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 9 participants 10 participants 10 participants 10 participants 9 participants
368.468
(187.618 to 723.644)
40.957
(23.071 to 72.712)
556.673
(290.404 to 1067.082)
91.215
(44.456 to 187.154)
100.000
(33.500 to 298.509)
285.832
(140.919 to 579.766)
181.844
(55.959 to 590.924)
201.187
(52.192 to 775.526)
475.445
(153.101 to 1476.465)
91.951
(27.684 to 305.406)
Day 394 Number Analyzed 15 participants 12 participants 14 participants 15 participants 7 participants 10 participants 10 participants 10 participants 10 participants 10 participants
727.556
(399.079 to 1326.400)
190.546
(51.219 to 708.876)
441.135
(110.864 to 1755.303)
61.113
(31.403 to 118.932)
79.878
(11.702 to 545.251)
114.078
(31.552 to 412.448)
183.781
(39.490 to 855.284)
285.957
(31.077 to 2631.214)
451.648
(113.720 to 1793.750)
110.892
(26.367 to 466.386)
9.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) in IgG Titer From Baseline Against S-2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Mean (95% Confidence Interval)
Unit of Measure: Fold Rise
Day 15 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
278.826
(120.686 to 644.185)
190.575
(92.860 to 391.117)
656.649
(327.031 to 1318.492)
915.658
(418.876 to 2001.617)
55.693
(9.591 to 323.405)
78.037
(39.479 to 154.251)
84.723
(33.765 to 212.586)
133.721
(54.358 to 328.953)
20.706
(6.404 to 66.946)
109.977
(31.717 to 381.332)
Day 29 Number Analyzed 15 participants 15 participants 15 participants 14 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
347.590
(170.815 to 707.305)
334.452
(129.835 to 861.536)
830.870
(379.340 to 1819.858)
1259.340
(532.930 to 2975.879)
93.735
(16.091 to 546.028)
79.671
(35.902 to 176.798)
176.685
(61.056 to 511.295)
522.637
(177.450 to 1539.307)
49.900
(15.513 to 160.514)
213.206
(102.237 to 444.622)
Day 36 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
2497.277
(1278.098 to 4879.431)
2450.191
(828.251 to 7248.329)
5943.834
(2823.630 to 12511.967)
6601.865
(2948.586 to 14781.533)
1662.647
(446.013 to 6198.010)
358.509
(157.061 to 818.338)
4779.693
(543.021 to 42071.027)
4145.720
(1610.338 to 10672.911)
297.577
(97.440 to 908.791)
2765.031
(796.460 to 9599.223)
Day 43 Number Analyzed 15 participants 14 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
2425.121
(1306.938 to 4499.992)
2512.713
(1008.639 to 6259.647)
6380.536
(2845.471 to 14307.382)
5007.258
(2114.555 to 11857.170)
2523.481
(856.050 to 7438.764)
744.903
(390.710 to 1420.187)
1548.460
(315.724 to 7594.384)
2737.159
(913.784 to 8198.917)
774.819
(213.610 to 2810.468)
8483.987
(2252.065 to 31960.904)
Day 57 Number Analyzed 15 participants 15 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
1976.059
(982.475 to 3974.462)
1588.791
(666.141 to 3789.374)
6157.842
(3199.803 to 11850.426)
6479.378
(2562.589 to 16382.782)
1715.932
(428.208 to 6876.149)
559.114
(319.663 to 977.930)
1393.157
(251.085 to 7729.989)
10169.509
(3720.365 to 27798.057)
483.727
(164.214 to 1424.920)
3815.048
(1262.647 to 11527.051)
Day 119 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
1964.265
(1092.299 to 3532.306)
511.132
(162.699 to 1605.762)
3148.715
(1628.418 to 6088.368)
3190.558
(1258.565 to 8088.311)
457.931
(131.073 to 1599.876)
134.834
(68.773 to 264.353)
385.745
(95.962 to 1550.604)
682.182
(271.806 to 1712.148)
184.289
(51.001 to 665.918)
204.739
(102.957 to 407.139)
Day 209 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 9 participants 10 participants 10 participants 10 participants 9 participants
532.926
(259.219 to 1095.636)
349.194
(133.310 to 914.681)
639.244
(330.763 to 1235.426)
391.021
(164.947 to 926.949)
149.796
(41.609 to 539.277)
127.513
(64.754 to 251.097)
131.644
(31.225 to 554.998)
374.024
(148.317 to 943.210)
193.464
(64.217 to 582.841)
114.639
(42.789 to 307.141)
Day 394 Number Analyzed 15 participants 12 participants 14 participants 15 participants 7 participants 10 participants 10 participants 10 participants 10 participants 10 participants
467.448
(196.093 to 1114.309)
426.170
(157.075 to 1156.273)
1079.124
(360.017 to 3234.598)
650.429
(219.338 to 1928.793)
217.986
(25.301 to 1878.122)
214.487
(53.375 to 861.917)
258.048
(80.107 to 831.244)
824.518
(106.753 to 6368.232)
824.138
(160.041 to 4243.928)
50.304
(22.538 to 112.273)
10.Secondary Outcome
Title Geometric Mean Titer (GMT) of Antibody Against RBD
Hide Description Geometric mean titer (GMT) of antibody against RBD
Time Frame Day 1 to Day 394
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Mean (95% Confidence Interval)
Unit of Measure: Titer
Day 1 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
55.539
(44.340 to 69.567)
588.031
(411.408 to 840.480)
166.061
(81.760 to 337.282)
575.528
(349.084 to 948.863)
203.610
(113.648 to 364.785)
348.980
(165.342 to 736.573)
223.049
(64.175 to 775.238)
111.224
(45.771 to 270.276)
193.821
(92.028 to 408.205)
503.037
(174.025 to 1454.084)
Day 15 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
6566.491
(3650.209 to 11812.694)
27298.157
(15906.715 to 46847.473)
34066.956
(21684.705 to 53519.636)
87471.519
(51857.424 to 147544.285)
2923.479
(576.391 to 14828.010)
8404.270
(5860.592 to 12051.983)
30974.193
(15895.840 to 60355.452)
4675.198
(2235.438 to 9777.713)
2134.519
(513.626 to 8870.598)
25668.471
(12391.568 to 53170.866)
Day 29 Number Analyzed 15 participants 15 participants 15 participants 14 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
18144.012
(11088.170 to 29689.766)
66619.290
(35965.306 to 123400.305)
93239.514
(59894.633 to 145148.347)
120088.107
(71026.274 to 203039.702)
4841.724
(1531.597 to 15305.782)
13598.782
(7948.752 to 23264.892)
45698.295
(26323.563 to 79333.264)
15339.104
(7087.422 to 33197.985)
8243.279
(2486.083 to 27332.811)
56363.766
(35061.830 to 90607.766)
Day 36 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
145612.950
(77796.145 to 272547.326)
659882.584
(466389.271 to 933651.463)
499497.517
(400839.447 to 622438.163)
625076.733
(437605.395 to 892861.300)
198655.229
(98717.264 to 399766.951)
105925.373
(50971.843 to 220125.148)
985598.423
(284610.485 to 3413100.720)
160546.189
(82581.200 to 312117.997)
78976.885
(25690.683 to 242786.399)
711377.295
(368425.491 to 1373568.519)
Day 43 Number Analyzed 15 participants 14 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
151891.452
(74930.671 to 307898.124)
572701.831
(398614.411 to 822818.689)
558929.643
(462950.139 to 674807.758)
541585.049
(347184.872 to 844836.250)
201511.576
(115921.617 to 350296.315)
244962.722
(154477.301 to 388450.181)
685172.620
(222613.551 to 2108863.173)
295188.885
(167304.797 to 520824.741)
127379.635
(44079.970 to 368093.979)
694544.378
(465009.324 to 1037381.118)
Day 57 Number Analyzed 15 participants 15 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
134834.181
(70747.115 to 256975.230)
515782.576
(328490.907 to 809860.058)
371290.883
(266713.944 to 516871.813)
483207.129
(303572.459 to 769138.051)
78036.898
(42855.978 to 142098.203)
201790.167
(135955.705 to 299503.957)
359418.146
(128908.940 to 1002113.613)
218323.256
(106760.447 to 446467.258)
121394.777
(43523.048 to 338595.123)
453523.713
(255612.038 to 804671.643)
Day 119 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
94856.406
(44231.293 to 203424.707)
115115.375
(75506.457 to 175502.205)
235179.791
(177210.044 to 312112.863)
199434.367
(127702.777 to 311458.121)
45425.530
(23050.545 to 89519.739)
54062.982
(36881.823 to 79247.873)
103347.506
(38416.686 to 278022.601)
65978.130
(33230.207 to 130998.691)
36408.266
(15287.605 to 86708.273)
157942.861
(94323.027 to 264473.564)
Day 209 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 9 participants 10 participants 10 participants 10 participants 9 participants
20464.446
(10276.948 to 40750.773)
24084.261
(14896.240 to 38939.467)
92441.432
(57141.666 to 149547.939)
52496.861
(34936.109 to 78884.582)
20361.042
(9275.521 to 44695.280)
123784.614
(69755.695 to 219661.357)
40560.192
(13771.075 to 119462.654)
22376.904
(11234.479 to 44570.454)
92150.989
(35818.319 to 237079.938)
49367.876
(25170.231 to 96828.163)
Day 394 Number Analyzed 15 participants 12 participants 14 participants 15 participants 7 participants 10 participants 10 participants 10 participants 10 participants 10 participants
40407.936
(23427.721 to 69695.268)
90573.260
(27756.903 to 295548.658)
70794.578
(30435.905 to 164669.732)
35172.238
(20744.761 to 59633.674)
12844.414
(3233.887 to 51015.689)
39810.717
(17869.264 to 88693.813)
40992.084
(14189.286 to 118423.929)
31805.337
(4545.268 to 222556.593)
87538.681
(35329.764 to 216899.856)
55782.760
(13635.712 to 228203.428)
11.Secondary Outcome
Title Geometric Mean Titer (GMT) of Antibody Against S-2P
Hide Description Geometric mean titer (GMT) of antibody against S-2P (Wa-1)
Time Frame Day 1 to Day 394
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Mean (95% Confidence Interval)
Unit of Measure: Titer
Day 1 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
115.700
(71.727 to 186.630)
353.726
(132.208 to 946.402)
131.442
(64.973 to 265.910)
178.484
(81.254 to 392.061)
188.712
(76.456 to 465.788)
563.378
(315.579 to 1005.753)
655.541
(270.066 to 1591.222)
110.943
(55.418 to 222.100)
324.564
(103.755 to 1015.294)
953.674
(493.489 to 1842.990)
Day 15 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
32260.171
(18721.778 to 55588.665)
67411.398
(32440.518 to 140080.890)
86311.103
(56413.130 to 132054.478)
163430.584
(102144.589 to 261487.722)
10509.934
(2841.259 to 38876.682)
43964.284
(20823.983 to 92818.854)
55539.249
(40604.778 to 75966.629)
14835.425
(6923.655 to 31788.101)
6720.475
(1734.084 to 26045.329)
104881.768
(22438.517 to 490236.733)
Day 29 Number Analyzed 15 participants 15 participants 15 participants 14 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
40216.104
(29088.696 to 55600.122)
118304.156
(71951.240 to 194518.861)
109211.071
(79048.399 to 150882.981)
213515.089
(128810.327 to 353921.103)
17688.866
(5303.052 to 59003.006)
44884.873
(23416.011 to 86037.364)
115824.384
(73271.749 to 183089.502)
57982.909
(31454.265 to 106885.911)
16195.710
(5218.359 to 50265.040)
203329.316
(97384.457 to 424531.922)
Day 36 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
288934.898
(166075.942 to 502681.932)
866695.749
(641509.478 to 1170928.175)
781267.935
(606074.064 to 1007103.952)
1178329.272
(889033.807 to 1561762.739)
313761.751
(160505.758 to 613351.431)
201976.108
(99730.675 to 409045.145)
3133285.724
(570561.057 to 17206711.371)
459938.749
(272869.372 to 775256.128)
96582.846
(39661.176 to 235198.426)
2636938.493
(1072568.674 to 6482983.127)
Day 43 Number Analyzed 15 participants 14 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
280586.432
(167983.735 to 468668.862)
734030.804
(588265.571 to 915914.933)
811094.448
(656186.213 to 1002572.427)
893716.961
(661380.499 to 1207670.935)
476211.633
(264023.482 to 858929.354)
419662.342
(303128.058 to 580996.964)
1015079.367
(408139.653 to 2524592.041)
303668.679
(167756.794 to 549692.591)
251478.001
(119947.760 to 527239.400)
8090958.992
(2546021.264 to 25712125.163)
Day 57 Number Analyzed 15 participants 15 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
228630.062
(134203.687 to 389495.298)
561996.141
(407302.734 to 775442.039)
782785.653
(619387.634 to 989289.008)
1156467.236
(859119.097 to 1556729.996)
323817.265
(182136.112 to 575710.221)
314992.345
(217858.591 to 455433.854)
913271.700
(287340.911 to 2902702.559)
1128236.122
(635868.259 to 2001856.089)
157000.126
(81997.547 to 300607.036)
3638312.512
(1315790.941 to 10060350.416)
Day 119 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
227265.406
(137995.234 to 374285.134)
180800.655
(109897.259 to 297449.430)
413872.592
(322840.850 to 530572.641)
569464.514
(422292.607 to 767926.854)
86417.162
(51215.401 to 145814.068)
75962.631
(52415.295 to 110088.503)
252871.567
(96427.352 to 663131.657)
75683.290
(53033.587 to 108006.278)
59813.608
(32284.811 to 110815.815)
195254.027
(117658.578 to 324023.422)
Day 209 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 9 participants 10 participants 10 participants 10 participants 9 participants
61659.500
(34984.758 to 108672.866)
123518.877
(75876.495 to 201075.616)
84023.351
(60469.283 to 116752.229)
69791.093
(52610.682 to 92581.896)
28268.320
(14750.596 to 54173.939)
74683.080
(55359.100 to 100752.405)
86297.855
(34927.116 to 213224.580)
41495.404
(31129.203 to 55313.610)
62791.376
(32873.371 to 119937.712)
112287.997
(57588.133 to 218944.311)
Day 394 Number Analyzed 15 participants 12 participants 14 participants 15 participants 7 participants 10 participants 10 participants 10 participants 10 participants 10 participants
54083.734
(29885.281 to 97875.950)
115722.196
(48958.299 to 273531.291)
151979.746
(65657.023 to 351795.467)
116091.387
(57500.772 to 234383.115)
44800.794
(6793.925 to 295427.350)
120837.018
(43121.651 to 338613.777)
169160.905
(75032.538 to 381373.369)
91474.491
(17505.769 to 477990.007)
267485.349
(100394.424 to 712673.167)
47973.345
(24336.780 to 94566.406)
12.Secondary Outcome
Title Percentage of Participants Who Seroconverted Against RBD
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 15 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
60
(26.2 to 87.8)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
90
(55.5 to 99.7)
60
(26.2 to 87.8)
90
(55.5 to 99.7)
Day 29 Number Analyzed 15 participants 15 participants 15 participants 14 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(76.8 to 100.0)
80
(44.4 to 97.5)
100
(69.2 to 100.0)
90
(55.5 to 99.7)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Day 36 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Day 43 Number Analyzed 15 participants 14 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(76.8 to 100.0)
100
(76.8 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Day 57 Number Analyzed 15 participants 15 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(76.8 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Day 119 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Day 209 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 9 participants 10 participants 10 participants 10 participants 9 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(66.4 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(66.4 to 100.0)
Day 394 Number Analyzed 15 participants 12 participants 14 participants 15 participants 7 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(73.5 to 100.0)
100
(76.8 to 100.0)
100
(78.2 to 100.0)
100
(59.0 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
90
(55.5 to 99.7)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
13.Secondary Outcome
Title Percentage of Participants Who Seroconverted Against S-2P
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description:
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age.
25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
Overall Number of Participants Analyzed 15 15 15 15 10 10 10 10 10 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 15 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
90
(55.5 to 99.7)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
90
(55.5 to 99.7)
100
(69.2 to 100.0)
Day 29 Number Analyzed 15 participants 15 participants 15 participants 14 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(76.8 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
90
(55.5 to 99.7)
100
(69.2 to 100.0)
Day 36 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Day 43 Number Analyzed 15 participants 14 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(76.8 to 100.0)
100
(76.8 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Day 57 Number Analyzed 15 participants 15 participants 14 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(76.8 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Day 119 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Day 209 Number Analyzed 15 participants 15 participants 15 participants 15 participants 10 participants 9 participants 10 participants 10 participants 10 participants 9 participants
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(78.2 to 100.0)
100
(69.2 to 100.0)
100
(66.4 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(66.4 to 100.0)
Day 394 Number Analyzed 15 participants 12 participants 14 participants 15 participants 7 participants 10 participants 10 participants 10 participants 10 participants 10 participants
100
(78.2 to 100.0)
100
(73.5 to 100.0)
100
(76.8 to 100.0)
100
(78.2 to 100.0)
100
(59.0 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
100
(69.2 to 100.0)
Time Frame Solicited (local and systemic) AEs were collected Day 1 through 7 days post vaccination (Days 1-8 and Days 29-36); Unsolicited AEs were collected from Day 1 through 28 days post second vaccination (Days 1-57); SAEs, MAAEs, and NOCMCs were collected from Day 1 through the end of the study (Days 1-394).
Adverse Event Reporting Description Systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
 
Arm/Group Title 25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Hide Arm/Group Description 25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. 50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. 100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. 250 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 18-55 years of age. 25 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age. 50 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age. 100 mcg of mRNA-1273 administered on Days 1 and 29 in participants from 56-70 years of age. 25 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older. 50 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older. 100 mcg of mRNA-1273 administered on Days 1 and 29 in participants 71 years of age or older.
All-Cause Mortality
25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      1/10 (10.00%)    
Renal and urinary disorders                     
Renal mass * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, MedDRA 25.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
25 mcg of mRNA-1273: 18-55 Years 50 mcg of mRNA-1273:18-55 Years 100 mcg of mRNA-1273: 18-55 Years 250 mcg of mRNA-1273: 18-55 Years 25 mcg of mRNA-1273: 56-70 Years 50 mcg of mRNA-1273: 56-70 Years 100 mcg of mRNA-1273: 56-70 Years 25 mcg of mRNA-1273: 71+ Years 50 mcg of mRNA-1273: 71+ Years 100 mcg of mRNA-1273: 71+ Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/15 (93.33%)      15/15 (100.00%)      15/15 (100.00%)      15/15 (100.00%)      10/10 (100.00%)      10/10 (100.00%)      9/10 (90.00%)      10/10 (100.00%)      10/10 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders                     
Lymphadenopathy * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Cardiac disorders                     
Bradycardia * 1  0/15 (0.00%)  0 2/15 (13.33%)  2 1/15 (6.67%)  1 1/15 (6.67%)  2 0/10 (0.00%)  0 2/10 (20.00%)  3 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1
Ear and labyrinth disorders                     
Cerumen impaction * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Vertigo * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Eye disorders                     
Eye Irritation * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Scintillating scotoma * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Posterior capsule opacification * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Retinal tear * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Visual field defect * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders                     
Abdominal discomfort * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Abdominal pain * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Abdominal pain upper * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Anal fissure * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Diarrhoea * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Dyspepsia * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Faeces discoloured * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Flatulence * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Gastritis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Inguinal hernia * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Lip disorder * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Pancreatitis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Parotid duct obstruction * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Tooth impacted * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Vomiting * 1  3/15 (20.00%)  3 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Gastrooesophageal reflux disease * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Haemorrhoids * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Oral lichenoid reaction * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Nausea † 1  2/15 (13.33%)  2 2/15 (13.33%)  3 7/15 (46.67%)  7 4/15 (26.67%)  5 2/10 (20.00%)  2 2/10 (20.00%)  2 4/10 (40.00%)  4 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
General disorders                     
Fatigue * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Feeling jittery * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection site bruising * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 3/15 (20.00%)  3 0/15 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 1/10 (10.00%)  1
Injection site erythema * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 2/15 (13.33%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Injection site irritation * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection site muscle weakness * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection site pruritus * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 2/15 (13.33%)  3 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Malaise * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Vaccination site erythema * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 1/15 (6.67%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Vaccination site induration * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Vessel puncture site bruise * 1  2/15 (13.33%)  4 1/15 (6.67%)  1 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 3/10 (30.00%)  4
Vessel puncture site haemorrhage * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Energy increased * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0
Chills † 1  1/15 (6.67%)  1 3/15 (20.00%)  3 12/15 (80.00%)  13 12/15 (80.00%)  14 2/10 (20.00%)  2 2/10 (20.00%)  2 5/10 (50.00%)  5 0/10 (0.00%)  0 0/10 (0.00%)  0 5/10 (50.00%)  5
Fatigue † 1  7/15 (46.67%)  9 10/15 (66.67%)  18 12/15 (80.00%)  16 10/15 (66.67%)  15 4/10 (40.00%)  6 5/10 (50.00%)  6 7/10 (70.00%)  10 3/10 (30.00%)  3 5/10 (50.00%)  9 7/10 (70.00%)  10
Pyrexia † 1  0/15 (0.00%)  0 1/15 (6.67%)  1 6/15 (40.00%)  6 8/15 (53.33%)  8 1/10 (10.00%)  1 1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Vaccination site erythema † 1  1/15 (6.67%)  1 4/15 (26.67%)  5 2/15 (13.33%)  4 4/15 (26.67%)  5 1/10 (10.00%)  2 1/10 (10.00%)  1 3/10 (30.00%)  3 3/10 (30.00%)  4 2/10 (20.00%)  2 4/10 (40.00%)  4
Vaccination site induration † 1  0/15 (0.00%)  0 3/15 (20.00%)  3 3/15 (20.00%)  4 4/15 (26.67%)  7 5/10 (50.00%)  6 3/10 (30.00%)  3 3/10 (30.00%)  5 2/10 (20.00%)  2 2/10 (20.00%)  2 3/10 (30.00%)  3
Vaccination site pain † 1  11/15 (73.33%)  20 14/15 (93.33%)  26 15/15 (100.00%)  29 15/15 (100.00%)  29 6/10 (60.00%)  8 9/10 (90.00%)  14 9/10 (90.00%)  16 8/10 (80.00%)  12 7/10 (70.00%)  11 10/10 (100.00%)  18
Immune system disorders                     
Seasonal allergy * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Allergy to arthropod sting * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Infections and infestations                     
Bacterial vaginosis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Epididymitis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Gastroenteritis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Hordeolum * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Infected cyst * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Post procedural infection * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Pustule * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Respiratory tract infection * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Upper respiratory tract infection * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Urinary tract infection * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2
Onychomycosis * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Paronychia * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Viral infection * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Cellulitis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Injury, poisoning and procedural complications                     
Contusion * 1  3/15 (20.00%)  3 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  3
Limb injury * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Muscle strain * 1  2/15 (13.33%)  2 0/15 (0.00%)  0 2/15 (13.33%)  2 1/15 (6.67%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Skin abrasion * 1  1/15 (6.67%)  1 2/15 (13.33%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 3/10 (30.00%)  3 0/10 (0.00%)  0 3/10 (30.00%)  3
Skin injury * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Skin laceration * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Thermal burn * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Wound * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Exposure via inhalation * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Tooth fracture * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Arthropod bite * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Iliotibial band syndrome * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Injury * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0
Procedural pain * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Sunburn * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Investigations                     
Blood glucose decreased * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Heart rate increased * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Smear cervix abnormal * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Bone density decreased * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Metabolism and nutrition disorders                     
Decreased appetite * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  2 3/15 (20.00%)  3 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Hypoglycaemia * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Iron deficiency * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Glucose tolerance impaired * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Hypercholesterolaemia * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Hyponatraemia * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Arthralgia * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 1/15 (6.67%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Axillary mass * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Muscle spasms * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Muscular weakness * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Myalgia * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1
Neck pain * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Osteoarthritis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Pain in extremity * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 1/15 (6.67%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Pain in jaw * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Foot deformity * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Osteoporosis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Arthritis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Exostosis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Joint swelling * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Medial tibial stress syndrome * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Muscle tightness * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Musculoskeletal chest pain * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Tendonitis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Arthralgia † 1  2/15 (13.33%)  2 2/15 (13.33%)  3 2/15 (13.33%)  4 8/15 (53.33%)  8 4/10 (40.00%)  4 1/10 (10.00%)  1 2/10 (20.00%)  2 1/10 (10.00%)  1 1/10 (10.00%)  1 2/10 (20.00%)  2
Myalgia † 1  4/15 (26.67%)  4 6/15 (40.00%)  8 8/15 (53.33%)  9 13/15 (86.67%)  17 6/10 (60.00%)  8 3/10 (30.00%)  3 7/10 (70.00%)  8 3/10 (30.00%)  4 2/10 (20.00%)  2 6/10 (60.00%)  8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Basal cell carcinoma * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Malignant melanoma * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Squamous cell carcinoma * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Nervous system disorders                     
Dizziness * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 3/10 (30.00%)  3 0/10 (0.00%)  0 1/10 (10.00%)  1
Headache * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 2/15 (13.33%)  4 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Presyncope * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Syncope * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Sciatica * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Ophthalmic migraine * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Headache † 1  4/15 (26.67%)  6 10/15 (66.67%)  13 10/15 (66.67%)  13 15/15 (100.00%)  21 3/10 (30.00%)  4 3/10 (30.00%)  4 7/10 (70.00%)  7 4/10 (40.00%)  5 1/10 (10.00%)  1 4/10 (40.00%)  4
Psychiatric disorders                     
Anxiety * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 2/15 (13.33%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Attention deficit hyperactivity disorder * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Bipolar II disorder * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Depression * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Insomnia * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Sleep disorder * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0
Reproductive system and breast disorders                     
Breast pain * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Vaginal haemorrhage * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Vulvovaginal pruritus * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 2/15 (13.33%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Benign prostatic hyperplasia * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Cough * 1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Diaphragmatic spasm * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Dyspnoea exertional * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Nasal congestion * 1  0/15 (0.00%)  0 1/15 (6.67%)  2 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Oropharyngeal pain * 1  1/15 (6.67%)  2 1/15 (6.67%)  1 1/15 (6.67%)  1 1/15 (6.67%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Upper-airway cough syndrome * 1  0/15 (0.00%)  0 1/15 (6.67%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders                     
Acne * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Dermatitis contact * 1  1/15 (6.67%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Erythema * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Hyperhidrosis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Night sweats * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1
Petechiae * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Photosensitivity reaction * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Rash * 1  0/15 (0.00%)  0 2/15 (13.33%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Urticaria * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Rash maculo-papular * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Actinic keratosis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Blister * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Dermatitis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Pruritus * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Seborrhoeic dermatitis * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Skin irritation * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Vascular disorders                     
Hypertension * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0
Hypotension * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Systolic hypertension * 1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Vasodilatation * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Diastolic hypertension * 1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
1
Term from vocabulary, MedDRA 25.0
*
Indicates events were collected by non-systematic assessment
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lisa Jackson, MD, MPH
Organization: Kaiser Permanente Washington
Phone: 206-442-5216
EMail: lisa.a.jackson@kp.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04283461    
Other Study ID Numbers: 20-0003
5UM1AI148373-05 ( U.S. NIH Grant/Contract )
First Submitted: February 21, 2020
First Posted: February 25, 2020
Results First Submitted: April 13, 2023
Results First Posted: May 9, 2023
Last Update Posted: March 18, 2024