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Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older

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: NCT04405076
Recruitment Status : Completed
First Posted : May 28, 2020
Results First Posted : December 30, 2022
Last Update Posted : December 30, 2022
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition SARS-CoV-2
Interventions Biological: Biological: mRNA-1273
Biological: Placebo
Biological: mRNA-1273.351
Enrollment 660
Recruitment Details Participants in Part A were blinded to study treatment. After completion of Part A, participants could have chosen to be unblinded and to participate in Part B (open-label). Participants in Part C (proof-of-concept rollover) were unblinded and had received 2 doses of mRNA-1273 in Study mRNA-1273-P301 (Study P301; NCT04470427).
Pre-assignment Details Part A participants received 50 microgram (µg) mRNA-1273, 100 µg mRNA-1273, or placebo (N=600). Participants who received placebo in Part A, received 100 ug mRNA-1273 in Part B (N=158). Participants who received 50 or 100 ug mRNA-1273 in Part A, received 50 ug mRNA-1273 in Part B (N=344). Participants in Part C (N=60) received a booster dose of 20 or 50 µg of mRNA-1273.351 or 50 µg mRNA-1273/mRNA-1273.351 mixture. Total number of enrolled participants for the study=660.
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: Placebo Then 100 ug mRNA-1273 Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Hide Arm/Group Description Participants received 1 intramuscular (IM) injection of 50 ug mRNA-1273 on Day 1 and on Day 29. Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29. Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29. Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B. Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B. Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B. Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1. Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1. Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
Period Title: Part A (Blinded Phase)
Started 200 200 200 0 0 0 0 0 0
Received at Least 1 Dose of Study Drug During Part A 200 200 200 0 0 0 0 0 0
Completed 188 185 182 0 0 0 0 0 0
Not Completed 12 15 18 0 0 0 0 0 0
Reason Not Completed
Lost to Follow-up             6             6             7             0             0             0             0             0             0
Physician Decision             1             2             0             0             0             0             0             0             0
Protocol Violation             3             3             8             0             0             0             0             0             0
Withdrawal of consent (COVID-19 non-infection related)             1             0             0             0             0             0             0             0             0
Withdrawal of consent (other)             1             4             0             0             0             0             0             0             0
Other than Specified             0             0             3             0             0             0             0             0             0
Period Title: Part B (Open-Label Interventional Phase)
Started 0 0 0 173 171 158 0 0 0
Received at Least 1 Dose of Study Drug During Part B 0 0 0 173 171 158 0 0 0
Completed 0 0 0 161 166 152 0 0 0
Not Completed 0 0 0 12 5 6 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             6             1             4             0             0             0
Physician Decision             0             0             0             0             1             0             0             0             0
Lost to Follow-up             0             0             0             6             3             2             0             0             0
Period Title: Part C (Rollover Proof of Concept)
Started 0 0 0 0 0 0 20 20 20
Completed 0 0 0 0 0 0 18 18 19
Not Completed 0 0 0 0 0 0 2 2 1
Reason Not Completed
Withdrawal of consent (other)             0             0             0             0             0             0             0             2             1
Lost to Follow-up             0             0             0             0             0             0             2             0             0
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture Total
Hide Arm/Group Description Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29. Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29. Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29. Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1. Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1. Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 200 200 200 20 20 20 660
Hide Baseline Analysis Population Description
Safety Set: All participants who received any study injection in their respective part of the study. Note, participants who received placebo in Part A, received 100 ug mRNA-1273 in Part B (N=158). Participants who received 50 or 100 ug mRNA-1273 in Part A, received 50 ug mRNA-1273 in Part B (N=344). Since Baseline Characteristics data for participants in Part B are included in Part A, separate columns are not reported here for Part B.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 200 participants 20 participants 20 participants 20 participants 660 participants
Between 18 and 55 years
100
  50.0%
100
  50.0%
100
  50.0%
13
  65.0%
9
  45.0%
9
  45.0%
331
  50.2%
>=55 years
100
  50.0%
100
  50.0%
100
  50.0%
7
  35.0%
11
  55.0%
11
  55.0%
329
  49.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 200 participants 20 participants 20 participants 20 participants 660 participants
Female
137
  68.5%
124
  62.0%
129
  64.5%
15
  75.0%
9
  45.0%
8
  40.0%
422
  63.9%
Male
63
  31.5%
76
  38.0%
71
  35.5%
5
  25.0%
11
  55.0%
12
  60.0%
238
  36.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 200 participants 20 participants 20 participants 20 participants 660 participants
Hispanic or Latino
15
   7.5%
16
   8.0%
16
   8.0%
1
   5.0%
0
   0.0%
1
   5.0%
49
   7.4%
Not Hispanic or Latino
184
  92.0%
184
  92.0%
184
  92.0%
19
  95.0%
20
 100.0%
19
  95.0%
610
  92.4%
Unknown or Not Reported
1
   0.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 200 participants 200 participants 200 participants 20 participants 20 participants 20 participants 660 participants
White 188 188 193 20 19 19 627
Black or African American 5 8 3 0 0 0 16
Asian 2 2 3 0 1 0 8
American Indian or Alaska Native 2 1 0 0 0 1 4
Native Hawaiian or Other Pacific Islander 1 0 0 0 0 0 1
Multiracial 1 0 1 0 0 0 2
Other 1 1 0 0 0 0 2
1.Primary Outcome
Title Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Hide Description Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Time Frame 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited Safety Set for Parts A, B, and C included all participants who received any study injection in the applicable part of the study and contributed any solicited AR data (that is, had at least 1 post-baseline solicited safety assessment in the applicable part of the study). Number Analyzed = participants who were evaluable at specified timepoints.
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: Placebo Then 100 ug mRNA-1273 Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Hide Arm/Group Description:
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
Overall Number of Participants Analyzed 200 200 200 164 167 157 19 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
95
  47.5%
69
  34.5%
72
  36.0%
65
  39.6%
73
  43.7%
50
  31.8%
13
  68.4%
10
  52.6%
12
  60.0%
Grade 2
61
  30.5%
90
  45.0%
21
  10.5%
59
  36.0%
59
  35.3%
71
  45.2%
6
  31.6%
2
  10.5%
3
  15.0%
Grade 3
25
  12.5%
32
  16.0%
6
   3.0%
29
  17.7%
18
  10.8%
28
  17.8%
0
   0.0%
2
  10.5%
2
  10.0%
Grade 4
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%
2.Primary Outcome
Title Number of Participants With Unsolicited AEs
Hide Description An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Month 15), regardless of causality, is located in the Reported "Adverse Events" section.
Time Frame Up to 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: All participants who received any study injection in their respective part of the study.
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: Placebo Then 100 ug mRNA-1273 Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Hide Arm/Group Description:
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
Overall Number of Participants Analyzed 200 200 200 173 171 158 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
57
  28.5%
56
  28.0%
51
  25.5%
17
   9.8%
25
  14.6%
42
  26.6%
3
  15.0%
3
  15.0%
4
  20.0%
3.Primary Outcome
Title Number of Participants With Medically-Attended Adverse Events (MAAEs)
Hide Description An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Time Frame Up to Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: All participants who received any study injection in their respective part of the study.
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: Placebo Then 100 ug mRNA-1273 Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Hide Arm/Group Description:
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
Overall Number of Participants Analyzed 200 200 200 173 171 158 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
74
  37.0%
38
  19.0%
64
  32.0%
42
  24.3%
47
  27.5%
59
  37.3%
7
  35.0%
3
  15.0%
7
  35.0%
4.Primary Outcome
Title Number of Participants With SAEs
Hide Description An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Time Frame Up to Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: All participants who received any study injection in their respective part of the study.
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: Placebo Then 100 ug mRNA-1273 Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Hide Arm/Group Description:
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B.
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
Overall Number of Participants Analyzed 200 200 200 173 171 158 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
5
   2.5%
2
   1.0%
0
   0.0%
2
   1.2%
2
   1.2%
2
   1.3%
0
   0.0%
1
   5.0%
0
   0.0%
5.Primary Outcome
Title Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Hide Description The geometric mean (GM) level of VAC58 spike immunoglobulin G (IgG) antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 1 and ULOQ was 2052. The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.
Time Frame Days 1 (Baseline), 29, 43, 57, and 209
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants evaluable at specified timepoints.
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo
Hide Arm/Group Description:
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Overall Number of Participants Analyzed 185 189 186
Geometric Mean (95% Confidence Interval)
Unit of Measure: arbitrary units per mL (AU/mL)
Day 1 (Baseline) Number Analyzed 185 participants 189 participants 186 participants
0.70
(0.63 to 0.78)
0.67
(0.60 to 0.73)
0.67
(0.61 to 0.73)
Day 29 Number Analyzed 183 participants 189 participants 182 participants
59.42
(52.05 to 67.82)
81.51
(70.19 to 94.67)
0.68
(0.61 to 0.76)
Day 43 Number Analyzed 176 participants 180 participants 180 participants
720.85
(660.30 to 786.96)
834.66
(765.28 to 910.33)
0.65
(0.59 to 0.71)
Day 57 Number Analyzed 176 participants 174 participants 174 participants
519.48
(474.00 to 569.33)
647.22
(588.98 to 711.21)
0.67
(0.60 to 0.75)
Day 209 Number Analyzed 170 participants 174 participants 154 participants
97.02
(87.58 to 107.47)
128.00
(114.44 to 143.18)
0.91
(0.73 to 1.14)
6.Primary Outcome
Title Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA
Hide Description The GM level of VAC65 spike IgG antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 1 and ULOQ was 2052. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
Time Frame Days 1 (Baseline) and 29
Hide Outcome Measure Data
Hide Analysis Population Description
PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the "Part B: Placebo then 100 ug mRNA" arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.
Arm/Group Title Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Hide Arm/Group Description:
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Overall Number of Participants Analyzed 146 149
Geometric Mean (95% Confidence Interval)
Unit of Measure: AU/mL
Day 1 (Baseline) Number Analyzed 145 participants 147 participants
86.29
(76.89 to 96.83)
109.56
(96.79 to 124.02)
Day 29 Number Analyzed 143 participants 149 participants
1069.73
(992.92 to 1152.49)
1083.21
(1018.75 to 1151.75)
7.Primary Outcome
Title Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD
Hide Description The GM level of SARS-CoV-2 protein antibody against B.1.351, as measured by MSD MULTIPLEX is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 18 and ULOQ was 4200000. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.
Time Frame Days 1 (Baseline), 8, 15, and 29
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Hide Analysis Population Description
PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Arm/Group Title Part C: 20 ug mRNA-1273.351 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Hide Arm/Group Description:
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
Overall Number of Participants Analyzed 19 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: AU/mL
Day 1 (Baseline) Number Analyzed 19 participants 20 participants 20 participants
59742.3
(43057.8 to 82891.8)
44921.5
(28539.6 to 70706.5)
33409.8
(25264.8 to 44180.6)
Day 8 Number Analyzed 19 participants 19 participants 20 participants
240180.0
(166361.1 to 346754.3)
267002.2
(199939.9 to 356558.2)
228572.0
(178986.7 to 291894.2)
Day 15 Number Analyzed 19 participants 20 participants 20 participants
297880.2
(224089.6 to 395969.4)
418215.3
(311988.7 to 560610.2)
384521.1
(282461.4 to 523457.3)
Day 29 Number Analyzed 19 participants 20 participants 20 participants
297962.7
(227337.5 to 390528.5)
345765.9
(251640.5 to 475098.5)
367714.1
(268913.2 to 502815.1)
8.Secondary Outcome
Title Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
Hide Description The GM titer (microneutralization [MN] and MN50) of serum nAb against SARS-CoV-2 as measured by live virus MN assays is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280 at Days 1 (Baseline), 29, 43, and 57. For MN50, LLOQ was 91.10 and ULOQ was 2031.87 at Days 1 (Baseline), 29, 43, and 57. For MN, LLOQ was 160 and ULOQ was 1280 at Day 209. For MN50, LLOQ was 318.46 and ULOQ was 1917.83 at Day 209. The 95% CI was calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM titer, then back transformed to the original scale for presentation.
Time Frame Days 1 (Baseline), 29, 43, 57, and 209
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Hide Analysis Population Description
PP Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo
Hide Arm/Group Description:
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Overall Number of Participants Analyzed 185 189 186
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
MN, Day 1 (Baseline) Number Analyzed 185 participants 189 participants 186 participants
20.6
(20.0 to 21.2)
20.6
(19.7 to 21.5)
20.8
(20.1 to 21.4)
MN, Day 29 Number Analyzed 184 participants 187 participants 184 participants
112.2
(94.9 to 132.7)
149.6
(127.3 to 175.9)
21.9
(20.5 to 23.5)
MN, Day 43 Number Analyzed 174 participants 181 participants 180 participants
1145.4
(1101.3 to 1191.1)
1185.8
(1142.9 to 1230.3)
21.2
(20.1 to 22.4)
MN, Day 57 Number Analyzed 176 participants 177 participants 175 participants
1090.6
(1038.9 to 1144.9)
1095.5
(1041.5 to 1152.2)
21.8
(20.4 to 23.4)
MN, Day 209 Number Analyzed 171 participants 174 participants 153 participants
254.4
(219.4 to 294.9)
354.8
(309.2 to 407.2)
85.3
(80.6 to 90.2)
MN50, Day 1 (Baseline) Number Analyzed 185 participants 189 participants 186 participants
46.500
(45.425 to 47.600)
46.684
(44.957 to 48.477)
47.109
(45.745 to 48.512)
MN50, Day 29 Number Analyzed 184 participants 187 participants 184 participants
173.750
(148.550 to 203.225)
227.433
(194.207 to 266.343)
49.231
(46.355 to 52.285)
MN50, Day 43 Number Analyzed 174 participants 181 participants 180 participants
1761.660
(1690.216 to 1836.124)
1813.480
(1741.280 to 1888.673)
48.059
(45.820 to 50.408)
MN50, Day 57 Number Analyzed 176 participants 177 participants 175 participants
1632.442
(1550.245 to 1718.998)
1656.064
(1570.464 to 1746.330)
49.141
(46.267 to 52.194)
MN50, Day 209 Number Analyzed 171 participants 174 participants 153 participants
401.508
(350.667 to 459.720)
538.798
(472.772 to 614.045)
167.002
(159.249 to 175.133)
9.Secondary Outcome
Title Part B: Titer of SARS-CoV-2-Specific nAb
Hide Description The GM titer (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 18.5 and ULOQ was 45118 for IC50. LLOQ was 14.3 and ULOQ was 10232 for ID80. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
Time Frame Days 1 (Baseline), 29, and 181
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PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the "Part B: Placebo then 100 ug mRNA" arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.
Arm/Group Title Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Hide Arm/Group Description:
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Overall Number of Participants Analyzed 146 149
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
ID50, Day 1 (Baseline) Number Analyzed 145 participants 149 participants
104.658
(88.282 to 124.070)
150.224
(125.726 to 179.495)
ID50, Day 29 Number Analyzed 146 participants 149 participants
1834.309
(1600.233 to 2102.623)
1951.735
(1729.606 to 2202.392)
ID50, Day 181 Number Analyzed 38 participants 147 participants
915.331
(622.504 to 1345.904)
673.273
(578.167 to 784.025)
ID80, Day 1 (Baseline) Number Analyzed 145 participants 149 participants
39.646
(33.789 to 46.518)
55.686
(47.459 to 65.341)
ID80, Day 29 Number Analyzed 146 participants 149 participants
696.085
(609.203 to 795.358)
736.617
(661.040 to 820.835)
ID80, Day 181 Number Analyzed 38 participants 147 participants
291.791
(203.597 to 418.189)
228.635
(197.044 to 265.291)
10.Secondary Outcome
Title Part C: Titer of SARS-CoV-2-Specific nAb
Hide Description The GM titer (ID50, ID80) of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. For NAb ID50 Titers, LLOQ was 18.5 and ULOQ was 45118. For NAb ID80 Titers, LLOQ was 14.3 and ULOQ was 10232. For NAb ID50 Titers against B.1.351, LLOQ was 19.5 and ULOQ was 385.7. For NAb ID80 Titers against B.1.351, LLOQ was 12.5 and ULOQ was 102.2. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation.
Time Frame Days 1 (Baseline), 8, 15, 29, and 181
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Hide Analysis Population Description
PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Arm/Group Title Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Hide Arm/Group Description:
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
Overall Number of Participants Analyzed 19 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
ID50 Against Original Strain, Day 1 (Baseline) Number Analyzed 19 participants 20 participants 20 participants
196.107
(133.338 to 288.424)
156.011
(80.546 to 302.180)
79.572
(53.625 to 118.074)
ID50 Against Original Strain, Day 8 Number Analyzed 19 participants 19 participants 20 participants
1089.901
(748.146 to 1587.770)
1568.894
(1030.722 to 2388.062)
1183.096
(900.313 to 1554.700)
ID50 Against Original Strain, Day 15 Number Analyzed 19 participants 20 participants 20 participants
2221.382
(1434.353 to 3440.255)
1725.415
(1212.131 to 2456.053)
3082.946
(1891.502 to 5024.874)
ID50 Against Original Strain, Day 29 Number Analyzed 19 participants 20 participants 20 participants
1808.133
(1323.211 to 2470.767)
1757.179
(1117.782 to 2762.324)
3691.896
(2330.908 to 5847.548)
ID50 Against Original Strain, Day 181 Number Analyzed 0 participants 18 participants 0 participants
512.129
(303.261 to 864.853)
ID80 Against Original Strain, Day 1 (Baseline) Number Analyzed 19 participants 20 participants 20 participants
76.279
(53.035 to 109.712)
56.344
(33.804 to 93.911)
30.774
(21.565 to 43.915)
ID80 Against Original Strain, Day 8 Number Analyzed 19 participants 19 participants 20 participants
448.109
(300.430 to 668.381)
500.158
(341.180 to 733.214)
458.435
(351.348 to 598.161)
ID80 Against Original Strain, Day 15 Number Analyzed 19 participants 20 participants 20 participants
730.018
(509.454 to 1046.073)
678.926
(462.561 to 996.498)
947.774
(647.781 to 1386.696)
ID80 Against Original Strain, Day 29 Number Analyzed 19 participants 20 participants 20 participants
632.263
(460.549 to 868.001)
615.967
(397.103 to 955.460)
1156.267
(743.617 to 1797.907)
ID80 Against Original Strain, Day 181 Number Analyzed 0 participants 18 participants 0 participants
182.837
(108.300 to 308.673)
ID50 Against B.1.351, Day 1 (Baseline) Number Analyzed 19 participants 20 participants 20 participants
45.574
(28.832 to 72.036)
32.026
(19.758 to 51.911)
18.338
(13.572 to 24.776)
ID50 Against B.1.351, Day 8 Number Analyzed 19 participants 19 participants 20 participants
919.281
(592.738 to 1425.720)
1088.511
(670.315 to 1767.610)
706.141
(456.010 to 1093.475)
ID50 Against B.1.351, Day 15 Number Analyzed 19 participants 20 participants 20 participants
1088.432
(736.353 to 1608.854)
1113.392
(652.885 to 1898.716)
1166.830
(760.230 to 1790.895)
ID50 Against B.1.351, Day 29 Number Analyzed 19 participants 20 participants 20 participants
1537.029
(1066.352 to 2215.458)
1116.885
(714.119 to 1746.813)
1129.955
(742.454 to 1719.699)
ID50 Against B.1.351, Day 181 Number Analyzed 0 participants 18 participants 0 participants
141.773
(76.471 to 262.839)
ID80 Against B.1.351, Day 1 (Baseline) Number Analyzed 19 participants 20 participants 20 participants
17.403
(10.870 to 27.863)
15.046
(10.088 to 22.442)
8.326
(6.727 to 10.306)
ID80 Against B.1.351, Day 8 Number Analyzed 19 participants 19 participants 20 participants
289.360
(196.260 to 426.626)
313.644
(203.582 to 483.210)
225.475
(160.419 to 316.915)
ID80 Against B.1.351, Day 15 Number Analyzed 19 participants 20 participants 20 participants
435.078
(300.742 to 629.418)
371.579
(228.889 to 603.223)
413.424
(284.856 to 600.020)
ID80 Against B.1.351, Day 29 Number Analyzed 19 participants 20 participants 20 participants
486.398
(341.630 to 692.511)
345.827
(214.472 to 557.633)
362.540
(249.138 to 527.560)
ID80 Against B.1.351, Day 181 Number Analyzed 0 participants 18 participants 0 participants
55.887
(29.969 to 104.220)
11.Secondary Outcome
Title Part A: Percentage of Participants With Seroconversion From Baseline
Hide Description Based on MN titers and MN50 titers of serum nAb against SARS-CoV-2 as measured by live virus MN assays, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using the Clopper-Pearson method at each post-baseline timepoint. Seroconversion at a participant level was defined as a change of nAb titer from below the limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280. For MN50, LLOQ was 91.10 and ULOQ was 2031.87.
Time Frame Days 29, 43, and 57
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Hide Analysis Population Description
PP Set included randomized participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo
Hide Arm/Group Description:
Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29.
Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29.
Overall Number of Participants Analyzed 168 180 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
MN Titer, Day 29 Number Analyzed 168 participants 180 participants 178 participants
78.0
(70.9 to 84.0)
88.9
(83.4 to 93.1)
1.7
(0.3 to 4.8)
MN Titer, Day 43 Number Analyzed 141 participants 150 participants 175 participants
100
(97.4 to 100.0)
100
(97.6 to 100.0)
0.6
(0.0 to 3.1)
MN Titer, Day 57 Number Analyzed 150 participants 152 participants 171 participants
100
(97.6 to 100.0)
100
(97.6 to 100.0)
1.8
(0.4 to 5.0)
MN50 Titer, Day 29 Number Analyzed 168 participants 180 participants 178 participants
65.5
(57.8 to 72.6)
76.7
(69.8 to 82.6)
1.1
(0.1 to 4.0)
MN50 Titer, Day 43 Number Analyzed 141 participants 150 participants 175 participants
100
(97.4 to 100.0)
100
(97.6 to 100.0)
0.6
(0.0 to 3.1)
MN50 Titer, Day 57 Number Analyzed 150 participants 152 participants 171 participants
100
(97.6 to 100.0)
100
(97.6 to 100.0)
1.8
(0.4 to 5.0)
12.Secondary Outcome
Title Part B: Percentage of Participants With Seroconversion From Baseline
Hide Description Based on ID50 and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay, % of participants with seroconversion from baseline reported with 2-sided 95% CI using Clopper-Pearson method at each postbaseline timepoint. Seroconversion at participant level defined as change of nAb titer from below LOD or LLOQ to equal to or above LOD or LLOQ (respectively) or 4-times or higher titer ratio in participants with preexisting nAb titers. Antibody values <LLOQ replaced by 0.5*LLOQ. Values >ULOQ converted to ULOQ. LLOQ: 18.5 and ULOQ: 45118 for IC50. LLOQ: 14.3 and ULOQ: 10232 for ID80. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation. PP Set: participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
Time Frame Days 29 and 181
Hide Outcome Measure Data
Hide Analysis Population Description
PP Set. Number Analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the "Part B: Placebo then 100 ug mRNA" arm were not tested and no data were generated as results were not thought to provide additional information. After Part B samples were obtained, it was determined that the extensive results for immunogenicity profiles of 2 doses of 100 ug mRNA-1273 that were obtained during Part A of this study and in Study P301 demonstrated enough immune response data.
Arm/Group Title Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273
Hide Arm/Group Description:
Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B.
Overall Number of Participants Analyzed 146 149
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
ID50, Day 29 Number Analyzed 146 participants 149 participants
92.4
(86.8 to 96.2)
87.9
(81.6 to 92.7)
ID50, Day 181 Number Analyzed 38 participants 147 participants
81.6
(65.7 to 92.3)
54.4
(46.0 to 62.6)
ID80, Day 29 Number Analyzed 146 participants 149 participants
95.2
(90.3 to 98.0)
93.3
(88.0 to 96.7)
ID80, Day 181 Number Analyzed 38 participants 147 participants
78.9
(62.7 to 90.4)
53.7
(45.3 to 62.0)
13.Secondary Outcome
Title Part C: Percentage of Participants With Seroconversion From Baseline
Hide Description Based on ID50 titers and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using Clopper-Pearson method at each post-baseline timepoint. Seroconversion at participant level defined as a change of nAb titer from below LOD or LLOQ ≥LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values >ULOQ were converted to ULOQ. NAb ID50 Titers: LLOQ was 18.5 and ULOQ was 45118. NAb ID80 Titers: LLOQ was 14.3 and ULOQ was 10232. NAb ID50 Titers against B.1.351: LLOQ was 19.5 and ULOQ was 385.7. NAb ID80 Titers against B.1.351: LLOQ was 12.5 and ULOQ was 102.2. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation.
Time Frame Days 8, 15, 29, and 181
Hide Outcome Measure Data
Hide Analysis Population Description
PP Set included participants who received any study injection, had required baseline (Day 1) data, had ≥1 post-injection assessment for the analysis endpoint, complied with injection schedule, had post-injection results available for ≥1 assay component corresponding to immunogenicity analysis, did not have SARS-CoV-2 infection, and had no major protocol deviations impacting applicable immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Arm/Group Title Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Hide Arm/Group Description:
Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1.
Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
Overall Number of Participants Analyzed 19 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
ID50 Against Original Strain, Day 8 Number Analyzed 19 participants 19 participants 20 participants
47.4
(24.4 to 71.1)
78.9
(54.4 to 93.9)
100
(83.2 to 100.0)
ID50 Against Original Strain, Day 15 Number Analyzed 19 participants 20 participants 20 participants
78.9
(54.4 to 93.9)
90.0
(68.3 to 98.8)
95.0
(75.1 to 99.9)
ID50 Against Original Strain, Day 29 Number Analyzed 19 participants 20 participants 20 participants
84.2
(60.4 to 96.6)
95.0
(75.1 to 99.9)
100
(83.2 to 100.0)
ID50 Against Original Strain, Day 181 Number Analyzed 0 participants 18 participants 0 participants
38.9
(17.3 to 64.3)
ID80 Against Original Strain, Day 8 Number Analyzed 19 participants 19 participants 20 participants
68.4
(43.4 to 87.4)
84.2
(60.4 to 96.6)
95.0
(75.1 to 99.9)
ID80 Against Original Strain, Day 15 Number Analyzed 19 participants 20 participants 20 participants
84.2
(60.4 to 96.6)
95.0
(75.1 to 99.9)
100
(83.2 to 100.0)
ID80 Against Original Strain, Day 29 Number Analyzed 19 participants 20 participants 20 participants
84.2
(60.4 to 96.6)
95.0
(75.1 to 99.9)
95.0
(75.1 to 99.9)
ID80 Against Original Strain, Day 181 Number Analyzed 0 participants 18 participants 0 participants
38.9
(17.3 to 64.3)
ID50 Against B.1.351, Day 8 Number Analyzed 19 participants 19 participants 20 participants
100
(82.4 to 100.0)
100
(82.4 to 100.0)
100
(83.2 to 100.0)
ID50 Against B.1.351, Day 15 Number Analyzed 19 participants 20 participants 20 participants
94.7
(74.0 to 99.9)
100
(83.2 to 100.0)
100
(83.2 to 100.0)
ID50 Against B.1.351, Day 29 Number Analyzed 19 participants 20 participants 20 participants
100
(82.4 to 100.0)
100
(83.2 to 100.0)
100
(83.2 to 100.0)
ID50 Against B.1.351, Day 181 Number Analyzed 0 participants 18 participants 0 participants
61.1
(35.7 to 82.7)
ID80 Against B.1.351, Day 8 Number Analyzed 19 participants 19 participants 20 participants
94.7
(74.0 to 99.9)
94.7
(74.0 to 99.9)
100
(83.2 to 100.0)
ID80 Against B.1.351, Day 15 Number Analyzed 19 participants 20 participants 20 participants
94.7
(74.0 to 99.9)
100
(83.2 to 100.0)
100
(83.2 to 100.0)
ID80 Against B.1.351, Day 29 Number Analyzed 19 participants 20 participants 20 participants
100
(82.4 to 100.0)
100
(83.2 to 100.0)
100
(83.2 to 100.0)
ID80 Against B.1.351, Day 181 Number Analyzed 0 participants 18 participants 0 participants
55.6
(30.8 to 78.5)
Time Frame Up to Month 15
Adverse Event Reporting Description Safety Set: All participants who received any study injection in their respective part of the study. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
 
Arm/Group Title Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: Placebo Then 100 ug mRNA-1273 Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
Hide Arm/Group Description Participants received 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29. Participants received 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29. Participants received 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29. Participants who chose to be unblinded and received 50 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B. Participants who chose to be unblinded and received 100 ug mRNA-1273 during Part A, received 1 IM injection of 50 ug mRNA-1273 during Part B. Participants who chose to be unblinded and received mRNA-1273-matching placebo during Part A, received 2 IM injections of 100 ug mRNA-1273 28 days apart during Part B. Participants received 1 IM injection of 20 ug mRNA-1273.351 (booster dose) on Day 1. Participants received 1 IM injection of 50 ug mRNA-1273.351 (booster dose) on Day 1. Participants received 1 IM injection of 50 ug mRNA-1273/mRNA-1273.351 mixture (booster dose) on Day 1.
All-Cause Mortality
Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: Placebo Then 100 ug mRNA-1273 Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
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   0/200 (0.00%)   0/200 (0.00%)   0/200 (0.00%)   0/173 (0.00%)   0/171 (0.00%)   0/158 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: Placebo Then 100 ug mRNA-1273 Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
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   5/200 (2.50%)   2/200 (1.00%)   0/200 (0.00%)   2/173 (1.16%)   2/171 (1.17%)   2/158 (1.27%)   0/20 (0.00%)   1/20 (5.00%)   0/20 (0.00%) 
Cardiac disorders                   
Acute myocardial infarction † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Arrhythmia † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Bradycardia † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pericarditis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Atrioventricular block complete † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Gastrointestinal disorders                   
Peptic ulcer perforation † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Infections and infestations                   
Pneumonia † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Sepsis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pancreatic carcinoma stage IV † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Injury, poisoning and procedural complications                   
Struck by lightning † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tendon rupture † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Spondylolisthesis † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nervous system disorders                   
Nervous system cyst † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pregnancy, puerperium and perinatal conditions                   
Abortion missed † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Abortion spontaneous † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Pulmonary embolism † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vascular disorders                   
Deep vein thrombosis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
1
Term from vocabulary, MedDRA version 23.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A: 50 ug mRNA-1273 Part A: 100 ug mRNA-1273 Part A: Placebo Part B: 50 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: 100 ug mRNA-1273 Then 50 ug mRNA-1273 Part B: Placebo Then 100 ug mRNA-1273 Part C: 20 ug mRNA-1273.351 Part C: 50 ug mRNA-1273.351 Part C: 50 ug mRNA-1273/mRNA-1273.351 Mixture
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   105/200 (52.50%)   76/200 (38.00%)   94/200 (47.00%)   51/173 (29.48%)   62/171 (36.26%)   70/158 (44.30%)   8/20 (40.00%)   4/20 (20.00%)   9/20 (45.00%) 
Blood and lymphatic system disorders                   
Lymphadenopathy † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  2/173 (1.16%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Leukopenia † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Lymphadenitis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Cardiac disorders                   
Diastolic dysfunction † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tachycardia † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  2/158 (1.27%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Angina pectoris † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Ventricular extrasystoles † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Arrhythmia † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Extrasystoles † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Ear and labyrinth disorders                   
Deafness unilateral † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Ear pain † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Excessive cerumen production † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tinnitus † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vertigo † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Endocrine disorders                   
Hypothyroidism † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hyperoestrogenism † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Thyroid cyst † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Thyroid disorder † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Eye disorders                   
Cataract † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Conjunctivitis allergic † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Glaucoma † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Retinal detachment † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Macular fibrosis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Gastrointestinal disorders                   
Nausea † 1  3/200 (1.50%)  4/200 (2.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Diarrhoea † 1  4/200 (2.00%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Gastrooesophageal reflux disease † 1  3/200 (1.50%)  1/200 (0.50%)  1/200 (0.50%)  1/173 (0.58%)  2/171 (1.17%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vomiting † 1  1/200 (0.50%)  2/200 (1.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Abdominal discomfort † 1  0/200 (0.00%)  2/200 (1.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Gastritis † 1  2/200 (1.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Haemorrhoids † 1  1/200 (0.50%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Toothache † 1  2/200 (1.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Abdominal pain † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Aphthous ulcer † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dental caries † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Diverticulum † 1  0/200 (0.00%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dry mouth † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Inguinal hernia † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Intestinal obstruction † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Irritable bowel syndrome † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Oesophageal food impaction † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Paraesthesia oral † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tongue discomfort † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Abdominal tenderness † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Duodenitis † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Large intestine polyp † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Odynophagia † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Oral disorder † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Constipation † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pulpless tooth † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
General disorders                   
Fatigue † 1  16/200 (8.00%)  5/200 (2.50%)  7/200 (3.50%)  1/173 (0.58%)  7/171 (4.09%)  5/158 (3.16%)  0/20 (0.00%)  1/20 (5.00%)  1/20 (5.00%) 
Injection site pain † 1  3/200 (1.50%)  3/200 (1.50%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injection site induration † 1  1/200 (0.50%)  4/200 (2.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injection site erythema † 1  1/200 (0.50%)  3/200 (1.50%)  1/200 (0.50%)  0/173 (0.00%)  1/171 (0.58%)  2/158 (1.27%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injection site swelling † 1  0/200 (0.00%)  4/200 (2.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  2/158 (1.27%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Axillary pain † 1  1/200 (0.50%)  2/200 (1.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Chest discomfort † 1  3/200 (1.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Chills † 1  1/200 (0.50%)  2/200 (1.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pain † 1  2/200 (1.00%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pyrexia † 1  0/200 (0.00%)  3/200 (1.50%)  1/200 (0.50%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Chest pain † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injection site bruising † 1  1/200 (0.50%)  0/200 (0.00%)  2/200 (1.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injection site mass † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injection site pruritus † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Malaise † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Mass † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Peripheral swelling † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injection site rash † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hepatobiliary disorders                   
Hepatic lesion † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Immune system disorders                   
Seasonal allergy † 1  1/200 (0.50%)  2/200 (1.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Allergy to arthropod sting † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Infections and infestations                   
Upper respiratory tract infection † 1  4/200 (2.00%)  2/200 (1.00%)  4/200 (2.00%)  2/173 (1.16%)  2/171 (1.17%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
COVID-19 † 1  3/200 (1.50%)  2/200 (1.00%)  26/200 (13.00%)  9/173 (5.20%)  8/171 (4.68%)  16/158 (10.13%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Urinary tract infection † 1  3/200 (1.50%)  2/200 (1.00%)  3/200 (1.50%)  0/173 (0.00%)  2/171 (1.17%)  2/158 (1.27%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Sinusitis † 1  3/200 (1.50%)  1/200 (0.50%)  3/200 (1.50%)  4/173 (2.31%)  4/171 (2.34%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Viral infection † 1  3/200 (1.50%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Bronchitis † 1  2/200 (1.00%)  1/200 (0.50%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  3/158 (1.90%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Viral upper respiratory tract infection † 1  3/200 (1.50%)  0/200 (0.00%)  1/200 (0.50%)  2/173 (1.16%)  2/171 (1.17%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Acute sinusitis † 1  0/200 (0.00%)  2/200 (1.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  4/158 (2.53%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nasopharyngitis † 1  1/200 (0.50%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Otitis media † 1  0/200 (0.00%)  2/200 (1.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pharyngitis † 1  1/200 (0.50%)  1/200 (0.50%)  0/200 (0.00%)  1/173 (0.58%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Suspected COVID-19 † 1  2/200 (1.00%)  0/200 (0.00%)  2/200 (1.00%)  2/173 (1.16%)  2/171 (1.17%)  3/158 (1.90%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Cellulitis † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Eye infection † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Fungal skin infection † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Gastroenteritis † 1  0/200 (0.00%)  1/200 (0.50%)  2/200 (1.00%)  0/173 (0.00%)  1/171 (0.58%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Gastroenteritis viral † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Herpes zoster † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Infected bite † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Influenza † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Oral candidiasis † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pneumonia † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tinea pedis † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tooth abscess † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  3/173 (1.73%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tooth infection † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Urethritis † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Asymptomatic COVID-19 † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  3/171 (1.75%)  0/158 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Gingivitis † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Herpes simplex † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hordeolum † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Localised infection † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Otitis externa † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Diverticulitis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Ear infection † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Respiratory tract infection viral † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Sinusitis bacterial † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  2/158 (1.27%)  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%) 
Rhinitis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  2/158 (1.27%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Cryptosporidiosis infection † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Gastrointestinal bacterial overgrowth † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Laryngitis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Onychomycosis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Cystitis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Labyrinthitis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Pyelonephritis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Staphylococcal infection † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Pharyngitis streptococcal † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injury, poisoning and procedural complications                   
Arthropod bite † 1  2/200 (1.00%)  1/200 (0.50%)  1/200 (0.50%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Meniscus injury † 1  1/200 (0.50%)  2/200 (1.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Muscle strain † 1  1/200 (0.50%)  2/200 (1.00%)  1/200 (0.50%)  0/173 (0.00%)  1/171 (0.58%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Concussion † 1  1/200 (0.50%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Breast injury † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Chemical burn † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Corneal abrasion † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Epicondylitis † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Foreign body in eye † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Heat exhaustion † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Joint injury † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Limb injury † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Muscle contusion † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Muscle rupture † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Post-traumatic pain † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Procedural pain † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Road traffic accident † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tendon rupture † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  2/171 (1.17%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tooth fracture † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  1/173 (0.58%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nail avulsion † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Skin laceration † 1  0/200 (0.00%)  0/200 (0.00%)  2/200 (1.00%)  1/173 (0.58%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tendon injury † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Animal bite † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  2/173 (1.16%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Foot fracture † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hand fracture † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Fascial rupture † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Wrist fracture † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Humerus fracture † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Investigations                   
Blood pressure increased † 1  1/200 (0.50%)  2/200 (1.00%)  2/200 (1.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Blood alkaline phosphatase increased † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Blood cholesterol increased † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Blood pressure diastolic increased † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Haematocrit increased † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Haemoglobin increased † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hormone level abnormal † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Platelet count decreased † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Platelet count increased † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Staphylococcus test positive † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
White blood cell count decreased † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Blood testosterone decreased † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Blood triglycerides increased † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Cardiac murmur † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Computerised tomogram coronary artery abnormal † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Heart rate decreased † 1  0/200 (0.00%)  0/200 (0.00%)  2/200 (1.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vitamin D decreased † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Heart rate increased † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Glycosylated haemoglobin increased † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Weight decreased † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Metabolism and nutrition disorders                   
Gout † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hyperlipidaemia † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Insulin resistance † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vitamin B12 deficiency † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vitamin D deficiency † 1  0/200 (0.00%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  1/171 (0.58%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hypercholesterolaemia † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dyslipidaemia † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Obesity † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia † 1  7/200 (3.50%)  4/200 (2.00%)  4/200 (2.00%)  1/173 (0.58%)  2/171 (1.17%)  2/158 (1.27%)  0/20 (0.00%)  1/20 (5.00%)  2/20 (10.00%) 
Myalgia † 1  6/200 (3.00%)  2/200 (1.00%)  3/200 (1.50%)  0/173 (0.00%)  4/171 (2.34%)  2/158 (1.27%)  0/20 (0.00%)  1/20 (5.00%)  3/20 (15.00%) 
Neck pain † 1  2/200 (1.00%)  2/200 (1.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Back pain † 1  2/200 (1.00%)  1/200 (0.50%)  2/200 (1.00%)  0/173 (0.00%)  2/171 (1.17%)  2/158 (1.27%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Muscle spasms † 1  1/200 (0.50%)  2/200 (1.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Musculoskeletal pain † 1  2/200 (1.00%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Musculoskeletal chest pain † 1  1/200 (0.50%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Plantar fasciitis † 1  1/200 (0.50%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Axillary mass † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Joint swelling † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Musculoskeletal stiffness † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Periarthritis † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Rotator cuff syndrome † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tendonitis † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Bursitis † 1  0/200 (0.00%)  0/200 (0.00%)  2/200 (1.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Exostosis † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pain in extremity † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  3/158 (1.90%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Haematoma muscle † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Intervertebral disc degeneration † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Osteopenia † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Sjogren's syndrome † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Spinal osteoarthritis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Intervertebral disc protrusion † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/20 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Basal cell carcinoma † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Benign neoplasm of skin † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Skin papilloma † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nervous system disorders                   
Headache † 1  16/200 (8.00%)  9/200 (4.50%)  8/200 (4.00%)  3/173 (1.73%)  8/171 (4.68%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Dizziness † 1  2/200 (1.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Syncope † 1  2/200 (1.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Migraine † 1  1/200 (0.50%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  2/158 (1.27%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Paraesthesia † 1  1/200 (0.50%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tension headache † 1  2/200 (1.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Ageusia † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Cerebrovascular accident † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dysgeusia † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Lethargy † 1  1/200 (0.50%)  0/200 (0.00%)  2/200 (1.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Sinus headache † 1  0/200 (0.00%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Tremor † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Neuralgia † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Restless legs syndrome † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Burning sensation † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Memory impairment † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Facial paralysis † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pregnancy, puerperium and perinatal conditions                   
Pregnancy † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Psychiatric disorders                   
Anxiety † 1  5/200 (2.50%)  2/200 (1.00%)  3/200 (1.50%)  2/173 (1.16%)  2/171 (1.17%)  1/158 (0.63%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Depression † 1  3/200 (1.50%)  4/200 (2.00%)  2/200 (1.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  1/20 (5.00%) 
Insomnia † 1  3/200 (1.50%)  0/200 (0.00%)  0/200 (0.00%)  2/173 (1.16%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Major depression † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Attention deficit hyperactivity disorder † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Renal and urinary disorders                   
Nephrolithiasis † 1  1/200 (0.50%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Haematuria † 1  0/200 (0.00%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hypertonic bladder † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Reproductive system and breast disorders                   
Breast pain † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Prostatomegaly † 1  0/200 (0.00%)  1/200 (0.50%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Postmenopausal haemorrhage † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Testicular cyst † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Benign prostatic hyperplasia † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Ovarian cyst † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Oropharyngeal pain † 1  7/200 (3.50%)  1/200 (0.50%)  4/200 (2.00%)  2/173 (1.16%)  3/171 (1.75%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Rhinorrhoea † 1  2/200 (1.00%)  3/200 (1.50%)  2/200 (1.00%)  1/173 (0.58%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Cough † 1  3/200 (1.50%)  0/200 (0.00%)  3/200 (1.50%)  1/173 (0.58%)  2/171 (1.17%)  4/158 (2.53%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nasal congestion † 1  3/200 (1.50%)  0/200 (0.00%)  1/200 (0.50%)  1/173 (0.58%)  3/171 (1.75%)  3/158 (1.90%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Rhinitis allergic † 1  1/200 (0.50%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dyspnoea † 1  1/200 (0.50%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nasal pruritus † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pharyngeal erythema † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Sneezing † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dry throat † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Sinus congestion † 1  0/200 (0.00%)  0/200 (0.00%)  2/200 (1.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Upper respiratory tract inflammation † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dyspnoea exertional † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pharyngeal inflammation † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Respiratory disorder † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Sleep apnoea syndrome † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Wheezing † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Respiratory tract congestion † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  2/158 (1.27%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Acute respiratory failure † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Oropharyngeal pain † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Upper respiratory tract congestion † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Asthma † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nasal polyps † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Nasal septum deviation † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders                   
Dermatitis contact † 1  5/200 (2.50%)  3/200 (1.50%)  3/200 (1.50%)  1/173 (0.58%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Rash † 1  4/200 (2.00%)  0/200 (0.00%)  2/200 (1.00%)  0/173 (0.00%)  1/171 (0.58%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Acne † 1  1/200 (0.50%)  1/200 (0.50%)  2/200 (1.00%)  1/173 (0.58%)  1/171 (0.58%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Pruritus † 1  1/200 (0.50%)  1/200 (0.50%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dermatitis † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Ecchymosis † 1  1/200 (0.50%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Erythema † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Skin discolouration † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Angioedema † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Hirsutism † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Rash papular † 1  0/200 (0.00%)  0/200 (0.00%)  1/200 (0.50%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Dermatitis exfoliative † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  1/173 (0.58%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Rash pruritic † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  2/158 (1.27%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Eczema † 1  0/200 (0.00%)  0/200 (0.00%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  1/158 (0.63%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vascular disorders                   
Hypertension † 1  5/200 (2.50%)  1/200 (0.50%)  0/200 (0.00%)  2/173 (1.16%)  0/171 (0.00%)  2/158 (1.27%)  0/20 (0.00%)  2/20 (10.00%)  2/20 (10.00%) 
Diastolic hypertension † 1  0/200 (0.00%)  1/200 (0.50%)  0/200 (0.00%)  0/173 (0.00%)  0/171 (0.00%)  0/158 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
1
Term from vocabulary, MedDRA version 23.0
†
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: Moderna Clinical Trials Support Center
Organization: ModernaTX, Inc.
Phone: 1-877-777-7187
EMail: clinicaltrials@modernatx.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04405076    
Other Study ID Numbers: mRNA-1273-P201
75A50120C00034 ( Other Grant/Funding Number: BARDA )
First Submitted: May 13, 2020
First Posted: May 28, 2020
Results First Submitted: October 21, 2022
Results First Posted: December 30, 2022
Last Update Posted: December 30, 2022