Trial Outcomes & Findings for Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults (NCT NCT04785144)
NCT ID: NCT04785144
Last Updated: 2024-03-18
Results Overview
Number of participants that experienced MAAEs during the course of the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
135 participants
Primary outcome timeframe
Day 1 to study completion, up to 1 year post last dose
Results posted on
2024-03-18
Participant Flow
Participants recruited for this study include males and non-pregnant females of 18 or more years of age, who were in good health, had no known history of COVID-19 or SARS-CoV-2 infection, and met all other eligibility criteria. Participants were recruited from the Phase 1 clinical trial (NCT04283461) and from the community surrounding the clinical sites. Enrollment occurred between 31MAR2021 and 27MAY2021.
Participant milestones
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from a Phase 1 clinical trial (NCT04283461).
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from a Phase 1 clinical trial (NCT04283461).
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
5
|
6
|
12
|
13
|
13
|
12
|
13
|
13
|
|
Overall Study
COMPLETED
|
20
|
22
|
5
|
6
|
11
|
9
|
9
|
10
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
0
|
0
|
1
|
4
|
4
|
2
|
5
|
3
|
Reasons for withdrawal
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from a Phase 1 clinical trial (NCT04283461).
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from a Phase 1 clinical trial (NCT04283461).
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
Participants were recruited from the community surrounding the clinical sites.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
0
|
0
|
0
|
2
|
2
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
4
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Unable to continue due to work schedule
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Participants in Arms 1A-B were recruited from a previous trial (NCT04283461) and were administered a booster dose in this trial. Thus, they had varying times between the previous trial dose and dose 1 administration. Arms 2A-H were naïve participants and had a set schedule between doses.
Baseline characteristics by cohort
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 Participants
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 19.0 • n=25 Participants
|
43.7 years
STANDARD_DEVIATION 17.0 • n=23 Participants
|
39.2 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 11.9 • n=6 Participants
|
39.1 years
STANDARD_DEVIATION 11.5 • n=12 Participants
|
35.8 years
STANDARD_DEVIATION 13.0 • n=13 Participants
|
32.7 years
STANDARD_DEVIATION 9.8 • n=13 Participants
|
36.1 years
STANDARD_DEVIATION 10.8 • n=12 Participants
|
34.9 years
STANDARD_DEVIATION 11.4 • n=13 Participants
|
36.7 years
STANDARD_DEVIATION 10.0 • n=13 Participants
|
39.2 years
STANDARD_DEVIATION 14.4 • n=135 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=25 Participants
|
12 Participants
n=23 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=12 Participants
|
5 Participants
n=13 Participants
|
6 Participants
n=13 Participants
|
8 Participants
n=12 Participants
|
6 Participants
n=13 Participants
|
6 Participants
n=13 Participants
|
63 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=25 Participants
|
11 Participants
n=23 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=12 Participants
|
8 Participants
n=13 Participants
|
7 Participants
n=13 Participants
|
4 Participants
n=12 Participants
|
7 Participants
n=13 Participants
|
7 Participants
n=13 Participants
|
72 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=25 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
9 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=25 Participants
|
22 Participants
n=23 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=12 Participants
|
12 Participants
n=13 Participants
|
11 Participants
n=13 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
125 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=135 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=25 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
6 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=25 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
19 Participants
n=135 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=25 Participants
|
22 Participants
n=23 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=12 Participants
|
11 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
9 Participants
n=12 Participants
|
10 Participants
n=13 Participants
|
10 Participants
n=13 Participants
|
105 Participants
n=135 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=135 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
23 participants
n=23 Participants
|
5 participants
n=5 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
13 participants
n=13 Participants
|
13 participants
n=13 Participants
|
12 participants
n=12 Participants
|
13 participants
n=13 Participants
|
13 participants
n=13 Participants
|
135 participants
n=135 Participants
|
|
Height
|
171.62 centimeters
STANDARD_DEVIATION 7.60 • n=25 Participants
|
172.70 centimeters
STANDARD_DEVIATION 11.39 • n=23 Participants
|
170.44 centimeters
STANDARD_DEVIATION 8.96 • n=5 Participants
|
175.10 centimeters
STANDARD_DEVIATION 10.27 • n=6 Participants
|
177.44 centimeters
STANDARD_DEVIATION 10.13 • n=12 Participants
|
175.30 centimeters
STANDARD_DEVIATION 13.25 • n=13 Participants
|
173.22 centimeters
STANDARD_DEVIATION 11.16 • n=13 Participants
|
169.83 centimeters
STANDARD_DEVIATION 10.44 • n=12 Participants
|
178.17 centimeters
STANDARD_DEVIATION 9.88 • n=13 Participants
|
175.08 centimeters
STANDARD_DEVIATION 8.14 • n=13 Participants
|
173.75 centimeters
STANDARD_DEVIATION 10.17 • n=135 Participants
|
|
Weight
|
73.68 kilograms
STANDARD_DEVIATION 13.68 • n=25 Participants
|
76.40 kilograms
STANDARD_DEVIATION 13.10 • n=23 Participants
|
78.44 kilograms
STANDARD_DEVIATION 19.60 • n=5 Participants
|
72.13 kilograms
STANDARD_DEVIATION 12.53 • n=6 Participants
|
81.43 kilograms
STANDARD_DEVIATION 17.92 • n=12 Participants
|
83.19 kilograms
STANDARD_DEVIATION 21.04 • n=13 Participants
|
74.53 kilograms
STANDARD_DEVIATION 21.89 • n=13 Participants
|
84.59 kilograms
STANDARD_DEVIATION 21.19 • n=12 Participants
|
87.53 kilograms
STANDARD_DEVIATION 17.54 • n=13 Participants
|
88.42 kilograms
STANDARD_DEVIATION 19.65 • n=13 Participants
|
79.66 kilograms
STANDARD_DEVIATION 17.82 • n=135 Participants
|
|
BMI
|
24.86 kg/m^2
STANDARD_DEVIATION 3.27 • n=25 Participants
|
25.53 kg/m^2
STANDARD_DEVIATION 3.12 • n=23 Participants
|
27.30 kg/m^2
STANDARD_DEVIATION 8.13 • n=5 Participants
|
23.47 kg/m^2
STANDARD_DEVIATION 2.97 • n=6 Participants
|
25.77 kg/m^2
STANDARD_DEVIATION 4.73 • n=12 Participants
|
26.76 kg/m^2
STANDARD_DEVIATION 4.56 • n=13 Participants
|
24.34 kg/m^2
STANDARD_DEVIATION 4.80 • n=13 Participants
|
29.09 kg/m^2
STANDARD_DEVIATION 5.78 • n=12 Participants
|
27.47 kg/m^2
STANDARD_DEVIATION 4.54 • n=13 Participants
|
28.85 kg/m^2
STANDARD_DEVIATION 6.28 • n=13 Participants
|
26.23 kg/m^2
STANDARD_DEVIATION 4.74 • n=135 Participants
|
|
Time Between Previous Trial Dose and Dose 1
|
321.4 Days
STANDARD_DEVIATION 24.8 • n=25 Participants • Participants in Arms 1A-B were recruited from a previous trial (NCT04283461) and were administered a booster dose in this trial. Thus, they had varying times between the previous trial dose and dose 1 administration. Arms 2A-H were naïve participants and had a set schedule between doses.
|
319.4 Days
STANDARD_DEVIATION 25.7 • n=23 Participants • Participants in Arms 1A-B were recruited from a previous trial (NCT04283461) and were administered a booster dose in this trial. Thus, they had varying times between the previous trial dose and dose 1 administration. Arms 2A-H were naïve participants and had a set schedule between doses.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
320.5 Days
STANDARD_DEVIATION 25.0 • n=48 Participants • Participants in Arms 1A-B were recruited from a previous trial (NCT04283461) and were administered a booster dose in this trial. Thus, they had varying times between the previous trial dose and dose 1 administration. Arms 2A-H were naïve participants and had a set schedule between doses.
|
PRIMARY outcome
Timeframe: Day 1 to study completion, up to 1 year post last dosePopulation: The Safety Analysis Population includes all participants who received one dose of vaccine.
Number of participants that experienced MAAEs during the course of the study.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 Participants
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Medically-attended Adverse Events (MAAEs)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to study completion, up to 1 year post last dosePopulation: The Safety Analysis Population includes all participants who received one dose of vaccine.
Number of participants that experienced any NOCMCs during the course of the study.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 Participants
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to study completion, up to 1 year post last dosePopulation: The Safety Analysis Population includes all participants who received one dose of vaccine.
Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem inflammatory disorders, thrombocytopenia, acute aseptic arthritis, new onset of or worsening of neurologic disease, anaphylaxis, and other syndromes.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 Participants
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to study completion, up to 1 year post last dosePopulation: The Safety Analysis Population includes all participants who received one dose of vaccine.
The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 Participants
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2BPopulation: The Safety Analysis Population includes all participants who received one dose of vaccine.
The number of participants that experienced at least one solicited (local and systemic) AE through 7 days post vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 Participants
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Solicited Reactogenicity Adverse Events (AEs)
Local Events
|
24 Participants
|
20 Participants
|
5 Participants
|
6 Participants
|
10 Participants
|
12 Participants
|
13 Participants
|
11 Participants
|
12 Participants
|
13 Participants
|
|
Frequency of Solicited Reactogenicity Adverse Events (AEs)
Systemic Events
|
22 Participants
|
20 Participants
|
5 Participants
|
6 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, Day 57-64 for Arms 2A-2BPopulation: The Safety Analysis Population includes all participants who received one dose of vaccine.
Number of participants who experienced any solicited (local and systemic) AEs through 7 days post vaccination by grade. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever. Local events include: pain at injection site, erythema, and induration.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 Participants
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
None
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Mild
|
4 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Moderate
|
18 Participants
|
13 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
|
Grade of Solicited Reactogenicity Adverse Events (AEs)
Severe
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2BPopulation: The Safety Analysis population includes all participants who received one dose of vaccine.
Number of events of any unsolicited AE through 28 days post vaccination by relationship to study product and severity, experienced by participants in the Safety Analysis population. Unsolicited AEs were events that were spontaneously reported by the subject, or revealed by observation, physical examination or other diagnostic procedures.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 Participants
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product
Not Related
|
10 Events
|
11 Events
|
4 Events
|
5 Events
|
6 Events
|
0 Events
|
3 Events
|
6 Events
|
7 Events
|
8 Events
|
|
Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product
Related
|
12 Events
|
3 Events
|
3 Events
|
1 Events
|
5 Events
|
16 Events
|
4 Events
|
2 Events
|
13 Events
|
10 Events
|
PRIMARY outcome
Timeframe: Day 1 through Day 29 for Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, Day 57 through Day 85 from Arms 2A-2BPopulation: The Safety Analysis Population includes all participants who received one dose of vaccine.
Number of any unsolicited AEs through 28 days post vaccination by severity.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 Participants
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Grade of Any Unsolicited Adverse Events (AEs)
Mild
|
14 Events
|
7 Events
|
4 Events
|
4 Events
|
9 Events
|
11 Events
|
4 Events
|
4 Events
|
15 Events
|
5 Events
|
|
Grade of Any Unsolicited Adverse Events (AEs)
Moderate
|
6 Events
|
6 Events
|
3 Events
|
2 Events
|
1 Events
|
5 Events
|
3 Events
|
3 Events
|
5 Events
|
10 Events
|
|
Grade of Any Unsolicited Adverse Events (AEs)
Severe
|
2 Events
|
1 Events
|
0 Events
|
0 Events
|
1 Events
|
0 Events
|
0 Events
|
1 Events
|
0 Events
|
3 Events
|
SECONDARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B
Day 1, Pre-Booster Dose
|
40555.5 Titer
Interval 29458.3 to 55833.2
|
35988.3 Titer
Interval 28423.6 to 45566.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B
Day 15
|
1065642.8 Titer
Interval 831651.5 to 1365469.3
|
993561.1 Titer
Interval 808666.6 to 1220730.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B
Day 29
|
1276347.8 Titer
Interval 996652.8 to 1634534.8
|
1169728.7 Titer
Interval 935192.8 to 1463083.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B
Day 91
|
660179.8 Titer
Interval 482539.5 to 903216.0
|
623572.3 Titer
Interval 476570.8 to 815917.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B
Day 181
|
335476.6 Titer
Interval 225669.7 to 498713.5
|
320314.1 Titer
Interval 236469.5 to 433887.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 1A and 1B
Day 366
|
287835.1 Titer
Interval 175517.5 to 472027.2
|
268030.8 Titer
Interval 165874.5 to 433101.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=5 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=6 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 1, Pre-Dose
|
1687.1 Titer
Interval 7.1 to 399625.2
|
601.5 Titer
Interval 35.0 to 10335.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 15
|
408309.5 Titer
Interval 42298.5 to 3941435.8
|
103325.5 Titer
Interval 15879.5 to 672322.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 29
|
348738.5 Titer
Interval 58387.7 to 2082947.7
|
85622.2 Titer
Interval 15912.6 to 460715.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 43
|
1028488.1 Titer
Interval 427257.0 to 2475764.6
|
622864.8 Titer
Interval 369077.3 to 1051163.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 57
|
689051.1 Titer
Interval 311987.0 to 1521830.7
|
440293.4 Titer
Interval 252560.9 to 767570.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 71
|
687273.1 Titer
Interval 354218.2 to 1333484.0
|
485649.5 Titer
Interval 319892.3 to 737296.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 85
|
565917.9 Titer
Interval 329154.7 to 972986.3
|
373198.2 Titer
Interval 263014.4 to 529540.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 147
|
254433.8 Titer
Interval 141392.1 to 457851.2
|
144121.2 Titer
Interval 102293.2 to 203052.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 237
|
66652.9 Titer
Interval 32372.9 to 137232.1
|
37379.9 Titer
Interval 26884.8 to 51972.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2A and 2B
Day 422
|
86226.1 Titer
Interval 13571.1 to 547849.5
|
254786.0 Titer
Interval 67095.1 to 967520.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric mean titer (GMT) of antibody against WA-1 S2-P using a 4-plex ECLIA Assay
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=12 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Day 1, Pre-Dose
|
271.4 Titer
Interval 56.6 to 1301.5
|
92.3 Titer
Interval 44.2 to 193.1
|
346.7 Titer
Interval 106.4 to 1129.4
|
645.6 Titer
Interval 131.8 to 3162.9
|
159.8 Titer
Interval 66.1 to 386.6
|
192.7 Titer
Interval 85.3 to 435.2
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Day 15
|
30368.1 Titer
Interval 12103.4 to 76194.9
|
21710.7 Titer
Interval 8990.4 to 52429.1
|
156640.9 Titer
Interval 49419.1 to 496495.6
|
91564.4 Titer
Interval 23858.3 to 351410.3
|
67811.1 Titer
Interval 33999.0 to 135249.3
|
62111.1 Titer
Interval 21508.0 to 179365.2
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Day 29
|
28662.2 Titer
Interval 12663.2 to 64874.5
|
25301.5 Titer
Interval 11770.7 to 54386.3
|
125557.3 Titer
Interval 43644.1 to 361209.1
|
118461.4 Titer
Interval 42867.4 to 327360.8
|
63247.3 Titer
Interval 30848.1 to 129674.8
|
73048.1 Titer
Interval 31225.8 to 170885.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Day 43
|
225186.6 Titer
Interval 179455.3 to 282571.7
|
258723.7 Titer
Interval 177985.0 to 376087.6
|
550894.5 Titer
Interval 307970.4 to 985435.0
|
427940.0 Titer
Interval 296902.0 to 616811.9
|
433732.7 Titer
Interval 321427.9 to 585275.9
|
313325.4 Titer
Interval 142344.2 to 689686.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Day 57
|
171256.0 Titer
Interval 129663.6 to 226190.2
|
184762.6 Titer
Interval 131348.8 to 259897.5
|
380485.7 Titer
Interval 199113.7 to 727069.0
|
320340.2 Titer
Interval 213401.9 to 480866.6
|
301884.2 Titer
Interval 214565.4 to 424738.1
|
321259.8 Titer
Interval 233943.1 to 441166.4
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Day 119
|
78575.3 Titer
Interval 57452.9 to 107463.4
|
86821.0 Titer
Interval 62315.8 to 120962.7
|
176619.9 Titer
Interval 91660.5 to 340327.6
|
142765.3 Titer
Interval 79953.4 to 254922.7
|
142664.0 Titer
Interval 86638.7 to 234918.3
|
134238.4 Titer
Interval 99246.4 to 181567.8
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Day 209
|
33582.4 Titer
Interval 20553.9 to 54869.3
|
32839.3 Titer
Interval 24068.6 to 44806.1
|
71377.9 Titer
Interval 38729.6 to 131548.1
|
43724.8 Titer
Interval 26058.5 to 73367.7
|
44229.8 Titer
Interval 22017.3 to 88851.7
|
40884.3 Titer
Interval 26065.6 to 64127.4
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against WA-1 S2-P for Arms 2C-H
Day 394
|
234021.1 Titer
Interval 118055.7 to 463898.6
|
77061.1 Titer
Interval 19964.5 to 297449.5
|
399456.3 Titer
Interval 136582.2 to 1168273.1
|
218022.7 Titer
Interval 129671.7 to 366571.2
|
347444.1 Titer
Interval 124288.7 to 971266.2
|
499494.9 Titer
Interval 217234.3 to 1148507.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B
Day 1, Pre-Booster Dose
|
16714.5 Titer
Interval 12487.0 to 22373.1
|
14513.9 Titer
Interval 11417.0 to 18451.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B
Day 15
|
598971.7 Titer
Interval 463182.5 to 774569.7
|
465312.9 Titer
Interval 377354.5 to 573773.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B
Day 29
|
633384.7 Titer
Interval 495342.5 to 809896.5
|
495722.6 Titer
Interval 399293.1 to 615439.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B
Day 91
|
334468.3 Titer
Interval 248187.1 to 450744.8
|
279134.2 Titer
Interval 214470.3 to 363294.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B
Day 181
|
158501.6 Titer
Interval 109437.9 to 229561.9
|
136205.1 Titer
Interval 100841.4 to 183970.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 1A and 1B
Day 366
|
131964.9 Titer
Interval 82509.5 to 211063.5
|
119198.6 Titer
Interval 73758.3 to 192633.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=5 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=6 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 1, Pre-Dose
|
733.5 Titer
Interval 2.4 to 225877.7
|
328.9 Titer
Interval 22.3 to 4844.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 15
|
244620.3 Titer
Interval 19555.8 to 3059912.2
|
54497.0 Titer
Interval 8122.1 to 365658.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 29
|
192969.1 Titer
Interval 27809.7 to 1338997.0
|
39611.5 Titer
Interval 6922.0 to 226679.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 43
|
402295.2 Titer
Interval 143809.2 to 1125389.9
|
195404.8 Titer
Interval 103020.2 to 370636.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 57
|
277548.7 Titer
Interval 108735.7 to 708445.2
|
142696.8 Titer
Interval 72199.7 to 282028.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 71
|
310800.9 Titer
Interval 148772.2 to 649295.8
|
192337.7 Titer
Interval 117452.4 to 314968.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 85
|
264416.1 Titer
Interval 141960.4 to 492502.6
|
152131.5 Titer
Interval 102734.3 to 225280.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 147
|
115520.5 Titer
Interval 54985.1 to 242702.0
|
56873.6 Titer
Interval 41022.8 to 78849.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 237
|
37901.7 Titer
Interval 14721.7 to 97579.8
|
17270.3 Titer
Interval 13122.3 to 22729.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2A and 2B
Day 422
|
46726.0 Titer
Interval 8400.5 to 259904.3
|
113969.3 Titer
Interval 32167.4 to 403794.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Dose, Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P using a 4-plex ECLIA Assay.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=12 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Day 1, Pre-Dose
|
197.8 Titer
Interval 46.2 to 846.0
|
47.3 Titer
Interval 15.8 to 141.8
|
229.3 Titer
Interval 71.9 to 731.7
|
267.5 Titer
Interval 51.9 to 1377.8
|
63.8 Titer
Interval 20.3 to 200.6
|
104.4 Titer
Interval 39.9 to 273.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Day 15
|
26421.7 Titer
Interval 10770.1 to 64818.6
|
19904.5 Titer
Interval 7952.6 to 49819.2
|
96043.2 Titer
Interval 34594.5 to 266641.0
|
37894.4 Titer
Interval 9601.4 to 149559.6
|
44484.5 Titer
Interval 21394.3 to 92495.4
|
44725.5 Titer
Interval 15959.5 to 125340.2
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Day 29
|
26830.7 Titer
Interval 12625.6 to 57018.0
|
23453.5 Titer
Interval 10893.1 to 50496.9
|
70695.1 Titer
Interval 27514.5 to 181641.9
|
45830.5 Titer
Interval 15820.3 to 132768.7
|
42977.0 Titer
Interval 20315.3 to 90917.8
|
50232.1 Titer
Interval 21540.3 to 117141.6
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Day 43
|
307328.7 Titer
Interval 254174.5 to 371598.7
|
344899.3 Titer
Interval 246574.6 to 482432.3
|
291453.2 Titer
Interval 162217.6 to 523648.3
|
212624.2 Titer
Interval 139205.5 to 324764.6
|
357231.6 Titer
Interval 267417.1 to 477211.1
|
255274.4 Titer
Interval 113042.9 to 576462.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Day 57
|
224236.3 Titer
Interval 186925.2 to 268994.9
|
251732.7 Titer
Interval 188930.7 to 335410.6
|
209943.5 Titer
Interval 113481.0 to 388402.1
|
161775.1 Titer
Interval 100793.2 to 259652.2
|
252862.2 Titer
Interval 186024.0 to 343715.4
|
257459.9 Titer
Interval 193904.8 to 341846.2
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Day 119
|
107644.5 Titer
Interval 85403.5 to 135677.5
|
127871.2 Titer
Interval 95537.2 to 171148.3
|
105382.0 Titer
Interval 55465.4 to 200221.5
|
80663.9 Titer
Interval 44544.0 to 146072.8
|
115540.1 Titer
Interval 74664.1 to 178794.3
|
104319.3 Titer
Interval 76850.4 to 141606.4
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Day 209
|
53366.1 Titer
Interval 35371.4 to 80515.3
|
51958.2 Titer
Interval 38148.2 to 70767.3
|
47486.8 Titer
Interval 27079.6 to 83272.9
|
28167.4 Titer
Interval 17107.2 to 46378.1
|
39447.9 Titer
Interval 21334.5 to 72940.0
|
32817.3 Titer
Interval 21453.7 to 50200.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Antibody Against B.1.351 S2-P for Arms 2C-H
Day 394
|
208767.5 Titer
Interval 104731.8 to 416147.6
|
83893.8 Titer
Interval 26424.9 to 266345.4
|
259147.4 Titer
Interval 92939.4 to 722593.2
|
135964.4 Titer
Interval 76772.8 to 240792.7
|
266166.9 Titer
Interval 98556.9 to 718821.7
|
331123.7 Titer
Interval 148034.1 to 740659.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 366Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1B
Day 15
|
25 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1B
Day 29
|
25 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1B
Day 91
|
24 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1B
Day 181
|
19 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 1A and 1B
Day 366
|
16 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=5 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=6 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Day 15
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Day 29
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Day 43
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Day 57
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Day 71
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Day 85
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Day 147
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Day 237
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2A and 2B
Day 422
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=12 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H
Day 15
|
11 Participants
|
13 Participants
|
13 Participants
|
12 Participants
|
13 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H
Day 29
|
11 Participants
|
13 Participants
|
13 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H
Day 43
|
11 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H
Day 57
|
11 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H
Day 119
|
11 Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H
Day 209
|
11 Participants
|
12 Participants
|
12 Participants
|
9 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against WA-1 S2-P for Arms 2C-H
Day 394
|
11 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 366Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1B
Day 15
|
25 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1B
Day 29
|
25 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1B
Day 91
|
25 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1B
Day 181
|
20 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 1A and 1B
Day 366
|
18 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 147, Day 237, Day 422Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=5 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=6 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Day 15
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Day 29
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Day 43
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Day 57
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Day 71
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Day 85
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Day 147
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Day 237
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2A and 2B
Day 422
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=12 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H
Day 15
|
11 Participants
|
13 Participants
|
13 Participants
|
12 Participants
|
13 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H
Day 29
|
11 Participants
|
13 Participants
|
13 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H
Day 43
|
11 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H
Day 57
|
11 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H
Day 119
|
11 Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H
Day 209
|
11 Participants
|
12 Participants
|
12 Participants
|
9 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 S2-P for Arms 2C-H
Day 394
|
11 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B
Day 1, Pre-Booster Dose
|
127.0 Titer
Interval 96.1 to 167.8
|
114.9 Titer
Interval 87.9 to 150.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B
Day 15
|
2111.4 Titer
Interval 1615.0 to 2760.3
|
2460.4 Titer
Interval 1952.2 to 3100.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B
Day 29
|
2544.6 Titer
Interval 1872.3 to 3458.3
|
2829.8 Titer
Interval 2112.4 to 3790.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B
Day 91
|
3175.5 Titer
Interval 2124.4 to 4746.6
|
3572.8 Titer
Interval 2668.0 to 4784.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B
Day 181
|
1623.6 Titer
Interval 1045.0 to 2522.6
|
1794.5 Titer
Interval 1198.6 to 2686.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 1A and 1B
Day 366
|
749.6 Titer
Interval 422.1 to 1331.1
|
653.8 Titer
Interval 308.4 to 1386.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=5 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=6 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B
Day 1, Pre-Dose
|
37.2 Titer
Interval 4.3 to 318.7
|
9.4 Titer
Interval 4.0 to 21.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B
Day 29
|
1587.5 Titer
Interval 72.4 to 34798.3
|
135.5 Titer
Interval 15.9 to 1156.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B
Day 57
|
3759.4 Titer
Interval 1566.5 to 9022.1
|
2600.2 Titer
Interval 1296.4 to 5215.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B
Day 85
|
3046.9 Titer
Interval 1732.8 to 5357.7
|
1875.4 Titer
Interval 776.3 to 4530.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B
Day 147
|
1855.5 Titer
Interval 931.1 to 3697.7
|
705.8 Titer
Interval 377.1 to 1320.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B
Day 237
|
484.8 Titer
Interval 200.0 to 1175.2
|
120.9 Titer
Interval 62.8 to 232.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2A and 2B
Day 422
|
604.0 Titer
Interval 77.6 to 4700.2
|
1372.1 Titer
Interval 313.1 to 6012.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=12 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H
Day 119
|
178.6 Titer
Interval 86.1 to 370.7
|
147.6 Titer
Interval 82.3 to 264.5
|
1042.3 Titer
Interval 486.4 to 2233.8
|
476.1 Titer
Interval 182.6 to 1241.3
|
749.9 Titer
Interval 326.4 to 1722.8
|
938.9 Titer
Interval 393.3 to 2241.4
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H
Day 1, Pre-Dose
|
10.8 Titer
Interval 3.2 to 36.5
|
5.3 Titer
Interval 4.6 to 6.2
|
12.5 Titer
Interval 5.9 to 26.6
|
12.1 Titer
Interval 5.3 to 27.5
|
6.8 Titer
Interval 4.6 to 9.9
|
12.7 Titer
Interval 3.5 to 46.4
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H
Day 29
|
24.1 Titer
Interval 6.5 to 89.8
|
16.0 Titer
Interval 5.3 to 48.0
|
357.3 Titer
Interval 93.1 to 1372.0
|
366.9 Titer
Interval 88.2 to 1525.8
|
89.9 Titer
Interval 29.0 to 278.5
|
102.7 Titer
Interval 21.2 to 497.4
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H
Day 43
|
316.9 Titer
Interval 161.2 to 622.9
|
—
|
—
|
—
|
1926.4 Titer
Interval 1099.7 to 3374.6
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H
Day 57
|
280.8 Titer
Interval 141.1 to 558.6
|
313.6 Titer
Interval 162.7 to 604.4
|
1914.4 Titer
Interval 895.5 to 4092.3
|
939.9 Titer
Interval 395.9 to 2231.7
|
1316.6 Titer
Interval 725.9 to 2388.1
|
2017.1 Titer
Interval 939.4 to 4331.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H
Day 209
|
113.1 Titer
Interval 56.0 to 228.6
|
85.2 Titer
Interval 51.6 to 140.8
|
497.5 Titer
Interval 222.9 to 1110.1
|
183.2 Titer
Interval 63.7 to 527.4
|
272.2 Titer
Interval 98.9 to 749.0
|
315.0 Titer
Interval 114.8 to 863.8
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G for Arms 2C-H
Day 394
|
863.1 Titer
Interval 354.7 to 2100.3
|
179.8 Titer
Interval 33.8 to 957.8
|
1793.5 Titer
Interval 670.6 to 4796.8
|
1091.6 Titer
Interval 605.4 to 1968.1
|
2265.8 Titer
Interval 480.4 to 10686.0
|
2958.7 Titer
Interval 1677.1 to 5219.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 366Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B
Day 1, Pre-Booster Dose
|
23.2 Titer
Interval 16.4 to 32.6
|
24.2 Titer
Interval 17.3 to 33.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B
Day 15
|
1100.1 Titer
Interval 867.3 to 1395.5
|
864.6 Titer
Interval 665.9 to 1122.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B
Day 29
|
1773.8 Titer
Interval 1306.2 to 2408.8
|
1326.1 Titer
Interval 916.0 to 1919.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B
Day 91
|
1150.2 Titer
Interval 761.5 to 1737.5
|
792.8 Titer
Interval 537.9 to 1168.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B
Day 181
|
482.0 Titer
Interval 295.0 to 787.5
|
367.7 Titer
Interval 220.7 to 612.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 1A and 1B
Day 366
|
291.8 Titer
Interval 149.2 to 570.4
|
301.0 Titer
Interval 163.3 to 554.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 422Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=5 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=6 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Day 1, Pre-Dose
|
12.1 Titer
Interval 4.1 to 35.7
|
5.8 Titer
Interval 4.0 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Day 29
|
129.9 Titer
Interval 5.5 to 3085.5
|
18.0 Titer
Interval 2.5 to 130.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Day 57
|
518.4 Titer
Interval 147.9 to 1817.0
|
163.9 Titer
Interval 58.9 to 456.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Day 85
|
670.9 Titer
Interval 321.2 to 1401.5
|
298.6 Titer
Interval 135.7 to 657.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Day 147
|
298.3 Titer
Interval 144.1 to 617.7
|
105.5 Titer
Interval 63.2 to 176.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Day 237
|
106.3 Titer
Interval 32.2 to 351.0
|
30.6 Titer
Interval 24.6 to 38.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2A and 2B
Day 422
|
275.5 Titer
Interval 28.6 to 2650.4
|
382.2 Titer
Interval 51.3 to 2847.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Dose, Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=12 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
Day 1, Pre-Dose
|
10.1 Titer
Interval 3.4 to 30.3
|
6.3 Titer
Interval 4.7 to 8.4
|
7.7 Titer
Interval 5.4 to 10.9
|
7.4 Titer
Interval 5.0 to 10.9
|
7.0 Titer
Interval 5.1 to 9.7
|
14.5 Titer
Interval 3.8 to 55.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
Day 29
|
40.7 Titer
Interval 12.7 to 130.2
|
25.4 Titer
Interval 10.2 to 63.2
|
51.9 Titer
Interval 12.5 to 215.2
|
44.9 Titer
Interval 10.1 to 200.1
|
51.6 Titer
Interval 19.1 to 139.0
|
132.5 Titer
Interval 31.0 to 567.6
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
Day 43
|
1711.4 Titer
Interval 1031.9 to 2838.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
Day 57
|
918.5 Titer
Interval 612.6 to 1377.3
|
916.8 Titer
Interval 654.0 to 1285.3
|
589.8 Titer
Interval 284.7 to 1222.0
|
338.3 Titer
Interval 145.5 to 786.5
|
946.7 Titer
Interval 541.2 to 1656.2
|
1435.4 Titer
Interval 651.7 to 3161.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
Day 119
|
386.2 Titer
Interval 277.7 to 537.1
|
404.5 Titer
Interval 277.7 to 589.1
|
348.9 Titer
Interval 168.7 to 721.9
|
214.7 Titer
Interval 83.5 to 551.8
|
479.0 Titer
Interval 188.3 to 1218.1
|
643.1 Titer
Interval 274.5 to 1506.7
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
Day 209
|
164.0 Titer
Interval 84.2 to 319.6
|
138.4 Titer
Interval 84.4 to 226.9
|
137.9 Titer
Interval 65.3 to 291.5
|
75.4 Titer
Interval 30.4 to 186.9
|
133.1 Titer
Interval 55.0 to 322.0
|
170.6 Titer
Interval 50.5 to 576.2
|
—
|
—
|
—
|
—
|
|
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 for Arms 2C-H
Day 394
|
1281.6 Titer
Interval 449.8 to 3651.4
|
341.1 Titer
Interval 72.2 to 1611.8
|
1006.9 Titer
Interval 359.8 to 2818.0
|
671.1 Titer
Interval 286.9 to 1569.9
|
1609.1 Titer
Interval 276.9 to 9349.4
|
2349.3 Titer
Interval 1024.0 to 5389.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 366Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against D614G for Arms 1A and 1B
Day 15
|
24 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 1A and 1B
Day 29
|
24 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 1A and 1B
Day 91
|
25 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 1A and 1B
Day 181
|
19 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 1A and 1B
Day 366
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29, Day 57, Day 85, Day 147, Day 237, Day 422Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=5 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=6 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against D614G for Arms 2A and 2B
Day 29
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2A and 2B
Day 57
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2A and 2B
Day 85
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2A and 2B
Day 147
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2A and 2B
Day 237
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2A and 2B
Day 422
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=12 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against D614G for Arms 2C-H
Day 29
|
3 Participants
|
3 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2C-H
Day 43
|
10 Participants
|
—
|
—
|
—
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2C-H
Day 57
|
11 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2C-H
Day 119
|
11 Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2C-H
Day 209
|
10 Participants
|
11 Participants
|
11 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against D614G for Arms 2C-H
Day 394
|
11 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 366Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1B
Day 15
|
25 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1B
Day 29
|
25 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1B
Day 91
|
25 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1B
Day 181
|
22 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 1A and 1B
Day 366
|
18 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29, Day 57, Day 85, Day 147, Day 237, Day 422Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=5 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=6 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2B
Day 29
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2B
Day 57
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2B
Day 85
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2B
Day 147
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2B
Day 237
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2A and 2B
Day 422
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29, Day 43, Day 57, Day 119, Day 209, Day 394Population: The modified intent-to-treat (mITT) population includes all participants who received one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported.
Number of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351. Arms 2C and 2G Day 43 samples were used for pseudovirus neutralization assay validation and results included for completeness. Samples for other vaccination groups at Day 43 were not tested for neutralization.
Outcome measures
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=12 Participants
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 Participants
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=13 Participants
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=12 Participants
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-H
Day 29
|
4 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-H
Day 43
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-H
Day 57
|
11 Participants
|
12 Participants
|
12 Participants
|
9 Participants
|
12 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-H
Day 119
|
11 Participants
|
12 Participants
|
11 Participants
|
9 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-H
Day 209
|
11 Participants
|
12 Participants
|
11 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Seroconverted Against B.1.351 for Arms 2C-H
Day 394
|
11 Participants
|
8 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Arm 1A: 50 mcg of mRNA-1273.351
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 participants at risk
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 participants at risk
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 participants at risk
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 participants at risk
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 participants at risk
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 participants at risk
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 participants at risk
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 participants at risk
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 participants at risk
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 participants at risk
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Paresthesia of upper extremity
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
4.3%
1/23 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
Other adverse events
| Measure |
Arm 1A: 50 mcg of mRNA-1273.351
n=25 participants at risk
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 1B: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=23 participants at risk
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273.
|
Arm 2A: 100 mcg mRNA-1273/100 mcg mRNA-1273/50 mcg mRNA-1273.351
n=5 participants at risk
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2B: 50 mcg mRNA-1273/50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=6 participants at risk
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57.
|
Arm 2C: 100 mcg mRNA-1273.351/100 mcg mRNA-1273.351
n=12 participants at risk
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2D: 50 mcg mRNA-1273.351/50 mcg mRNA-1273.351
n=13 participants at risk
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2E: 100 mcg mRNA-1273/100 mcg mRNA-1273.351
n=13 participants at risk
100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2F: 50 mcg mRNA-1273/50 mcg mRNA-1273.351
n=12 participants at risk
50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29.
|
Arm 2G: 50 mcg mRNA-1273 + 50 mcg mRNA-1273.351/50 mcg mRNA-1273 + 50 mcg mRNA-1273.351
n=13 participants at risk
50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
Arm 2H: 25 mcg mRNA-1273 + 25 mcg mRNA-1273.351/25 mcg mRNA-1273 + 25 mcg mRNA-1273.351
n=13 participants at risk
25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.0%
1/25 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
4.3%
1/23 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
15.4%
2/13 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Cardiac disorders
Athletic heart syndrome
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
33.3%
2/6 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
4.3%
1/23 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
1/5 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Gastrointestinal disorders
Nausea
|
24.0%
6/25 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
39.1%
9/23 • Number of events 9 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
2/5 • Number of events 3 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
1/6 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
50.0%
6/12 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
15.4%
2/13 • Number of events 3 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
38.5%
5/13 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
25.0%
3/12 • Number of events 3 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
38.5%
5/13 • Number of events 7 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.8%
4/13 • Number of events 5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Chest discomfort
|
4.0%
1/25 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Fatigue
|
88.0%
22/25 • Number of events 22 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
82.6%
19/23 • Number of events 19 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
100.0%
5/5 • Number of events 11 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
83.3%
5/6 • Number of events 8 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
75.0%
9/12 • Number of events 14 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
84.6%
11/13 • Number of events 19 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
92.3%
12/13 • Number of events 20 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
75.0%
9/12 • Number of events 15 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
76.9%
10/13 • Number of events 14 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
84.6%
11/13 • Number of events 17 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Injection site bruising
|
8.0%
2/25 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
1/6 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Injection site erythema
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Peripheral swelling
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Supraclavicular fossa pain
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Swelling
|
4.0%
1/25 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Vaccination site pain
|
96.0%
24/25 • Number of events 24 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
87.0%
20/23 • Number of events 20 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
100.0%
5/5 • Number of events 12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
100.0%
6/6 • Number of events 17 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
83.3%
10/12 • Number of events 18 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
92.3%
12/13 • Number of events 23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
100.0%
13/13 • Number of events 22 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
91.7%
11/12 • Number of events 20 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
92.3%
12/13 • Number of events 22 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
100.0%
13/13 • Number of events 22 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
COVID-19
|
8.0%
2/25 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
17.4%
4/23 • Number of events 4 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
1/6 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
15.4%
2/13 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
1/5 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
1/5 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
48.0%
12/25 • Number of events 12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
26.1%
6/23 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
80.0%
4/5 • Number of events 8 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
33.3%
2/6 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
41.7%
5/12 • Number of events 5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
53.8%
7/13 • Number of events 8 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
38.5%
5/13 • Number of events 7 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
2/12 • Number of events 3 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.8%
4/13 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
15.4%
2/13 • Number of events 3 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
1/6 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
68.0%
17/25 • Number of events 17 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
87.0%
20/23 • Number of events 20 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
80.0%
4/5 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
83.3%
5/6 • Number of events 8 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
66.7%
8/12 • Number of events 9 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
76.9%
10/13 • Number of events 13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
69.2%
9/13 • Number of events 14 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
66.7%
8/12 • Number of events 11 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
76.9%
10/13 • Number of events 14 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
61.5%
8/13 • Number of events 10 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
1/5 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
1/6 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Nervous system disorders
Headache
|
76.0%
19/25 • Number of events 19 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
52.2%
12/23 • Number of events 12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
60.0%
3/5 • Number of events 7 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
83.3%
5/6 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
83.3%
10/12 • Number of events 12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
69.2%
9/13 • Number of events 13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
84.6%
11/13 • Number of events 18 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
58.3%
7/12 • Number of events 9 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
69.2%
9/13 • Number of events 15 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
69.2%
9/13 • Number of events 13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
4.3%
1/23 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Psychiatric disorders
Depression
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
1/5 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
1/5 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
1/5 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/25 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/23 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/13 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Chills
|
68.0%
17/25 • Number of events 17 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
43.5%
10/23 • Number of events 10 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
80.0%
4/5 • Number of events 7 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
83.3%
5/6 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
58.3%
7/12 • Number of events 9 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.8%
4/13 • Number of events 4 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
46.2%
6/13 • Number of events 11 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
33.3%
4/12 • Number of events 5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
61.5%
8/13 • Number of events 9 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
46.2%
6/13 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Pyrexia
|
24.0%
6/25 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
21.7%
5/23 • Number of events 5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
60.0%
3/5 • Number of events 4 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
1/6 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
33.3%
4/12 • Number of events 5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
7.7%
1/13 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
23.1%
3/13 • Number of events 3 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/12 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
15.4%
2/13 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
15.4%
2/13 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Vaccination site erythema
|
8.0%
2/25 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
17.4%
4/23 • Number of events 4 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
20.0%
1/5 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
1/6 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
2/12 • Number of events 3 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
23.1%
3/13 • Number of events 4 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
15.4%
2/13 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
2/12 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
30.8%
4/13 • Number of events 5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
23.1%
3/13 • Number of events 3 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
|
General disorders
Vaccination site induration
|
20.0%
5/25 • Number of events 5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.7%
2/23 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
40.0%
2/5 • Number of events 5 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
0.00%
0/6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
16.7%
2/12 • Number of events 4 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
15.4%
2/13 • Number of events 2 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
23.1%
3/13 • Number of events 3 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
8.3%
1/12 • Number of events 1 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
46.2%
6/13 • Number of events 6 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
38.5%
5/13 • Number of events 7 • Solicited (local and systemic) AEs were collected from Day 1 through Day 7 for Arms 1A-2H, Day 29 through Day 36 for Arms 2A-2H, and Day 57-64 for Arms 2A-2B. Unsolicited AEs were collected from Day 1 through Day 29 from Arms 1A-2H, Day 29 through Day 57 for Arms 2A-2H, and Day 57 through Day 85 for Arms 2A-2B. SAEs, MAAEs, and NOCMCs were collected from Day 1 through Day 366 for Arms 1A and 1B, Day 1 to Day 422 for Arms 2A and 2B, and Day 1 to Day 394 for Arms 2C-2H.
Systemic AEs include headache, fatigue, myalgia, arthralgia, nausea, fever, and chills. Local events include injection site pain, injection site erythema, injection site edema/induration. Unsolicited AEs were all AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60